Table of Contents Title 46 PROFESSIONAL AND ..., Summaries of Pharmacy

Download Table of Contents Title 46 PROFESSIONAL AND ... and more Summaries Pharmacy in PDF only on Docsity! Table of Contents Title 46 PROFESSIONAL AND OCCUPATIONAL STANDARDS Part LIII. Pharmacists Chapter 1. Introduction ............................................................................................................................ 1 §101. Preamble .................................................................................................................................. 1 §103. Pharmacy Board Organization ................................................................................................ 1 §105. Board Procedures ..................................................................................................................... 1 §107. Board Committees and Subcommittees ................................................................................... 2 §109. Standing Board Committees .................................................................................................... 2 §111. Official Journal ........................................................................................................................ 2 §113. Rulemaking Procedures ........................................................................................................... 2 §115. Fees .......................................................................................................................................... 3 Chapter 3. Board Hearings ...................................................................................................................... 4 §301. Board Hearing Procedures and Jurisdiction ............................................................................ 4 §303. Summons ................................................................................................................................. 4 §305. Service ..................................................................................................................................... 4 §307. Default Proceedings ................................................................................................................. 4 §309. Joinder ..................................................................................................................................... 4 §311. Consolidation ........................................................................................................................... 5 §313. Severance ................................................................................................................................. 5 §315. Motions .................................................................................................................................... 5 §317. Recusation ............................................................................................................................... 5 §319. Sequestration ........................................................................................................................... 5 §321. Sanction Guidelines ................................................................................................................. 5 §323. Administrative Investigation ................................................................................................... 6 §325. Violations Committee .............................................................................................................. 6 §327. Impairment Committee ............................................................................................................ 7 §329. Formal Hearing ........................................................................................................................ 7 §331. Formal Hearing Procedures ..................................................................................................... 8 §333. Pre-Hearing Conference .......................................................................................................... 8 §335. Consent Agreements ................................................................................................................ 8 §337. Opening Statement .................................................................................................................. 9 §339. Evidence .................................................................................................................................. 9 §341. Closing Arguments .................................................................................................................. 9 §343. Board Decisions ....................................................................................................................... 9 §345. Complaint Dismissal ............................................................................................................... 9 §347. Transcripts ............................................................................................................................... 9 §349. Contempt ............................................................................................................................... 10 §351. Administrative Review .......................................................................................................... 10 §353. Judicial Review ..................................................................................................................... 10 §355. Reporting ............................................................................................................................... 10 §357. Reinstatement ........................................................................................................................ 10 §359. Declaratory Statements and Advisory Opinions ................................................................... 10 §361. Cease and Desist Orders; Injunctive Relief ........................................................................... 11 Table of Contents Chapter 5. Pharmacists .......................................................................................................................... 11 Subchapter A. Licensure Procedures ........................................................................................................... 11 §501. Application ............................................................................................................................ 11 §503. Examination ........................................................................................................................... 11 §505. Licensure ............................................................................................................................... 11 §506. Preferential Licensing Procedures for Military-Trained Applicants and Their Dependents ................................................................................................................... 12 §507. Continuing Education Program ............................................................................................. 13 §509. Address Change ..................................................................................................................... 13 §511. Employment Change ............................................................................................................. 13 §514. Impairment ............................................................................................................................ 13 Subchapter B. Professional Practice Procedures ......................................................................................... 14 §515. Prospective Drug Utilization Review .................................................................................... 14 §517. Patient Counseling ................................................................................................................. 14 §519. State of Emergency ................................................................................................................ 14 §521. Administration of Medications .............................................................................................. 15 §523. Collaborative Drug Therapy Management ............................................................................ 16 §525. Cognitive Services ................................................................................................................. 20 Chapter 7. Pharmacy Interns ................................................................................................................. 20 §701. Definition ............................................................................................................................... 20 §703. Registration ............................................................................................................................ 20 §705. Professional Experience ........................................................................................................ 21 §707. Impairment ............................................................................................................................ 22 §709. Scope of Practice ................................................................................................................... 22 §711. Administration of Medications .............................................................................................. 22 Chapter 9. Pharmacy Technicians ......................................................................................................... 23 §901. Definitions ............................................................................................................................. 23 §903. Pharmacy Technician Candidates .......................................................................................... 23 §904. Preferential Licensing Procedures for Military-Trained Applicants and Their Dependents ................................................................................................................... 24 §905. Pharmacy Technician Certificate .......................................................................................... 26 §907. Scope of Practice ................................................................................................................... 26 §909. Continuing Education ............................................................................................................ 27 §911. Impairment ............................................................................................................................ 27 §913. Administration of Medications .............................................................................................. 27 Chapter 11. Pharmacies ........................................................................................................................... 28 Subchapter A. General Requirements .......................................................................................................... 28 §1101. Pharmacy ............................................................................................................................... 28 §1103. Prescription Department Requirements ................................................................................. 28 §1105. Pharmacist-in-Charge ............................................................................................................ 29 §1107. Pharmacy Operations ............................................................................................................. 30 §1109. Pharmacist Temporary Absence ............................................................................................ 30 §1111. Pharmacist Absence ............................................................................................................... 31 §1113. Mechanical Drug Dispensing Devices .................................................................................. 31 §1115. Advertising ............................................................................................................................ 31 Subchapter B. Pharmacy Records ............................................................................................................... 31 §1119. Definitions ............................................................................................................................. 31 §1121. General Requirements ........................................................................................................... 32 §1123. Records of Prescription Drug Orders and Chart Orders ........................................................ 32 Table of Contents Chapter 24. Limited Service Providers .................................................................................................... 64 Subchapter A. Durable Medical Equipment ................................................................................................ 64 §2401. Definitions ............................................................................................................................. 64 §2403. Durable Medical Equipment (DME) Permit ......................................................................... 64 §2405. Standards of Practice ............................................................................................................. 65 §2407. Exemptions ............................................................................................................................ 67 §2409. (Reserved) .............................................................................................................................. 68 Subchapter B. Special Event Pharmacy Permit ........................................................................................... 68 §2411. Special Event Pharmacy Permit ............................................................................................ 68 §2413. General Requirements ........................................................................................................... 68 §2415. Standards of Practice ............................................................................................................. 69 Subchapter C. Telepharmacy Services ........................................................................................................ 69 §2421. Purpose .................................................................................................................................. 69 §2423. Definitions ............................................................................................................................. 69 §2425. Telepharmacy Dispensing Site .............................................................................................. 70 Subchapter D. Remote Processor Pharmacy ................................................................................................ 72 §2431. Purpose .................................................................................................................................. 72 §2433. Definitions ............................................................................................................................. 72 §2435. General Requirements ........................................................................................................... 72 §2437. Standards of Practice ............................................................................................................. 73 Subchapter E. Marijuana Pharmacy ............................................................................................................ 73 §2440. Preamble; Warning; Consultation Suggested ........................................................................ 73 §2441. Definitions ............................................................................................................................. 74 §2443. Marijuana Products ................................................................................................................ 75 §2445. Marijuana Pharmacy Permit .................................................................................................. 79 §2447. Licensing Procedures ............................................................................................................. 80 §2449. Marijuana Pharmacy Personnel ............................................................................................. 83 §2451. Operation of Marijuana Pharmacy ........................................................................................ 84 §2453. Security Requirements for Marijuana Pharmacies ................................................................ 85 §2455. Reportable Security Events ................................................................................................... 87 §2457. Standards of Practice ............................................................................................................. 87 §2459. Advertising ............................................................................................................................ 89 Chapter 25. Prescriptions, Drugs, and Devices ....................................................................................... 90 Subchapter A. General Requirements .......................................................................................................... 90 §2501. Prescription Drugs and Devices ............................................................................................ 90 §2503. Drug Returns; Drug Disposal ................................................................................................ 90 §2505. Investigational Drugs ............................................................................................................. 91 §2507. Veterinary Prescription Drugs ............................................................................................... 91 §2509. Prescription Devices .............................................................................................................. 91 Subchapter B. Prescriptions ......................................................................................................................... 92 §2511. Prescriptions and Chart Orders .............................................................................................. 92 §2513. Prescription Receipt and Verification of Prescription Drug Orders and Chart Orders ......... 93 §2515. Prescriptions Based upon Electronic Questionnaires ............................................................ 93 §2517. Prescription Dispensing; Equivalent Drug Product Interchange; Drug Returns; Drug Disposal ........................................................................................................................ 94 §2519. Prescription Refills; Medication Synchronization and Refill Consolidation ........................ 95 §2521. Emergency Refills ................................................................................................................. 95 §2523. Transfer of Prescription Information ..................................................................................... 95 Table of Contents §2525. Prescription Expiration .......................................................................................................... 96 §2527. Prescription Labeling ............................................................................................................. 96 §2529. Pharmacy Prepackaging ........................................................................................................ 96 Subchapter C. Compounding of Drugs ........................................................................................................ 97 §2531. Purpose and Scope ................................................................................................................. 97 §2533. Definitions ............................................................................................................................. 97 §2535. General Standards .................................................................................................................. 97 Subchapter D. Prescription Drugs ............................................................................................................... 99 §2541. Standing Orders for Distribution of Naloxone and Other Opioid Antagonists ..................... 99 Chapter 27. Controlled Dangerous Substances ..................................................................................... 100 Subchapter A. General Provisions ............................................................................................................. 100 §2701. Definitions ........................................................................................................................... 100 §2703. Controlled Substances ......................................................................................................... 102 Subchapter B. Licenses .............................................................................................................................. 103 §2705. Licenses and Exemptions .................................................................................................... 103 §2707. Licensing Procedures ........................................................................................................... 105 §2709. Actions on Applications ...................................................................................................... 106 §2711. Actions on Licenses ............................................................................................................. 106 Subchapter C. Security Requirements ....................................................................................................... 109 §2713. General Requirements ......................................................................................................... 109 §2715. Physical Security Controls for Non-Practitioners, Narcotic Treatment Programs, and Compounders for Narcotic Treatment Programs ................................................................ 110 §2717. Physical Security Controls for Practitioners and Pharmacies ............................................. 113 §2719. Security Controls for Freight Forwarding Facilities ........................................................... 113 §2721. Employee Screening by Non-Practitioners ......................................................................... 113 Subchapter D. Labeling and Packaging Requirements .............................................................................. 114 §2723. Symbol Required ................................................................................................................. 114 §2725. Location and Size of Symbol on Label and Labeling ......................................................... 114 §2727. Sealing of Controlled Substances ........................................................................................ 114 §2729. Labeling and Packaging Requirements for Imported and Exported Controlled Substances ........................................................................................................................... 114 Subchapter E. Recordkeeping Requirements ............................................................................................ 115 §2731. General Information ............................................................................................................ 115 §2733. Inventory Requirements ...................................................................................................... 117 §2735. Continuing Records ............................................................................................................. 118 §2737. Reports ................................................................................................................................. 122 Subchapter F. Production, Distribution, and Utilization ........................................................................... 124 §2739. Manufacture ......................................................................................................................... 124 §2741. Distribution .......................................................................................................................... 125 §2743. Procurement Requirements ................................................................................................. 125 §2745. Prescriptions ........................................................................................................................ 126 §2747. Dispensing Requirements .................................................................................................... 130 §2749. Disposal of Controlled Substances ...................................................................................... 136 §2751. Distributions and Transfers of Controlled Substances ........................................................ 137 Subchapter G. Administrative Procedures ................................................................................................. 137 §2753. Inspections ........................................................................................................................... 137 §2755. Seizures ................................................................................................................................ 137 §2757. Hearings ............................................................................................................................... 138 Table of Contents Chapter 29. Prescription Monitoring Program ...................................................................................... 138 §2901. Definitions ........................................................................................................................... 138 §2911. Reporting of Prescription Monitoring Information ............................................................. 138 §2913. Required Data Elements ...................................................................................................... 138 §2914. Record Retention of Prescription Transaction Information ................................................ 139 §2915. Failure to Report Prescription Information ......................................................................... 139 §2917. Authorized Direct Access Users of Prescription Monitoring Information .......................... 139 §2919. Registration Procedures for Authorized Direct Access Users ............................................. 139 §2921. Methods of Access to Prescription Monitoring Information and Audit Trail Information ....................................................................................................... 140 §2923. Unlawful Use or Disclosure of Prescription Monitoring Information ................................ 141 §2925. Release of Prescription Monitoring Information to Other Entities ..................................... 141 §2927. Legislative Oversight ........................................................................................................... 141 §2929. Program Evaluation ............................................................................................................. 141 Chapter 30. Pharmacy Benefit Managers .............................................................................................. 141 §3003. Pharmacy Benefit Manager Permit ..................................................................................... 141 §3005. Permitting Procedures ......................................................................................................... 142 Chapter 31. Illegal Payments; Required Disclosures of Financial Interests .......................................... 143 Subchapter A. General Information ........................................................................................................... 143 §3101. Scope and Purpose of Chapter ............................................................................................. 143 §3103. Definitions ........................................................................................................................... 143 Subchapter B. Illegal Payments ................................................................................................................. 144 §3105. Prohibition of Payments for Referrals ................................................................................. 144 §3107. Prohibited Arrangements ..................................................................................................... 144 §3109. Exceptions ........................................................................................................................... 144 §3111. Effect of Violation ............................................................................................................... 144 Subchapter C. Disclosure of Financial Interests in Third-Party Health Care Providers ........................... 144 §3113. Required Disclosure of Financial Interest ........................................................................... 144 §3115. Form of Disclosure .............................................................................................................. 145 §3117. Effect of Violation; Sanctions ............................................................................................. 145 §3119. Disclosure of Financial Interest ........................................................................................... 145 Chapter 33. Severability ........................................................................................................................ 145 §3301. Severability .......................................................................................................................... 145 PROFESSIONAL AND OCCUPATIONAL STANDARDS Louisiana Administrative Code August 2022 2 party as relevant testimony, and received in accordance with the Administrative Procedure Act, R.S. 49:950 et seq. AUTHORITY NOTE: Promulgated in accordance with R.S. 37:1182. HISTORICAL NOTE: Promulgated by the Department of Health and Hospitals, Board of Pharmacy, LR 14:708 (October 1988), effective January 1, 1989, amended LR 29:2076 (October 2003), effective January 1, 2004. §107. Board Committees and Subcommittees A. Board committees are working bodies created by the board comprising members appointed or removed by the president to address and deliberate specific pharmacy matters referred by the board for specified periods consisting of the following. 1. Standing Committees. Standing committees are permanent bodies and are created by the board comprising members appointed by the president with the duty to address and deliberate specific subject matters referred by the board. 2. Special Committees. Special committees are appointed by the president for a particular period to address or deliberate special matters. 3. Board Subcommittees. Board subcommittees are created by the board comprising members and ex-officio non-voting members appointed by the president that are ancillary to a standing or special committee to address or deliberate a limited committee subject matter. AUTHORITY NOTE: Promulgated in accordance with R.S. 37:1182. HISTORICAL NOTE: Promulgated by the Department of Health and Hospitals, Board of Pharmacy, LR 14:708 (October 1988), effective January 1, 1989, amended LR 29:2076 (October 2003), effective January 1, 2004. §109. Standing Board Committees A. Executive Committee. The executive committee, comprised of the president, vice-presidents, and secretary shall function to address interim administrative board matters that require immediate attention between regularly scheduled board meetings. B. Regulation Revision Committee. The regulation revision committee, consisting of at least three board members appointed at the discretion of the president, shall function to preliminarily draft rules, regulations, and policies to be considered by the full board for promulgation and/or resolution or order. C. Reciprocity Committee. The reciprocity committee, consisting of at least three board members appointed at the discretion of the president, shall function to document the qualifications, compliance, and credentials of reciprocity candidates. D. Impairment Committee. The impairment committee, consisting of at least three board members appointed at the discretion of the president, shall function to study, recognize, address the need to identify, and monitor the recovery of impaired persons in order to protect the public and the practitioner. Additionally, the impairment committee shall function to investigate, review, and interview impaired or allegedly impaired persons practicing or assisting in the practice of pharmacy and tender findings and recommendations to the board. E. Violations Committee. The violations committee shall consist of at least three board members appointed at the discretion of the president. Board-designated staff shall preliminarily determine the disposition of complaints and alleged offenses. Thereafter, the violations committee shall function to receive complaints, receive staffs' reports, and evaluate and review findings. The disposition of alleged offenses shall be determined by conducting an informal inquiry conference, an interlocutory hearing, and/or referring the matter to special counsel for formal hearing by the full board. F. Reinstatement Committee. The reinstatement committee, consisting of at least three board members appointed at the discretion of the president, shall function to receive complaints, receive staffs' reports, evaluate and review findings, interview applicants, deliberate, and tender recommendations to the full board. AUTHORITY NOTE: Promulgated in accordance with R.S. 37:1182. HISTORICAL NOTE: Promulgated by the Department of Health and Hospitals, Board of Pharmacy, LR 14:708 (October 1988), effective January 1, 1989, amended LR 29:2076 (October 2003), effective January 1, 2004. §111. Official Journal A. The official journal of the board is the Louisiana Board of Pharmacy Newsletter. The newsletter may be used in administrative hearings as proof of notification to pharmacists, interns, pharmacy technicians, pharmacy technician trainees, and holders of pharmacy permits. AUTHORITY NOTE: Promulgated in accordance with R.S. 37:1182. HISTORICAL NOTE: Promulgated by the Department of Health and Hospitals, Board of Pharmacy, LR 14:708 (October 1988), effective January 1, 1989, amended LR 29:2077 (October 2003), effective January 1, 2004). §113. Rulemaking Procedures A. Petitions from Interested Persons 1. All petitions, whether requesting the adoption, amendment, or repeal of a rule shall be submitted in written form on plain white bond paper which is letter size (8 1/2” by 11”). The text shall be framed with a margin of at least one inch on all sides, shall have a pitch of not less than 10 characters per inch, and shall be double-spaced; provided however that quotations may be single-spaced as may other matter customarily presented in that manner. 2. The petition shall include the name, address, telephone number and email address of the petitioner as well as any organization the petitioner represents. 3. The petition shall explain the reason(s) for the requested action as well as what results would be expected from such action. The petition shall provide an estimate of Title 46, Part LIII Louisiana Administrative Code August 2022 3 the revenues and expenditures expected if the requested action is adopted. 4. The petition shall be considered by the board at its next regular meeting provided the complete petition is received at least 30 days prior to that meeting. B. Board Initiatives 1. The board may refer topics to the Regulation Revision Committee, either during a board meeting or through the president in the interim between board meetings. C. Administrative Procedure Act 1. When the board approves a regulatory proposal for rulemaking, the board shall comply with the Administrative Procedure Act at R.S. 49:950 et seq. AUTHORITY NOTE: Promulgated in accordance with R.S. 49:953. HISTORICAL NOTE: Promulgated by the Department of Health, Board of Pharmacy, LR 46:586 (April 2020). §115. Fees A. The fees charged and collected by the board shall not be less nor more than the following schedule. 1. Credentialing Fees for Persons a. Pharmacy Technician Candidate i. Application fee for new pharmacy technician candidate registration—$50. b. Pharmacy Technician i. Application fee for new pharmacy technician certificate—$100. ii. Certificate renewal fee, per year—$60. iii. Delinquent renewal fee, per year (50 percent of renewal fee)—$30. iv. Reinstatement fee for lapsed, suspended, or revoked certificate—$200. c. Pharmacy Intern i. Application fee for new pharmacy intern registration—$50. d. Pharmacist i. Application fee for new pharmacist license— $300. ii. Application fee for transfer of pharmacist license—$150. iii. License renewal fee, per year—$150. iv. Delinquent renewal fee, per year (50 percent of renewal fee)—$75. v. Reinstatement fee for lapsed, suspended, or revoked license—$200. vi. Pharmacy education support fee, per year— $100. 2. Credentialing Fees for Businesses a. Pharmacy i. Application fee for new pharmacy permit— $500. ii. Application fee for change of location of pharmacy permit—$200. iii. Pharmacy permit renewal fee, per year—$200. iv. Delinquent renewal fee for pharmacy permit, per year (50 percent of renewal fee)—$100. v. Application fee for new controlled dangerous substance (CDS) license for pharmacy—$25. vi. CDS license renewal fee, per year—$25. vii. Delinquent renewal fee for CDS license, per year (50 percent of renewal fee)—$12.50 viii. Application fee for new emergency drug kit (EDK) permit—$50. ix. EDK permit renewal fee, per year—$50. x. Application fee for new automated medication system (AMS) registration—$150. xi. AMS registration renewal fee, per year—$150. xii. Application fee for new sterile compounding pharmacy permit—$500. xiii. Sterile compounding pharmacy permit renewal fee, per year—$500. xiv. Reinstatement fee for lapsed, suspended, or revoked pharmacy permit, CDS license, EDK permit, AMS registration, or sterile compounding pharmacy permit— $200. xv. Pharmacy education support fee, per year— $100. b. Durable Medical Equipment Provider i. Application fee for new durable medical equipment (DME) permit—$200. ii. DME permit renewal fee, per year—$200. iii. Delinquent renewal fee for DME permit, per year (50 percent of renewal fee)—$100. iv. Reinstatement fee for lapsed, suspended, or revoked DME permit—$200. v. Pharmacy education support fee, per year— $100. c. Pharmacy Benefit Manager i. Application fee for new pharmacy benefit manager (PBM) permit—$500. ii. PBM permit renewal fee, per year—$500. iii. delinquent renewal fee for PBM permit, per year (50 percent of renewal fee)—$250. PROFESSIONAL AND OCCUPATIONAL STANDARDS Louisiana Administrative Code August 2022 4 3. Fees for Products and Services a. Products i. Pharmacist certificate—$75. ii. Pharmacist silver certificate—$100. iii. Louisiana Pharmacy Law Book—$40. iv. Official list of licensees, per credential type— $150. v. Photocopies of documents, per page—$0.50 b. Services i. Administrative hearing fee—$250. ii. Certification of credential—$20. iii. Certification of practical experience to another jurisdiction—$25. iv. Certification of document as true copy of office record—$5. v. Handling and mailing, per page—$1. 4. Board member per diem, per day—$75. AUTHORITY NOTE: Promulgated in accordance with R.S. 37:1182(A)(21). HISTORICAL NOTE: Promulgated by the Department of Health, Board of Pharmacy, LR 48:1901 (July 2022). Chapter 3. Board Hearings §301. Board Hearing Procedures and Jurisdiction A. Person. The board has jurisdictional authority over the person practicing pharmacy, assisting in the practice of pharmacy, operating a pharmacy, or otherwise licensed, registered, certified, or permitted by the board. A person is as defined in R.S. 37:1164(33) of the Pharmacy Practice Act. B. Subject Matter. The board has jurisdiction over any subject matter related to the practice of pharmacy or any other matter regarding the dispensing or selling of prescription drugs in a safe manner so as not to endanger the public health, safety, or welfare. C. Board Authority. The board has authority to adopt rules pursuant to the Pharmacy Practice Act, R.S. 37:1161 et seq., and the Administrative Procedure Act, R.S. 49:950 et seq., regarding due process disciplinary hearings. D. Venue. A due process hearing shall convene in a designated Louisiana parish at a regularly called board meeting. AUTHORITY NOTE: Promulgated in accordance with R.S. 37:1182. HISTORICAL NOTE: Promulgated by the Department of Health and Hospitals, Board of Pharmacy, LR 14:708 (October 1988), effective January 1, 1989, amended LR 29:2077 (October 2003), effective January 1, 2004. §303. Summons A. A summons shall represent a complaint of an alleged violation directed to a respondent. B. Hearing Notice. The board shall initiate a hearing by issuing a notice summons. The notice summons shall be forwarded to the respondent commanding his presence to appear before the board for a due process hearing setting forth the following. 1. Name. The notice shall include the respondent's name and address. 2. Time. The notice shall state the designated time, date, and place. 3. Allegation. The notice shall recite the alleged violation(s) establishing a cause of action and the nature of the hearing. 4. Authority. The notice shall make references to specific board, state, or federal statutes, regulations, rules, policies, or code of ethics involved in the alleged violation(s). 5. Citation. The notice shall cite legal or jurisdictional authority constituting an alleged violation(s). 6. Documents. The notice may include supporting documents, reports, and/or other relevant material. AUTHORITY NOTE: Promulgated in accordance with R.S. 37:1182. HISTORICAL NOTE: Promulgated by the Department of Health and Hospitals, Board of Pharmacy, LR 14:708 (October 1988), effective January 1, 1989, amended LR 29:2077 (October 2003), effective January 1, 2004. §305. Service A. Method. Service of a summons shall be made either by regular, registered, or certified mail, with a return receipt requested, or board or court designated process servers confected by tendering the summons to the respondent personally or domiciliary at the last known address. B. Time. Service shall be made at least 30 days prior to the date of the hearing as per R.S. 37:1245. AUTHORITY NOTE: Promulgated in accordance with R.S. 37:1245. HISTORICAL NOTE: Promulgated by the Department of Health and Hospitals, Board of Pharmacy, LR 14:708 (October 1988), effective January 1, 1989, amended LR 29:2077 (October 2003), effective January 1, 2004. §307. Default Proceedings A. The board may proceed with a hearing in the event the respondent fails to appear after due notice was perfected or a diligent effort had been made to perfect service on the respondent at the last known address of record. AUTHORITY NOTE: Promulgated in accordance with R.S. 37:1182. HISTORICAL NOTE: Promulgated by the Department of Health and Hospitals, Board of Pharmacy, LR 14:708 (October 1988), effective January 1, 1989, amended LR 29:2077 (October 2003), effective January 1, 2004. §309. Joinder A. Several complaints may be joined or incorporated and the respondents may be joined in the same or similar Title 46, Part LIII Louisiana Administrative Code August 2022 7 whether a probation violation proceeding is warranted. Should a probation violation hearing be determined warranted, the violations committee shall proceed by interlocutory hearing or informal hearing as deemed appropriate. 2. Notice. Notice shall be afforded the respondent of the allegation(s) forming the basis of the alleged violation status, and the time and place of the appropriate hearing to be conducted. 3. Disposition. Disposition of the hearing shall be according to the appropriate procedures to informal hearings or interlocutory hearings. AUTHORITY NOTE: Promulgated in accordance with R.S. 37:1182. HISTORICAL NOTE: Promulgated by the Department of Health and Hospitals, Board of Pharmacy, LR 14:708 (October 1988), effective January 1, 1989, amended LR 29:2078 (October 2003), effective January 1, 2004. §327. Impairment Committee A. Impairment. Impairment means a condition that causes an infringement on the ability of an individual to practice, or assist in the practice of, pharmacy sufficient to pose a danger to the public. Impairment may be caused by, but is not limited to, alcoholism, substance abuse or addiction, mental illness, or physical illness. B. The impairment committee shall have the following responsibilities: 1. supervise the Practitioner Recovery Program; 2. recommend for board consideration any addictionists or other professionals utilized by the program; 3. recommend for board consideration any action for reinstatement of recovering persons; 4. any other related responsibilities deemed appropriate by the board. C. Practitioner Recovery Program. The board may establish and maintain a recovery program to assist impaired persons through the recovery process so that they may safely return to practice. The board may utilize the services of outside agencies to assist in the recovery of the impaired person. D. Informal Hearing 1. The board may convene an informal administrative hearing to identify an impaired person and to take appropriate action. The board may require the appearance of any persons deemed necessary to properly conduct an informal hearing. This process shall be conducted by the impairment committee chairman or any other member(s) of the board or staff as the president deems necessary. 2. Any knowledge acquired by any board member or staff in identifying and assisting an allegedly impaired person shall not automatically be grounds for recusal at any later hearing on that same matter. 3. An impaired or allegedly impaired person may enter into a preliminary consent agreement that shall include a mandatory surrender of that person's license, permit, certification, or registration, which shall be delivered to the board office and shall effectively prohibit that person from practicing, or assisting in the practice of, pharmacy. Such person shall agree to enter into an approved treatment and monitoring program as determined by the board. This consent agreement shall not restrain the board from conducting violations proceedings in the matter as it deems necessary. 4. The impairment committee may make recommendations to the full board and/or the violations committee as it deems appropriate on an impaired or allegedly impaired person. E. Impaired Reinstatement. An application for reinstatement of an impaired person shall be filed with the impairment committee for consideration and recommendation to the violations committee and/or the full board. 1. An impaired person may petition the board for reinstatement of his license, permit, certification, or registration, provided he has: a. documented proof from an attending physician that he has successfully completed an alcohol or substance abuse recovery program; and b. a current post-treatment evaluation from a board- approved addictionist; and c. successfully completed any requirements the board deems necessary with respect to the particular type of impairment; d. the impairment committee may waive the above requirements for impairments not related to alcohol or substance abuse. 2. After the above stipulations have been met, the person applying for reinstatement may be scheduled for an interview with the impairment committee for consideration of any recommendation to the reinstatement committee and/or the full board. 3. Upon reinstatement, the board may place the reinstated person on probation for a specified length of time and may assign conditions of the probation. AUTHORITY NOTE: Promulgated in accordance with R.S. 37:1182. HISTORICAL NOTE: Promulgated by the Department of Health and Hospitals, Board of Pharmacy, LR 14:708 (October 1988), effective January 1, 1989, amended LR 29:2079 (October 2003), effective January 1, 2004. §329. Formal Hearing A. Authority. The board shall provide a formal administrative hearing pertaining to the proprietary rights or privilege to practice pharmacy, or operate a pharmacy, or hold a certificate or registration, in accordance with the Administrative Procedure Act, R.S. 49:950 et seq., with PROFESSIONAL AND OCCUPATIONAL STANDARDS Louisiana Administrative Code August 2022 8 authority to take disciplinary action pursuant to R.S. 37:1241 of the Pharmacy Practice Act. B. Ex-Parte Communication. Once a formal hearing has been initiated and notice served, board members participating in the decision process shall not communicate with a respondent or a respondent's attorney concerning any issue of fact or law involved in the formal hearing. C. Notice. A formal disciplinary public proceeding may be initiated upon proper notice to a respondent and held at a designated time and place based upon the following grounds: 1. violation―sufficient evidence or a serious complaint of an alleged violation to require a formal hearing shall be directed to legal or special counsel for administrative prosecution to justify a formal hearing; or 2. failure to respond―a failure by the respondent to respond to the violations committee informal inquiry; or 3. irresolvable issues―a violations committee informal hearing fails to resolve all issues and requires further formal action; or 4. irreconcilable issues―an interlocutory hearing fails to resolve all pertinent pending issues thus requiring further formal action; or 5. reaffirmation―reaffirmation of an interlocutory decree; or 6. requirement―a formal administrative hearing requirement. AUTHORITY NOTE: Promulgated in accordance with R.S. 37:1182. HISTORICAL NOTE: Promulgated by the Department of Health and Hospitals, Board of Pharmacy, LR 14:708 (October 1988), effective January 1, 1989, amended LR 29:2080 (October 2003), effective January 1, 2004. §331. Formal Hearing Procedures A. Hearing Officers 1. Administrative Hearing Officer. The presiding hearing officer may be the board president, a vice-president, or other individual appointed by the president or his successor. The hearing officer has the responsibility to conduct a fair and impartial proceeding with the administrative duty and authority to: a. convene an administrative board hearing; b. rule on motions and procedural questions arising during the hearing such as objections or admissibility of evidence or examination of witnesses; c. issue or direct staff to issue subpoenas; d. declare recess; e. maintain order; f. enforce a standard of conduct to insure a fair and orderly hearing; g. remove disruptive person(s) from a hearing. 2. Oaths. The presiding hearing officer, executive director, or other board designee may administer oaths. B. Administrative Jury. The board, comprised of a quorum of members, shall serve as an administrative jury to hear and determine the disposition of the pending matter based on the finding(s) of fact and conclusion(s) of law by receiving evidence and reaching a decision and/or ordering sanctions with an affirmative majority record vote of board members participating in the decision process. C. Administrative Hearing Clerk. The board's executive director shall serve as the administrative hearing clerk and shall maintain administrative hearing records. D. Administrative Prosecutor. The legal or special counsel shall prosecute the pending matter and bear the burden of proof to be presented to the board. E. Administrative Reporting. The board-designated stenographer shall record all testimony dictated and evidence received at the hearing. The utilization of recording equipment may be employed. F. Hearing Order 1. Docket. Contested matters shall be identified by reference docket number and caption title. The administrative hearing clerk or other staff or board member designated by the presiding hearing officer shall announce the docket and identify persons present or absent in the hearing chambers. 2. Complaint. The complaint may be read at an open hearing unless waived by the respondent. AUTHORITY NOTE: Promulgated in accordance with R.S. 37:1182. HISTORICAL NOTE: Promulgated by the Department of Health and Hospitals, Board of Pharmacy, LR 14:708 (October 1988), effective January 1, 1989, amended LR 29:2080 (October 2003), effective January 1, 2004. §333. Pre-Hearing Conference A. Respondents and/or their legal counsel in matters pending before the board may be directed by the presiding administrative hearing officer to appear at a pre-hearing conference to consider the simplification of the issues, admission of facts, or stipulations to documents which may avoid unnecessary proof and such other items as may aid in the disposition of the matter(s) pending. AUTHORITY NOTE: Promulgated in accordance with R.S. 37:1182. HISTORICAL NOTE: Promulgated by the Department of Health and Hospitals, Board of Pharmacy, LR 14:708 (October 1988), effective January 1, 1989, amended LR 29:2081 (October 2003), effective January 1, 2004. §335. Consent Agreements A. Respondents may enter into consent agreements with the board on any matter pending before the board. A consent agreement is not final until the board approves the consent agreement by majority vote of the administrative jury. If the consent agreement is rejected in full or part, the matter shall be heard at the next regularly scheduled board hearing. Title 46, Part LIII Louisiana Administrative Code August 2022 9 However, nothing herein shall limit the board from modifying a consent agreement, with respondent's approval, to include less severe sanctions than those originally agreed to in a pending consent agreement. AUTHORITY NOTE: Promulgated in accordance with R.S. 37:1182. HISTORICAL NOTE: Promulgated by the Department of Health and Hospitals, Board of Pharmacy, LR 14:708 (October 1988), effective January 1, 1989, amended LR 29:2081 (October 2003), effective January 1, 2004. §337. Opening Statement A. An opening statement by legal or special counsel may present a brief position comment with an outline of evidence to be offered. Respondent or respondent's legal counsel may present an opening defense position statement. AUTHORITY NOTE: Promulgated in accordance with R.S. 37:1182. HISTORICAL NOTE: Promulgated by the Department of Health and Hospitals, Board of Pharmacy, LR 14:708 (October 1988), effective January 1, 1989, amended LR 29:2081 (October 2003), effective January 1, 2004. §339. Evidence A. Testimony Received. Testimony shall be received under oath administered by the presiding hearing officer, the executive director, or other staff or board member designated by the hearing officer. B. Evidence Introduction. All parties shall be afforded an opportunity to present evidence on all issues of fact and argue on all issues of law and respond by direct testimony, followed with cross examination as may be required for a full and true disclosure of the facts. The direct presentation of evidence shall be introduced by the legal or special counsel and shall be followed by the respondent in proper person or by legal counsel by direct and/or cross- examination and/or rebuttal. C. Examination. Witnesses may be directly examined and cross-examined. Additionally, witnesses and/or respondents may be questioned during an administrative hearing by members of the administrative jury on matters for clarification. D. Rule Interpretation. Liberal rules of evidence shall be employed by the presiding hearing officer to provide adequate facts and law necessary for the board to deliberate and decide each case. The board's administrative hearing shall not be bound to strict rules of evidence. E. Admissibility. Admissibility of evidence and testimony shall be determined by the presiding hearing officer as provided by law. AUTHORITY NOTE: Promulgated in accordance with R.S. 37:1182. HISTORICAL NOTE: Promulgated by the Department of Health and Hospitals, Board of Pharmacy, LR 14:708 (October 1988), effective January 1, 1989, amended LR 29:2081 (October 2003), effective January 1, 2004. §341. Closing Arguments A. Closing arguments may be made by respondent in proper person or by legal counsel followed by closing arguments from prosecuting legal or special counsel. AUTHORITY NOTE: Promulgated in accordance with R.S. 37:1182. HISTORICAL NOTE: Promulgated by the Department of Health and Hospitals, Board of Pharmacy, LR 14:708 (October 1988), effective January 1, 1989, amended LR 29:2081 (October 2003), effective January 1, 2004. §343. Board Decisions A. The board's decision shall be based on finding(s) of fact and conclusion(s) of law. The board's decision shall be based on a preponderance of the evidence presented at a formal hearing, together with the board's determination of any appropriate sanctions, by an affirmative majority record vote of the board members participating in the decision process. Decisions shall be recorded and made a part of the record. 1. Board Order. The board's order shall be rendered at the open hearing or taken under advisement and rendered within 30 days of the hearing and then served personally or domiciliary at the respondent's last known address by regular, registered, or certified mail, or by a diligent attempt thereof. 2. Finality of Board Order. The board's order becomes final eleven days after receipt of notification of the board's decision by respondent, provided an appeal is not filed. AUTHORITY NOTE: Promulgated in accordance with R.S. 37:1182. HISTORICAL NOTE: Promulgated by the Department of Health and Hospitals, Board of Pharmacy, LR 14:708 (October 1988), effective January 1, 1989, amended LR 29:2081 (October 2003), effective January 1, 2004, LR 33:1124 (June 2007). §345. Complaint Dismissal A. The board, in their discretion and based upon lack of evidence, may orally dismiss at an open hearing a pending matter or parts thereof. AUTHORITY NOTE: Promulgated in accordance with R.S. 37:1182. HISTORICAL NOTE: Promulgated by the Department of Health and Hospitals, Board of Pharmacy, LR 14:708 (October 1988), effective January 1, 1989, amended LR 29:2081 (October 2003), effective January 1, 2004. §347. Transcripts A. A complete record of all formal hearing proceedings shall be transcribed, maintained, and available upon written request with sufficient costs of the preparation of the transcript for a minimum of three years from the date the pertinent order(s) is final. AUTHORITY NOTE: Promulgated in accordance with R.S. 37:1182. HISTORICAL NOTE: Promulgated by the Department of Health and Hospitals, Board of Pharmacy, LR 14:708 (October 1988), effective January 1, 1989, amended LR 29:2081 (October 2003), effective January 1, 2004. PROFESSIONAL AND OCCUPATIONAL STANDARDS Louisiana Administrative Code August 2022 12 scheduled meeting. The board may reinstate an expired license upon payment of applicable annual, delinquent, and lapsed license fees pursuant to R.S. 37:1184, as amended, and other conditions as the board deems appropriate. AUTHORITY NOTE: Promulgated in accordance with R.S. 37:1182. HISTORICAL NOTE: Promulgated by the Department of Health and Hospitals, Board of Pharmacy, LR 14:708 (October 1988), effective January 1, 1989, amended LR 29:2083 (October 2003), effective January 1, 2004, LR 33:1124 (June 2007), LR 38:1234 (May 2012), amended by the Department of Health, Board of Pharmacy, LR 46:1227 (September 2020). §506. Preferential Licensing Procedures for Military- Trained Applicants and Their Dependents A. Definitions. The following terms shall have the meaning ascribed to them in this Subsection: Dependent—a resident spouse or resident unmarried child under the age of 21 years, a child who is a student under the age of 24 years and who is financially dependent upon the parent, or a child of any age who is disabled and dependent upon the parent. Jurisdiction—any state or territory of the United States of America. Military—the armed forces or reserves of the United States, including the Army, Navy, Marine Corps, Coast Guard, Air Force, and the reserve components thereof, the National Guard of any state, the Military Reserves of any state, or the naval militia of any state. B. Eligibility. The following persons are eligible for the preferential licensing procedures provided by this Section: 1. a member of the military who has been assigned to duty in Louisiana or his dependent; 2. a civilian employee of the United States Department of Defense who has been assigned to duty in Louisiana or his dependent; 3. a member of the military or civilian employee of the United States Department of Defense or their dependents who have established this state as their state of legal residence in their military record. C. Requirements. Eligible persons seeking preferential licensing procedures shall demonstrate compliance with the following requirements: 1. the applicant holds a current and valid pharmacist license in another jurisdiction; 2. the applicant has held the license in the other jurisdiction for at least one year; 3. the applicant has satisfied all educational and experiential requirements required by the pharmacy regulatory authority in the other jurisdiction; 4. the applicant is held in good standing by the pharmacy regulatory authority in the other jurisdiction, or in the event such status is not used in this jurisdiction, the applicant holds an unrestricted license in that jurisdiction; 5. the applicant does not have a disqualifying criminal record as determined by the board; 6. the applicant has not had an occupational license revoked by a board in another jurisdiction due to negligence or intentional misconduct related to the applicant’s work in the occupation in another jurisdiction; 7. the applicant has not surrendered an occupational license due to negligence or intentional misconduct related to the applicant’s work in the occupation in another jurisdiction; 8. the applicant does not have a complaint, allegation, or investigation pending before a pharmacy regulatory authority in another jurisdiction which relates to unprofessional conduct or an alleged crime. If the applicant has a complaint, allegation, or investigation pending, the board shall not issue or deny a license until the complaint, allegation, or investigation is resolved, or the applicant otherwise satisfies the criteria for licensure in this state to the satisfaction of the board; 9. the applicant has paid all applicable fees in this state; 10. the applicant has applied for permanent licensure in this state. In the event the applicant fails to qualify for a permanent license as determined by the board, the special work permit issued under the authority of Subsection E of this Section shall be automatically terminated. D. Upon receipt of an application for pharmacist licensure by an eligible applicant, the board staff shall mark the application for priority processing and preserve that status until the license is issued, or in the alternative, the board gives notice of its intent to deny the application and refuse to issue the license. The board shall notify the applicant of its licensing decision within 30 calendar days after receiving an application. E. In the event the applicant intends to practice pharmacy before the issuance of the permanent license, the board may issue a special work permit to the applicant. 1. The special work permit shall expire 120 days after the date of issue and the permit shall not be renewable. 2. The special work permit shall identify the applicant, and further, shall indicate the authority for that person to practice pharmacy within the state of Louisiana as well as the dates of issue and expiration of the credential. 3. No applicant may practice pharmacy prior to the issuance of a special work permit or pharmacist license, or with an expired special work permit or pharmacist license. 4. The special work permit shall not be eligible for license transfer or reciprocity to any other jurisdiction. 5. The provisions of this Section shall not apply to a member of the military who has received, or is in the process of receiving, a dishonorable discharge from the military. Further, the provisions of this Section shall not apply to the spouse of a member of the military who has received, or is in Title 46, Part LIII Louisiana Administrative Code August 2022 13 the process of receiving, a dishonorable discharge from the military. AUTHORITY NOTE: Promulgated in accordance with R.S. 37:3650. HISTORICAL NOTE: Promulgated by the Department of Health and Hospitals, Board of Pharmacy, LR 39:3075 (November 2013), amended by the Department of Health, Board of Pharmacy, LR 47:244 (February 2021). §507. Continuing Education Program A. The board, recognizing that professional competency is a safeguard for the health, safety, and welfare of the public, shall require continuing pharmacy education as a prerequisite for annual licensure renewal for pharmacists. B. Definitions 1. ACPE―Accreditation Council for Pharmacy Education. 2. CPE―continuing pharmacy education, a structured postgraduate educational program for pharmacists to enhance professional competence. 3. CPE Monitor—a collaborative service from the National Association of Boards of Pharmacy (NABP) and the Accreditation Council for Pharmacy Education (ACPE) that provides an electronic system for pharmacists and pharmacy technicians to record and track their completed CPE activities. 4. CPE Unit—a standard of measurement adopted by the ACPE for the purpose of accreditation of CPE programs. One CPE unit is equivalent to 10 credit hours. C. Requirements 1. A minimum of 1 1/2 ACPE or board-approved CPE units, or 15 hours, shall be required each year as a prerequisite for pharmacist licensure renewal. Of this number, no less than 3/10 ACPE or board-approved CPE units, or three hours, shall be acquired through live presentations, as designated by ACPE or the board. Alternatively, should a pharmacist choose to not acquire at least 3/10 ACPE or board-approved CPE units, or three hours, through live presentations, then he shall acquire an additional 5/10 ACPE or board-approved CPE units, or five hours, through any other acceptable method, over and above the minimum requirement, for a total of two ACPE or board- approved CPE units, or 20 hours. 2. Pharmacists shall maintain individual records of personal CPE activities with CPE Monitor and shall authorize the board’s access to their file by recording their Louisiana pharmacist license number within that file, and shall present a copy of their CPE Monitor transcript when requested by the board. 3. When deemed appropriate and necessary by the board, some or all of the required number of hours may be mandated on specific subjects. When so deemed, the board shall notify all licensed pharmacists prior to the beginning of the year in which the CPE is required. 4. When deemed appropriate and necessary by the board, the number of hours to be acquired through live presentations as designated by ACPE or the board may be increased. When so deemed, the board shall notify all licensed pharmacists prior to the beginning of the year in which the CPE is required. D. Compliance 1. Complete compliance with CPE rules is a prerequisite for pharmacist licensure renewal. 2. Non-compliance with the CPE requirements shall be considered a violation of R.S. 37:1241(A)(2), and shall constitute a basis for the board to refuse licensure renewal. 3. The failure to maintain an individual record of personal CPE activities, or falsification of CPE documents, shall be considered a violation of R.S. 37:1241(A)(22). AUTHORITY NOTE: Promulgated in accordance with R.S. 37:1182. HISTORICAL NOTE: Promulgated by the Department of Health and Hospitals, Board of Pharmacy, LR 14:708 (October 1988), effective January 1, 1989, amended LR 23:1306 (October 1997), LR 29:2083 (October 2003), effective January 1, 2004, LR 33:1125 (June 2007), amended by the Department of Health, Board of Pharmacy, LR 46:569 (April 2020). §509. Address Change A. A licensed pharmacist shall notify the board within 10 days, with documentation, attesting to any change of mailing and/or home address. This documented notice shall include the pharmacist's full name and license number, and the old and new address. AUTHORITY NOTE: Promulgated in accordance with R.S. 37:1182. HISTORICAL NOTE: Promulgated by the Department of Health and Hospitals, Board of Pharmacy, LR 14:708 (October 1988), effective January 1, 1989, amended LR 29:2083 (October 2003), effective January 1, 2004. §511. Employment Change A. A licensed pharmacist shall notify the board within 10 days, with documentation, attesting to any change in employment. This documented notice shall include the pharmacist's full name and license number, the name and address of old and new employment, and the permit numbers of those pharmacies involved. AUTHORITY NOTE: Promulgated in accordance with R.S. 37:1182. HISTORICAL NOTE: Promulgated by the Department of Health and Hospitals, Board of Pharmacy, LR 14:708 (October 1988), effective January 1, 1989, amended LR 29:2084 (October 2003), effective January 1, 2004. §514. Impairment A. Impairment or Impaired—a condition that causes an infringement on the ability of a person to practice, or assist in the practice, of pharmacy sufficient to pose a danger to the public. Impairment may be caused by, but is not limited to, alcoholism, substance abuse or addiction, mental illness, or physical illness. PROFESSIONAL AND OCCUPATIONAL STANDARDS Louisiana Administrative Code August 2022 14 B. Pharmacists shall be non-impaired. C. Pharmacists who have knowledge another pharmacist, pharmacy intern, pharmacy technician, or pharmacy technician candidate is impaired shall notify the board of that fact as soon as possible. D. Pharmacists may be subject to a medical evaluation for impairment by a board-approved addictionist, as authorized by the Louisiana Pharmacy Practice Act, R.S. 37:1161 et seq. AUTHORITY NOTE: Promulgated in accordance with R.S. 37:1182. HISTORICAL NOTE: Promulgated by the Department of Health and Hospitals, Board of Pharmacy, LR 33:1125 (June 2007). Subchapter B. Professional Practice Procedures §515. Prospective Drug Utilization Review A. A pharmacist shall review the patient record and each prescription presented for dispensing for purposes of enhancing pharmacy care and therapeutic outcomes by recognizing the following potential situations: 1. drug over-utilization or under-utilization; 2. therapeutic duplication; 3. drug-disease contraindications; 4. drug-drug interactions; 5. inappropriate drug dosage or treatment duration; 6. drug-allergy interactions; or 7. clinical abuse/misuse. B. Upon recognizing any of the above situations, the pharmacist, using professional judgment, shall take appropriate actions. AUTHORITY NOTE: Promulgated in accordance with R.S. 37:1182. HISTORICAL NOTE: Promulgated by the Department of Health and Hospitals, Board of Pharmacy, LR 14:708 (October 1988), effective January 1, 1989, amended LR 29:2084 (October 2003), effective January 1, 2004. §517. Patient Counseling A. Patient counseling means the effective communication by a pharmacist of information to the patient or caregiver, in order to ensure proper use of drugs and devices. B. Minimum Requirements. At a minimum, the pharmacist should be convinced that the patient or caregiver is informed of the following: 1. name and description of the medication; 2. dosage form, dosage, route of administration, and duration of therapy; 3. special directions and precautions for preparation, administration, and use by the patient; 4. common severe side effects or adverse effects or interactions and therapeutic contraindications that may be encountered, including their avoidance, and the action required in the event of their occurrence; 5. techniques for self-monitoring drug therapy; 6. proper storage of the medication; 7. prescription refill information, if any; and 8. the action to be taken in the event of a missed dose. C. The pharmacist may supplement oral information with written information, but shall not use written information alone to fulfill the counseling requirement. D. Patient Information 1. The pharmacist shall make a reasonable effort to obtain, record, and maintain the following information: a. name, address, and telephone number; b. date of birth (or age) and gender; c. allergies/drug reactions, disease state(s); and d. current list of all medications. E. Communication to the Patient 1. A pharmacist shall counsel the patient or caregiver "face-to-face" when possible or appropriate. If it is not possible or appropriate to counsel the patient or caregiver "face-to-face," then a pharmacist should counsel the patient or caregiver by using alternative methods. The pharmacist shall exercise his professional judgment in the selection of alternative methods, including but not limited to, telephonic or electronic communication with the patient or caregiver. 2. A pharmacist shall provide patient counseling to patients discharged from hospitals and/or other institutions, where applicable. However, counseling shall not be required for inpatients of a hospital or institution where a nurse or other licensed health care professional is authorized to administer medication(s). 3. The pharmacist shall maintain appropriate patient- oriented drug information materials for use by the patient upon request. F. Waiver. No pharmacist or pharmacy may solicit or encourage blanket waivers for patient counseling. However, nothing in this regulation shall prohibit the patient or caregiver from declining patient counseling. AUHTORITY NOTE: Promulgated in accordance with R.S. 37:1182. HISTORICAL NOTE: Promulgated by the Department of Health and Hospitals, Board of Pharmacy, LR 14:708 (October 1988), effective January 1, 1989, amended LR 29:2084 (October 2003), effective January 1, 2004. §519. State of Emergency A. When the Governor issues, or renews, a state of emergency pursuant to the Emergency Assistance and Disaster Act of 1993, R.S. 29:721 et seq. or a state of public Title 46, Part LIII Louisiana Administrative Code August 2022 17 Order Seta written set of directives or instructions containing each of the components specified elsewhere in this Section for collaborative drug therapy management of disease specific drug therapy for a specific patient. The order set shall be signed by the physician and represents the physician orders for the collaborative drug therapy management to be provided to the patient. B. Registration 1. Eligibility a. No pharmacist shall engage in collaborative drug therapy management in this state until registered with the board in accordance with this Section. To be eligible for registration, a pharmacist shall, as of the date of the application: i. possess a current, unrestricted license to practice pharmacy issued by the board and not be the subject of a pending investigation or complaint by the board or by the pharmacy licensing authority of any other state or jurisdiction; ii. be actively engaged in the practice of pharmacy in this state and the provision of pharmacist care similar to the activities anticipated in the collaborative drug therapy management agreement. b. A pharmacist shall be deemed ineligible for registration of collaborative drug therapy management who: i. does not possess the qualifications prescribed by §523.B.1.a; ii. has voluntarily surrendered or had suspended, revoked, or restricted his controlled dangerous substances license, permit, or registration (state or federal); iii. has had a pharmacy license suspended, revoked, placed on probation or restricted in any manner by the board or by the pharmacy licensing authority of any other state or jurisdiction; iv. has had an application for pharmacist licensure rejected or denied; or v. has been, or is currently in the process of being denied, terminated, suspended, refused, limited, placed on probation or under other disciplinary action with respect to participation in any private, state, or federal health insurance program. c. The board may, in its discretion, waive the limitations referenced in Subparagraph B.1.b of this Section on a case-by-case basis. d. The board may deny registration to an otherwise eligible pharmacist for any of the causes enumerated in R.S. 37:1241(A), or any other violation of the provisions of the Pharmacy Practice Act or the board’s rules. e. The burden of satisfying the board as to the eligibility of a pharmacist for registration to engage in collaborative drug therapy management shall be upon the pharmacist. A pharmacist shall not be deemed to possess such qualifications unless and until the pharmacist demonstrates and evidences such qualifications in the manner prescribed by and to the satisfaction of the board. 2. Application and Issuance a. Application for registration to engage in collaborative drug therapy management shall be made upon forms supplied by the board. Application forms and instructions may be obtained from the board’s website or by contacting the board’s office. b. An application for registration to engage in collaborative drug therapy management shall include: i. the pharmacist’s full name, license number, mailing address of record, and emergency contact information; ii. the nature of the collaborative drug therapy management activities contemplated, i.e., the disease or condition proposed for management; iii. a description of the pharmacist’s professional education that qualifies him to engage in collaborative drug therapy management activities described in the application; iv. proof documented in a form satisfactory to the board that the pharmacist possesses the qualifications set forth in this Section; and v. such other information and documentation as the board may require to evidence qualification for registration. c. The board may reject or refuse to consider any application for registration which is not complete in every detail required by the board. The board may, in its discretion, require a more detailed or complete response to any request for information set forth in the application as a condition to consideration. d. A pharmacist seeking registration to engage in collaborative drug therapy management shall be required to appear before the board or its designee if the board has questions concerning the nature or scope of the pharmacist’s application, finds discrepancies in the application, or for other good cause as determined by the board. e. When all the qualifications, requirements, and procedures of this Section are met to the satisfaction of the board, the board shall approve and register a pharmacist to engage in collaborative drug therapy management. Registration of authority to engage in collaborative drug therapy management shall not be effective until the pharmacist receives notification of approval from the board. f. Although a pharmacist shall notify the board each time he intends to engage in collaborative drug therapy management with a physician other than the physician identified in the pharmacist’s original application, registration with the board is only required once. The board shall maintain a list of pharmacists who are registered to engage in collaborative drug therapy management. g. Each pharmacist registered to engage in collaborative drug therapy management shall be responsible PROFESSIONAL AND OCCUPATIONAL STANDARDS Louisiana Administrative Code August 2022 18 for updating the board within 10 days in the event of any change in the information recorded in the original application. 3. Expiration of Registration; Renewal a. A pharmacist's registration to engage in collaborative drug therapy management with a physician shall terminate and become void, null and without effect upon the earlier of: i. death of either the pharmacist or physician; ii. loss of license of the pharmacist; iii. disciplinary action limiting the ability of the pharmacist to enter into collaborative drug therapy management; iv. notification to the board that the pharmacist has withdrawn from collaborative drug therapy management; v. a finding by the board of any of the causes that would render a pharmacist ineligible for registration; or vi. expiration of a pharmacist’s license or registration to engage in collaborative drug therapy management for failure to timely renew such license or registration. b. Registration of authority to engage in collaborative drug therapy management shall expire annually on the same day as a pharmacist’s license unless renewed by the pharmacist by completing the application form supplied by the board. An application for registration renewal shall be made part of and/or accompany a pharmacist’s renewal application for pharmacist licensure. c. The timely submission of an application for renewal of registration shall operate to continue the expiring registration in effect pending renewal of registration or other final action by the board on such application for renewal. C. Advisory Committee. The Collaborative Drug Therapy Management Advisory Committee, constituted as provided for in LAC 46:XLV.7417, shall assist the Board of Medical Examiners and the Board of Pharmacy on matters relative to collaborative drug therapy management. The president of the Board of Pharmacy shall appoint a pharmacist to serve on the committee, and said pharmacist shall serve at the pleasure of the Board of Pharmacy. D. Standards of Practice 1. Authority, Responsibility, and Limitations of Collaborative Drug Therapy Management a. A pharmacist registered with the board under this Section may engage in collaborative drug therapy management with a physician in accordance with a patient specific, drug specific, disease specific order set satisfying the requirements of this Section. b. A pharmacist engaged in collaborative drug therapy management shall: i. retain professional responsibility to his patient for the management of their drug therapy; ii. establish and maintain a pharmacist-patient relationship with each patient subject to collaborative drug therapy management; iii. be geographically located to be physically present to provide pharmacist care to a patient subject to collaborative drug therapy management; iv. provide on a scheduled basis no less than every three months, a status report on the patient, including but not limited to, any problem, complication, or other issues relating to patient non-compliance with drug therapy management. This requirement may be met by entering the information in the patient’s medical record.; and v. be available through direct telecommunication for consultation, assistance, and direction. c. A pharmacist's registration to engage in collaborative drug therapy management with a physician is personal to the pharmacist. A pharmacist registered to engage in drug therapy management shall not allow another pharmacist not so registered or any other individual to exercise the authority conferred by such registration. d. Collaborative drug therapy management shall only be utilized for disease specific drug therapy as defined in this Section. e. The scope of the collaborative drug therapy management shall not include: i. any patient of the physician for whom such physician has not prepared a patient specific, drug specific, disease or condition specific order set based on a face-to- face visit with the patient; ii. initiation or discontinuance of drug therapy by a pharmacist, except as specified in the order set; iii. the management of controlled substances or drugs of concern; or iv. substitution of a drug prescribed by a physician without the explicit written consent of such physician. 2. Informed Consent a. A pharmacist shall not engage in collaborative drug therapy management of a patient without the patient’s written informed consent. b. In addition to the requirements provided by law for obtaining a patient’s informed consent, each patient who is subject to collaborative drug therapy management shall be: i. informed of the collaborative nature of drug therapy management for the patient’s specific medical disease or condition and provided instructions and contact information for follow-up visits with the pharmacist and physician; ii. informed he may decline to participate in a collaborative drug therapy management practice and may withdraw at any time without terminating the physician- patient or pharmacist-patient relationship; and Title 46, Part LIII Louisiana Administrative Code August 2022 19 iii. provided written disclosure of any contractual or financial arrangement with any other party that may impact one of the party’s decision to participate in the agreement. c. All services provided shall be performed in a setting which insures patient privacy and confidentiality. 3. Order Sets a. A separate order set shall be written for each patient to be managed by collaborative drug therapy management. A copy of each order set shall be: i. provided to the collaborating physician and pharmacist; and ii. made part of the patient’s pharmacy record. b. A physician shall develop a patient specific order set for a particular patient or utilize a standard written protocol order set, incorporating what patient specific deviations, if any, the physician may deem necessary or appropriate for such patient. In either event, an order set for disease specific drug therapy shall adhere to generally accepted standards of care and shall identify, at a minimum: i. the pharmacist, the physician, and telephone number and other contact information for each; ii. the patient’s name, address, gender, date of birth, and telephone number; iii. the disease or condition to be managed; iv. the disease specific drug or drugs to be utilized; v. the type and extent of drug therapy management the physician authorizes the pharmacist to perform; vi. the specific responsibilities of the pharmacist and physician; vii. the procedures, criteria, or plan the pharmacist is required to follow in connection with drug therapy management; viii. the specific laboratory test or tests, if any, directly related to drug therapy management the physician authorizes the pharmacist to order and evaluate; ix. the reporting and documentation requirements of the pharmacist and physician respecting the patient and schedule by which such are to take place; x. the conditions and events upon which the pharmacist and physician are required to notify one another; and xi. procedures to accommodate immediate consultation by telephone or direct telecommunication with, between, or among the pharmacist, physician, and the patient. c. Each order set utilized for collaborative drug therapy management of a patient shall be reviewed annually by the collaborating physician, or more frequently as such physician deems necessary, to address patient needs and to insure compliance with the requirements of this Section. The physician’s signature and date of review shall be noted on the order set and maintained by the pharmacist in accordance with this Section. 4. Reporting Obligations and Responsibilities a. A pharmacist engaged in collaborative drug therapy management shall report annually, as a condition to the renewal of his registration, whether or not and the extent to which the pharmacist is engaged in collaborative drug therapy management and such other information as the board may request. b. A pharmacist engaged in collaborative drug therapy management shall comply with reasonable requests by the board for personal appearances or information relative to the functions, activities, and performance of a pharmacist or physician engaged in collaborative drug therapy management. 5. Records a. The following information shall be included in the pharmacy’s record of a patient subject to collaborative drug therapy management: i. the prescription or order implementing collaborative drug therapy management; ii. the order set applicable to the patient evidencing documentation of the physician’s annual review; iii. documentation of all activities performed by the pharmacist; iv. consultations and status reports by and between the pharmacist and physician; and v. documentation of the patient’s informed consent to collaborative drug therapy management. b. A pharmacist registered to engage in collaborative drug therapy management shall maintain and produce, upon inspection conducted by or at the request of a representative of the board, a copy of any order sets and such other records or documentation as may be requested by the board to assess a pharmacist’s compliance with requirements of this Section, the Pharmacy Practice Act, or other applicable board rules. E. Sanctions 1. Action against Registration. For noncompliance with any of the provisions of this Section, the board may, in addition to or in lieu of administrative proceedings against a pharmacist's license, suspend or revoke a pharmacist's registration to engage in collaborative drug therapy management, or may impose such terms, conditions, or restrictions thereon as the board may deem necessary or appropriate. 2. Action against Pharmacist License. Any violation or failure to comply with the provisions of this Section shall be deemed a violation of R.S. 37:1241(A)1, as well as a violation of any other applicable provisions of R.S. PROFESSIONAL AND OCCUPATIONAL STANDARDS Louisiana Administrative Code August 2022 22 b. Upon written request by the pharmacy intern, the Louisiana Board of Pharmacy may certify professional experience hours earned in Louisiana to a board of pharmacy in another jurisdiction. 5. Credited hours of experience shall expire two years after the expiration date of the intern registration and shall no longer be valid for licensure purposes. AUTHORITY NOTE: Promulgated in accordance with R.S. 37:1211. HISTORICAL NOTE: Promulgated by the Department of Health and Hospitals, Board of Pharmacy, LR 14:708 (October 1988), effective January 1, 1989, LR 26:2285 (October 2000), amended LR 29:2086 (October 2003), effective January 1, 2004, LR 32:636 (April 2006), LR 32:2256 (December 2006), LR 33:1130 (June 2007), LR 34:1409 (July 2008), amended by the Department of Health, Board of Pharmacy, LR 43:2163 (November 2017), effective January 1, 2018. §707. Impairment A. Impairment or Impaired—a condition that causes an infringement on the ability of a person to practice, or assist in the practice, of pharmacy sufficient to pose a danger to the public. Impairment may be caused by, but is not limited to, alcoholism, substance abuse or addiction, mental illness, or physical illness. B. Pharmacy interns shall be non-impaired. C. Pharmacy interns who have knowledge a pharmacist, pharmacy intern, pharmacy technician, or pharmacy technician candidate is impaired shall notify the board of that fact as soon as possible. D. Pharmacy interns may be subject to a medical evaluation for impairment by a board approved addictionist, as authorized by the Louisiana Pharmacy Practice Act, R.S. 37:1161 et seq. AUTHORITY NOTE: Promulgated in accordance with R.S. 37:1211. HISTORICAL NOTE: Promulgated by the Department of Health and Hospitals, Board of Pharmacy, LR 33:1130 (June 2007). §709. Scope of Practice A. Pharmacy interns may perform any duty of a pharmacist provided he is under the supervision of a pharmacist. B. The ratio of pharmacy interns to pharmacists shall be 1:1. However, the ratio of pharmacy interns on rotation with a board-approved college of pharmacy to pharmacists shall be no more than 3:1. C. A pharmacy intern may not: 1. present or identify himself as a pharmacist; 2. sign or initial any document which is required to signed or initialed by a pharmacist unless a preceptor cosigns the document; or 3. independently supervise pharmacy technicians or pharmacy technician candidates. AUTHORITY NOTE: Promulgated in accordance with R.S. 37:1182. HISTORICAL NOTE: Promulgated by the Department of Health and Hospitals, Board of Pharmacy, LR 36:755 (April 2010), amended by the Department of Health, Board of Pharmacy, LR 48:495 (March 2022). §711. Administration of Medications A. Education and Training Required; Supervision 1. Pharmacy interns who intend to administer medications to their patients shall obtain the education and training described within this Section prior to engaging in such activity. 2. Pharmacy interns, once properly qualified as required by the provisions of this Section, may only administer medications to patients while under the supervision of a pharmacist with the same qualification in medication administration as described in Chapter 5 of this Part. B. Education, Training and Continuing Competency 1. A pharmacy intern who intends to administer medications to patients shall possess a pharmacy intern registration in active status. In the event the registration is lapsed, suspended, or in any other inactive status, the pharmacy intern shall not administer medications. A pharmacy intern with a registration in restricted status may administer medications unless the restriction imposed by the board prevents such activity. 2. The pharmacy intern shall successfully complete a certificate program for medication administration which is an evidence-based didactic course that meets current Centers for Disease Control and Prevention (CDC) training guidelines. The certificate program shall be acquired from a provider accredited by ACPE, or in the alternative, by Joint Accreditation (JA); and further, the certificate program shall provide a minimum of 20 hours of instruction and experiential training in the following content areas: a. standards for medication administration practices; b. basic immunology; c. recommended medication administration schedules; d. vaccine storage and management; e. informed consent; f. physiology and techniques for medication administration; g. pre- and post-administration assessment and counseling; h. medication administration record management; and i. management of adverse events, including identification and appropriate response, as well as documentation and reporting. 3. The pharmacy intern shall complete a life safety certification by the American Heart Association through its Title 46, Part LIII Louisiana Administrative Code August 2022 23 Basic Life Support (BLS) CPR and AED Training for Healthcare Professionals course, or its successor, or through an equivalent course sponsored by an alternative vendor. The pharmacy intern may substitute the Advanced Cardiac Life Support (ACLS) course for the BLS standard; however, the Heartsaver CPR and AED or other courses intended for the general public shall not be sufficient to meet this standard. The pharmacy intern shall renew their certification prior to the expiration date assigned by the course provider. 4. To maintain continuing competency for medication administration, the pharmacy intern shall acquire at least one hour of continuing pharmacy education per year related to this topic. Continuing pharmacy education activities obtained for this purpose shall be acquired from a provider accredited by ACPE, or in the alternative, by JA. 5. The pharmacy intern shall retain evidence of their education, training and continuing competency; and further, shall furnish copies of such documentation upon request by the board. 6. Sanctions a. The failure of a pharmacy intern to obtain and maintain the education, training and continuing competency described in this Section prior to administering medications to patients shall substantiate a violation of R.S. 37:1241(A)(3), and shall subject the pharmacy intern to disciplinary action by the board. b. The failure of a pharmacy intern to provide documentation of their education, training and continuing competency to administer medications when requested by the board shall substantiate a violation of R.S. 37:1241(A)(22), and shall subject the pharmacy intern to disciplinary action by the board. AUTHORITY NOTE: Promulgated in accordance with R.S. 37:1182. HISTORICAL NOTE: Promulgated by the Department of Health, Board of Pharmacy, LR 48:495 (March 2022). Chapter 9. Pharmacy Technicians §901. Definitions A. As used in this Chapter, the following terms shall have the meaning ascribed to them in this Section. ACPE―Accreditation Council for Pharmacy Education. CPE―continuing pharmaceutical education, as part of a postgraduate educational program to enhance professional competence. CPE Monitor—a collaborative service from the National Association of Boards of Pharmacy (NABP) and the Accreditation Council for Pharmacy Education (ACPE) that provides an electronic system for pharmacists and pharmacy technicians to record and track their completed CPE activities. CPE unit―a standard of measurement adopted by the ACPE for the purpose of accreditation of CPE programs. One CPE unit is equivalent to 10 credit hours. Pharmacy Technician―an individual, certified by the board, who assists in the practice of pharmacy under the direct and immediate supervision of a Louisiana-licensed pharmacist. Pharmacy Technician Candidate—an individual, registered by the board, training to become a pharmacy technician, who assists in the practice of pharmacy under the direct and immediate supervision of a Louisiana-licensed pharmacist. Training Program—a pharmacy technician training program that is currently nationally-accredited and has been approved by the board. AUTHORITY NOTE: Promulgated in accordance with R.S. 37:1212. HISTORICAL NOTE: Promulgated by the Department of Health and Hospitals, Board of Pharmacy, LR 30:2485 (November 2004), effective January 1, 2005, amended LR 39:1777 (July 2013), amended by Department of Health, Board of Pharmacy, LR 43:2496 (December 2017), effective January 1, 2018. §903. Pharmacy Technician Candidates A. Registration 1. All pharmacy technician candidates shall obtain a registration from the board prior to performing any professional functions in a pharmacy; failure to do so may result in disciplinary action by the board. 2. Qualifications a. The applicant shall be at least 18 years of age, as evidenced by a valid and legible copy of a birth certificate or other appropriate credential. b. The applicant shall be of good moral character and non-impaired. c. The applicant shall satisfy one of the following eligibility criteria: i. proof of enrollment in a nationally-accredited and board-approved pharmacy technician training program; or ii. Proof of successful completion of a board- approved technician certification examination, and further, proof of successful completion of a high school approved by a state department of education or an equivalent degree of education, as evidenced by a valid and legible copy of a diploma, transcript, or other appropriate credential. d. Exceptions i. A pharmacist or pharmacist intern whose board credential has been denied, suspended, revoked, or restricted for disciplinary reasons by any board of pharmacy shall not be a pharmacy technician candidate or pharmacy technician. ii. A pharmacist or pharmacist intern whose board credential is lapsed shall not be a pharmacy technician candidate or pharmacy technician until such lapsed credential is recalled through non-disciplinary board action. 3. Issuance and Maintenance PROFESSIONAL AND OCCUPATIONAL STANDARDS Louisiana Administrative Code August 2022 24 a. Upon receipt of a properly completed application, appropriate fee, and any other documentation required by the board, the board may issue a Pharmacy Technician Candidate Registration to the applicant. b. The board reserves the right to refuse to issue, recall, or discipline a registration for cause. c. The registration shall expire 24 months after the date of issuance, and it shall not be renewable. d. Termination of Enrollment; Status of Registration i. In the event the candidate is no longer enrolled in a nationally-accredited and board-approved pharmacy technician training program for any reason other than graduation, the candidate no longer meets the eligibility criteria to possess the registration, and the candidate shall relinquish the registration to the board, giving notice of their last day of enrollment in the program. ii. In the event a candidate fails to relinquish their registration when required to do so, or when notified by the board office of that requirement, the board staff shall inactivate the registration and refer the matter to the board for its consideration of disciplinary action against the candidate. iii. In the event the candidate should re-enroll in the original program or a different program, and gives proof of that enrollment to the board, the board may re-issue the registration with the original expiration date preserved. iv. In its discretion, the board may grant an exception to the original expiration date upon request by the candidate demonstrating unusual circumstances. e. A pharmacy technician candidate shall notify the board, in writing, no later than 10 days following a change of mailing address. The written notice shall include the candidate’s name, registration number, and old and new addresses. f. A pharmacy technician candidate shall notify the board, in writing, no later than 10 days following a change in location(s) of employment. The written notice shall include the candidate’s name, registration number, and name, address, and permit numbers for old and new employers. B. Training Programs 1. All training programs approved by the board shall maintain their national accreditation. 2. The training program shall notify the board when a pharmacy technician candidate is no longer enrolled in the program. Evidence of a program’s failure to comply with this rule shall constitute sufficient basis for the withdrawal of the board’s approval for the program. 3. The training program shall provide an appropriate credential to the pharmacy technician candidate who has successfully completed the program, provided, however, that such credential shall not be formatted in such a manner to lead anyone to believe that credential resembles a document providing legal authority to practice as a pharmacy technician. C. Practical Experience 1. The candidate shall possess a registration prior to performing any permitted professional function or earning any practical experience in a pharmacy. 2. The candidate shall wear appropriate attire and be properly identified as to name and candidate status while on duty in the prescription department. 3. A candidate shall not work in a permitted site that is on probation with the board, or with a pharmacist who is on probation with the board. 4. The candidate’s registration shall evidence his authority to earn practical experience in a pharmacy, under the supervision of a pharmacist, in satisfaction of the requirements for pharmacy technician certification: a. in the event the registration was issued to an applicant enrolled in a nationally-accredited and board- approved training program, the candidate shall earn the amount of experience prescribed by the curriculum of that program, which may include hours earned in a consultant pharmacy practice which does not hold a pharmacy permit; or b. in the event the registration was issued to an applicant by any other method, the candidate shall earn at least 600 hours of practical experience in a pharmacy in Louisiana, provided however, that a candidate may receive board credit for a maximum of 50 hours per week. 5. Hours of practical experience earned by a candidate shall expire two years after the expiration date of the registration. D. Examination 1. A board-approved technician examination shall consist of integrated pharmacy subject matter and any other disciplines the board may deem appropriate in order to permit the candidate to demonstrate his competency. The candidate shall achieve a passing score, as determined by the board. 2. In the event the candidate fails the examination, the candidate may repeat the examination in compliance with the test administrator’s policy. AUTHORITY NOTE: Promulgated in accordance with R.S. 37:1212. HISTORICAL NOTE: Promulgated by the Department of Health and Hospitals, Board of Pharmacy, LR 30:2485 (November 2004), effective January 1, 2005, amended LR 39:1777 (July 2013), amended by the Department of Health, Board of Pharmacy, LR 43:2496 (December 2017), effective January 1, 2018, repromulgated LR 44:49 (January 2018), amended LR 46:574 (April 2020), amended LR 46:576 (April 2020). §904. Preferential Licensing Procedures for Military- Trained Applicants and Their Dependents A. Definitions. The following terms shall have the meaning ascribed to them in this Subsection: Title 46, Part LIII Louisiana Administrative Code August 2022 27 2. interpret prescription orders (however, a technician may translate prescription orders); 3. counsel patients. AUTHORITY NOTE: Promulgated in accordance with R.S. 37:1212. HISTORICAL NOTE: Promulgated by the Department of Health and Hospitals, Board of Pharmacy, LR 30:2486 (November 2004), effective January 1, 2005, amended LR 32:1049 (June 2006), amended by the Department of Health, Board of Pharmacy, LR 43:2498 (December 2017), effective January 1, 2018, amended LR 48:496 (March 2022). §909. Continuing Education A. A minimum of one technician-specific ACPE or board-approved CPE unit, or 10 credit hours, shall be required each year as a prerequisite for annual renewal of a pharmacy technician certificate. Such CPE units shall be credited in the 12-month period prior to the expiration date of the certificate. B. Certified pharmacy technicians shall maintain copies of their individual records of personal CPE activities with CPE monitor and shall authorize the board’s access to their file by recording their Louisiana pharmacy technician certificate number within that file, and shall present a copy of their CPE monitor transcript when requested by the board. C. If judged appropriate by the board, some or all of the required number of hours may be mandated on specific subjects. When so deemed, the board shall notify all certified pharmacy technicians prior to the beginning of the renewal year in which the CPE is required. D. Complete compliance with CPE rules is a prerequisite for renewal of a pharmacy technician certificate. 1. Non-compliance with the CPE requirements shall be considered a violation of R.S. 37:1241(A)(2) and shall constitute a basis for the board to refuse annual renewal. 2. The failure to maintain an individual record of personal CPE activities, or falsifying CPE documents, shall be considered a violation of R.S. 37:1241(A)(22). 3. The inability to comply with CPE requirements shall be substantiated by a written explanation, supported with extraordinary circumstances, and submitted to the board for consideration. AUTHORITY NOTE: Promulgated in accordance with R.S. 37:1212. HISTORICAL NOTE: Promulgated by the Department of Health and Hospitals, Board of Pharmacy, LR 30:2487 (November 2004), effective January 1, 2005, amended LR 39:1778 (July 2013), amended by the Department of Health, Board of Pharmacy, LR 43:2498 (December 2017), effective January 1, 2018. §911. Impairment A. Pharmacy technician candidates and pharmacy technicians shall be non-impaired. B. Pharmacy technician candidates and pharmacy technicians who have knowledge that a pharmacist, pharmacist intern, pharmacy technician candidate, or pharmacy technician is impaired shall notify the board of that fact. C. Pharmacy technician candidates and pharmacy technicians shall be subject to a medical evaluation for impairment by a board-approved addictionist, as authorized by the Louisiana Pharmacy Practice Act, R.S. 37:1161 et seq. AUTHORITY NOTE: Promulgated in accordance with R.S. 37:1212. HISTORICAL NOTE: Promulgated by the Department of Health and Hospitals, Board of Pharmacy, LR 14:708 (October 1988), effective January 1, 1989, LR 17:779 (August 1991), repromulgated LR 19:1025 (August 1993), LR 23:1308 (October 1997), LR 30:2487 (November 2004), effective January 1, 2005. §913. Administration of Medications A. Education and Training Required; Supervision 1. Pharmacy technicians who intend to administer medications to their patients shall obtain the education and training described within this Section prior to engaging in such activity. 2. Pharmacy technicians, once properly qualified as required by the provisions of this Section, may only administer medications to patients while under the supervision of a pharmacist with the same qualification in medication administration as described in Chapter 5 of this Part. B. Education, Training and Continuing Competency 1. A pharmacy technician who intends to administer medications to patients shall possess a pharmacy technician certificate in active status. In the event the certificate is lapsed, suspended, or in any other inactive status, the pharmacy technician shall not administer medications. A pharmacy technician with a certificate in restricted status may administer medications unless the restriction imposed by the board prevents such activity. 2. The pharmacy technician shall successfully complete a certificate program for medication administration which is an evidence-based didactic course that meets current Centers for Disease Control and Prevention (CDC) training guidelines. The certificate program shall be acquired from a provider accredited by ACPE, or in the alternative, by Joint Accreditation (JA); and further, the certificate program shall provide a minimum of six hours of instruction and experiential training in the following content areas: a. recognition of vaccines and other medications and their corresponding routes of administration; b. proper storage of vaccines and other medications; c. safety procedures to avoid accidental needlestick injuries; d. selection of proper needle length for injectable medications based on patient parameters; e. proper technique for preparation and administration of medication; PROFESSIONAL AND OCCUPATIONAL STANDARDS Louisiana Administrative Code August 2022 28 f. demonstration of appropriate patient distraction techniques during medication administration; g. demonstration of appropriate technique for intramuscular and subcutaneous injections; h. demonstration of use of universal precautions pertinent to bloodborne pathogens; i. procedures for management of adverse reactions; and j. proper documentation procedures. 3. The pharmacy technician shall complete a life safety certification by the American Heart Association through its Basic Life Support (BLS) CPR and AED Training for Healthcare Professionals course, or its successor, or through an equivalent course sponsored by an alternative vendor. The pharmacy technician may substitute the Advanced Cardiac Life Support (ACLS) course for the BLS standard; however, the Heartsaver CPR and AED or other courses intended for the general public shall not be sufficient to meet this standard. The pharmacy technician shall renew their certification prior to the expiration date assigned by the course provider. 4. To maintain continuing competency for medication administration, the pharmacy technician shall acquire at least one hour of continuing pharmacy education per year related to this topic. Continuing pharmacy education activities obtained for this purpose shall be acquired from a provider accredited by ACPE, or in the alternative, by JA; and further, the credit earned for such programs may be included within the total number of credits required to renew the pharmacy technician certificate. 5. The pharmacy technician shall retain evidence of their education, training and continuing competency; and further, shall furnish copies of such documentation upon request by the board. 6. Sanctions a. The failure of a pharmacy technician to obtain and maintain the education, training and continuing competency described in this Section prior to administering medications to patients shall substantiate a violation of R.S. 37:1241(A)(3), and shall subject the pharmacy technician to disciplinary action by the board. b. The failure of a pharmacy technician to provide documentation of their education, training and continuing competency to administer medications when requested by the board shall substantiate a violation of R.S. 37:1241(A)(22), and shall subject the pharmacy technician to disciplinary action by the board. AUTHORITY NOTE: Promulgated in accordance with R.S. 37:1182. HISTORICAL NOTE: Promulgated by the Department of Health, Board of Pharmacy, LR 48:496 (March 2022). Chapter 11. Pharmacies Subchapter A. General Requirements §1101. Pharmacy A. Qualification. Individuals, partnerships, corporations, limited liability companies, or associations desiring to operate a pharmacy in Louisiana, or outside the state where prescriptions drugs/devices are dispensed and delivered to Louisiana residents, shall execute an application for a pharmacy permit for their particular classification of pharmacy. B. Appearance. The applicants, including the pharmacist-in-charge, may be required to personally appear before the board prior to a board decision on the permit application. C. Pharmacy Permit 1. The initial pharmacy permit application shall be completed and signed by the pharmacist-in-charge and the owner of the pharmacy and submitted to the board for approval. An application for a pharmacy permit shall expire one year after the date of receipt in the board office. 2. Renewal. A pharmacy permit that has not been renewed by December 31 of each year shall expire and be null and void. AUTHORITY NOTE: Promulgated in accordance with R.S. 37:1182. HISTORICAL NOTE: Promulgated by the Department of Health and Hospitals, Board of Pharmacy, LR 14:708 (October 1988), effective January 1, 1989, LR 23:1310 (October 1997), amended LR 29:2087 (October 2003), effective January 1, 2004, LR 33:1131 (June 2007). §1103. Prescription Department Requirements A. A prescription department of a pharmacy shall provide sufficient floor space, fixtures, equipment and supplies commensurate with the nature and scope of the pharmacy’s practice to ensure that drugs are compounded and dispensed in a well-lighted, ventilated, climate controlled, and safely enclosed structure. B. Restricted. A prescription department is a restricted area. C. Prescription Department Plumbing. A sink equipped with hot and cold running water shall be located within the prescription department. A sink located in a pharmacy restroom shall not be sufficient to satisfy this requirement. D. Electronic Record Keeping System. An electronic record keeping system shall be utilized in a pharmacy department and shall be a complete, accurate, and readily retrievable prescription record keeping and storage system. E. Drug Inventory 1. Storage. The pharmacy shall provide an adequate prescription inventory in order to compound and dispense prescription orders. Drugs that require special storage shall be properly stored. Title 46, Part LIII Louisiana Administrative Code August 2022 29 2. Missing or Damaged Inventory. When significant drug inventory is missing or damaged for any reason, the pharmacy owner or pharmacist-in-charge shall file with the board a signed statement of the circumstances of such occurrence and evidence that the appropriate law enforcement authorities were notified as required by law. F. Pharmacy Security. The prescription department or the premises housing the prescription department shall be adequately secured by the installation of partitions and secured entrances, which shall be locked by a pharmacist and made inaccessible when the prescription department is closed. The prescription department or any premises housing a prescription department shall be adequately secured by an alarm system. G. Emergency Access. An additional key to the prescription department may be maintained in a secure location outside the prescription department for use during an emergency. A log shall be maintained with the key, indicating the name of each non-pharmacist using this key, the date and time of entry, and the nature of the emergency. H. References. The current edition of the Louisiana Board of Pharmacy Laws and Regulations shall be maintained and readily available within the prescription department of a pharmacy. The pharmacy shall maintain access to current and appropriate reference materials pertinent to the pharmacy practice, including but not limited to, veterinary pharmacy. I. Pharmacies hosting medication administration activities, as well as pharmacists administering medications in a location other than a pharmacy, shall comply with the following minimum standards. 1. There shall be sufficient staffing available for the pharmacist to administer the medication, supervise any other pharmacy personnel administering medications, and monitor the patient afterward without distraction from other responsibilities. 2. To facilitate emergency management of anaphylactic reactions, there shall be adequate supplies of medication and equipment, as well as pre-determined procedures for the arrangement of emergency medical services. AUTHORITY NOTE: Promulgated in accordance with R.S. 37:1182. HISTORICAL NOTE: Promulgated by the Department of Health and Hospitals, Board of Pharmacy, LR 23:1310 (October 1997), amended LR 29:2087 (October 2003), effective January 1, 2004, LR 39:315 (February 2013), amended by Department of Health, Board of Pharmacy, LR 46:579 (April 2020), LR 47:1642 (November 2021), LR 48:497 (March 2022). §1105. Pharmacist-in-Charge A. The opportunity to accept an appointment as the pharmacist-in-charge (PIC) of a pharmacy is a professional privilege. The following requirements are attached to a PIC privilege. 1. The acquisition of the PIC privilege shall require: a. possession of an active Louisiana pharmacist license; b. active pharmacy practice for a minimum of two years under the jurisdiction of any board of pharmacy in the United States; and c. the completion of the affidavit of responsibility and duties described below. 2. The PIC shall be present and practicing at the pharmacy for which he holds the PIC position no less than 20 hours per week during the pharmacy’s ordinary course of business. In the event the pharmacy’s normal hours of business are less than 20 hours per week the PIC shall be present and practicing at least 50 percent of the normal business hours. B. An initial and renewal pharmacy permit application shall designate and identify the licensed pharmacist-in- charge. C. Authority and Accountability. The pharmacist-in- charge shall be ultimately responsible for complete supervision, management, and compliance with all federal and state pharmacy laws and regulations pertaining to the practice of pharmacy of the entire prescription department. This responsibility necessarily includes accountability for any violation involving federal or state laws or regulations occurring within the prescription department supervised by a pharmacist-in-charge. D. Policy and Procedure Manual. The pharmacist-in- charge shall be responsible for the implementation of policies and procedures regarding quality pharmacy services including drug control, distribution, patient compliance accountability, inspection, and record keeping. E. Circumvention. It is a violation of the pharmacy permit for any person to subvert the authority of the pharmacist-in-charge by impeding the management of the prescription department in the compliance of federal and state pharmacy laws and regulations. F. Records. The pharmacist-in-charge shall be responsible for the proper maintenance of all prescription records. This necessarily includes electronic prescription records and the system's compliance and capacity to produce the required records. G. Recall. The pharmacist-in-charge shall be responsible for the implementation of a recall procedure that can be readily activated to assure patient safety. H. Discontinued and Outdated Drugs. The pharmacist-in- charge shall be responsible for the implementation of policies and procedures to ensure that discontinued or outdated drugs, or containers with worn, illegible, or missing labels are withdrawn from the pharmacy inventory. I. Change of Pharmacist-in-Charge. Written notice to the board shall be required when the pharmacist-in-charge designation for a pharmacy has changed. 1. The permit holder shall notify the board within 30 days of the prior pharmacist-in-charge’s departure date. The PROFESSIONAL AND OCCUPATIONAL STANDARDS Louisiana Administrative Code August 2022 32 Personal Identifiera unique user name or number for identifying and tracking a specific user’s access to a pharmacy information system such as Social Security number, user identification number, or employee number. Positive Identificationa method of identifying an individual who prescribes, administers, or dispenses a prescription drug. a. A method may not rely solely on the use of a private personal identifier such as a password, but must also include a secure means of identification such as the following: i. a manual signature on a hard copy record; ii. a magnetic card reader; iii. a bar code reader; iv. a thumbprint reader or other biometric method; v. a proximity badge reader; vi. a register in which each individual pharmacist dispensing a prescription shall sign a log each day, attesting to the fact that the information entered into the electronic record keeping system has been reviewed that day, and is correct as stated; vii. a printout of every transaction that is verified and manually signed within a reasonable period of time by the individual who prescribed, administered, or dispensed the prescription drug. The printout must be maintained for two years and made available on request to an agent of the board. b. A method relying on a magnetic card reader, a bar code reader, or a proximity badge reader must also include a private personal identifier, such as a password, for entry into a secure mechanical or electronic system. Prescription or Prescription Drug Order—an order from a practitioner authorized by law to prescribe for a drug or device that is patient-specific and is communicated by any means to a pharmacist in a permitted pharmacy, and is to be preserved on file as required by law or regulation. AUTHORITY NOTE: Promulgated in accordance with R.S. 37:1182. HISTORICAL NOTE: Promulgated by the Department of Health and Hospitals, Board of Pharmacy, LR 23:1312 (October 1997), LR 29:2090 (October 2003), effective January 1, 2004, LR 40:2252 (November 2014), effective January 1, 2015, amended by the Department of Health, Board of Pharmacy, LR 46:580 (April 2020). §1121. General Requirements A. Requirements 1. All records relating to the practice of pharmacy shall be uniformly maintained for a period of two years, be readily available, and promptly produced upon request for inspection by an agent of the board during regular business hours. 2. All records required by the laws and regulations of the board shall be provided to the board, or its agents, within 72 hours of request, unless a shorter period is required, as determined by the board or its agent. 3. The failure to produce any pharmacy records requested by the board or its agent within 72 hours of such request shall substantiate a violation of R.S. 37:1241(A)(22). B. Accountability. The holder of the pharmacy permit and the pharmacist-in-charge shall account for all prescription drug transactions, consisting of: 1. Acquisition Recordsinvoice receipts of drugs acquired; 2. Disposition Records—drugs dispensed pursuant to prescription drug orders or chart orders, administered pursuant to medical orders, or distributed pursuant to purchase orders, and 3. Inventory Records—drugs in current possession. C. Retention. Except as provided in Section 1123 of this Part, all records required by this Part and by Louisiana law shall be retained for a minimum of two years from the most recent transaction. The failure to retain such records for at least two years shall substantiate a violation of R.S. 37:1229. AUTHORITY NOTE: Promulgated in accordance with R.S. 37:1182. HISTORICAL NOTE: Promulgated by the Department of Health and Hospitals, Board of Pharmacy, LR 23:1312 (October 1997), amended LR 29:2090 (October 2003), effective January 1, 2004, LR 40:2252 (November 2014), effective January 1, 2015, amended by the Department of Health, Board of Pharmacy, LR 46:580 (April 2020). §1123. Records of Prescription Drug Orders and Chart Orders A. There shall be positive identification of the pharmacist, intern, technician, or technician candidate responsible for performing all activities related to the practice of pharmacy including, but not limited to: 1. prescription information entered into the pharmacy information system; 2. prospective drug utilization review; 3. prescription dispensing; 4. administration of immunizations. B. A pharmacy may use one of the following types of pharmacy information systems. 1. A system that utilizes the original hard copy prescription or chart order to document the initial dispensing, but utilizes a computerized system to dispense refills that does not document the positive identification of the pharmacist responsible for the practice of pharmacy. In order to document positive identification, this system shall require the manual signature or initials of a pharmacist on a hard copy record as specified in Subsection E of this Section. Title 46, Part LIII Louisiana Administrative Code August 2022 33 2. an electronic recordkeeping system that complies with the provisions of 21 CFR 1311 et seq. and documents the positive identification of the pharmacist responsible for the practice of pharmacy. Such systems shall provide for routine backups at least once per day. C. All pharmacy information systems shall be capable of providing immediate retrieval (via display and hard copy printout or other mutually agreeable transfer media) of patient profile information for all prescriptions drug orders and chart orders dispensed within the previous two years. This information shall include the following minimum data: 1. the original prescription number; 2. date of issuance of the original prescription drug order or chart order by the prescriber; 3. date of dispensing by the pharmacist; 4. full name and address of the patient; 5. full name and address of the prescriber; 6. directions for use; 7. the name, strength, dosage form, and quantity of the drug prescribed; 8. the quantity dispensed if different from the quantity prescribed; 9. the pharmacist responsible for prescription information entered into the computer system, the pharmacist responsible for prospective drug utilization review as defined in Section 515 of this Part, and the pharmacist responsible for dispensing; 10. the total number of refills authorized by the prescriber; and 11. the refill history of the prescription as defined in Subsection D of this Section. D. The refill history of the prescription record maintained in the pharmacy information system shall include, but is not limited to: 1. the prescription number; 2. the name and strength of the drug dispensed; 3. the date of the refill or partial fill; 4. the quantity dispensed; 5. the pharmacist responsible for prospective drug utilization review as defined in Section 515 of this Part, and the pharmacist responsible for dispensing each refill; 6. the total number of refills or partial fills dispensed to date for that prescription order. E. The hard copy documentation required pursuant to Paragraph B.1 of this Section shall be provided by each individual pharmacist who makes use of such system by signing a statement attesting to the fact that the prescription information entered into the computer is correct as displayed. F. Backup Support System 1. The pharmacy information system shall be capable of being reconstructed in the event of an electronic or computer malfunction or unforeseen accident resulting in the destruction of the system or the information contained therein. To prevent the accidental loss of electronic records, an adequate backup system shall be maintained. Backup support systems shall be updated at least once daily. 2. In the event the pharmacy information system experiences down time, a record of all refills dispensed during such time shall be recorded and then entered into the pharmacy information system as soon as it is available for use. During the time the pharmacy information system is not available, prescriptions drug orders and chart orders may only be refilled if, in the professional judgment of the pharmacist, the number of refills authorized by the prescriber has not been exceeded. G. A pharmacy purging a pharmacy information system of prescription records shall develop a method of recordkeeping capable of providing retrieval (via display, hard copy printout, or other mutually agreeable transfer media) of information for all prescription drug orders or chart orders filled or refilled within the previous two years. This information shall include, at a minimum, the following data: 1. pharmacy name and address; 2. original prescription number; 3. date of issuance of the original prescription drug order or chart order by the prescriber; 4. date of original dispensing by the pharmacist; 5. full name and address of the patient; 6. full name and address of the prescriber; 7. directions for use; 8. name, strength, dosage form, and quantity of the drug prescribed; 9. quantity dispensed if different from the quantity prescribed; 10. total number of refills authorized by the prescriber; 11. total number of refills dispensed to date for that prescription drug order or chart order; 12. date of each refill; 13. name or initials of each individual dispensing pharmacist. H. A log shall be maintained of all changes made to a prescription record after the prescription has been dispensed. Such log may be accessible to the pharmacist for review, but shall be protected from being altered in any way. At a minimum, the log shall contain the following information: 1. date and time of change; 2. change(s) made; PROFESSIONAL AND OCCUPATIONAL STANDARDS Louisiana Administrative Code August 2022 34 3. pharmacist making the change. I. Prescription drug orders and chart orders entered into a pharmacy information system but not dispensed shall meet all of the following requirements: 1. the complete prescription information shall be entered in the computer system; 2. the information shall appear in the patient’s profile; and 3. there is positive identification, in the pharmacy information system or on the hard copy prescription, of the pharmacist who is responsible for entering the prescription information into the system. J. With respect to oral prescriptions received in the pharmacy and then transcribed to written form in the pharmacy, or written prescription drug orders or chart orders received by facsimile in the pharmacy, or written prescriptions drug orders or chart orders presented to the pharmacy, a pharmacy may use an electronic imaging system to preserve such prescriptions, but only if: 1. the system is capable of capturing, storing, and reproducing the exact image of a prescription, including the reverse side of the prescription form and its annotations; 2. any notes of clarification of and alterations to a prescription shall identify the author and shall be directly associated with the electronic image of the prescription form; 3. the image of the prescription form and any associated notes of clarification to or alterations to a prescription are retained for a period of not less than two years from the date the prescription is last dispensed; 4. policies and procedures for the use of an electronic imaging system are developed, implemented, reviewed, and available for board inspection; and 5. the prescription is not for a controlled dangerous substance. K. Filing and Retention of Prescription Forms 1. Written prescription drug order or chart order forms (including transcriptions of verbal prescriptions received in the pharmacy, prescription drug orders or chart orders received by facsimile in the pharmacy, as well as written prescription drug order or chart order forms presented to the pharmacy) shall be assembled and stored in prescription number sequence. Prescriptions for controlled dangerous substances listed in Schedule II shall be filed separately from all other prescriptions. Where multiple medications are ordered on a single prescription form and includes one or more controlled dangerous substances listed in Schedule II, then such forms shall be filed with other Schedule II prescriptions. These original hard copy prescription drug order and chart order forms shall be retained in the prescription department for a minimum of two years following the most recent transaction. 2. For those pharmacies utilizing an electronic imaging system as described in Subsection J of this Section, written prescription drug order forms may be disposed of in a manner which protects the confidentiality of protected health information. 3. Prescription drug order and chart order forms received as an electronic image or electronic facsimile directly within the pharmacy information system shall be retained within the information system for a minimum of two years following the most recent transaction. Further, the pharmacy may produce a hard copy of the prescription drug order form but shall not be required to do so merely for recordkeeping purposes. 4. Electronic prescription drug orders and chart orders, those generated electronically by the prescriber, transmitted electronically to the pharmacy, and then received electronically directly into the pharmacy information system, shall be retained within the information system for a minimum of two years following the most recent transaction. The pharmacy may produce a hard copy of the prescription drug order or chart order, but shall not be required to do so merely for recordkeeping purposes. L. Patient Profiles. All pharmacies shall maintain a patient profile system which shall provide for immediate retrieval of information regarding those patients who have received prescriptions from that pharmacy. 1. The dispensing pharmacist shall be responsible for ensuring that a reasonable effort has been made to obtain, document, and maintain at least the following records: a. the patient’s data record, which should consist of, but is not limited to, the following information: i. full name of the patient for whom the drug is intended; ii. residential address and telephone number of the patient; iii. patient’s date of birth; iv. patient’s gender; v. a list of current patient specific data consisting of at least the following: (a). known drug related allergies; (b). previous drug reactions; (c). history of or active chronic conditions or disease states; (d). other drugs and nutritional supplements, including nonprescription drugs used on a routine basis, or devices; vi. the pharmacist’s comments relevant to the individual patient’s drug therapy, including any other necessary information unique to the specific patient or drug; b. The patient’s drug therapy record, which shall contain at least the following information for all the Title 46, Part LIII Louisiana Administrative Code August 2022 37 1. If the demand is made by a Medicaid managed care organization, the prescriber or pharmacy shall refer the demand to the Department of Health. 2. If the demand is made by any other third party payor, the prescriber or pharmacy shall refer the demand to the Department of Insurance. AUTHORITY NOTE: Promulgated in accordance with R.S. 22:1006.1(C) and 46:460.33(B). HISTORICAL NOTE: Promulgated by the Department of Health, Board of Pharmacy, LR 44:2157 (December 2018), effective January 1, 2019. §1130. Louisiana Uniform Prescription Drug Prior Authorization Form LOUISIANA UNIFORM PRESCRIPTION DRUG PRIOR AUTHORIZATION FORM SECTION I - SUBMISSION Submitted to: Phone: Fax: Date: SECTION II - PRESCRIBER INFORMATION Last Name, First Name MI: NPI# or Plan Provider #: Specialty: Address: City: State: ZIP Code: Phone: Fax: Office Contact Name: Contact Phone: SECTION III - PATIENT INFORMATION Last Name, First Name MI: DOB: Phone: Male Female Other Unknown Address: City: State: ZIP Code: Plan Name (if different from Section I): Member or Medicaid ID #: Plan Provider ID: Patient is currently a hospital inpatient getting ready for discharge? ____ Yes ____ No Date of Discharge:________________ Patient is being discharged from a psychiatric facility? ____ Yes ____ No Date of Discharge:________________ Patient is being discharged from a residential substance use facility? ____ Yes ____ No Date of Discharge:________________ Patient is a long-term care resident? ____ Yes ____ No If yes, name and phone number:______________________________ EPSDT Support Coordinator contact information, if applicable: SECTION IV - PRESCRIPTION DRUG INFORMATION Requested Drug Name: Strength: Dosage Form: Route of Admin: Quantity: Days’ Supply: Dosage Interval/Directions for Use: Expected Therapy Duration/Start Date: To the best of your knowledge this medication is: _____New therapy/Initial request _____Continuation of therapy/Reauthorization request For Provider Administered Drugs only: HCPCS/CPT-4 Code: NDC#:_________________Dose Per Administration:______________________ Other Codes:________________________________________________ Will patient receive the drug in the physician’s office? ____Yes ____No – If no, list name and NPI of servicing provider/facility: ______________________________________ SECTION V - PATIENT CLINICAL INFORMATION Primary diagnosis relevant to this request: ICD-10 Diagnosis Code: Date Diagnosed: Secondary diagnosis relevant to this request: ICD-10 Diagnosis Code: Date Diagnosed: For pain-related diagnoses, pain is: _______Acute ______Chronic For postoperative pain-related diagnoses: Date of Surgery_____________________ PROFESSIONAL AND OCCUPATIONAL STANDARDS Louisiana Administrative Code August 2022 38 Pertinent laboratory values and dates (attach or list below): Date Name of Test Value SECTION VI - THIS SECTION FOR OPIOID MEDICATIONS ONLY Does the quantity requested exceed the max quantity limit allowed? ___Yes ___No (If yes, provide justification below.) Cumulative daily MME___________________ Does cumulative daily MME exceed the daily max MME allowed? ___Yes ___No (If yes, provide justification below.) SH O R T A N D L O N G -A C TI N G O P IO ID S YES (True) NO (False) THE PRESCRIBER ATTESTS TO THE FOLLOWING: A. A complete assessment for pain and function was performed for this patient. B. The patient has been screened for substance abuse / opioid dependence. (Not required for recipients in long-term care facility.) C. The PMP will be accessed each time a controlled prescription is written for this patient. D. A treatment plan which includes current and previous goals of therapy for both pain and function has been developed for this patient. E. Criteria for failure of the opioid trial and for stopping or continuing the opioid has been established and explained to the patient. F. Benefits and potential harms of opioid use have been discussed with this patient. G. An Opioid Treatment Agreement signed by both the patient and prescriber is on file. (Not required for recipients in long-term care facility.) L O N G -A C TI N G O P IO ID S H. The patient requires continuous around the clock analgesic therapy for which alternative treatment options have been inadequate or have not been tolerated. I. Patient previously utilized at least two weeks of short-acting opioids for this condition. Please enter drug(s), dose, duration and date of trial in pharmacologic/non-pharmacologic treatment section below. J. Medication has not been prescribed to treat acute pain, mild pain, or pain that is not expected to persist for an extended period of time. K. Medication has not been prescribed for use as an as-needed (PRN) analgesic. L. Prescribing information for requested product has been thoroughly reviewed by prescriber. IF NO FOR ANY OF THE ABOVE (A-L), PLEASE EXPLAIN: SECTION VII - PHARMACOLOGIC & NON-PHARMACOLOGIC TREATMENT(S) USED FOR THIS DIAGNOSIS (BOTH PREVIOUS & CURRENT): Drug name Strength Frequency Dates Started and Stopped or Approximate Duration Describe Response, Reason for Failure, or Allergy Drug Allergies: Height (if applicable): Weight (if applicable): Is there clinical evidence or patient history that suggests the use of the plan’s pre-requisite medication(s), e.g. step medications, will be ineffective or cause an adverse reaction to the patient? ____Yes ____No (If yes, please explain in Section VIII below.) SECTION VIII - JUSTIFICATION (SEE INSTRUCTIONS) Title 46, Part LIII Louisiana Administrative Code August 2022 39 By signing this request, the prescriber attests that the information provided herein is true and accurate to the best of his/her knowledge. Also, by signing and submitting this request form, the prescriber attests to statements in the ‘Attestation’ section of the criteria specific to this request, if applicable. Signature of Prescriber:___________________________________________ Date:____________________ AUTHORITY NOTE: Promulgated in accordance with R.S. 22:1006.1(C) and 46:460.33(B). HISTORICAL NOTE: Promulgated by the Department of Health, Board of Medical Examiners, LR 44:2155 (December 2018), effective January 1, 2019. Subchapter C. Pharmacy Opening, Closing, Change of Ownership, and Change of Location Procedures §1131. Pharmacy Opening Procedures A. The board has established the following procedures as a prerequisite to the opening of any pharmacy: 1. Application Form. The applicant shall obtain the appropriate application form(s) from the board. The completed form(s) shall be signed by the pharmacist-in- charge and returned to the board office, with appropriate fees, not less than 30 days prior to the anticipated opening of the pharmacy. 2. Inspection. After the board has reviewed and approved the application, a board compliance officer shall conduct an on-site inspection of the premises. 3. Compliance. Upon receipt of satisfactory evidence that the applicant is in complete compliance, the board shall issue a pharmacy permit and, if requested, a Louisiana Controlled Dangerous Substance License. AUTHORITY NOTE: Promulgated in accordance with R.S. 37:1182. HISTORICAL NOTE: Promulgated by the Department of Health and Hospitals, Board of Pharmacy, LR 29:2091 (October 2003), effective January 1, 2004, amended by the Department of Health, Board of Pharmacy, LR 47:1643 (November 2021). §1133. Pharmacy Closing Procedures A. A pharmacy permit holder shall notify the public and the board prior to discontinuing a prescription department operation, or upon petitioning for bankruptcy. 1. Public Notice. The holder of a pharmacy permit shall post a closing notice in a conspicuous place in the front of the prescription department, and at all public entrance doors to the pharmacy. The closing notice to the public shall be posted not less than 10 days prior to the anticipated date of closure, and the notice shall contain the following minimum information: a. the anticipated date of closure of the prescription department; b. the anticipated date of transfer or relocation of prescription files, if different than closure date; c. the name and address of the pharmacy to which the prescription files will be transferred; and d. a statement that if a patient objects to the transfer of their prescription files to the intended recipient pharmacy, the patient shall make alternative arrangements for the transfer of their prescription files to another pharmacy prior to the anticipated file transfer date. 2. Board Notice. The holder of a pharmacy permit shall send written notice to the board not less than 10 days prior to the anticipated date of closure, and the notice shall include the following minimum information: a. the anticipated date of closure of the prescription department; b. the name and address of the permitted pharmacy operating within a reasonably close proximity of the closing pharmacy that shall be the custodian of the transferred prescription files; and c. any prescription drug sale or transfer, with a complete drug inventory including recipient's name and address and/or seizure action, sequestration, executory process, public auction, liquidation, creditor assignment, and bankruptcy. 3. Disposition of Inventory a. Drugs Listed in Schedule II. These drugs shall be either returned to the supplier or transferred to an authorized registrant, accompanied by an executed DEA Form 222, or its successor. Alternatively, these drugs shall be inventoried on the DEA Form 41 (Registrants Inventory of Drugs Surrendered), or its successor, and then either returned to the regional DEA office, or destroyed pursuant to permission from the DEA or agent of the board. The permit holder shall retain triplicate copies of returns, transfers, and/or destructions. PROFESSIONAL AND OCCUPATIONAL STANDARDS Louisiana Administrative Code August 2022 42 2. If an on-site pharmacy is not able to provide remote electronic access to the remote processor, both pharmacies shall have appropriate technology to allow access to the required patient information. C. Policies and Procedures 1. On-site pharmacies and remote processors engaging in the acquisition or provision of remote processing services shall maintain a policy and procedure manual for reference by all personnel; it shall also be available for inspection and copying by the board. 2. At a minimum, the manual shall include policies and procedures for: a identification of the responsibilities of each of the pharmacies; b. protection of the integrity and confidentiality of patient information; c. maintenance of appropriate records to identify the name, initials, or unique identification code of each pharmacist performing processing functions, the specific services performed, and the date of such services. AUTHORITY NOTE: Promulgated in accordance with R.S. 37:1182. HISTORICAL NOTE: Promulgated by the Department of Health and Hospitals, Board of Pharmacy, LR 33:1132 (June 2007), amended LR 38:1240 (May 2012), LR 39:313 (February 2013), LR 41:2148 (October 2015). §1145. Remote Access to Prescription Drug Orders, Medical Orders, and Chart Orders A. Notwithstanding any provision of rules to the contrary, nothing shall prohibit a Louisiana-licensed pharmacist who is an employee of or under contract with a pharmacy in Louisiana from accessing that pharmacy’s dispensing information system from a location other than the pharmacy in order to process prescription drug orders, medical orders, or chart orders, but only when all of the following conditions are satisfied: 1. the pharmacy establishes controls to protect the privacy and security of confidential records; 2. the pharmacist does not engage in the receiving of written prescription drug orders or medical orders or chart orders or the maintenance of such orders; and 3. no part of the pharmacy’s dispensing information system is duplicated, downloaded, or removed from the pharmacy’s dispensing information system. AUTHORITY NOTE: Promulgated in accordance with R.S. 37:1182. HISTORICAL NOTE: Promulgated by the Department of Health, Board of Pharmacy, LR 46:582 (April 2020). §1147. Starter Doses for Patients in Licensed Healthcare Facilities A. Definitions Starter Dose Order—a prescription drug order or chart order transmitted by a vendor pharmacy to a starter dose pharmacy for the purpose of obtaining medication for a patient in a licensed health care facility. Starter dose pharmacy—a Louisiana-licensed pharmacy that dispenses a starter dose of medication to a patient in a licensed health care facility pursuant to a starter dose order. Vendor Pharmacy—a Louisiana-licensed pharmacy which has a contract with a licensed health facility to dispense medications to patients within that facility. B. A vendor pharmacy may share a chart order with a starter dose pharmacy without the necessity of transferring such order, for the purpose of authorizing the starter dose pharmacy to dispense starter doses of medication to a patient in a licensed health care facility under the following circumstances: 1. the vendor pharmacy has secured authorization from the facility to utilize a starter dose pharmacy; 2. the vendor pharmacy is in possession of a valid chart order and is unable to furnish the medication ordered in a timely manner; and 3. the vendor pharmacy and starter dose pharmacy maintain records of all chart orders and starter dose orders for a period of not less than two years following date of transmission of such orders. AUTHORITY NOTE: Promulgated in accordance with R.S. 37:1182. HISTORICAL NOTE: Promulgated by the Department of Health, Board of Pharmacy, LR 46:582 (April 2020). Chapter 12. Automated Medication Systems §1201. Definitions Healthcare Setting—a place where healthcare services are rendered on a routine basis by credentialed healthcare professionals. Remote Dispensing System—a profile-driven automated medication dispensing system employing bidirectional audio-visual technology to facilitate pharmacist communication with a patient or caregiver. AUTHORITY NOTE: Promulgated in accordance with R.S. 37:1182.A. HISTORICAL NOTE: Promulgated by the Department of Health and Hospitals, Board of Pharmacy, LR 26:1271 (June 2000), effective July 1, 2000, amended by the Department of Health, Board of Pharmacy, LR 47:241 (February 2021). §1203. Automated Medication System Registration A. Requirement for Registration 1. A pharmacy intending to supply medications for use within an automated medication system, as defined at R.S. 37:1164, shall obtain an automated medication system (AMS) registration prior to engaging in such activity. 2. The placement of medications within an automated medication system in the absence of an AMS registration shall substantiate a violation of R.S. 37:1241(A)(12) and Title 46, Part LIII Louisiana Administrative Code August 2022 43 shall subject the pharmacy to disciplinary action by the board. 3. A pharmacy intending to supply controlled substances for use within an automated medication system shall obtain a controlled dangerous substance (CDS) license in addition to the AMS registration. The pharmacy shall also obtain a federal registration from the U.S. Drug Enforcement Administration (DEA) prior to placing controlled substances within the automated medication system. 4. The placement of controlled substances within an automated medication system in the absence of an AMS registration, CDS license, and DEA registration shall substantiate a violation of R.S. 37:1241(A)(12) and R.S. 40:973 and shall subject the pharmacy to disciplinary action by the board. 5. The operation of a remote dispensing system without an AMS registration shall substantiate a violation of R.S. 37:1241(A)(12) and shall subject the pharmacy to disciplinary action by the board. B. Eligibility for Registration; Exemption 1. A pharmacy intending to supply medications for use within an automated medication system may do so when the AMS is placed at any of the following locations: a. within a facility in possession of a controlled dangerous substance license issued by the board; b. within a hospital or other institutional facility in possession of an operating license issued by the state department of health; c. within a detention or correctional facility operated by or under contract with the state department of public safety and corrections or other local governmental entity. 2. A pharmacy may operate a remote dispensing system when the system is placed within a healthcare setting where the pharmacist-in-charge can ensure the security and environmental integrity of the medications and devices placed within the system as well as the security and confidentiality of the protected health information used therein. 3. A pharmacy intending to supply medications for use within an AMS which is placed within the building housing that pharmacy shall not be required to obtain an AMS registration; however, the pharmacist-in-charge of the pharmacy shall be responsible for compliance with the operational standards in this Chapter. C. Application for Initial Issuance of Registration 1. The board shall develop an application form suitable for the AMS registration. The board may revise that application on its own initiative in order to collect the information it deems necessary to properly evaluate an applicant. 2. The application shall be accompanied by payment of the registration fee authorized by R.S. 37:1184. 3. The board shall not process applications received by facsimile, or that are incomplete, or submitted with the incorrect fee. 4. The submission of a false or fraudulent application shall substantiate a violation of R.S. 37:1241(A)(2) and shall subject the applicant to disciplinary action by the board. 5. When determined appropriate by the board, the applicant may be required to meet with a committee or agent of the board prior to the issuance of the registration. D. Maintenance of Registration 1. A registration shall be valid only for the pharmacy to which it was issued and the physical location of the AMS identified on the application. The registration shall not be subject to sale, assignment or other transfer, voluntary or involuntary, nor shall the registration be valid for any premises other than the physical location for which it was issued. 2. A duplicate or replacement registration shall be issued upon the written request of the owner of the registration and payment of the fee authorized by R.S. 37:1184. A duplicate or replacement registration shall be marked as such, and it shall not serve or be used as an additional or second registration. 3. In the event a pharmacy intends to relocate an automated medication system to a different address, the pharmacy shall notify the board of its intent to do so, providing both current and new addresses. A change in business address may require an inspection by the board or its designee. E. Application for Renewal of Registration 1. The pharmacy shall complete an application for the renewal of the registration and submit it to the board prior to the expiration date of the registration. The application shall be accompanied by the fee authorized by R.S. 37:1184. 2. The board shall not process applications received by facsimile, or that are incomplete, or submitted with the incorrect fee. 3. An AMS registration not renewed by the expiration date shall be classified as expired. The operation of an automated medication system with an expired registration shall substantiate a violation of R.S. 37:1241(A)(12) and shall subject the pharmacy to disciplinary action by the board. F. Relinquishment of Registration 1. In the event a pharmacy intends to cease supplying medications or devices to an automated medication system, it shall relinquish the registration to the board no later than 10 days following the effective date of such decision. 2. A pharmacy may not transfer a registration to another pharmacy. G. Application for Reinstatement of Suspended or Revoked Registration PROFESSIONAL AND OCCUPATIONAL STANDARDS Louisiana Administrative Code August 2022 44 1. An application for the reinstatement of an AMS registration previously suspended or revoked by the board may only be approved in compliance with R.S. 37:1249. 2. The applicant shall complete an application form for this specific purpose supplied by the board and shall attach any documentation requested by the board and fees identified in R.S. 37:1184. AUTHORITY NOTE: Promulgated in accordance with R.S. 37:1182.A. HISTORICAL NOTE: Promulgated by the Department of Health and Hospitals, Board of Pharmacy, LR 26:1271 (June 2000), effective July 1, 2000, amended LR 38:1235 (May 2012), amended by the Department of Health, Board of Pharmacy, LR 47:241 (February 2021). §1205. Pharmacist-in-Charge Responsibilities A. The pharmacist-in-charge shall be a Louisiana- licensed pharmacist with the following responsibilities: 1. assuring that the system is in good working order and accurately provides the correct strength, dosage form, and quantity of the drug prescribed while maintaining appropriate recordkeeping and security safeguards. 2. establishment of a quality assurance program prior to implementation of a system and the supervision of an ongoing quality assurance program that monitors appropriate use and performance of a system, which is evidenced by policies and procedures developed by the pharmacist-in- charge. 3. define access to the system in policy and procedures of the pharmacy, in compliance with state and federal regulations. 4. assign, discontinue, or change access to the system. 5. ensure that access to the medications complies with state and federal regulations as applicable. 6. ensure that the system is stocked and restocked accurately and in accordance with established pharmacy policies and procedures. 7. maintain or have access to all records of documentation specified in this Chapter for two years or as otherwise required by law. 8. continuous monitoring and documentation of temperature in the drug storage areas including a mechanism to alert the pharmacist when defined parameters are out of range as well as an action plan to address such excursions. A pharmacy’s failure to document the integrity of the drug supply or remediate for excursions as appropriate shall substantiate a violation of R.S. 37:1241(A)(18) and shall subject the pharmacy to disciplinary action by the board. AUTHORITY NOTE: Promulgated in accordance with R.S. 37:1182.A. HISTORICAL NOTE: Promulgated by the Department of Health and Hospitals, Board of Pharmacy, LR 26:1271 (June 2000), effective July 1, 2000, amended by the Department of Health, Board of Pharmacy, LR 47:241 (February 2021). §1207. Pharmacist Review A. System shall be used in settings that ensure medication orders are reviewed by a pharmacist prior to administration and in accordance with established policies and procedures and good pharmacy practice. A policy and procedure shall be adopted for non-profile driven systems to retrospectively review medications orders which cannot be reviewed prior to medication administration. AUTHORITY NOTE: Promulgated in accordance with R.S. 37:1182.A. HISTORICAL NOTE: Promulgated by the Department of Health and Hospitals, Board of Pharmacy, LR 26:1272 (June 2000), effective July 1, 2000, amended by the Department of Health, Board of Pharmacy, LR 47:242 (February 2021). §1211. Documentation A. Documentation as to type of equipment, serial number, content, policies and procedures and location shall be maintained in the pharmacy for review by the board. Such documentation shall include, but is not limited to: 1. name, address, and permit number of the pharmacy and the location where the system is operational; 2. manufacturer’s name and model; 3. quality assurance policies and procedures to determine continued appropriate use and performance of the system; 4. policies and procedures for system operation, safety, security, accuracy, patient confidentiality, access, controlled substances, data retention, definitions, downtime procedures, emergency or first dose procedures, inspection, installation requirements, maintenance security, quality assurance, medication inventory, staff education and training, system set-up, and malfunction procedures; and 5. security procedures sufficient to prevent unauthorized access or use, prevent the illegal use or disclosure of protected health information, and comply with any applicable federal or state regulations. B. A current copy of all pharmacy policies and procedures related to the use of the system shall be maintained at all locations where the system is being used. AUTHORITY NOTE: Promulgated in accordance with R.S. 37:1182.A. HISTORICAL NOTE: Promulgated by the Department of Health and Hospitals, Board of Pharmacy, LR 26:1272 (June 2000), effective July 1, 2000, amended by the Department of Health, Board of Pharmacy, LR 47:242 (February 2021). §1213. Records A. Records and/or electronic data kept by the system shall meet the following requirements: 1. all events involving access to the contents of the system shall be recorded electronically; 2. in the event controlled substances are stored in the system, the records shall include the positive identification (as defined in §1119 of the board’s rules) of the personnel Title 46, Part LIII Louisiana Administrative Code August 2022 47 2. Inventories. The pharmacist-in-charge shall: a. perform an annual inventory on all controlled dangerous substances; and b. maintain a perpetual inventory of Schedule I and II controlled dangerous substances. 3. Records. The pharmacist-in-charge shall be responsible for maintaining the following records: a. a record of all drugs procured, the quantity received, and the name, address and wholesale distributor license number of the person from whom the drugs were procured; b. all drug orders and records relating to the practice of pharmacy: i. records of drugs dispensed shall include, but are not limited to: (a). the name, strength, and quantity of drugs dispensed; (b). the date of dispensing; (c). the name of the hospital patient to whom, or for whose use, the drug was dispensed; and (d). positive identification of all pharmacists involved in the dispensing; ii. all other records relating to the practice of pharmacy other than dispensing shall include, but are not limited to: (a). the name of the hospital patient to whom, or for whose benefit, the activity was performed; (b). the nature of the pharmacy practice activity performed; (c). the results of the activity, if applicable; and (d). positive identification of all pharmacists involved in the activity; identifying the function performed by each pharmacist; iii. Records of drugs dispensed to patients for use outside the hospital shall be maintained in compliance with Section 1123 of this Part. c. a record of all drugs compounded or prepackaged for use only within that hospital, which shall include at least the following: i. name of drug, strength, quantity, and dosage form; ii. manufacturer’s or distributor’s control number (except for patient-specific sterile compounded preparations); iii. manufacturer’s or distributor’s name, if a generic drug is used; iv. pharmacy control number; v. manufacturer’s or distributor’s expiration date (except for patient-specific sterile compounded preparations); vi. pharmacy’s expiration date or beyond-use date; vii. identification of the licensed person responsible for the compounding or prepackaging of the drug; d. a record of the distribution of drugs to patient care areas and other areas of the hospital held for administration, which shall include at least the following: i. the name, strength, dosage form, and amount of the drug distributed; ii. the area receiving the drug; iii. the date distributed; iv. identification of the individual receiving the drug if it is a controlled dangerous substance; v. the area of the hospital receiving the controlled dangerous substance shall make a record of all such drugs administered to patients. Such records shall include at least the following: (a). name of the patient; (b). name, dosage form, and strength when applicable of the drug; (c). date and time the drug was administered; (d). quantity administered; (e). positive identification of the personnel administering the drug; e. a log that shall be maintained of all changes made to a drug record in an electronic drug recordkeeping system after a drug transaction has been made. The log shall contain at least, but is not limited, to the following: i. date and time of change; ii. changes made; iii. person making the change. B. Automated Medication Systems. A hospital pharmacy may use one or more automated medication systems in compliance with the provisions of Chapter 12 of this Part. 1. When the pharmacy uses an electronic product verification process as described in Section 1217 of this Part, and in the absence of any subsequent human intervention in the automated drug product selection process, the pharmacist-in-charge may elect to forego manual checks of drug products selected in that manner, provided however, that such selection by the pharmacist-in-charge shall require an initial quality assurance validation followed by an ongoing quality review at intervals no greater than 90 days since the previous review, all conducted by a pharmacist. 2. The pharmacist-in-charge remains accountable to the board for the accuracy of all drug distribution activities. PROFESSIONAL AND OCCUPATIONAL STANDARDS Louisiana Administrative Code August 2022 48 AUTHORITY NOTE: Promulgated in accordance with R.S. 37:1182. HISTORICAL NOTE: Promulgated by the Department of Health and Hospitals, Board of Pharmacy, LR 29:2093 (October 2003), effective January 1, 2004, amended LR 40:2257 (November 2014), effective January 1, 2015, LR 41:1488 (August 2015), amended by Department of Health, Board of Pharmacy, LR 46:583 (April 2020). §1511. Prescription Drug Orders A. The pharmacist shall review the practitioner's medical order prior to dispensing the initial dose of medication, except in cases of emergency. AUTHORITY NOTE: Promulgated in accordance with R.S. 37:1182. HISTORICAL NOTE: Promulgated by the Department of Health and Hospitals, Board of Pharmacy, LR 29:2093 (October 2003), effective January 1, 2004. §1512. Hospital Pharmacy Prepackaging A. Prepackaging is the preparation of medication in a unit-of-use container by credentialed pharmacy personnel in a pharmacy prior to the receipt of a prescription or medical order for ultimate issuance by a pharmacist in Louisiana. B. Labeling. The label on the prepackaged container shall contain the following minimum information: 1. drug name; 2. dosage form; 3. strength; 4. quantity dispensed when appropriate; 5. special storage requirements; 6. a unique pharmacy prepackage lot number which shall correspond to the following: a. name of manufacturer and/or distributor; b. manufacturer's lot or batch number; c. date of preparation; and d. verifying pharmacist’s initials; 7. expiration date according to United States Pharmacopeia (USP) guidelines. AUTHORITY NOTE: Promulgated in accordance with R.S. 37:1182. HISTORICAL NOTE: Promulgated by the Department of Health and Hospitals, Board of Pharmacy, LR 38:1235 (May 2012). §1513. Labeling A. All drugs dispensed or compounded by a hospital pharmacy, intended for use within the facility, shall be dispensed in appropriate containers and adequately labeled as to identify patient name and location, drug name(s) and strength, and medication dose(s). Additionally, compounded preparations and sterile preparations shall be labeled with the expiration date or beyond-use date, initials of the preparer, and the pharmacist performing the final check. AUTHORITY NOTE: Promulgated in accordance with R.S. 37:1182. HISTORICAL NOTE: Promulgated by the Department of Health and Hospitals, Board of Pharmacy, LR 14:708 (October 1988), effective January 1, 1989, LR 29:2093 (October 2003), effective January 1, 2004, amended LR 38:1235 (May 2012). §1515. Ambulance Service Drugs A. Hospital pharmacies that supply prescription drugs, including any controlled dangerous substances, to any authorized ambulance service or emergency medical service shall maintain proper records to ensure control, proper utilization, inventory, and accountability. AUTHORITY NOTE: Promulgated in accordance with R.S. 37:1182. HISTORICAL NOTE: Promulgated by the Department of Health and Hospitals, Board of Pharmacy, LR 29:2093 (October 2003), effective January 1, 2004. §1517. Pharmacist Absence/Drug Cabinet A. Pharmacist Absence. In the absence of a licensed pharmacist, admittance to the pharmacy by unauthorized persons is prohibited. When the pharmacy is closed, a pharmacist shall be on emergency call. 1. Within a veterinary teaching hospital owned or operated by a public university in this state, the pharmacist- in-charge shall approve policies and procedures detailing the person(s) authorized to access the pharmacy after-hours. B. Drug Cabinets. In the absence of a licensed pharmacist, arrangements shall have been formulated in advance by the pharmacist-in-charge to provide drugs for the patients by the use of drug cabinets. 1. Emergency Use. A drug cabinet is solely intended for the proper and safe storage of needed drugs when the pharmacy is closed and shall be available for emergency use by authorized hospital personnel only. 2. Security. The drug cabinet shall be a securely constructed and locked enclosure located outside the permitted pharmacy ensuring access to authorized personnel only. 3. Inventory. The pharmacist-in-charge shall be responsible for the selection and quantity of the drugs to be maintained in the drug cabinet and shall maintain a perpetual inventory of any controlled dangerous substances stored in the drug cabinet. 4. Labeling. Medications stored in a drug cabinet shall be properly labeled. 5. Quantities. Prepackaged drugs shall be available in amounts sufficient for immediate therapeutic or emergency requirements. 6. Accessibility. Written medical practitioner's orders and proof of use, if applicable, shall be provided when a drug cabinet inventory is utilized. 7. Inspection. Medications stored in a drug cabinet shall be inspected every 30 days. 8. Policy Manual. A policy and procedure manual shall be maintained to implement the drug cabinet Title 46, Part LIII Louisiana Administrative Code August 2022 49 requirements and is to be made available to the board upon request for inspection and approval. AUTHORITY NOTE: Promulgated in accordance with R.S. 37:1182. HISTORICAL NOTE: Promulgated by the Department of Health and Hospitals, Board of Pharmacy, LR 29:2093 (October 2003), effective January 1, 2004, amended by the Department of Health, Board of Pharmacy, LR 46:587 (April 2020). §1519. Drug Returns; Drug Disposal A. In a hospital with a permitted hospital pharmacy on site, unused drugs may be returned to the pharmacy for re- dispensing in accordance with good professional practice standards. B. When a patient or his designee wishes to return previously dispensed prescription drugs to a pharmacy for disposal, the pharmacy shall inform the patient or his designee of the disposal mechanisms available to him. In the event the pharmacy elects to accept such previously dispensed products for disposal, the pharmacy shall comply with the following requirements. 1. From the time of receipt of such products until the time of disposal, the pharmacy shall quarantine such products to keep them separate from its active dispensing stock and shall take appropriate security measures to prevent the theft or diversion of such products. 2. The pharmacy shall comply with the provisions of 21 CFR §1317 or its successor for the pharmacy’s disposal of controlled substances and other non-hazardous waste pharmaceuticals. 3. The pharmacy shall comply with the provisions of 40 CFR §261 or its successor for the pharmacy’s disposal of hazardous waste pharmaceuticals. AUTHORITY NOTE: Promulgated in accordance with R.S. 37:1182. HISTORICAL NOTE: Promulgated by the Department of Health and Hospitals, Board of Pharmacy, LR 29:2094 (October 2003), effective January 1, 2004, amended by the Department of Health, Board of Pharmacy, LR 46:793 (June 2020). §1521. Off-Site Pharmacy Services A. Availability. Pharmacy services may be procured contractually from outside the hospital for inpatient administration. B. Contractual agreements shall provide for: 1. emergency―the pharmacy provider shall be available for on-call for emergency pharmacy services; 2. storage―adequate drug storage facilities shall be provided to the pharmacy provider; 3. labeling―prescription drugs supplied to hospital inpatients shall be properly labeled to ensure that adequate control, supervision, and recall of medication are monitored; 4. contractual pharmacy service―off-site contractual pharmacy services rendered to the hospital shall be in accordance with federal and state laws, rules, and regulations. C. A pharmacy providing off-site contractual pharmacy services to a hospital shall not be considered a hospital pharmacy. D. Medications. Prescription medications independently supplied to registered patients shall comply with all appropriate board regulations and statutes and/or hospital rules, regulations, and policies. AUTHORITY NOTE: Promulgated in accordance with R.S. 37:1182. HISTORICAL NOTE: Promulgated by the Department of Health and Hospitals, Board of Pharmacy, LR 29:2094 (October 2003), effective January 1, 2004. §1523. Outpatient Pharmacy Dispensing A. Hospital outpatient dispensing shall require a separate pharmacy permit for the specialty classification(s) under these regulations. All records including the annual inventory of controlled dangerous substances for the outpatient pharmacy shall be maintained and kept separate and apart from that of the inpatient pharmacy, as the outpatient pharmacy may not acquire drugs through the hospital pharmacy permit under the provisions of the Robinson- Patman Act, 15 U.S.C. §13(c). B. Nothing in this Section shall prohibit the dispensing of certain prescriptions from the hospital pharmacy, as allowed under the Robinson-Patman Act, 15 U.S.C. §13, including: 1. dispensing to the hospital inpatient for use in his treatment at the hospital; 2. dispensing to the patient admitted to the hospital's emergency facility for use in the patient's treatment at that location; 3. dispensing to the hospital outpatient for personal use on the hospital premises; 4. dispensing in the context of a genuine take-home prescription, intended for a limited and reasonable time as a continuation of, or supplement to, the treatment that was administered at the hospital to the recipient while an inpatient, an outpatient, or an emergency facility patient if the patient needs that treatment; or 5. dispensing to the hospital's physicians, employees, or its students for their personal use or for the personal use of their dependents. AUTHORITY NOTE: Promulgated in accordance with R.S. 37:1182. HISTORICAL NOTE: Promulgated by the Department of Health and Hospitals, Board of Pharmacy, LR 29:2094 (October 2003), effective January 1, 2004. §1525. Hospital Off-Site Satellite Pharmacy A. Issuance and Maintenance of Permit 1. A hospital pharmacy may establish a hospital off- site satellite pharmacy within a facility bearing the same hospital license number as the facility housing the provider pharmacy. PROFESSIONAL AND OCCUPATIONAL STANDARDS Louisiana Administrative Code August 2022 52 2003), effective January 1, 2004, amended LR 33:1133 (June 2007). Subchapter B. Emergency Drug Kits §1709. Definitions A. As used in this Subchapter, the following terms shall have the meaning ascribed to them in this Section: Emergency Drug Kit (EDK)―for long-term care facilities or other board-approved sites, other than a hospital, means a drug kit containing designated emergency drugs which may be required to meet the immediate therapeutic needs of a resident or patient. Emergency Drugs―those drugs which may be required to meet the immediate therapeutic needs of patients and which are not available from any other authorized source in sufficient time to prevent risk of harm to patients or residents because of delay resulting from obtaining such medications from such other source. AUTHORITY NOTE: Promulgated in accordance with R.S. 37:1182. HISTORICAL NOTE: Promulgated by the Department of Health and Hospitals, Board of Pharmacy, LR 29:2095 (October 2003), effective January 1, 2004. §1711. Emergency Drug Kit Permit A. A long-term care facility, institutional facility without an institutional pharmacy, or other board-approved site, other than a hospital, that desires to maintain an Emergency Drug Kit shall obtain an EDK permit from the board. B. Permit Application and Requirements. Application for an EDK permit shall be made on a form provided by the board. 1. The provider pharmacy shall apply to the board for an EDK permit. The administrator of the applicant facility shall also sign the application for said permit. Upon compliance with the required provisions, the provider pharmacy shall be issued a permit by the board for the provider pharmacy to establish and maintain an EDK in the facility. 2. The provider pharmacy shall be a Louisiana- licensed pharmacy. 3. Only one provider pharmacy shall be assigned to and be responsible for each EDK. 4. EDK permits are institutional facility-specific and not transferable. 5. A separate permit is required for each EDK. 6. The original EDK permit shall be readily retrievable at the provider pharmacy. A copy of the EDK permit shall be maintained in the room where the EDK is located. C. Pharmacist-in-Charge. The pharmacist-in-charge of the provider pharmacy shall be the pharmacist-in-charge of the EDK. The maintenance of the EDK shall at all times remain the responsibility of the pharmacist-in-charge. D. Renewal. Each EDK permit issued by the board shall be renewed annually by the provider pharmacy, at the time designated by the board. If an EDK permit is not renewed by July 1 of each year, the existing permit shall expire and become null and void. E. Cancellation Prior to Renewal. In the event the facility or provider pharmacy elects to cancel the permit prior to the renewal date, the pharmacy shall relinquish the permit to the board office no later than 10 days following the date of cancellation. AUTHORITY NOTE: Promulgated in accordance with R.S. 37:1182. HISTORICAL NOTE: Promulgated by the Department of Health and Hospitals, Board of Pharmacy, LR 29:2095 (October 2003), effective January 1, 2004, amended by the Department of Health Board of Pharmacy, LR 46:584 (April 2020). §1713. Emergency Drug Kit Requirements A. Emergency Use. An EDK is solely intended for the immediate therapeutic emergency needs of a resident or patient. B. Security. The EDK shall be tamper-evident and shall be maintained in a secure enclosure located within the institutional facility and shall be available for emergency use by authorized personnel only. C. Exterior Identification and Labeling. The EDK shall be clearly labeled to indicate that it is an emergency drug kit. In addition, the attached exterior label shall have an inventory of contents and contact information of the provider pharmacy. D. Labeling. Medications stored in an EDK shall bear a label with the following minimum information: 1. drug name; 2. dosage form; 3. strength; 4. name of manufacturer and/or distributor; 5. manufacturer's lot or batch number; and 6. expiration date, according to United States Pharmacopeia guidelines. E. Storage. All drugs in an EDK shall be stored to ensure a proper environment for the preservation of the drugs. If federal or state laws or regulations require adequate storage outside the EDK, documentation shall be kept with the EDK properly identifying this special storage requirement and drug(s) involved. F. Policies and Procedures. Policies and procedures shall be maintained by the provider pharmacy and the applicant facility to implement the EDK requirements. G. Accountability. Documented medical practitioner's orders and proof of use shall be provided when an EDK inventory is utilized. Medication administered to patients from the EDK shall be documented with the following information, in accordance with the institutional facility Title 46, Part LIII Louisiana Administrative Code August 2022 53 policy manual, that shall be immediately reduced to writing and a copy delivered to the provider pharmacy: 1. name of the resident patient; 2. drug name, strength, and quantity; 3. nature of the emergency; 4. time and date of administration; 5. name of person administering the medication; and 6. name of prescriber authorizing the medication. H. Records. Records shall be readily retrievable and comply with applicable federal and state laws and regulations. I. Inspection 1. The provider pharmacy shall inspect the EDK every 30 days, plus or minus five days. Proper documentation of these inspections, EDK inventory, and all records of use shall be maintained and made available to the board upon request. 2. The EDK shall be available for inspection by the board. J. The placement of controlled dangerous substances in an EDK in non-federally registered long-term care facilities shall be deemed in compliance with the Comprehensive Drug Abuse Prevention and Control Act of 1970 provided that: 1. controlled dangerous substances shall be stored in the EDK as deemed necessary and jointly approved by the pharmacist, medical director and the director of nursing services; 2. the source from which the controlled dangerous substances for EDKs are obtained shall be a pharmacy licensed by the board in possession of a valid DEA registration and Louisiana CDS license; 3. the number of different controlled dangerous substances in a single EDK shall be limited to a maximum of eight separate drug entities with not more than eight single- use containers of each drug entity; 4. the EDK containing controlled dangerous substances shall be closed with a tamper proof seal and kept in a locked medication room, cart or closet; 5. access to controlled dangerous substances stored in an EDK shall be limited to the pharmacist, a practitioner, the director of nursing services, or the registered nurse or licensed practical nurse on duty; 6. controlled dangerous substances stored in an EDK shall be administered to a patient only by authorized personnel and only as expressly authorized by an individual practitioner and in compliance with the provisions of 21 CFR 1306.11 and 21 CFR 1306.21 or their successors; 7. a usage record shall be retained in the EDK for each separate drug included which shall be completed by the nursing staff when retrieving any controlled dangerous substance(s) from the EDK; 8. the pharmacist at the provider pharmacy shall receive and retain all completed usage records for a minimum of two years; 9. when the EDK is opened: a. the pharmacist shall be notified by the facility within 24 hours; and b. shift counts shall be performed by the nursing staff on all controlled dangerous substances until the kit is resealed by the pharmacist; 10. shift counts of the controlled dangerous substances contained in the EDK shall not be required when the EDK is sealed; 11. the pharmacist shall check the controlled dangerous substances in the EDK at least monthly and so document that check inside the kit. AUTHORITY NOTE: Promulgated in accordance with R.S. 37:1182. HISTORICAL NOTE: Promulgated by the Department of Health and Hospitals, Board of Pharmacy, LR 29:2096 (October 2003), effective January 1, 2004, amended LR 39:312 (February 2013), amended by Department of Health, Board of Pharmacy, LR 46:584 (April 2020). Subchapter C. Drug Abuse Treatment Center Pharmacies §1715. Purpose A. The board may issue a pharmacy permit for a drug abuse treatment center operating in the state of Louisiana where drugs are dispensed and pharmacy primary care is provided. AUTHORITY NOTE: Promulgated in accordance with R.S. 37:1182. HISTORICAL NOTE: Promulgated by the Department of Health and Hospitals, Board of Pharmacy, LR 29:2096 (October 2003), effective January 1, 2004. §1717. Cross References A. For all regulations that apply to drug abuse treatment center pharmacies concerning pharmacy practices not specifically stated in this subchapter, refer to Chapter 11 of this Part. AUTHORITY NOTE: Promulgated in accordance with R.S. 37:1182. HISTORICAL NOTE: Promulgated by the Department of Health and Hospitals, Board of Pharmacy, LR 29:2096 (October 2003), effective January 1, 2004, amended by Department of Health, Board of Pharmacy, LR 46:584 (April 2020). §1719. Definitions A. As used in this Subchapter, the following terms shall have the meaning ascribed to them in this Section: Administer or Administration―the direct application of a drug to the body of a patient or research subject by injection, inhalation, ingestion, or any other means. PROFESSIONAL AND OCCUPATIONAL STANDARDS Louisiana Administrative Code August 2022 54 Authorized Personnel―individuals who, within the scope of their authority granted by mutual agreement of the drug abuse treatment center's pharmacist-in-charge and director, are granted access to the drug abuse treatment center's pharmacy department as part of his duties. Dispense or Dispensing―the interpretation, evaluation, and implementation of a prescription drug order, including the preparation and delivery of a drug or device to a patient or patient's agent in a suitable container appropriately labeled for subsequent administration to, or use by, a patient. Dispense necessarily includes a transfer of possession of a drug or device to the patient or the patient's agent. Drug Abuse Treatment Center―any establishment, facility, or institution, public or private, whether operated for profit or not, which primarily offers, or purports to offer, maintain, or operate facilities for the residential or outpatient diagnosis, care, treatment, or rehabilitation of two or more non-related individuals, who are patients as defined herein, excluding, however, any hospital or mental hospital otherwise licensed by the Department of Health. Patient or Client―a person who is dependent on, or otherwise suffering physically or mentally from the use of, or abuse of, controlled dangerous substances and who requires continuing care of a drug abuse treatment center. Perpetual Inventory―a computer record of inventory kept continuously up to date by detailed entries of all incoming and outgoing items. This includes inventory on hand, purchases, and dispensing. AUTHORITY NOTE: Promulgated in accordance with R.S. 37:1182. HISTORICAL NOTE: Promulgated by the Department of Health and Hospitals, Board of Pharmacy, LR 29:2096 (October 2003), effective January 1, 2004, amended by Department of Health, Board of Pharmacy, LR 46:584 (April 2020). §1721. Drug Abuse Treatment Center Pharmacy Permit A. A drug abuse treatment center pharmacy permit shall be required to operate a pharmacy department located within a drug abuse treatment facility for patients of that facility. The permit shall be applied for, and renewed, in the manner prescribed by the board in Chapter 11 of this Part. AUTHORITY NOTE: Promulgated in accordance with R.S. 37:1182. HISTORICAL NOTE: Promulgated by the Department of Health and Hospitals, Board of Pharmacy, LR 29:2097 (October 2003), effective January 1, 2004, amended by Department of Health, Board of Pharmacy, LR 46:584 (April 2020). §1723. Minimum Security Controls for Drug Abuse Treatment Centers A. Persons enrolled in a drug abuse treatment center shall wait for their prescriptions in an area physically separated from the controlled dangerous substance (CDS) storage and dispensing area. This requirement shall be enforced by the drug abuse treatment center physician(s), pharmacist(s), and employees. B. All CDS used in a drug abuse treatment center shall be securely locked and accessible to authorized personnel within that facility only. AUTHORITY NOTE: Promulgated in accordance with R.S. 37:1182. HISTORICAL NOTE: Promulgated by the Department of Health and Hospitals, Board of Pharmacy, LR 29:2097 (October 2003), effective January 1, 2004. §1725. Records and Reports of Drug Abuse Treatment Centers A. All persons licensed by the Department of Health to operate a drug abuse treatment center and who possess a Drug Enforcement Administration (DEA) registration to purchase, possess, and use CDS shall keep the following records: 1. records of CDS received by approved persons, including date of receipt, name and address of distributor, type and quantity of such drugs received, and the signature of the individual receiving the CDS. A duplicate invoice or separate itemized list furnished by the distributor will be sufficient to satisfy this record requirement, provided it includes all required information and is maintained in a separate file. In addition, duplicate copies of federal order forms for CDS listed in Schedule II must be retained; and 2. records of CDS administered or dispensed, including date of administration or dispensing, name of patient, signature of person administering or dispensing, type and quantity of drug, and such other information as may be required by state and federal laws and regulations. B. Records of perpetual inventories shall be kept at the permitted site as prescribed by law. AUTHORITY NOTE: Promulgated in accordance with R.S. 37:1182. HISTORICAL NOTE: Promulgated by the Department of Health and Hospitals, Board of Pharmacy, LR 29:2097 (October 2003), effective January 1, 2004, amended by Department of Health, Board of Pharmacy, LR 46:584 (April 2020). Chapter 18. Correctional Center Pharmacy §1801. Correctional Center Pharmacy Permit A. A correctional center pharmacy permit shall be required to operate a pharmacy located within a correctional center owned and/or operated by the Louisiana Department of Public Safety and Corrections or its successor (hereinafter “the department”), or a local law enforcement agency, to provide medications and pharmacy care for offenders residing in that correctional center or another correctional center owned and operated by the department or local law enforcement agency. The pharmacy in the correctional center may also provide medications and pharmacy care to offenders assigned to that facility and residing at home or another housing location. B. In the event a pharmacy located within the state but outside a correctional center intends to provide medications and pharmacy care on a contractual basis to offenders Title 46, Part LIII Louisiana Administrative Code August 2022 57 Emergency Drug Kit (EDK)—a container holding designated emergency drugs which may be required to meet the immediate therapeutic needs of an offender. Emergency Drugs—those drugs which may be required to meet the immediate therapeutic needs of an offender and which are not available from any other authorized source in sufficient time to prevent risk of harm to the offender because of a delay resulting from obtaining such medications from such other source. AUTHORITY NOTE: Promulgated in accordance with R.S. 37:1226.3. HISTORICAL NOTE: Promulgated by the Department of Health and Hospitals, Board of Pharmacy, LR 38:1237 May 2012), repromulgated by the Department of Health, Board of Pharmacy, LR 46:572 (April 2020). §1813. Emergency Drug Kit Permit A. A correctional center pharmacy located outside a correctional center intending to use one or more emergency drug kits within the correctional center shall first obtain an EDK permit from the board. B. Application for Initial Issuance of Permit 1. The correctional center pharmacy shall apply to the board for the permit. 2. The applicant shall complete the application form supplied by the board and submit it with the required attachments and appropriate fees, as set forth in R.S. 37:1184, to the board. 3. Once received by the board, an application for the permit shall expire one year thereafter. Fees attached to an expired application shall be forfeited by the applicant and deposited by the board. 4. The board shall not process applications received by facsimile, or that are incomplete, or submitted with the incorrect fees. C. Application for Renewal of Permit 1. Without respect to the date of initial issuance, an EDK permit shall expire at midnight on June 30 of every year, unless relinquished, surrendered, suspended, or revoked sooner in accordance with the Pharmacy Practice Act or this Part. 2. An EDK shall not be maintained or used with an expired permit. 3. The correctional center pharmacy shall complete the renewal application form supplied by the board and submit it with any required attachments and appropriate fees on or before the expiration date. 4. The board shall not process applications received by facsimile, or that are incomplete, or submitted with the incorrect fees. D. Application for Reinstatement of Expired Permit 1. The applicant shall complete an application form for this specific purpose supplied by the board and submit it with any required attachments and appropriate fees to the board. 2. The board shall not process applications received by facsimile, or that are incomplete, or submitted with the incorrect fees. 3. An application for the reinstatement of an EDK permit which has been expired: a. less than one year may be approved by the board’s administrative personnel; b. more than one year but less than five years may be approved by a member of the board charged with such duties; c. more than five years may only be approved by the full board following a hearing to determine whether the reinstatement of the permit is in the public’s best interest. 4. Applications requiring a reinstatement hearing shall be accompanied by payment of the administrative hearing fee authorized by R.S. 37:1184. E. Maintenance of Permit 1. EDK permits are specific to a correctional center and to a correctional center pharmacy and they are not transferable. 2. In the event multiple kits are required for a correctional center, a separate permit shall be required for each EDK. 3. The original EDK permit shall be displayed in the correctional center pharmacy supplying the EDK, and a copy of the permit shall be maintained in the room or area where the EDK is located. AUTHORITY NOTE: Promulgated in accordance with R.S. 37:1226.3. HISTORICAL NOTE: Promulgated by the Department of Health and Hospitals, Board of Pharmacy, LR 38:1237 (May 2012), amended by the Department of Health, Board of Pharmacy, LR 46:573 (April 2020). §1815. Emergency Drug Kit Requirements A. The EDK shall be tamper-evident, shall be maintained in a secure enclosure located within the correctional center, and shall be available for emergency use by authorized personnel only. B. The EDK shall be clearly labeled to indicate it is an emergency drug kit, and further, the attached exterior label shall identify the inventory of contents as well as contact information for the correctional center pharmacy responsible for maintaining the kit. C. Medications stored in an EDK shall bear a label with the following minimum information: 1. drug name; 2. dosage form; 3. drug strength; 4. name of manufacturer and/or distributor; PROFESSIONAL AND OCCUPATIONAL STANDARDS Louisiana Administrative Code August 2022 58 5. manufacturer’s lot or batch number; and 6. expiration date, according to relevant standards from the United States Pharmacopeia (USP). D. The EDK shall be stored in a proper environment for the preservation of the drugs contained therein, in compliance with the relevant USP standards. In the event federal or state laws or rules require storage outside the EDK for one or more drugs in the EDK, documentation shall be maintained with the EDK properly identifying this special storage requirement and the drug(s) affected. E. The correctional center and correctional center pharmacy shall maintain policies and procedures to implement and maintain these requirements. These policies and procedures may be maintained in written or electronic format and shall be available for review by the board or its agents. F. When an authorized prescriber issues an order for the administration of a drug contained within the EDK, the order and proof of use shall be delivered in written or electronic format to the correctional center pharmacy; further, such records shall contain the following minimum information: 1. name of offender; 2. drug name, strength, and quantity; 3. nature of the emergency; 4. time and date of administration; 5. name of prescriber authorizing the medication; and 6. name of person administering the medication. G. The correctional center pharmacy shall inspect the EDK periodically, but in no event more than 30 days after the previous inspection. Proper documentation of these inspections, EDK inventory, and all records of use shall be maintained by the correctional center pharmacy and available for review by the board or its agents. H. The EDK shall be available for inspection by the board or its agents. AUTHORITY NOTE: Promulgated in accordance with R.S. 37:1226.3. HISTORICAL NOTE: Promulgated by the Department of Health and Hospitals, Board of Pharmacy, LR 38:1238 (May 2012), amended by the Department of Health, Board of Pharmacy, LR 46:573 (April 2020). §1817. Drug Donations to Correctional Center Pharmacies A. A correctional center pharmacy may accept the donation of a prescription drug, except a controlled substance, previously dispensed to another patient provided the following procedures are satisfied. 1. The physical transfer of the donated drug shall be accomplished by an individual authorized to do so by the correctional center pharmacy. 2. An inventory list of the drugs being donated shall accompany the drugs received in the correctional center pharmacy; the list shall contain, at a minimum, the name and strength of the drug, the quantity received, and expiration date. The correctional center pharmacy receiving the donated drugs shall maintain this list as an acquisition record. 3. The correctional center pharmacy shall not knowingly accept the donation of any expired drugs. In the event expired drugs are received by a correctional center pharmacy, the pharmacist-in-charge shall destroy them as required by law. 4. the patient’s name, prescription number, and any other identifying marks shall be obliterated from the packaging prior to its receipt in the penal pharmacy; 5. the drug name, strength, and expiration date shall remain on the medication package or label. B. The pharmacist-in-charge of the correctional center pharmacy receiving donated drugs shall be responsible for determination of suitability of the drug product for reuse. 1. No product where integrity cannot be assured shall be accepted for re-dispensing by the pharmacist. 2. A re-dispensed prescription medication shall be assigned the expiration date stated on the package. 3. No product shall be re-dispensed more than one time. C. Once accepted by the correctional center pharmacy, under no circumstances may the donated drugs be transferred to another location. AUTHORITY NOTE: Promulgated in accordance with R.S. 37:1226.3. HISTORICAL NOTE: Promulgated by the Department of Health and Hospitals, Board of Pharmacy, LR 38:1238 (May 2012), amended by the Department of Health, Board of Pharmacy, LR 46:573 (April 2020). §1819. Medication Use Procedures A. The pharmacist shall review the practitioner’s medical order or prescription prior to dispensing or otherwise provide access to the initial dose of the medication, except in cases of emergency. B. All drugs dispensed by the pharmacy or held for administration to offenders at the facility shall be packaged in appropriate containers that comply with the relevant standards of the USP. C. The compounding of drug preparations shall comply with the relevant standards of the USP, as well as the provisions of Sections 2531 through 2535 of this Part. D. All drugs dispensed by the pharmacy, intended for use within the correctional center, shall be labeled as to identify the offender’s name and location as well as the drug name and strength. Further, compounded preparations shall include the expiration date or beyond-use date, initials of the preparer, and initials of the pharmacist performing the final check on the label. E. Drugs dispensed by the correctional center pharmacy may be returned to that correctional center pharmacy for re- Title 46, Part LIII Louisiana Administrative Code August 2022 59 use, in accordance with good professional practice procedures, subject to the following limitations. 1. Drugs returned to the pharmacy for re-use shall not be further distributed to another entity. 2. Drugs that may be dispensed only to patients registered with the drug manufacturer in accordance with federal Food and Drug Administration (FDA) requirements shall not be accepted for return or re-dispensed. AUTHORITY NOTE: Promulgated in accordance with R.S. 37:1226.3. HISTORICAL NOTE: Promulgated by the Department of Health and Hospitals, Board of Pharmacy, LR 38:1239 (May 2012), amended by the Department of Health, Board of Pharmacy, LR 46:573 (April 2020). Chapter 19. Nuclear Pharmacy §1901. Cross References A. For all regulations that apply to permitted nuclear pharmacies concerning pharmacy practices not specifically stated in this Chapter, refer to Chapter 11. AUTHORITY NOTE: Promulgated in accordance with R.S. 37:1182. HISTORICAL NOTE: Promulgated by the Department of Health and Hospitals, Board of Pharmacy, LR 14:708 (October 1988), effective January 1, 1989, amended LR 29:2097 (October 2003), effective January 1, 2004. §1903. Definitions A. As used in this Chapter, the following terms shall have the meaning ascribed to them in this Section. Nuclear Pharmacy―a board-approved facility limited to procuring, possessing, compounding, or dispensing radiopharmaceuticals or any interventional drug used in conjunction with nuclear medicine procedures. This definition shall not apply to hospital nuclear medicine departments and nuclear medicine clinics operating under the auspices of a licensed practitioner of medicine. Radiation―any electromagnetic or ionizing radiation including gamma rays, X-rays, alpha and beta particles, high-speed electrons, neutrons, protons, and other nuclear particles. Radioactive Material―any solid, liquid, or gas that emits radiation spontaneously. Radiopharmaceutical―a drug that is a radioactive material and includes any drug that is intended to be made radioactive, as defined by the appropriate federal agency. AUTHORITY NOTE: Promulgated in accordance with R.S. 37:1182. HISTORICAL NOTE: Promulgated by the Department of Health and Hospitals, Board of Pharmacy, LR 14:708 (October 1988), effective January 1, 1989, amended LR 29:2097 (October 2003), effective January 1, 2004. §1905. Nuclear Pharmacy Permit Requirements A. A nuclear pharmacy permit shall be required to operate a nuclear pharmacy department. The permit shall be applied for, and renewed, in the manner prescribed by the board in Chapter 11 of these regulations. 1. A nuclear pharmacy shall have a Louisiana Radioactive Material License. 2. Nuclear Pharmacist-in-Charge. A pharmacist-in- charge of a nuclear pharmacy operation shall be a qualified nuclear pharmacist, as defined in §1907, and shall be responsible for the entire nuclear pharmacy operation. 3. Structural Requirements. A nuclear pharmacy shall provide adequate space separate and apart from other areas commensurate with the scope of service and with the following space requirements. a. Dispensing Area. The radiopharmaceutical compounding or preparation area shall be separate and apart from other facility areas and shall be not less than 300 square feet, which may include storage and decay areas. The pharmacy area shall be sufficient to provide a work environment for the safe handling, compounding, and dispensing of radiopharmaceuticals. This area shall be separate and inaccessible to non-pharmacy personnel. b. Delivery and Receipt Area. An area designated for the delivery and receipt of materials requiring after-hours handling by non-pharmacy personnel. This area shall be separate from the dispensing area of the pharmacy. c. Storage Area. A storage area sufficient to maintain the scope and content of unused and returned material for decay and disposal commensurate with the compounding and dispensing requirements of the facility. d. Maintenance. A nuclear pharmacy shall be well maintained, clean, orderly, lighted, and properly ventilated. e. Plumbing. A sink equipped with hot and cold running water shall be located within the nuclear pharmacy. A sink located in a pharmacy lavatory or restroom shall not be sufficient to satisfy this requirement. 4. Equipment. There shall be adequate equipment commensurate with the scope of services required and provided by the facility. 5. Supplies. There shall be adequate supplies commensurate with the compounding and dispensing needs of the facility, as well as any other services provided for by the facility, including appropriate shielding and safety devices and any other supplies necessary for the safe and legal transport of materials compounded or dispensed from the facility. There shall be appropriate supplies for the safe handling and disposal of used and unused material by employees and staff of the facility. The appropriateness of personal protective equipment shall be reviewed on an annual basis. AUTHORITY NOTE: Promulgated in accordance with R.S. 37:1182. HISTORICAL NOTE: Promulgated by the Department of Health and Hospitals, Board of Pharmacy, LR 14:708 (October 1988), effective January 1, 1989, amended LR 29:2097 (October 2003), effective January 1, 2004. PROFESSIONAL AND OCCUPATIONAL STANDARDS Louisiana Administrative Code August 2022 62 HISTORICAL NOTE: Promulgated by the Department of Health and Hospitals, Board of Pharmacy, LR 29:2099 (October 2003), effective January 1, 2004. Chapter 23. Nonresident Pharmacy §2301. Purpose A. Out-of-state pharmacies shall comply with the provisions of this Chapter in order to be and remain permitted to operate in Louisiana as an out-of-state pharmacy. B. This Chapter applies to any place physically located outside the state of Louisiana that provides services in the state of Louisiana where prescription drugs are dispensed and/or pharmacy care is provided to residents of the state of Louisiana. This includes, but is not limited to, pharmacies providing goods and services via U.S. mail carrier, commercial carrier, the Internet, and/or directly to Louisiana residents. AUTHORITY NOTE: Promulgated in accordance with R.S. 37:1182. HISTORICAL NOTE: Promulgated by the Department of Health and Hospitals, Board of Pharmacy, LR 14:708 (October 1988), effective January 1, 1989, amended LR 18:1380 (December 1992), effective January 1, 1993, LR 29:2099 (October 2003), effective January 1, 2004. §2303. Nonresident Pharmacy Requirements A. The nonresident pharmacy shall hold a current pharmacy permit in good standing in the state(s) in which it is located and/or practicing pharmacy. B. Each pharmacist dispensing drugs into Louisiana shall be licensed as a pharmacist in good standing in the state(s) where he practices. C. Every nonresident pharmacy doing business in Louisiana by dispensing and delivering prescription drugs and devices to Louisiana residents shall designate a resident agent and a registered office in Louisiana for the service of process. D. Every nonresident pharmacy doing business in Louisiana by dispensing and delivering prescription drugs and devices to offenders in the custody of the Louisiana Department of Public Safety and Corrections or local law enforcement agency shall obtain and maintain a nonresident correctional center pharmacy permit, and further, shall comply with the provisions of Chapter 18 of this Part, with the single exception of the necessity for acquiring a separate correctional center pharmacy permit. AUTHORITY NOTE: Promulgated in accordance with R.S. 37:1182 and R.S. 37:1226.3. HISTORICAL NOTE: Promulgated by the Department of Health and Hospitals, Board of Pharmacy, LR 14:708 (October 1988), effective January 1, 1989, amended LR 18:1380 (December 1992), effective January 1, 1993, LR 29:2100 (October 2003), effective January 1, 2004, LR 39:3074 (November 2013), amended by the Department of Health, Board of Pharmacy, LR 46:574 (April 2020). §2305. Nonresident Pharmacy Permit Requirements A. The out-of-state pharmacy shall apply for a permit and annual permit renewals on forms provided by the board. The board may require such information as reasonably necessary to carry out the provisions of R.S. 37:1232, including, without limitation, the name, address, and position of each officer and director of a corporation or of the owners, if the pharmacy is not a corporation. B. The out-of-state pharmacy shall pay an annual permit fee as defined in R.S. 37:1184. AUTHORITY NOTE: Promulgated in accordance with R.S. 37:1182. HISTORICAL NOTE: Promulgated by the Department of Health and Hospitals, Board of Pharmacy, LR 14:708 (October 1988), effective January 1, 1989, amended LR 18:1380 (December 1992), effective January 1, 1993, LR 29:2100 (October 2003), effective January 1, 2004. §2307. Pharmacist-in-Charge A. The opportunity to accept an appointment as the pharmacist-in-charge (PIC) of a pharmacy is a professional privilege. The following requirements are attached to a PIC privilege. 1. The acquisition of the PIC privilege shall require: a. possession of an active Louisiana pharmacist license; b. possession of an active license in the state in which the pharmacy is located, and further, said license shall not have any restrictions which prohibit the position of pharmacist-in-charge; c. active practice as a pharmacist for a minimum of two years under the jurisdiction of any board of pharmacy in the United States; and d. the completion of the affidavit of responsibility and duties described in Subsection J of this Section. 2. The PIC shall be present and practicing at the pharmacy for which he holds the PIC position no less than 20 hours per week during the pharmacy’s ordinary course of business. In the event the pharmacy’s normal hours of business are less than 20 hours per week, the PIC shall be present and practicing at least 50 percent of the normal business hours. B. An initial and renewal pharmacy permit application shall designate and identify the licensed pharmacist-in- charge. C. Authority and Accountability. The designated pharmacist-in-charge of the pharmacy and the pharmacy owner(s), or partners, or corporate officer(s) of the permit holder, where applicable, shall be responsible for the complete supervision, management, and compliance with all federal and state pharmacy laws and regulations pertaining to the practice of pharmacy of the entire prescription department. This responsibility necessarily includes accountability for any violation involving federal or state Title 46, Part LIII Louisiana Administrative Code August 2022 63 laws or regulations occurring within the prescription department supervised by a pharmacist-in-charge. D. Policy and Procedure Manual. The pharmacist-in- charge shall be responsible for the development and maintenance of policies regarding quality pharmacy services including drug control, distribution, patient compliance accountability, inspection, and record keeping. E. Circumvention. It is a violation of the pharmacy permit for any person to subvert the authority of the pharmacist-in-charge by impeding the management of the prescription department in the compliance of federal and state pharmacy laws and regulations. F. Records. The pharmacist-in-charge is responsible for the proper maintenance of all prescription records. This necessarily includes electronic prescription records and the system's compliance and capacity to produce the required records. G. Recall. The pharmacist-in-charge shall be responsible for the implementation of a recall procedure that can be readily activated to assure patient safety. H. Discontinued or Outdated Drugs. The pharmacist-in- charge shall be responsible for the implementation of policies and procedures to ensure that discontinued drugs, outdated drugs, or drug containers with worn, illegible, or missing labels are withdrawn from the pharmacy inventory. I. Change of Pharmacist-in-Charge. Written notice to the board shall be required when the pharmacist-in-charge designation for a pharmacy has changed. 1. The permit holder shall notify the board within 10 days of the prior pharmacist-in-charge's departure date. The permit holder shall designate a new pharmacist-in-charge within 10 days of the departure of the prior pharmacist-in- charge. 2. The new pharmacist-in-charge shall afford the board written notice of his newly designated pharmacist-in- charge status within 10 days of the departure of the prior pharmacist-in-charge. 3. A pharmacist-in-charge who voluntarily leaves a pharmacy shall give written notice to the board and the owner of the permit at least 10 days prior to this voluntary departure, unless replaced in a shorter period of time. J. Affidavit of Responsibility and Duties. The designated pharmacist-in-charge shall sign an affidavit on a form supplied by the board indicating his understanding and acceptance of the duties and responsibilities of a pharmacist- in-charge. This notarized document shall be submitted to the board for inclusion in the pharmacy's record in the board office. AUTHORITY NOTE: Promulgated in accordance with R.S. 37:1182. HISTORICAL NOTE: Promulgated by the Department of Health and Hospitals, Board of Pharmacy, LR 14:708 (October 1988), effective January 1, 1989, amended LR 18:1381 (December 1992), effective January 1, 1993, LR 29:2100 (October 2003), effective January 1, 2004, LR 33:1133 (June 2007), amended by the Department of Health, Board of Pharmacy, LR 43:50 (January 2017). §2309. Applicable Laws and Regulations A. Louisiana pharmacy laws and regulations shall be applicable to regulate the practice of pharmacy for that portion of the out-of-state pharmacy's Louisiana pharmacy practice or operation. AUTHORITY NOTE: Promulgated in accordance with R.S. 37:1182. HISTORICAL NOTE: Promulgated by the Department of Health and Hospitals, Board of Pharmacy, LR 14:708 (October 1988), effective January 1, 1989, amended LR 18:1381 (December 1992), effective January 1, 1993, LR 29:2100 (October 2003), effective January 1, 2004. §2311. Inspection A. The facilities and records of the out-of-state pharmacy shall be subject to inspection by the board or its designated agent(s). AUTHORITY NOTE: Promulgated in accordance with R.S. 37:1182. HISTORICAL NOTE: Promulgated by the Department of Health and Hospitals, Board of Pharmacy, LR 14:708 (October 1988), effective January 1, 1989, amended LR 18:1381 (December 1992), effective January 1, 1993, LR 29:2101 (October 2003), effective January 1, 2004. §2313. Records A. Records shall be maintained for not less than two years. B. The pharmacy shall maintain records of drugs dispensed to Louisiana residents in such a manner so as to be identifiable, readily retrievable, and available upon request. Said records shall be made available for inspection by the board. The pharmacy permit holder or the pharmacist-in- charge shall produce within 72 hours any information, documentation, and/or records requested by the board. AUTHORITY NOTE: Promulgated in accordance with R.S. 37:1182. HISTORICAL NOTE: Promulgated by the Department of Health and Hospitals, Board of Pharmacy, LR 14:708 (October 1988), effective January 1, 1989, amended LR 18:1381 (December 1992), effective January 1, 1993, LR 29:2101 (October 2003), effective January 1, 2004. §2315. Counseling Services A. The pharmacy shall maintain an incoming toll-free telephone number for use by Louisiana consumers during regular office hours. Readily available telephone counseling services shall be provided that are consistent with the reasonable standard of due care. This telephone number, plus other numbers available for use, shall be printed on each container of drugs dispensed to Louisiana residents. The toll- free telephone number shall have sufficient extensions to provide reasonable access to incoming callers. AUTHORITY NOTE: Promulgated in accordance with R.S. 37:1182. HISTORICAL NOTE: Promulgated by the Department of Health and Hospitals, Board of Pharmacy, LR 14:708 (October 1988), effective January 1, 1989, amended LR 18:1381 (December PROFESSIONAL AND OCCUPATIONAL STANDARDS Louisiana Administrative Code August 2022 64 1992), effective January 1, 1993, LR 29:2101 (October 2003), effective January 1, 2004. §2317. Nonresident Pharmacy Closure Procedures A. Notice. Notice shall be afforded the board not less than 10 days prior to the anticipated closure date of an out- of-state pharmacy. Said notice shall include the location of all transferred prescription files for Louisiana residents. B. Permit. The out-of-state pharmacy permit holder shall surrender the pharmacy permit to the board upon closure. AUTHORITY NOTE: Promulgated in accordance with R.S. 37:1182. HISTORICAL NOTE: Promulgated by the Department of Health and Hospitals, Board of Pharmacy, LR 14:708 (October 1988), effective January 1, 1989, amended LR 18:1381 (December 1992), effective January 1, 1993, LR 29:2101 (October 2003), effective January 1, 2004. §2319. Jurisdiction A. Out-of-state pharmacies soliciting, receiving, and dispensing and delivering prescription drugs and devices, including controlled dangerous substances as defined in 21 U.S.C. 1 et seq., and 21 CFR 1 et seq., or their successors, and delivered to residents in Louisiana constitutes doing business in Louisiana. AUTHORITY NOTE: Promulgated in accordance with R.S. 37:1182. HISTORICAL NOTE: Promulgated by the Department of Health and Hospitals, Board of Pharmacy, LR 14:708 (October 1988), effective January 1, 1989, amended LR 18:1381 (December 1992), effective January 1, 1993, LR 29:2101 (October 2003), effective January 1, 2004. Chapter 24. Limited Service Providers Subchapter A. Durable Medical Equipment §2401. Definitions A. As used in this Chapter, the following terms shall have the meaning ascribed to them in this Section. Durable Medical Equipment (DME)—technologically sophisticated medical devices that may be used in a residence, including the following: a. oxygen and oxygen delivery system; b. ventilators; c. respiratory disease management devices; d. continuous positive airway pressure (CPAP) devices; e. electronic and computerized wheelchairs and seating systems; f. apnea monitors; g. transcutaneous electrical nerve stimulator (TENS) units; h. low air loss cutaneous pressure management devices; i. sequential compression devices; j. feeding pumps; k. home phototherapy devices; l. infusion delivery devices; m. distribution of medical gases to end users for human consumption; n. hospital beds; o. nebulizers; and p. other similar equipment as determined by rule. Legend Device—an instrument, apparatus, implement, machine, contrivance, implant, or other similar or related article, including any component part or accessory, which is required under federal law to bear the label, “Caution: federal or state law requires dispensing by or on the order of a physician” and/or “Rx Only,” or any other designation required under federal law. Legend Drug— a. any substance recognized as a drug in the official compendium, or supplement thereto, designated by the board for use in the diagnosis, cure, mitigation, treatment or prevention of diseases in humans or animals; b. any substance intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in humans or other animals; or c. any substance other than food intended to affect the structure or any function of the body of humans or other animals. Medical Gas—compressed oxygen and liquid oxygen intended for human consumption. AUTHORITY NOTE: Promulgated in accordance with R.S. 37:1182. HISTORICAL NOTE: Promulgated by the Department of Health and Hospitals, Board of Pharmacy, LR 39:502 (March 2013). §2403. Durable Medical Equipment (DME) Permit A. No person or other entity shall sell, rent or provide, or offer to sell, rent or provide, directly or indirectly, to consumers in this state any durable medical equipment, legend devices, and/or medical gas until such person has obtained a durable medical equipment (DME) permit from the board. B. A DME permit shall authorize the permit holder to procure, possess and provide legend devices to the patient or end user; however, the DME permit shall not authorize the permit holder to procure, possess, or provide any prescription or legend drugs. C. The board shall not issue a DME permit to any person or other entity that has not registered with the Louisiana Secretary of State to conduct business within the state. D. Licensing Procedures Title 46, Part LIII Louisiana Administrative Code August 2022 67 assessment of the safety of the home environment, the ability of the patient or care giver to comply with the prescription or medical order, and the ability of the patient or care giver to operate and clean the equipment as instructed. D. Requirements for Providers of Other Durable Medical Equipment 1. Providers who sell, rent or furnish other DME or legend devices shall comply with the following: a. provide proper training to personnel for the safe delivery and use of any DME or legend device; and b. ensure that all manufacturer’s recommended assembly and maintenance procedures are followed; and c. adhere to the following safety inspection measures: i. demonstrate that each piece of DME or legend device has been checked, is free of defect and operates within the manufacturer’s specifications; ii. refrain from modifying equipment to the extent that the modification might reasonably cause harm; iii. maintain all electrical components so they do not present fire or shock hazard; and iv. ensure that all appropriate warning labels or labeling, including tags, are present on the equipment provided. 2. The provider shall comply with the following maintenance and cleaning requirements: a. maintain documentation demonstrating that a function and safety check of equipment was performed prior to set-up; b. maintain an established protocol for cleaning and disinfecting equipment which addresses both aerobic and anaerobic pathogens; c. maintain a material safety data sheet (MSDS) on file for solutions and products used in cleaning and disinfecting procedures; d. maintain segregated areas on the premises and in delivery vehicles for clean, dirty and contaminated equipment; e. clean and disinfect equipment according to manufacturers’ specifications; and f. instruct the patient or caregiver on proper cleaning techniques as specified by the manufacturer. E. Records Management for All DME Providers 1. An electronic record keeping system shall be implemented and maintained by the provider. The system shall provide adequate safeguards against unauthorized access, manipulation or alternation, and further, shall be susceptible to reconstruction in the event of electronic or computer malfunction or an unforeseen accident resulting in the destruction of the system or the information contained therein. 2. All records required in this Chapter shall be retained for a minimum of two years from the last transaction. 3. All records required in this Chapter shall be available and readily retrievable upon request for board inspection and review. In particular, such records shall be produced within 72 hours of the request. AUTHORITY NOTE: Promulgated in accordance with R.S. 37:1182. HISTORICAL NOTE: Promulgated by the Department of Health and Hospitals, Board of Pharmacy, LR 39:503 (March 2013). §2407. Exemptions A. The credentialing requirements of this Subchapter shall not apply to the following persons or entities unless such persons or entities have separate business entities engaged in the business of providing DME to patients at their home: 1. chiropractors; 2. dentists; 3. occupational therapists; 4. optometrists; 5. physical therapists; 6. physicians; 7. podiatrists; 8. respiratory therapists; 9. speech pathologists; 10. veterinarians; 11. distributors; 12. home health agencies; 13. hospice programs; 14. hospitals; 15. long term care facilities; 16. manufacturers; and 17. pharmacies. B. Pharmacies, although excluded from the credentialing requirements of this Subchapter, shall be subject to and comply with the standards of practice identified herein. C. Nothing in this Subchapter shall be construed to prohibit the pre-hospital emergency administration of oxygen by licensed health care providers, emergency medical technicians, first responders, fire fighters, law enforcement officers and other emergency personnel trained in the proper use of emergency oxygen. AUTHORITY NOTE: Promulgated in accordance with R.S. 37:1182. HISTORICAL NOTE: Promulgated by the Department of Health and Hospitals, Board of Pharmacy, LR 39:504 (March 2013). PROFESSIONAL AND OCCUPATIONAL STANDARDS Louisiana Administrative Code August 2022 68 §2409. (Reserved) Subchapter B. Special Event Pharmacy Permit §2411. Special Event Pharmacy Permit A. For good cause shown, the board may issue a special event pharmacy permit when the scope, degree, or type of pharmacy practice or service to be provided is of a special, limited, or unusual nature as compared to a regular pharmacy service. The permit to be issued shall be based on special conditions as requested by the applicant and imposed by the board in cases where certain requirements or standards of practice may be waived. AUTHORITY NOTE: Promulgated in accordance with R.S. 37:1223. HISTORICAL NOTE: Promulgated by the Department of Health and Hospitals, Board of Pharmacy, LR 41:100 (January 2015). §2413. General Requirements A. Authority and Limitation 1. A special event pharmacy permit shall authorize the permit holder to procure and possess prescription and non- prescription drugs and devices, and hold such items for immediate administration directly to a patient and/or dispense such items to a patient for later use upon the order of a practitioner with prescriptive authority. 2. In the absence of a Louisiana controlled dangerous substance (CDS) license, the holder of a special event pharmacy permit shall not procure or possess any controlled dangerous substances. B. Licensing Procedure 1. A person or other entity desiring to obtain a special event pharmacy permit shall complete the application form supplied by the board and submit it with any required attachments and the application fee to the board. 2. The applicant shall provide a complete physical address reflecting the location where the applicant will hold the drugs and devices and engage in the activity for which the permit is acquired. The board shall not issue more than one permit for the same physical space. 3. The board shall not process applications received by facsimile, or that are incomplete, or submitted with the incorrect fee. 4. A person or other entity who knowingly or intentionally submits a false or fraudulent application shall be deemed to have violated R.S. 37:1241(A)(2). 5. Once issued, the special event permit shall expire 30 days thereafter. No person or other entity shall operate a special event pharmacy with an expired permit; the continued operation of a special event pharmacy with an expired permit shall constitute a violation of R.S. 37:1241(A)(12). Upon written request to the board, and with the concurrence of the board’s president and executive director, the expiration date of the special event pharmacy permit may be extended up to an additional 30 days. No special event pharmacy permit shall be valid for more than 60 days. C. Maintenance of Permit 1. A special event pharmacy permit shall be valid only for the person or other entity to whom it is issued and shall not be subject to sale, assignment or other transfer, voluntary or involuntary, nor shall a special event pharmacy permit be valid for any premises other than the physical location for which it is issued. 2. A duplicate or replacement permit shall be issued upon the written request of the permit holder and payment of the required fee. A duplicate or replacement permit shall not serve or be used as an additional or second permit. D. Closure of Permit 1. At the conclusion of the special event, the permit holder shall terminate the dispensing and/or distribution of drugs and/or devices from the pharmacy. 2. Disposition of Inventory a. Controlled Dangerous Substances Listed in Schedule II. These drugs shall be either returned to the supplier or transferred to an authorized registrant, accompanied by an executed DEA Form 222, or its successor. Alternatively, these drugs shall be inventoried on the DEA Form 41 (registrant’s inventory of drugs surrendered), or its successor, and then either returned to the regional DEA office or destroyed, but only pursuant to permission from the DEA or agent of the board. The permit holder shall retain triplicate copies of returns, transfers, and/or destructions. b. Controlled Dangerous Substances Listed in Schedules III, IV, or V. These drugs shall be either returned to the supplier or transferred to an authorized registrant, accompanied by appropriate inventory records. Alternatively, these drugs shall be inventoried on the DEA Form 41, or its successor, and then either returned to the regional DEA office, or destroyed pursuant to permission from the DEA or agent of the board. c. All Other Prescription and Non-prescription Drugs and/or Devices. These items shall be returned to the supplier, transferred to an authorized registrant, or destroyed. 3. Surrender of Credentials and Board Notice a. All drugs, devices, prescription records and other pharmacy records have been removed from the premises, the permit holder shall prepare and render a final closure notice to the board. The notice shall contain the following: i. disposition and destination of all drugs and/or devices held by the pharmacy; ii. disposition and destination of all prescriptions and medical orders dispensed or administered to patients; Title 46, Part LIII Louisiana Administrative Code August 2022 69 iii. disposition and destination of all other pharmacy records, including acquisition, inventory, and disposition records for all drugs and/or devices; iv. the commitment to store such records for no less than two years following the closure of the pharmacy, and further, to make any and all such records available for inspection by the board no later than 72 hours following a request from the board; v. the certification that all signage indicating the presence of a pharmacy has been removed from the premises; vi. the confirmation of the surrender of any federal DEA registration held by the pharmacy to the regional DEA office; and vii. the original and all duplicate copies of the special event pharmacy, and if applicable, Louisiana CDS license. b. The pharmacist-in-charge of the special event pharmacy permit has the primary responsibility for the proper closure of the pharmacy permit. However, in the event the pharmacist-in-charge fails to complete the task, then the permit holder shall be responsible for the proper closure of the pharmacy permit. AUTHORITY NOTE: Promulgated in accordance with R.S. 37:1182. HISTORICAL NOTE: Promulgated by the Department of Health and Hospitals, Board of Pharmacy, LR 41:100 (January 2015). §2415. Standards of Practice A. General Requirements 1. The special event pharmacy shall be of sufficient size and shall contain sufficient fixtures, equipment, and supplies commensurate with the scope of practice for that pharmacy, provided: a. the pharmacy shall be of sufficient size to allow for the safe and proper storage of prescription drugs and, if applicable, controlled dangerous substances; b. all areas where drugs and devices are stored shall be dry, well-lighted, well ventilated, and maintained at temperatures which will ensure the integrity of drugs prior to their dispensing as stipulated by the United States Pharmacopeia (USP) and/or manufacturer’s or distributor’s product labeling unless otherwise indicated by the board; c. the pharmacy shall be secured by either a physical barrier with suitable locks and/or an electronic barrier to detect entry at a time when the pharmacist is not present; and d. prescription and other patient healthcare information shall be maintained in a manner that protects the integrity and confidentiality of such information. 2. The pharmacist-in-charge of the special event pharmacy shall be responsible for all pharmacy operations including supervision of all pharmacy personnel. 3. The pharmacy shall have at least one licensed pharmacist on duty and physically present in the pharmacy at all times the pharmacy is open for the transaction of business. 4. The pharmacy shall have a sufficient number of pharmacists and/or other pharmacy personnel on duty to operate the pharmacy competently, safely, and adequately to meet the needs of the patients of the pharmacy. 5. When the pharmacy is closed or there is no pharmacist on duty, other individuals shall not have access to the pharmacy except for temporary absences as provided for in Chapter 11 of these rules. 6. The special event pharmacy shall comply with the recordkeeping requirements identified in Chapter 11 of these rules. 7. The compounding of preparations in a special event pharmacy shall be accomplished in compliance with the current federal standards applicable to such practices: USP chapter 795, or its successor, for the compounding of non- sterile preparations and USP chapter 797, or its successor, for the compounding of sterile preparations. AUTHORITY NOTE: Promulgated in accordance with R.S. 37:1182. HISTORICAL NOTE: Promulgated by the Department of Health and Hospitals, Board of Pharmacy, LR 41:101 (January 2015). Subchapter C. Telepharmacy Services §2421. Purpose A. As market forces continue to adversely impact community pharmacies, some pharmacies have or will close permanently. In certain parts of the state, such closures create critical access issues for citizens in need of pharmacy services. B. As the pharmacy workforce continues to evolve, with changing patterns of distribution of the workforce, certain parts of the state have experienced a shortage of pharmacists, which can adversely impact access to pharmacist care. C. In an effort to improve access to pharmacist care and pharmacy services, the board has determined it appropriate to establish standards for the operation and regulation of telepharmacy services. AUTHORITY NOTE: Promulgated in accordance with R.S. 37:1182. HISTORICAL NOTE: Promulgated by the Department of Health and Hospitals, Board of Pharmacy, LR 41:2149 (October 2015). §2423. Definitions A. As used in this Subchapter, the following terms shall have the meaning ascribed to them in this Section. Central Pharmacy—a permitted pharmacy in Louisiana that supervises a telepharmacy dispensing site. PROFESSIONAL AND OCCUPATIONAL STANDARDS Louisiana Administrative Code August 2022 72 b. Prescriptions filled at the telepharmacy dispensing site shall be distinguishable on records from those filled at the central pharmacy c. Records of activities at the telepharmacy dispensing site shall be distinguishable from the records of activities at the central pharmacy. d. Telepharmacy dispensing sites holding controlled substances shall maintain a perpetual inventory of controlled dangerous substances and drugs of concern. AUTHORITY NOTE: Promulgated in accordance with R.S. 37:1182. HISTORICAL NOTE: Promulgated by the Department of Health and Hospitals, Board of Pharmacy, LR 41:2149 (October 2015), amended by the Department of Health, Board of Pharmacy, LR 46:586 (April 2020), LR 47:1643 (November 2021). Subchapter D. Remote Processor Pharmacy §2431. Purpose A. The purpose of this Subchapter is to establish standards for the operation and regulation of remote processor pharmacies to be located within the state of Louisiana. AUTHORITY NOTE: Promulgated in accordance with R.S. 37:1182. HISTORICAL NOTE: Promulgated by the Department of Health and Hospitals, Board of Pharmacy, LR 41:2148 (October 2015). §2433. Definitions A. As used in this Subchapter, the following terms shall have the meaning ascribed to them in this Section. On-Site Pharmacy—a permitted pharmacy which utilizes remote processing services from a remote processor pharmacy. Remote Processing Services—the processing of a medical order or prescription drug order by one permitted pharmacy on behalf of another permitted pharmacy, including: a. receipt, interpretation, or clarification of an order; b. data entry and information transfer; c. interpretation of clinical data; d. performance of drug utilization review; and e. provision of drug information concerning a patient’s drug therapy; provided, however, that remote processing does not include the physical preparation or physical transfer of drugs. Remote Processor—a pharmacy holding a remote processor pharmacy permit and provides remote processing services for another permitted pharmacy, AUTHORITY NOTE: Promulgated in accordance with R.S. 37:1182. HISTORICAL NOTE: Promulgated by the Department of Health and Hospitals, Board of Pharmacy, LR 41:2148 (October 2015). §2435. General Requirements A. Authority and Limitations 1. A remote processor pharmacy permit shall authorize the permit holder to engage in remote processing services. 2. A remote processor pharmacy permit shall not authorize the procurement or possession of any prescription medications or any controlled substances. 3. The holder of a remote processor pharmacy permit shall not be eligible to acquire a Louisiana controlled dangerous substance license or a federal registration from the U.S. Drug Enforcement Administration. B. Licensing Procedure 1. A person or other entity intending to operate a remote processor pharmacy shall complete the application form supplied by the board, and then submit it with any required attachments and the application fee to the board. 2. The board shall not process applications received by facsimile, or that are incomplete, or submitted with the incorrect fee. 3. A person or other entity who submits a false or fraudulent application shall be deemed to have violated R.S. 37:1241(A)(2) and shall be subject to disciplinary action by the board. 4. If determined appropriate by the board, the applicant may be required to meet with a committee of the board or an agent of the board prior to the issuance of the permit. 5. Regardless of the date issued, the pharmacy permit shall expire on December 31 of every year. No person or other entity may operate a remote processor pharmacy with an expired permit; the continued operation of a remote processor pharmacy with an expired permit shall substantiate a violation of R.S. 37:1241(A)(12). C. Maintenance of Permit 1. A remote processor pharmacy permit shall be valid only for the person or other entity to whom it is issued, and it shall not be subject to sale, assignment or other transfer, voluntary or involuntary, nor shall the permit be valid for any premises other than the physical location for which it was issued. 2. A duplicate or replacement permit shall be issued upon the written request of the permit holder and payment of the required fee. A duplicate or replacement permit shall be marked as such, and it shall not serve or be used as an additional or second permit. D. Closure of Permit 1. When the owner of the permit intends to close the remote processor pharmacy permanently, the owner’s Title 46, Part LIII Louisiana Administrative Code August 2022 73 managing officer and the pharmacist-in-charge shall be accountable to the board for the proper closure of the pharmacy in compliance with Section 1133 of the board’s rules. AUTHORITY NOTE: Promulgated in accordance with R.S. 37:1182. HISTORICAL NOTE: Promulgated by the Department of Health and Hospitals, Board of Pharmacy, LR 41:2148 (October 2015). §2437. Standards of Practice A. Environmental Standards 1. The remote processor pharmacy shall be of sufficient size and shall contain sufficient fixtures, equipment, and supplies commensurate with the nature and scope of practice for that pharmacy. 2. The pharmacy shall be well-lighted, well ventilated and in compliance with the Louisiana Sanitary Code. 3. The pharmacy shall be secured by either a physical barrier with suitable locks and/or an electronic barrier to detect entry by any unauthorized personnel. 4. Prescription and other patient healthcare information shall be maintained in a manner that protects the integrity and confidentiality of such information. B. Staffing Requirements 1. The pharmacist-in-charge shall be a Louisiana- licensed pharmacist who is accountable to the board for compliance with the provisions of Section 1105 of the board’s rules. 2. The pharmacist-in-charge shall assemble and manage a staff of appropriately-credentialed people as necessary to perform its work in a safe manner. 3. For those pharmacies using pharmacy interns, pharmacy technicians, and pharmacy technician candidates, the staffing ratios cited in the board’s rules are applicable to those types of personnel. C. Operations 1. The remote processor pharmacy shall comply with the provisions of Section 1143 of the board’s rules. 2. The remote processor shall comply with the recordkeeping provisions of Section 1123 of the board’s rules. AUTHORITY NOTE: Promulgated in accordance with R.S. 37:1182. HISTORICAL NOTE: Promulgated by the Department of Health and Hospitals, Board of Pharmacy, LR 41:2149 (October 2015). Subchapter E. Marijuana Pharmacy §2440. Preamble; Warning; Consultation Suggested A. Pursuant to Act 261 of the Regular Session of the 2015 Legislature as well as subsequent amendments, the Board of Pharmacy was directed to: 1. develop an annual, nontransferable specialty license for a pharmacy to dispense recommended marijuana for therapeutic use, to limit the number of such licenses to a maximum of 10, and to adopt rules regarding the geographical locations of dispensing pharmacies in the state; and 2. adopt rules relating to the dispensing of recommended marijuana for therapeutic use, with such rules to include, at a minimum, the following: a. standards, procedures, and protocols for the effective use of recommended marijuana for therapeutic use as authorized by state law and related rules; b. standards, procedures, and protocols for the dispensing and tracking of recommended therapeutic marijuana; c. procedures and protocols to provide that no recommended therapeutic marijuana may be dispensed from, produced from, obtained from, sold to, or transferred to a location outside of this state; d. standards, procedures, and protocols for determining the amount of usable recommended therapeutic marijuana that is necessary to constitute an adequate supply to ensure uninterrupted availability for a period of one month, including amount for topical treatments; e. standards, procedures, and protocols to ensure all recommended therapeutic marijuana dispensed, with the exception of raw or crude marijuana product, is consistently pharmaceutical grade. f. standards and procedures for the revocation, suspension, and nonrenewal of licenses; g. other licensing, renewal, and operational standards deemed necessary by the Board of Pharmacy; h. standards and procedures for testing recommended therapeutic marijuana samples for levels of tetrahydrocannabinols (THC) or other testing parameters deemed appropriate by the Board of Pharmacy; i. standards for the protection of health, safety, and security for dispensers of recommended therapeutic marijuana; j. standards for the licensure of dispensers of recommended therapeutic marijuana; and k. standards for financial capacity to operate a marijuana pharmacy. l. limitations on dispensing of raw or crude marijuana. B. Marijuana is classified as a schedule I controlled substance by the U.S. Department of Justice, Drug Enforcement Administration. 1. As provided by the federal Controlled Substances Act, the procurement, possession, prescribing, distribution, dispensing, or administering of any schedule I controlled substance, including marijuana, is a violation of federal law. PROFESSIONAL AND OCCUPATIONAL STANDARDS Louisiana Administrative Code August 2022 74 2. Neither Louisiana law nor this Part can preempt federal law. Therefore, the provisions of this Subchapter notwithstanding, persons engaged in the activities described herein remain subject to the full force of federal law enforcement, including arrest and prosecution of criminal charges, the assessment of civil fines and forfeitures, as well as administrative consequences such as forfeiture of federal controlled substance registrations and exclusion from Medicare and other federal payer programs. C. For the foregoing reasons, pharmacists and other persons credentialed by the board may wish to consult with their own legal counsel as well as any health care facility, private or governmental payor with which they are affiliated, professional liability insurers, and financial institutions with which they maintain depository relationships before engaging in the activities described herein. AUTHORITY NOTE: Promulgated in accordance with R.S. 40:1046. HISTORICAL NOTE: Promulgated by the Department of Health, Board of Pharmacy, LR 43:1538 (August 2017), amended LR 48:1902 (July 2022). §2441. Definitions A. As used in this Subchapter, the following terms shall have the meaning ascribed to them in this Section: Administer—the direct application of marijuana to the body of a qualifying patient by ingestion or any other means. Advertisement—all representations disseminated in any manner or by any means, other than by labeling, for the purpose of inducing, or which are likely to induce, directly or indirectly, the purchase of marijuana, excluding information of an educational nature designed to inform citizens of the nature and form of the state’s therapeutic marijuana program and its legally permitted products. Agent—an authorized person who acts on behalf of or at the direction of another person. It does not include a common or contract carrier, public warehouseman, or employee of the carrier or warehouseman. Approved Safe—a safe which conforms to or exceeds all of the following standards: a. shall have the following specifications or the equivalent: i. 30 man-minutes against surreptitious entry; ii. 10 man-minutes against forced entry; iii. 20 man-hours against lock manipulation; and iv. 20 man-hours against radiological techniques; b. if it weighs less than 750 pounds, is bolted or cemented to the floor or wall in such a way it cannot be readily removed; and c. is equipped with an alarm system which, upon attempted unauthorized entry, shall transmit a signal directly to a central protection company or a local or state police agency which has a legal duty to respond, or a 24-hour control station operated by the licensee, or such other protection as the board or its designee may approve. Approved Vault— a. a vault constructed before, or under construction on, September 1, 1971, which is of substantial construction with a steel door, combination or key lock, and an alarm system; or b. a vault constructed after September 1, 1971: i. the walls, floors, and ceilings of which are constructed of at least 8 inches of reinforced concrete or other substantial masonry, reinforced vertically and horizontally with one-half inch steel rods tied 6 inches on center, or the structural equivalent to such reinforced walls, floors, and ceilings; ii. the door and frame unit of which vault shall conform to the following specifications or the equivalent: (a). thirty man-minutes against surreptitious entry; (b). ten man-minutes against forced entry; (c). twenty man-hours against lock manipulation; and (d). twenty man-hours against radiological techniques; iii. which vault, if operations require it to remain open for frequent access, is equipped with a “day gate” which is self-closing and self-locking or the equivalent, for use during the hours of operation in which the vault door is open; iv. the walls or perimeter of which are equipped with an alarm which, upon unauthorized entry, shall transmit a signal directly to a central station protection company, or a local or state police agency which has a legal responsibility to respond, or a 24-hour control station operated by the licensee, or such other protection as the board or its designee may approve, and if necessary, alarm buttons at strategic points of entry to the perimeter area of the vault; v. the door of which shall be equipped with one or more contact switches; and vi. which vault has one of the following: (a). complete electrical lacing of the walls, floor and ceiling; (b). sensitive ultrasonic equipment within the vault; (c). sensitive sound accumulator system; or (d). such other device designed to detect illegal entry as may be approved by the board. Board—the Louisiana Board of Pharmacy. CFR—Code of Federal Regulations. Title 46, Part LIII Louisiana Administrative Code August 2022 77 does not contain any residues appearing on LDAF’s approved list and any approved residues present are less than the limits allowed by LDAF. e. With respect to the residual solvent test, a marijuana sample shall be deemed to have passed if the following solvents are below the listed limits: i. butanes < 800 ppm; ii. heptanes < 500 ppm; iii. benzene < 1 ppm; iv. toluene < 1 ppm; v. hexanes < 10 ppm; vi. total xylenes < 1 ppm; and vii. ethanol < 5,000 ppm. f. With respect to the test for homogeneity, a marijuana sample shall be deemed passed if each aliquot tested is within plus or minus 15 percent of the total aliquots average finding for potency for each labeled active ingredient. Any solid product will be considered not homogenous if 10 percent of the product contains more than 20 percent of the total active ingredient. g. Every sample shall undergo an active ingredient analysis or potency analysis. i. For medical marijuana concentrate samples, the potency test is to establish the presence of active ingredients and their concentrations for accurate calculations of amounts needed for the production of products. The analysis must identify the following substances: (a). THC (tetrahydrocannabinol); (b). THCA (tetrahydrocannabinolic acid); (c). CBD (cannabidiol); and (d). CBDA (cannabidiolic acid). ii. For product samples, the potency test is to establish the active ingredient composition for verification of labeling to ensure accurate dosing. The maximum variance permitted is 15 percent from the labeled amount. For example, a product labeled as containing 10 milligrams of tetrahydrocannabinol (THC) shall contain no less than 8.5 milligrams THC and no more than 11.5 milligrams THC. For final products containing THCA, the total THC determined shall also be within the variance allowed for the THC as labeled. 5. Procedures for Sample Failures a. In the event a medical marijuana concentrate sample fails testing for pesticides, heavy metals or mycotoxin, the entire batch from which the sample was taken shall be disposed of in accordance with the disposal rules promulgated by LDAF. b. In the event a medical marijuana concentrate sample fails residual solvent testing, then, with prior approval of LDAF, the product may be subjected to an appropriate remedy, e.g., vacuum drying, reformulated and tested again. The reformulation must pass all required tests for a medical marijuana concentrate in duplicate before it can be released for use in products. If either duplicate fails any test, the entire batch shall be disposed of in accordance with the disposal rules promulgated by LDAF. A batch of medical marijuana concentrate can only be reformulated once and only to remedy excessive residual solvents. c. In the event a product fails the microbiological testing, the entire batch from which the sample was taken shall be disposed of in accordance with the disposal rules promulgated by LDAF. d. In the event a product fails the potency or homogeneity testing, then, with prior approval of LDAF, the product can be re-sized and tested again. The reformulated product shall be tested again in duplicate and pass all required tests before it can be released for sale or consumption. If either duplicate fails any test, the entire batch shall be disposed of in accordance with the disposal rules promulgated by LDAF. 6. In the event of any test failure, the laboratory shall transmit to LDAF an electronic copy of such test result at the same time it transmits those results to the producer. In addition, the laboratory shall maintain the laboratory test results including all relevant chromatograms and quality control documentation for at least five years and make them available to LDAF at its request. 7. The laboratory shall dispose of any remaining medical marijuana concentrate or product samples no sooner than 60 days following the completion of any testing, in compliance with the disposal rules promulgated by LDAF. 8. A producer shall provide the laboratory test results to the marijuana pharmacy for each batch of marijuana used in a product acquired by the marijuana pharmacy. The pharmacy shall make such testing results available upon request to their patients, caregivers, and physicians who recommended such marijuana products dispensed to their patients. C. Product Dosage Forms 1. The producer shall limit their production of pharmaceutical grade products to the following dosage forms: a. oils, extracts, tinctures, or sprays; b. solid oral dosage forms, e.g., capsules or pills; c. liquid oral dosage forms, e.g., solutions or suspensions; d. gelatin-based or pectin-based chewables; e. topical applications, oils or lotions; f. transdermal patches; g. suppositories; or h. metered-dose inhalers i. bulk raw product. PROFESSIONAL AND OCCUPATIONAL STANDARDS Louisiana Administrative Code August 2022 78 2. The producer may produce other products from raw or crude marijuana, including dried flower, buds, and other plant material, intended for the following methods of administration: a. combustible forms for inhalation, including but not limited to pre-rolls; and b. edible forms for ingestion. 3. No marijuana product shall: a. include alcoholic liquor, dietary supplements, or any drug, except for marijuana. For purposes of this provision, alcoholic liquor does not include any liquid or solid containing less than 0.5 percent of alcohol by volume, or ethanol-based tinctures. b. be manufactured or sold in a form or with a design that: i. is obscene or indecent; ii. may encourage the use of marijuana for recreational purposes; iii. may encourage the use of marijuana for a condition other than a debilitating medical condition; or iv. is customarily associated with persons under the age of 18 years; or c. have had pesticide chemicals or organic solvents used during the production or manufacturing process other than those which may be approved by the commissioner of LDAF. 4. Any marijuana product not in compliance with the provisions of this Section shall be deemed adulterated. D. Packaging and Labeling Requirements 1. Packaging a. The producer shall ensure every product intended for dispensing to a patient is placed within a child-resistant, light-resistant, tamper-evident container prior to sale or transport to the pharmacy. i. A package shall be deemed child-resistant if it satisfies the standard for ‘special packaging’ as set forth in the United States Consumer Product Safety Commission’s “poison prevention packaging” as found in 16 CFR 1700.1(b)(4) or its successor. ii. A package shall be deemed light-resistant if it satisfies the standard set forth in chapter 671, “containers: performance testing,” of the United States Pharmacopeia (USP). iii. A package shall be deemed tamper-evident if it clearly indicates prior access to the container. b. Packaging selected by the producer shall be subject to the following restrictions: i. shall not specifically target individuals under the age of 18 years; ii. shall not bear any resemblance to a trademarked, characteristic or product-specialized packaging of any commercially available candy, snack, baked good or beverage; iii. shall not use the words “candy” or “candies”; iv. shall not use a cartoon, color scheme, image, graphic or feature that might make the package attractive to children; and v. shall not use a seal, flag, crest, coat of arms or other insignia that could reasonably lead any person to believe the product has been endorsed, manufactured by, or used by any state, parish, municipality, or any agent thereof. 2. Labeling a. Each product shall be labeled by the producer prior to its sale to the marijuana pharmacy. b. Each label shall be securely affixed to the package and shall comply with labeling standards for marijuana products promulgated by LDAF. c. The label for each product shall bear a product identification code registered with the board. d. The producer may utilize a two-dimensional quick response (QR) code or a package insert which is enclosed or attached to the product container to provide the information required in this Section. If the producer elects to use such supplementary labeling, the label affixed to the outer surface of the product container shall contain the following information, at a minimum: i. the batch or lot number; ii. the potency of any THC or CBD contained therein; iii. the net weight; iv. the expiration date; and v. any caution statements. E. Distribution of Marijuana Products to Marijuana Pharmacies 1. The producer shall maintain complete inventory records in the Louisiana medical marijuana tracking system (LMMTS), as required and delineated in rules promulgated by LDAF. 2. The producer shall maintain comprehensive records in LMMTS of all marijuana products distributed to the marijuana pharmacies, whether by transport and delivery to the pharmacy or by transfer to the agent of the pharmacy at the production facility. 3. In the event the producer delivers the products to the pharmacy, such activities must be in compliance with the rules for that activity promulgated by LDAF. 4. In the event the pharmacy elects to send an agent to the production facility to retrieve products ordered by the pharmacy, the personnel at the production facility shall Title 46, Part LIII Louisiana Administrative Code August 2022 79 verify the identity and credentials of the pharmacy’s agent before releasing the products to the agent. a. The producer shall provide a copy of the transport manifest generated by LMMTS, which shall contain the following information: i. the name and address of the producer selling the product; ii. the name and address of the pharmacy purchasing the product; iii. the name and quantity (by weight or unit) of marijuana products included in the delivery; iv. the date of transport and time of departure from the production facility; v. the make, model, and license plate number of the delivery vehicle; vi. the date and time of arrival at the pharmacy; and vii. the name and signature of the pharmacy’s agent. b. The pharmacy’s agent shall compare the transport manifest to the products transferred to his possession, and when correct, shall return a signed copy of the manifest to the producer before departing from the production facility. c. The pharmacy’s agent shall place the products in a locked, safe, and secure storage compartment that is part of the motor vehicle, or in the alternative, in a locked storage container that has a separate key or combination pad, and further, the product shall not visible or recognizable from outside the vehicle, and further, the vehicle shall not bear the name of the pharmacy or any markings to indicate the vehicle contains marijuana. d. The pharmacy’s agent shall maintain physical control of the vehicle at all times during the transport, and shall not leave the vehicle unattended at any time. e. The pharmacy’s agent shall have access to a secure form of communication with the pharmacy as well as the ability to contact law enforcement through the 911 emergency system. f. Upon arrival at the pharmacy, the pharmacy’s agent shall deliver the product to a pharmacist for verification of receipt; the pharmacist shall time, date, and sign the delivery manifest. AUTHORITY NOTE: Promulgated in accordance with R.S. 40:1046. HISTORICAL NOTE: Promulgated by the Department of Health, Board of Pharmacy, LR 43:1540 (August 2017), amended LR 45:1473 (October 2019), amended LR 46:568 (April 2020), LR 46:1227 (September 2020), LR 47:590 (May 2021), LR 48:1902 (July 2022). §2445. Marijuana Pharmacy Permit A. The board shall develop and configure a pharmacy permit designated as a marijuana pharmacy permit. B. The dispensing of marijuana for therapeutic purposes shall be limited to those pharmacies holding a marijuana pharmacy permit issued by the board, and only when that permit is in active or restricted status. C. When issued to a successful applicant, the permit will authorize the operation of a marijuana pharmacy in compliance with the provisions of this Subchapter. D. When the permit is issued, it shall be valid only for the owner and the specific location noted on the application and recorded on the permit. E. A marijuana pharmacy permit is non-transferable from one owner to another owner, and moreover, in the event the ownership of the organization that acquired the permit changes by 50 percent or more, then the ownership will be deemed sufficiently different as to require a new marijuana pharmacy permit. A marijuana pharmacy permit owner continuing to operate a marijuana pharmacy after its ownership has changed by 50 percent or more without obtaining a new marijuana pharmacy permit shall be deemed guilty of operating a pharmacy without a valid permit, in violation of R.S. 37:1221. F. Although a change of ownership of less than 50 percent shall not require a new pharmacy permit, any proposed change of ownership shall require prior notice to the board, and further, approval by the board. G. The board shall not have more than 10 active marijuana pharmacy permits at any given time. To facilitate compliance with that legislative restriction, the board recognizes the nine regions previously declared by the Department of Health, to wit: 1. metropolitan, composed of the parishes of Jefferson, Orleans, Plaquemines, and St. Bernard; 2. capitol, composed of the parishes of Ascension, East Baton Rouge, East Feliciana, Iberville, Pointe Coupee, West Baton Rouge, and West Feliciana; 3. Teche, composed of the parishes of Assumption, Lafourche, St. Charles, St. James, St. John, St. Mary, and Terrebonne; 4. Acadian, composed of the parishes of Acadia, Evangeline, Iberia, Lafayette, St. Landry, St. Martin, and Vermilion; 5. southwest, composed of the parishes of Allen, Beauregard, Calcasieu, Cameron, and Jefferson Davis; 6. central, composed of the parishes of Avoyelles, Catahoula, Concordia, Grant, LaSalle, Rapides, Vernon, and Winn; 7. northwest, composed of the parishes of Bienville, Bossier, Caddo, Claiborne, DeSoto, Natchitoches, Red River, Sabine, and Webster; 8. northeast, composed of the parishes of Caldwell, East Carroll, Franklin, Jackson, Lincoln, Madison, Morehouse, Ouachita, Richland, Tensas, Union, and West Carroll; and PROFESSIONAL AND OCCUPATIONAL STANDARDS Louisiana Administrative Code August 2022 82 15. During the hearing held by the board’s application review committee, the members shall consider, but are not limited to, the following criteria when evaluating an application for a marijuana pharmacy permit: a. the character and fitness of the owner’s managing officer, the pharmacist-in-charge, any of the owners and any other person who may have control or influence over the operation of the proposed marijuana pharmacy; b. the location for the proposed marijuana pharmacy including, but not limited to: i. its proximity to previously approved marijuana pharmacies or locations of proposed marijuana pharmacies with pending applications; ii. whether the patient population in the area proposed by the marijuana pharmacy permit applicant justifies the need for a marijuana pharmacy, or an additional marijuana pharmacy, in that area; iii. whether the proximity of the proposed marijuana pharmacy will have a detrimental effect upon any place used primarily for religious worship, public or private school, convent, charitable institution, whether supported by private or public funds, hospital or veterans' home or any camp or military establishment; or iv. whether the number of marijuana pharmacies in the locality is such that the granting of a permit is detrimental to the public interest. In reaching a conclusion in this respect, the board may consider the population of, the number of like permits and number of all permits existent in, the particular municipality and the immediate neighborhood concerned, the effect that a new permit may have on such town or neighborhood or on like permits existent in such municipality or neighborhood; c. the applicant’s ability to maintain adequate control against the diversion, theft and loss of marijuana; d. the applicant’s ability to maintain the knowledge, understanding, judgment, procedures, security controls and ethics to ensure optimal safety and accuracy in the dispensing and sale of marijuana; and e. the extent to which the applicant or any of the applicant’s owners have a financial interest in any other permittee, licensee, registrant, or other applicant currently or previously credentialed by the board; and f. Any other reason provided by any federal law or rule or state law or rule that is not inconsistent with R.S. 40:1046 or 40:1047 or this Subchapter. 16. Following their evaluation of the applications for a marijuana pharmacy permit, the committee shall develop a recommendation for presentation to the board at the board’s next meeting. The board may accept the committee’s recommendation, select an alternative applicant, reject all of the applicants, or return all the applicants to the committee for their reconsideration. 17. The board may disqualify any applicant who: a. submits an incomplete, false, inaccurate, or misleading application; b. fails to submit an application by the published deadline; or c. fails to pay all applicable fees. 18. The decision of the board to award or not to award a marijuana pharmacy permit to an applicant shall be final. 19. Upon the approval of an application, the board shall award the marijuana pharmacy permit and state controlled dangerous substance license to the applicant. Upon completion of a satisfactory inspection of the pharmacy premises, the board shall issue the marijuana pharmacy permit and state controlled dangerous substance license to the applicant awarded the permit. 20. If an applicant has been awarded a marijuana pharmacy permit and has not commenced operation of such pharmacy within 310 days of being notified of the marijuana pharmacy permit award, the board may, in the board’s discretion, rescind such marijuana pharmacy permit, unless such delay was caused by force majeure. A marijuana pharmacy shall be deemed to have commenced operation if the pharmacy is capable of operating in accordance with the applicant’s approved application. In the event a marijuana pharmacy permit is rescinded pursuant to this Subsection, the board shall award a marijuana pharmacy permit by selecting among the qualified applicants who applied for the marijuana pharmacy permit that was rescinded. If no other qualified applicant applied for such marijuana pharmacy permit or satisfied the criteria for awarding a permit, the board shall publish, in accordance with this Section, a notice of open applications for marijuana pharmacy permits. B. Application for Renewal of Permit 1. All marijuana pharmacy permits expire at midnight on December 31 of every year, regardless of the date of its initial issuance. 2. The owner’s managing officer and pharmacist-in- charge of the marijuana pharmacy permit shall complete, sign and date a permit renewal application form supplied by the board, and further, shall include all information requested on the form and attach the pharmacy permit renewal fee and state controlled dangerous substance license renewal fee authorized in R.S. 37:1184 and the prescription monitoring program fee authorized in R.S. 40:1013, and further, shall submit the renewal application package to the board office prior to the expiration date of the pharmacy permit. 3. The board shall not process applications received by facsimile, or that are incomplete, or submitted with the incorrect fees. 4. In the event the pharmacy does not submit a properly completed renewal application form and fee to the board prior to the expiration of the permit, the permit shall be rendered null and void. A marijuana pharmacy shall not operate with an expired permit. Evidence it has done so will Title 46, Part LIII Louisiana Administrative Code August 2022 83 provide sufficient basis for the board to discipline the permit for violation of R.S. 37:1241(12). 5. An application for the late renewal of an expired (lapsed) marijuana pharmacy permit that is received in the board office no later than 30 days after the expiration date of the permit may be processed by the board staff, provided the appropriate delinquent fee authorized in R.S. 37:1184 is included with the application. 6. A marijuana pharmacy permit not renewed by 30 days after the expiration date shall be automatically terminated by the board. 7. An application for the reinstatement of a terminated marijuana pharmacy permit shall be referred to the board’s reinstatement committee for its consideration. C. Application for Reinstatement of Terminated, Suspended, or Revoked Marijuana Pharmacy Permits 1. The applicant shall complete an application form for this specific purpose supplied by the board; the application shall require the inclusion of the annual renewal fee, the delinquent fee, the administrative hearing fee, and the reinstatement fees authorized in R.S. 37:1184 and the program fee authorized in R.S. 40:1013. 2. An application for the reinstatement of a marijuana pharmacy permit previously terminated, suspended or revoked by the board may only be approved following a preliminary hearing to determine whether the reinstatement of the permit is in the public’s best interest. D. Maintenance of Marijuana Pharmacy Permit 1. A marijuana pharmacy permit is valid only for the entity or person to whom it is issued and shall not be subject to sale, assignment or other transfer, voluntary or involuntary, nor shall the permit be valid for any premises other than the business location recorded thereon. 2. A duplicate or replacement permit shall be issued upon the written request of the licensee and payment of the fee authorized in R.S. 37:1184. A duplicate or replacement license shall not serve or be used as an additional or second license. 3. Prior to making any change in the marijuana pharmacy’s name or trade name, the owner of the permit shall notify the board and request approval of the contemplated name or trade name. The board shall reasonably accommodate such requests, unless there is cause not to do so (e.g., duplicative or misleading names). The marijuana pharmacy shall not change its name or trade name until approved by the board. 4. Prior to any modification, remodeling, expansion, reduction, or other physical, non-cosmetic alteration of the marijuana pharmacy, the owner of the permit shall notify the board and request approval of the contemplated change(s). The board shall reasonably accommodate such request, unless there is cause not to do so (e.g., inconsistent with operating requirements). The marijuana pharmacy shall not make such changes until approved by the board. 5. Prior to any change in the location of a marijuana pharmacy, the owner of the permit shall submit an application form for that purpose supplied by the board and pay the appropriate fee authorized in R.S. 37:1184. The board may require an inspection of the new location prior to the issuance of the permit for the new location. No marijuana pharmacy shall commence operation in a new location until approved by the board. 6. The owner of the pharmacy permit shall notify the board no later than 30 days following a change in the pharmacist-in-charge for the marijuana pharmacy permit. 7. The owner of the pharmacy permit shall notify the board no later than 30 days following a change in the owner’s managing officer for the marijuana pharmacy permit. 8. In the event a marijuana pharmacy contemplates permanent closure, the pharmacist-in-charge shall notify the board in accordance with the rules governing the permanent closure of a pharmacy as described in Chapter 11 of this Part. AUTHORITY NOTE: Promulgated in accordance with R.S. 40:1046. HISTORICAL NOTE: Promulgated by the Department of Health, Board of Pharmacy, LR 43:1544 (August 2017), amended LR 46:577 (April 2020), LR 48:2102 (August 2022). §2449. Marijuana Pharmacy Personnel A. No person shall be employed by, or affiliated with, a marijuana pharmacy prior to their eighteenth birthday. B.1. The PIC shall insure and document the initial and continuing competency of the entire professional staff to provide the pharmacy care services rendered at the marijuana pharmacy. At a minimum, the PIC shall provide access to education and training in the following domains: a. policies and procedures of the pharmacy, especially those relating to the tasks and functions that employee is expected to perform; b. professional conduct, ethics, and patient confidentiality; and c. developments in the therapeutic use of marijuana. 2. Further, the PIC shall document such education and training, provide such records to the board when requested, and retain such records for at least two years after the employee disassociates with the pharmacy. C. The PIC shall comply with the professional supervision rules and ratios found in Chapter 7 (pharmacy interns) and Chapter 9 (pharmacy technicians) of this Part. D. In addition to the scope of practice limitations found in Chapter 9 of this Part, pharmacy technicians practicing in a marijuana pharmacy shall not: 1. consult with a patient or the patient’s caregiver regarding marijuana or other drugs, either before or after marijuana has been dispensed, or regarding any medical information contained in a patient medication record; PROFESSIONAL AND OCCUPATIONAL STANDARDS Louisiana Administrative Code August 2022 84 2. consult with the physician who issued the recommendation/prescription/order for marijuana to the patient, or the physician’s agent, regarding a patient or any medical information pertaining to the patient’s marijuana or any other drug the patient may be taking; 3. interpret the patient’s clinical data or provide medical advice; 4. perform professional consultations with physicians, nurses, or other health care professionals or their authorized agents; or 5. determine whether a different brand or formulation of marijuana should be dispensed for the marijuana product or formulation recommended/prescribed/ordered by the physician or requested by the patient or his caregiver. AUHORITY NOTE: Promulgated in accordance with R.S. 40:1046. HISTORICAL NOTE: Promulgated by the Department of Health, Board of Pharmacy, LR 43:1546 (August 2017), amended LR 48:2103 (August 2022). §2451. Operation of Marijuana Pharmacy A. No person may operate a marijuana pharmacy without a marijuana pharmacy permit issued by the board, and further, that permit shall be in active or restricted status. A pharmacist shall be on duty at all times during the regular open hours of the marijuana pharmacy. B. A marijuana pharmacy shall not dispense marijuana from, obtain marijuana from, or transfer marijuana to, a location outside of the state of Louisiana. C. A marijuana pharmacy shall not obtain, cultivate, deliver, transfer, transport, sell or dispense marijuana except: 1. it may acquire marijuana from an authorized producer pursuant to the provisions of R.S. 40:1046; and 2. it may dispense and sell marijuana to a patient with a recommendation/prescription/order for such marijuana or the patient’s caregiver. D. No person at a marijuana pharmacy shall provide marijuana samples. E. A marijuana pharmacy shall sell marijuana products only in a secure and light-resistant container. Nothing herein shall preclude a pharmacist from compounding a marijuana product appropriate for his patient. F. Only a pharmacist may dispense marijuana, however, other licensed pharmacy personnel may assist the pharmacist in the dispensing process. The sale of dispensed marijuana products may be accomplished by any pharmacy employee. G. A marijuana pharmacy shall place all products sold to the patient or caregiver in an opaque package that shall not indicate the contents of the package, the originating facility or in any other way cause another person to believe that the package may contain marijuana. H. A marijuana pharmacy shall not permit any person to enter the prescription department unless that person’s responsibilities necessitate access to the department and then for only as long as necessary to perform the person’s job duties. I. While inside the pharmacy, all pharmacy employees shall wear name tags or similar forms of identification that clearly identify them to the public, including their position at the pharmacy. J. A marijuana pharmacy shall be open for qualifying patients and primary caregivers to purchase marijuana products for a minimum of 10 hours per week. 1. A marijuana pharmacy that closes during its normal hours of operation shall implement procedures to notify patients and caregivers of when the marijuana pharmacy will resume normal hours of operation. Such procedures may include, but are not limited to, telephone system messages and conspicuously posted signs. 2. In the event the pharmacist on duty leaves the prescription department, the prescription department shall comply with the provisions of §1109 (temporary absence) or §1111 (closure) of this Part. K. A marijuana pharmacy shall provide information to patients and caregivers regarding the possession and use of marijuana. Such informational material shall include information related to: 1. limitations on the right to possess and use marijuana pursuant to R.S. 40:1046; 2. safe techniques for proper use of marijuana and paraphernalia; 3. alternative methods and forms of consumption by which one can use marijuana; 4. signs and symptoms of substance abuse; and 5. opportunities to participate in substance abuse programs. L. The marijuana pharmacy shall establish, implement and adhere to a written alcohol-free, drug-free and smoke- free work place policy, which shall be available to the board upon request. M. The receipt of all deliveries from producers shall be carried out under the direct supervision of a pharmacist who shall be present to accept the delivery. Upon delivery, the marijuana shall immediately be placed in an approved safe or approved vault within the pharmacy where marijuana is stored. N. No marijuana pharmacy shall acquire, possess or dispense any controlled substance other than medical marijuana products authorized by R.S. 40:1046. O. No marijuana shall be administered on the premises of a marijuana pharmacy, except during patient counseling, education or training. P. No person associated with a marijuana pharmacy shall enter into any agreement with a physician or health care facility concerning the provision of services or equipment that may adversely affect any person's freedom to Title 46, Part LIII Louisiana Administrative Code August 2022 87 §2455. Reportable Security Events A. Upon becoming aware of discrepancies identified during inventory, diversion, theft, loss, or unauthorized destruction of any marijuana, or of any loss or unauthorized alternation of records related to marijuana or patients, a pharmacy shall immediately notify: 1. appropriate law enforcement authorities; and 2. the board. B. A pharmacy shall provide the written notice to the board by way of a signed statement which details the circumstances of the event, including an accurate inventory of the quantity and brand names of the marijuana diverted, stolen, lost, destroyed, or damaged, along with confirmation that the local law enforcement authorities were notified. A pharmacy shall make such notice no later than 24 hours after discovery of the event. C. A pharmacy shall notify the board no later than the next business day, followed by written notification no later than 10 business days, of any of the following: 1. an alarm activation or other event that requires response by public safety personnel; 2. a breach of security; 3. the failure of the security alarm system due to a loss of electrical support or mechanical malfunction that is expected to last longer than eight hours; and 4. corrective measures taken, if any. D. A pharmacy shall maintain and shall make available all documentation related to an occurrence that is reportable. AUTHORITY NOTE: Promulgated in accordance with R.S. 40:1046. HISTORICAL NOTE: Promulgated by the Department of Health, Board of Pharmacy, LR 43:1550 (August 2017). §2457. Standards of Practice A. Environmental Standards 1. The prescription department shall be of sufficient size commensurate with the nature and scope of practice. The space occupied by the prescription department shall be restricted to authorized personnel only, as determined by the pharmacist-in-charge, and shall not be accessible to the general public. 2. The prescription department shall contain sufficient fixtures, equipment, and supplies commensurate with the nature and scope of practice for that pharmacy. 3. The prescription department shall include a sink with a hot and cold water supply, exclusive of restroom facilities, with approved sewage disposal. 4. All areas where drugs and devices are stored shall be dry, well-lighted, well-ventilated, and maintained at temperatures which will ensure the integrity of drugs during their storage and prior to their dispensing as stipulated by the United States Pharmacopeia and/or manufacturer’s or distributor’s product labeling unless otherwise indicated by the board. 5. The prescription department shall be secured by one or more physical barriers with suitable locks and a monitored alarm system capable of detecting unauthorized entry, and further, complies with security requirements identified elsewhere in this Subchapter. 6. Prescription and other patient healthcare information shall be maintained in a manner that protects the integrity and confidentiality of such information. B. Minimum Staffing Requirements 1. There shall be at least one pharmacist on duty at all times the pharmacy is open for business. 2. Every pharmacist practicing in the pharmacy shall possess a Louisiana pharmacist license in active status as well as access privileges to the state prescription monitoring program. 3. A pharmacy intern, pharmacy technician or pharmacy technician candidate may assist the pharmacist in the prescription department, but only when in possession of valid credentials issued by the board. The supervising pharmacist may establish a delegate credential in the state prescription monitoring program for any licensed pharmacy personnel affiliated with that pharmacy. 4. Additional clerical personnel may also be present at the pharmacy. C. Operational Standards 1. The marijuana pharmacy shall comply with the provisions of Chapters 11, 25, 27, 29, and 31 of this Part except when this Subchapter grants exceptions or imposes more stringent requirements. 2. In the event the marijuana pharmacy intends to close permanently, the pharmacist-in-charge (PIC) shall comply with the pharmacy closure procedures described in Chapter 11 of this Part, and further, the owner of the pharmacy permit shall not prevent or interfere with the PIC’s performance of those tasks. a. In addition to the other closure requirements, the closing pharmacy shall include in its notice to the board and to the public the identification of the destination pharmacy where the closing pharmacy’s prescription records will be transferred. That destination pharmacy shall be the marijuana pharmacy nearest the closing pharmacy, unless otherwise approved by the board. D. Recordkeeping Requirements 1. When the pharmacy receives a request for marijuana from a recommending physician in written form, the pharmacist shall cause the form to be scanned and filed using an electronic imaging system in compliance with Section 1123 of this Part. 2. Request forms (and electronic images thereof) shall be retained on the pharmacy’s premises for at least two years PROFESSIONAL AND OCCUPATIONAL STANDARDS Louisiana Administrative Code August 2022 88 after the date of dispensing, and further, shall be readily retrievable upon request by the board. 3. Inventory of Marijuana Product a. The pharmacist-in-charge shall develop and maintain a perpetual inventory of all marijuana products acquired, held, dispensed, and disposed by the pharmacy. b. The pharmacy shall access the LMMTS and enter all acquisitions and product transfer transactions in that system. c. In the event the pharmacist-in-charge designates an agent to retrieve new marijuana product inventory from the production facility, the pharmacist shall verify the agent is at least 21 years of age and is eligible to drive on public roadways. d. The pharmacist-in-charge shall conduct an annual inventory of all marijuana products in the possession of the pharmacy on any date which is within one year of the previous annual inventory, and further, shall conduct additional inventory counts on the following occasions: i. arrival of a new pharmacist-in-charge; ii. discovery of any significant loss, disappearance, or theft of marijuana product; iii. departure of a pharmacist-in-charge; and iv. permanent closure of the pharmacy. e. Inventory records shall be retained on the pharmacy’s premises for at least two years after the most recent entry. 4. The pharmacy shall develop and maintain sufficient records to fully reveal the business transactions related to marijuana products, including their procurement and sale, for the current tax year as well as the two immediately preceding tax years, all of which shall be made available to the board upon request. 5. The board may require any pharmacy or its owners to furnish such information as the board considers necessary for the proper administration of R.S. 40:1046, and may require a financial audit of the business of any marijuana pharmacy, and the expense thereof shall be paid by the marijuana pharmacy. E. Professional Practice Standards 1. Recommendation / opinion (hereinafter, “request”) for Therapeutic Marijuana a. The pharmacist may accept any request for a marijuana product which has been: i. issued by a physician in possession of a current and unrestricted license to practice medicine from the Louisiana State Board of Medical Examiners as well as a current and unrestricted state controlled substance license with therapeutic marijuana privileges from the board; and ii. received directly from the physician and not from the patient or any third party other than the entity transmitting the request, either by electronic means conforming with the provisions of 21 CFR 1311 or its successor, or in the alternative, by facsimile bearing a handwritten or digital signature of the physician. b. The request shall disclose the following information at a minimum: i. name, address, telephone number, and national provider identifier (NPI) number of the physician issuing the request; ii. name, address, and date of birth (or age) of the patient for whom the request was issued; iii. identification of the debilitating medical condition for which the treatment has been requested; iv. type of marijuana product requested; v. date request was issued; vi. self-certification the physician holds a current and unrestricted license to practice medicine issued by the Louisiana State Board of Medical Examiners; and vii. Signature of the physician issuing the recommendation, excluding any proxy or agent. c. Requests for marijuana products shall expire one year after the date of issue, unless a shorter period of time is indicated by the physician. A pharmacist shall not dispense marijuana product pursuant to an expired request. d. Requests for raw or crude marijuana products intended for persons under 21 years of age shall specifically indicate a recommendation for raw or crude forms of marijuana for such persons. e. A marijuana pharmacy shall transfer an unexpired request for marijuana product to another marijuana pharmacy when requested by the patient or his caregiver. 2. Upon request by the patient or caregiver and prior to dispensing any marijuana product to a patient, the pharmacist shall provide product testing results available to the pharmacist for the product contemplated for dispensing. 3. Dispensing Marijuana Products a. Prior to dispensing any marijuana product to a patient, the pharmacist shall review the patient’s records in the state prescription monitoring program. The pharmacist shall resolve any concerns identified in that review by consultation with the recommending physician. b. Dispensing Limitations i. A pharmacist shall not dispense more than two and one-half ounces, or 71 grams, of raw or crude marijuana every 14 days to any person. ii. Subject to the above limitation on dispensing raw or crude marijuana products, a pharmacist may dispense marijuana products on multiple occasions as indicated by the physician and needed by the patient until the request expires; however, the pharmacist shall not dispense more than a 90- Title 46, Part LIII Louisiana Administrative Code August 2022 89 day supply of marijuana product at one time nor more than a one-year supply pursuant to a single request 4. Labeling of Marijuana Product Dispensed a. The pharmacist shall not dispense any marijuana product that does not bear the producer label required by the LDAF, and further, the pharmacy dispensing label shall not overlay or obscure the producer label in any way. b. The pharmacy’s dispensing label shall contain, at a minimum, the following data elements: i. name and address of the pharmacy dispensing the product; ii. telephone number or other contact information of the pharmacy dispensing the product; iii. name of the recommending physician; iv. name of the patient; v. date the product was dispensed; vi. prescription number, which shall be a unique identifier for that specific transaction; vii. name of the marijuana product, including any concentration, strength, or other identifiers of the marijuana product; viii. quantity of marijuana dispensed; ix. directions for use of the product; x. expiration date of the product, which shall not exceed the expiration date determined by the producer of the product; and xi. other information selected by the dispensing pharmacist to inform the patient as to the best use of the product for the intended purpose. 5. The pharmacist shall comply with the rules on drug utilization review and patient counseling in Chapter 5 of this Part. 6. Reporting transactions to state prescription monitoring program. The pharmacy shall comply with the reporting requirements as found in Chapter 29 of this Part. 7. Disposal of Marijuana Product a. A pharmacy may refuse to accept the delivery of marijuana product from a producer when it is determined to be misbranded, adulterated, expired, deteriorated, undesired, excess, unauthorized, or unfit for dispensing. b. When the pharmacist determines a marijuana product is no longer suitable for dispensing, the product shall be removed from active dispensing stock and quarantined in the pharmacy pending its disposal c. The pharmacist-in-charge shall render the waste unusable by grinding and incorporating the waste with other ground materials so the resulting mixture is at least 50 percent non-marijuana waste by volume. Material used to grind with the waste may include: i. yard waste; ii. paper waste; iii. cardboard waste; iv. plastic waste; or v. soil or sand. d. Waste shall be rendered unusable prior to leaving the pharmacy. Waste rendered unusable shall be disposed of by delivery to an approved solid waste facility for final disposition. i. Examples of acceptable permitted solid waste facilities include: (a). compost; anaerobic digester; (b). landfill, incinerator; or (c). waste-to-energy facility. e. The pharmacist-in-charge shall prepare a record of each disposal, and that record shall contain, at a minimum, the following information: i. brand name and other specific identifiers of the marijuana product disposed; ii. quantity of product disposed; iii. manner of disposal; and iv. signatures of the pharmacist-in-charge disposing the product plus at least one witness who is either a credentialed staff member of that pharmacy or an agent of the board. AUTHORITY NOTE: Promulgated in accordance with R.S. 40:1046. HISTORICAL NOTE: Promulgated by the Department of Health, Board of Pharmacy, LR 43:1550 (August 2017), amended LR 45:1473 (October 2019), LR 47:246 (February 2021), LR 47:1111 (August 2021), LR 48:1903 (July 2022), LR 48:2103 (August 2022). §2459. Advertising A. The marijuana pharmacy shall not advertise through any public medium, including but not limited to newspapers, billboards, television, radio, internet, social media, or any other means designed to market its products to the general public. B. The marijuana pharmacy may market its products through direct mail, brochures, or other means to Louisiana- licensed physicians, but only when such advertising is directed solely to the practitioner and is not available to the general public. C. Any advertisement permitted in Subsection B of this Section shall not: 1. make any deceptive, false, or misleading assertions or statements regarding any product; or 2. assert that its products are safe because they are regulated by LDAF or the board. The pharmacy may advertise that its products have been tested by an approved