La. Admin. Code tit. 46 § LIII-2413

Current through Register Vol. 50, No. 9, September 20, 2024

Section LIII-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 boards 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 (registrants 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;

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.

La. Admin. Code tit. 46, § LIII-2413

Promulgated by the Department of Health and Hospitals, Board of Pharmacy, LR 41100 (1/1/2015).

AUTHORITY NOTE: Promulgated in accordance with R.S. 37:1182.