La. Admin. Code tit. 46 § LIII-2415

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

Section LIII-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 manufacturers or distributors 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.

La. Admin. Code tit. 46, § LIII-2415

Promulgated by the Department of Health and Hospitals, Board of Pharmacy, LR 41101 (1/1/2015).

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