La. Admin. Code tit. 46 § LIII-2501

Current through Register Vol. 50, No. 11, November 20, 2024

Section LIII-2501 - Prescription Drugs and Devices

A. Prescription Drugs or Devices. A prescription drug or device is a medication or mechanism that may only be dispensed by a pharmacist on the order of a licensed practitioner and shall bear the "Rx Only" notation or any other designation of similar import required by law on the label of a commercial container.

1. Dispensing. Prescription drugs or devices shall be dispensed only by a Louisiana-licensed pharmacist.

2. Possession. Prescription drugs or devices shall be procured and possessed in the course of the practice of pharmacy by a permitted pharmacy.

3. Storage

a. Prescription drugs or devices shall be stored in a permitted pharmacy under the immediate control and responsibility of a pharmacist.

b. All areas where drugs are stored shall be maintained under environmental conditions which will ensure the integrity of the drug, as specified by the United States Pharmacopeia (USP) and/or manufacturer's or distributor's product information or labeling.

B. Misbranded Drugs

1. Misbranded drugs are:

a. those drugs whose labeling is false or misleading in any particular manner; or

b. those drugs whose label does not bear the name and address of the manufacturer, packer, or distributor, and does not have an accurate statement of the quantities of the active ingredients; or

c. those drugs without an accurate monograph; or

d. those drugs meeting the qualifications for misbranded drugs as noted in the Federal Food, Drug, and Cosmetic Act, or its successor.

2. It is unlawful to possess or dispense misbranded drugs.

C. Adulterated Drugs

1. Adulterated drugs are contaminated medicinal substances having deleterious foreign or injurious materials, which fail to meet safety, quality, and/or purity standards.

2. It is unlawful to possess or dispense adulterated drugs.

D. Expired Drugs. Expired drugs shall not be dispensed and shall be removed from the pharmacy drug inventory.

E. Recalled Drugs. Recalled drugs shall be removed from the pharmacy inventory immediately upon notice. Recalls are classified as:

1. Class I-a situation in which there is a strong likelihood that the use of, or exposure to, a violative product will cause serious adverse health consequences or death;

2. Class II-a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote;

3. Class III-a situation in which the use of, or exposure to, a violative product is not likely to cause adverse health consequences.

La. Admin. Code tit. 46, § LIII-2501

Promulgated by the Department of Health and Hospitals, Board of Pharmacy, LR 14:708 (October 1988), effective January 1, 1989, amended LR 29:2101 (October 2003), effective January 1, 2004, Amended LR 501156 (8/1/2024).

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