La. Admin. Code tit. 46 § LIII-2505

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

Section LIII-2505 - Investigational Drugs

A. The pharmacist shall conduct, participate in, and support medical and pharmaceutical research appropriate to the goals, objectives, and resources of the facility.

B. The pharmacist shall ensure the development of policies and procedures for the appropriate use of investigational drugs; such policies shall be consistent with the applicable federal rules pertaining to investigational drugs.

1. The use of investigational drugs shall be authorized by the principal investigator, or his authorized clinician.

2. The pharmacist shall ensure the development of a central repository for the acquisition and maintenance of essential information and the dissemination of that information to all personnel tasked with procurement, storage, dispensing, or administration of investigational drugs.

3. The pharmacist shall retain a copy of the research protocol in the pharmacy; the dispensing pharmacist shall review the protocol prior to dispensing the investigational drug.

4. The dispensing label for investigational drugs shall comply with the provisions of this Chapter; in addition, the label shall bear the phrase "For Investigational Use Only" or a similar caution.

C. The pharmacist shall store investigational drugs in the pharmacy separate from the active dispensing stock of approved drugs.

1. The storage location shall be consistent with the environmental standards for temperature, humidity, and light indicated by the manufacturer.

2. The storage location shall be secured against improper access or diversion.

D. The pharmacist shall maintain a perpetual inventory record for each investigational drug, with such record to contain, at a minimum, the following data elements:

1. drug's name, dosage form, strength, lot number, and expiration date;

2. name, address, and telephone name of the study sponsor;

3. protocol number;

4. identification of dispensing pharmacist; and

5. disposition of any remaining drug supply

La. Admin. Code tit. 46, § LIII-2505

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 by the Department of Health, Board of Pharmacy, LR 46575 (4/1/2020).

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