La. Admin. Code tit. 46 § LIII-2705

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

Section LIII-2705 - Licenses and Exemptions

A. Every person who conducts research with, manufactures, distributes, procures, possesses, prescribes, or dispenses any controlled dangerous substance within this state, including third-party logistics providers, or who proposes to engage in the research, manufacture, distribution, procurement, possession, prescribing, or dispensing of any controlled dangerous substance within this state shall obtain a controlled dangerous substance (CDS) license from the board prior to engaging in such activities. Only persons actually engaged in such activities are required to obtain a CDS license; related or affiliated persons, e.g., stockholder in manufacturing corporation, who are not engaged in such activities, are not required to be licensed. The performance of such activities in the absence of a valid CDS license shall be a violation of R.S. 40:973 and this Part.

B. The following persons are exempt from the CDS license requirements of this Chapter:

1. a manufacturer's or distributor's workman, contract carrier, warehouseman or any employee thereof whose handling of controlled substances is in the usual course of his business or employment while on the premises of the employer or under direct transfer orders of the employer;

2. a person who obtains or possesses a controlled substance pursuant to a valid prescription, either for his own use or for the use of a member of his household or for the administration to an animal owned by him or a member of his household;

3. an agent or employee of any licensed manufacturer, distributor, dispenser or researcher in the course of his employment and only on the premises of his employer, but not a sales representative or professional medical representative.

C. Practitioners

1. The issuance of a CDS license to a practitioner, and the renewal thereof, shall require the possession of a valid and verifiable license or other credential issued by a standing professional board in the state of Louisiana or other agency of competent jurisdiction.

2. For the purpose of prescribing controlled substances, a Louisiana CDS license issued to a practitioner shall be valid in any location in Louisiana; however, the procurement and possession of controlled substances shall require a separate CDS license for each such location where controlled substances are possessed.

3. A prescribing practitioner desiring to procure and possess controlled substances at only one location need only obtain a single CDS license.

4. A physician in possession of the appropriate credential issued by the Louisiana State Board of Medical Examiners may apply for and be issued a CDS license to authorize the prescription or recommendation of the following controlled substances classified in Schedule I: marijuana, tetrahydrocannabinols, and synthetic derivatives of tetrahydrocannabinols; provided however that such prescriptions or recommendations shall only be authorized for therapeutic use in compliance with R.S. 40:1046.

D. Pharmacies

1. The issuance of a CDS license to a pharmacy, and the renewal thereof, shall require the possession of a valid and verifiable permit to operate a pharmacy issued by the board.

2. A Louisiana CDS license issued to a pharmacy shall be valid for the premises identified on the license.

3. The possession of controlled substances under the control of the pharmacy at a different location shall require a separate CDS license for each separate location.

E. Healthcare Facilities and Hemp Facilities

1. The issuance of a CDS license to a healthcare facility, and the renewal thereof, shall require the possession of a valid and verifiable license or other credential issued by the department, or its successor.

2. The issuance of a CDS license to a hemp facility, and the renewal thereof, shall require a valid and verifiable license as a hemp seed producer, hemp grower, hemp handler or hemp processor issued by the Louisiana Department of Agriculture and Forestry (LDAF).

F. Manufacturers, Distributors and Third-Party Logistics Providers

1. The issuance of a CDS license to a manufacturer, and the renewal thereof, shall require the possession of a valid and verifiable license or other credential from the Food and Drug Control Unit of the Office of Public Health in the Louisiana Department of Health, or its successor. Further, the applicant shall submit to an initial and periodic inspection by the board or its designee.

2. The issuance of a CDS license to a distributor, and the renewal thereof, shall require the possession of a valid and verifiable license or other credential from the Food and Drug Control Unit of the Office of Public Health in the Louisiana Department of Health, as well as the Louisiana Board of Drug and Device Distributors, or their successors. Further, the applicant shall submit to an initial and periodic inspection by the board or its designee.

3. The issuance of a CDS license to a third-party logistics provider, and the renewal thereof, shall require the possession of a valid and verifiable license or other credential from the Louisiana Board of Drug and Device Distributors.

4. The sale or transportation of controlled substances within the State of Louisiana by manufacturers, distributors and third-party logistics providers located outside the State of Louisiana shall require the possession of a valid CDS license issued by the board prior to the engagement of such activities.

G. Researchers

1. The issuance of a CDS license to a researcher, and the renewal thereof, shall require the attachment to the application of a properly completed form supplied by the board describing the research, and further, when the research involves human subjects, the attachment to the application of proof of approval by the appropriate Institutional Review Board.

2. A determination of qualification shall be made by the board or its designee.

H. Drug Detection Canine Trainers/Handlers

1. The issuance of a CDS license to a drug detection canine trainer or handler, and the renewal thereof, shall require the attachment to the application of a properly completed form supplied by the board describing the policies and procedures for the use of controlled substances.

2. A determination of qualification shall be made by the board or its designee.

3. This Section shall not apply to a law enforcement agency or its personnel in the performance of its official duties.

I. Certified Animal Euthanasia Technician. The issuance of a CDS license to a certified animal euthanasia technician, and the renewal thereof, shall require the possession of a valid and verifiable license or other credential issued by the Louisiana Board of Veterinary Medicine, or its successor.

J. Professional Medical Representatives. The issuance of a CDS license to professional medical representative, and the renewal thereof, shall require the attachment to the application of written verification of employment from the manufacturer or distributor, as well as their authorization for the representative to receive, possess, and deliver controlled substances.

La. Admin. Code tit. 46, § LIII-2705

Promulgated by the Department of Health and Hospitals, Board of Pharmacy, LR 34:2129 (October 2008), amended LR 39:312 (February 2013), Amended by the Department of Health, Board of Pharmacy, LR 46570 (4/1/2020), Amended LR 471640 (11/1/2021), Amended LR 48494 (3/1/2022).

AUTHORITY NOTE: Promulgated in accordance with R.S. 40:972.