La. Admin. Code tit. 46 § LIII-2701

Current through Register Vol. 50, No. 11, November 20, 2024
Section LIII-2701 - Definitions
A. Words not defined in this Chapter shall have their common usage and meaning as stated in the Merriam Webster's Collegiate Dictionary-Tenth Edition, as revised, and other similarly accepted reference texts. As used in this Chapter, the following terms shall have the meaning ascribed to them in this Section unless the context clearly indicates otherwise:

Administer or Administration-the direct application of a drug to the body of a patient or research subject by injection, inhalation, ingestion, or any other means.

Agent-an individual who acts on behalf or at the direction of a manufacturer, distributor, or other licensee, but does not include a common or contract carrier, public warehouseman, or employee thereof.

Ambulatory Surgical Center or Surgical Center-a facility licensed by the department to operate as an ambulatory surgery center.

BNDD-United States Bureau of Narcotics and Dangerous Drugs.

Board-the Louisiana Board of Pharmacy.

Central Fill Pharmacy-a pharmacy which provides centralized dispensing services to other pharmacies, in compliance with the provisions of §1141 of the board's rules.

Certified Animal Euthanasia Technician-an individual authorized by law and certified by the Louisiana State Board of Veterinary Medicine to practice animal euthanasia.

CFR-Code of Federal Regulations

Client Pharmacy-a pharmacy which has engaged the services of a central fill pharmacy.

Collegiate Dictionary-Tenth Edition, as revised, and other similarly accepted reference texts. As used in this Chapter, the following terms shall have the meaning ascribed to them in this Section unless the context clearly indicates otherwise:

Controlled Dangerous Substance or Controlled Substance-any substance defined, enumerated, or included in federal or state statute or regulations, 21 CFR § 1308.11-15 or R.S. 40:964, or any substance which may hereafter be designated as a controlled dangerous substance by amendment or supplementation of such regulations or statute. The term shall not include distilled spirits, wine, malt beverages, or tobacco.

CRT-cathode ray tube video display unit.

DEA-United States Drug Enforcement Administration.

Deliver or Delivery-the actual, constructive, or attempted transfer of a drug or device containing a controlled substance, from one person to another, whether or not for consideration, or whether or not there exists an agency relationship.

Dentist-an individual authorized by law and licensed by the Louisiana State Board of Dentistry to engage in the practice of dentistry.

Department-the Louisiana Department of Health.

Dispense or Dispensing-the interpretation, evaluation, and implementation of a prescription drug order for a controlled substance, including the preparation and delivery of a drug or device to a patient or patient's agent in a suitable container appropriately labeled for subsequent administration to, or use by, a patient.

Dispenser-an individual currently licensed, registered, or otherwise authorized by the appropriate licensing board to dispense drugs or devices containing controlled substances to his own patients in the course of professional practice.

Distribute or Distributing-the delivery of a drug or device containing a controlled substance in response to a non-patient specific purchase order, requisition, or similar communication, other than by administering or dispensing.

Distributor or Wholesaler-a facility authorized by law and licensed by the Louisiana Board of Drug and Device Distributors to engage in the distribution of drugs or devices, including controlled substances.

a. any substance recognized as a drug in the official compendium, or supplement thereto, designated by the board for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in humans or animals;
b. any substance intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in humans or animals; or
c. any substance other than food intended to affect the structure or any function of the body of humans or animals.

Drug-

Drug Detection Canine Trainer-an individual qualified to conduct experiments using controlled substances in training canines to detect the presence of contraband controlled dangerous substances.

Drug Detection Canine Handler-an individual qualified to handle canines in the detection of contraband controlled substances.

Electronic Prescription-a prescription generated, signed, and transmitted in electronic form.

Emergency Clinic-a facility staffed by at least one physician and other licensed medical personnel for the purpose of providing emergency medical treatment.

Facility-an organized health care setting authorized by law and licensed by the department to engage in the provision of health care.

Hemp Facility-a facility licensed by the Louisiana Department of Agriculture and Forestry as a hemp seed producer, hemp grower, hemp handler or hemp processor.

Hospital-a facility licensed by the department to operate as a hospital.

LDAF-Louisiana Department of Agriculture and Forestry, or its successor.

License-a Louisiana Controlled Dangerous Substances (CDS) License.

Licensee-an individual or facility in possession of a Louisiana CDS license.

Manufacturer-a person authorized by law and licensed by the federal Food and Drug Administration to engage in the production of drugs, including controlled substances.

Narcotic Treatment Program-a program authorized by law and licensed by the department and the federal Drug Enforcement Administration to operate a substance abuse program using narcotic replacement procedures for individuals dependent upon opium, heroin, morphine, or any other derivative or synthetic drug in that classification of drugs.

Optometrist-an individual authorized by law and licensed by the Louisiana State Board of Optometry Examiners to engage in the practice of optometry.

Person-an individual, corporation, partnership, association, or any other legal entity, including government or governmental subdivision or agency.

Pharmacist-an individual authorized by law and licensed by the board to engage in the practice of pharmacy.

Pharmacy-a place authorized by law and permitted by the board to procure, possess, compound, distribute, and dispense drugs, including controlled substances.

Physician-an individual authorized by law and licensed by the Louisiana State Board of Medical Examiners to engage in the practice of medicine.

Podiatrist-an individual authorized by law and licensed by the Louisiana State Board of Medical Examiners to engage in the practice of podiatry.

Practice Affiliation-a practice relationship, collaboration, or practice under the supervision of a physician licensed to practice medicine, applicable to advanced practice registered nurses and physician assistants.

Practitioner-an individual currently licensed, registered, or otherwise authorized by the appropriate licensing board to prescribe and administer drugs in the course of professional practice.

Prescribe or Prescribing-to order a drug or device to be administered or dispensed to a specific patient.

Prescriber-an individual currently licensed, registered, or otherwise authorized by the appropriate licensing board to prescribe drugs in the course of professional practice.

Prescription or Prescription Drug Order-an order from a practitioner authorized by law to prescribe a drug or device that is patient specific and is to be preserved on file as required by law or regulation.

Researcher-an individual qualified to conduct medical, educational, or scientific experiments on animals, humans, or in laboratories which require the use of controlled substances. For the purpose of this Chapter, manufacturers which use controlled substances in the manufacturing process, but do not manufacture controlled substances as an end product, shall be considered researchers and not manufacturers as defined in R.S. 40:961(24).

Reverse Distribute-to acquire controlled substances from another registrant or law enforcement for the purpose of:

a. return to the registered manufacturer or another registrant authorized by the manufacturer to accept returns on the manufacturer's behalf; or
b. destruction.

Reverse Distributor-is a person registered by the DEA as a reverse distributor.

Sales Representative or Professional Medical Representative-an individual employed by a manufacturer or distributor and authorized by the employer to receive, possess, and deliver controlled substances to a person licensed to possess controlled dangerous substances.

Supplier-any person registered by the DEA who is entitled to fill order forms for controlled substances.

Third-Party Logistics Provider-a person who provides or coordinates warehousing, facilitation of delivery, or other logistic services for a legend drug or legend device in interstate or intrastate commerce on behalf of a manufacturer, distributor, or dispenser of a legend drug or legend device but does not take ownership of the legend drug or legend device nor have responsibility to direct the sale or disposition of the legend drug or legend device.

Veterinarian-an individual authorized by law and licensed by the Louisiana State Board of Veterinary Medicine to engage in the practice of veterinary medicine.

La. Admin. Code tit. 46, § LIII-2701

Promulgated by the Department of Health and Hospitals, Board of Pharmacy, LR 34:2127 (October 2008), Amended by the Department of Health, Board of Pharmacy, LR 46569 (4/1/2020), Amended by the Department of Health, Board of Pharmacy, LR 46793 (6/1/2020), Amended LR 471640 (11/1/2021), Amended LR 48494 (3/1/2022).
AUTHORITY NOTE: Promulgated in accordance with R.S. 40:972.