La. Admin. Code tit. 46 § XXXIV-103

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

Section XXXIV-103 - Definition

A. As used in this regulation, unless the context otherwise requires, the following terms are defined as:

Adulterated Drug or Device-a drug or device shall be deemed adulterated if:

a. it consists, in whole or in part, of any filthy, putrid, or decomposed substance; or

b.

i. it has been produced, prepared, packed, or held under unsanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health; or

ii. the methods used in, or the facilities or controls used for, its manufacture, processing, packing, or holding do not conform to or are not operated or administered in conformity with current good manufacturing practice to assure that the drug or device meets with the requirements of this part as to safety and has the identity and strength, and meets with the quality and purity characteristics which it purports or is represented to possess; or

c. its container is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health; or

d. it bears or contains, for purposes of coloring only, a color additive which is unsafe within the meaning of federal or Louisiana law or rule; or

e. it purports to be or is represented as a drug or device the name of which is recognized in an official compendium, and its strength differs from, or its quality or purity falls below, the standard set forth in the compendium. Such a determination as to strength, quality, or purity shall be made in accordance with the tests or methods of assay set forth in the compendium, or in the absence of or inadequacy of these tests or methods of assay, those prescribed under the authority of federal or state law or rule. No drug or device defined in an official compendium shall be deemed to be adulterated under this paragraph because it differs from the standard of strength, quality, or purity therefore set forth in the compendium, if its difference in strength, quality, or purity from the standard is plainly stated on its label;

f. it is not subject to Subparagraph e above and its strength differs from, or its quality or purity falls below that which it purports or is represented to possess; or

g. it is a drug or any substance has been:

i. mixed or packed therewith so as to reduce its quality or strength; or

ii. substituted wholly or in part thereof.

Blood-whole blood collected from a single donor and processed either for transfusion or further manufacturing.

Blood Components-that part of blood separated by physical or mechanical means.

Consumer or Patient-a person who is the end user of a drug or device.

Contraband Drug or Device-a drug or device which is counterfeit, stolen, misbranded, obtained by fraud, purchased and placed in commerce in violation of its own use agreement for that drug or device, or for which the documentation in existence has been forged, counterfeited, falsely created, or contains any altered, false, or misrepresented information.

Controlled Substance-those substances, drugs, or immediate precursors listed in schedules I through VI of the Uniform Controlled Substances Act.

Counterfeit Drug or Device-a drug or device which, or the container, shipping container, seal, or labeling of which, without authorization, bears the trademark, trade name, or other identifying mark, imprint, or any likeness thereof, of a manufacturer, processor, packer, or distributor, other than the person who in fact manufactured, processed, packed, or distributed such drug or device and which thereby falsely purports or is represented to be the product of, or to have been packed or distributed by, such other manufacturer, processor, packer, or distributor.

Delivery-actual, constructive, or attempted transfer of a drug or device from one person to another, whether or not for consideration.

Dispense or Dispenser or Dispensing-the interpretation, evaluation, and implementation of a drug order, including the preparation and delivery or transfer of possession of a drug or device to a patient or patients agent in a suitable container appropriately labeled for subsequent administration to, or use by, a patient.

Distribute-to sell, offer to sell, broker, give away, or transfer, drugs or devices whether by passage of title, physical movement, or both.

Drug or Device-any legend drug or legend device.

Drug Sample- a unit of a prescription drug that is labeled "sample," "not to be sold," or "complimentary,", or other words to that effect, which is provided as a courtesy and not intended to be sold but is intended to promote the sale of the drug.

Facility or Physical Location-structure, warehouse, or building used by a person for the reception, storage, handling, repackaging, and/or offering for sale of a drug or device.

Label or Labeling-a display of written, printed, or graphic matter located immediately upon, or accompanying, a drug or device.

Medical Gas-any pure gas or gas mixture packaged as any liquefied (cryogenic) or compressed gas (vaporized) that is designated as a drug product.

Misbranded-a drug or device shall be deemed misbranded if the label is false or misleading in any particular, or the 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 in case of a drug, or does not show an accurate monograph for legend drug, or other considerations as required in the federal Food, Drug, and Cosmetic Act.

Off-Site Storage Facility-a structure, warehouse, or building used by a licensed wholesale drug or device distributor strictly for storage of legend drugs or devices.

Standard Distributors-distributors of legend drugs and legend devices not to include third-party logistics providers and wholesale distributors.

La. Admin. Code tit. 46, § XXXIV-103

Promulgated by the Department of Health and Hospitals, Board of Wholesale Drug Distributors, LR 18:381 (April 1992), amended LR 29:1479 (August 2003), LR 32:394 (March 2006), LR 34:874 (May 2008), LR 35:1537 (August 2009), amended by the Department of Health, Board of Drug and Device Distributors, LR 42:2182 (December 2016).

AUTHORITY NOTE: Promulgated in accordance with R.S. 37:3461-3482.