Louisiana Administrative Code › Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS › Part XXXIV - Drug and Device Distributors › Chapter 1 - General Provisions › Section XXXIV-103 - Definition

Current through Register Vol. 50, No. 6, June 20, 2024
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.