Flashcards in Ch 19 P 8 Wholesale Distributors; Third-party logistics providers; Repackagers; Drug supply chain security Deck (57)
a drug or device shall be deemed to be adulterated if it:
(1) consists in whole or part of any filthy, putrid, or decomposed substance;
(2) 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;
(3) is a drug and the methods used in or the facilities of 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 such drug meets the requirements of the New Mexico Drug, Device and Cosmetic Act (this article) as to safety and has the identity and strength and meets the quality and purity characteristics which purports or is represented to possess;
(4) is a drug and its container is composed in whole or part of any poisonous or deleterious substance which may render the contents injurious to health;
(5) is a drug and it bears or contains for purposes of coloring only a color additive which is unsafe within the meaning of the Federal Act or it is a color additive the intended use of which in drugs is for the purpose of coloring only and is unsafe within the meaning of the Federal Act;
(6) purports to be or is represented as a drug 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 such compendium; such determination as to strength, quality and purity shall be made in accordance with the tests or methods of assay set forth in such compendium or in the absence of or inadequacy of such rests or methods of assay, those prescribed under the authority of the Federal Act; no drug 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 if such standard is plainly stated on its label; whenever a drug is recognized both in the United States pharmacopoeia and the homeopathic pharmacopoeia of the United States it shall be subject to the requirements of the United States pharmacopoeia unless it is labeled and offered for sale as a homeopathic drug, in which case it shall be subject to the provisions of the homeopathic pharmacopoeia of the United States and not those of the United States pharmacopoeia;
(7) is not subject to the provisions of Paragraph (6) of this subsection and its strength differs from or its purity or quality falls below that which it purports or is represented to possess;
(8) is a drug and any substance has been mixed or packed therewith so as to reduce its quality or strength or substituted wholly or in part therefore.
a business entity that has a relationship with a second business entity if, directly or indirectly:
(1) one business entity controls, or has the power to control, the other business entity; or
(2) a third-party controls, or has the power to control, both of the business entities
(1) in the case of a manufacturer or repackager, having a valid registration as a drug establishment with the FDA under Section 510 of the Federal Act;
(2) a licensed wholesale distributor, who is compliant with the licensure reporting requirements under section 503(e) of the Federal Act;
(3) a licensed third-party logistics provider, who is compliant with the licensure reporting requirements under section 584(b) of the Federal Act;
(4) in the case of a dispenser, having a valid license under New Mexico state law.
The whole blood collected from a single donor and processed either for transfusion or further manufacturing.
That part of blood separated by physical or mechanical means.
Co-licensed partner or product
An instance where two or more parties have the right to engage in the manufacturing or marketing of a prescription drug, consistent with FDA’s implementation of the Drug Supply Chain Security Act (DSCSA).
Any person or entity who undertakes, whether directly or by any other arrangement, to transport property including prescription drugs for compensation.
Engaging in activities that create a counterfeit drug.
A drug that is deliberately and fraudulently mislabeled with respect to its identity, ingredients or sources. Types of such pharmaceutical counterfeits may include:
(1) identical copies: which are counterfeits made with the same ingredients, formulas and packaging as the originals but not made by the original manufacturer;
(2) look-alikes: which feature high-quality packaging and convincing appearances but contain little or no active ingredients and may contain harmful substances;
(3) rejects: which are drugs that have been rejected by the manufacturer for not meeting quality standards;
(4) re-labels: which have passed their expiration dates or have been distributed by unauthorized foreign sources and may include placebos created for late-phase clinical trials.
Counterfeit prescription drug
A dangerous drug which, or the container or labeling of which, without authorization:
(1) bears the trademark, trade name, or other identifying mark, print, device, or any likeness thereof, of a drug manufacturer, processor, packer, or distributor other than the person or persons who in fact manufactured, processed, packaged, or distributed such drug and which thereby falsely purports or is represented to be the product of, or to have been packed or distributed by such other drug manufacturer, processor, packer, or distributor;
(2) from the original manufacturer is an imitation of another dangerous drug or has been deliberately mislabeled (for example, as to its strength or expiration date) but it shall not include a dangerous drug or placebo intended for use in a clinical trial that is intentionally labeled or marked to maintain proper blinding of the study.
a “prescription drug” means a drug other than a controlled substance enumerated in Schedule I of the Controlled Substance Act, that because of potentiality for harmful effect or the method of its use or the collateral measures necessary to its use is not safe except under the supervision of a practitioner licensed by law to direct the use of such drug and hence for which adequate directions for use (directions under which the layman can use a drug or device safely and for the purposes for which intended) cannot be prepared. A drug shall be dispensed only upon the prescription of a practitioner licensed by law to administer or prescribe the drug if it:
(1) is a habit-forming drug and contains any quantity of a narcotic or hypnotic substance or a chemical derivative of such substance that has been found under the Federal Act and the board to be habit-forming;
(2) because of its toxicity or other potential for harmful effect or the method of its use or the collateral measures necessary to its use is not safe for use except under the supervision of a practitioner licensed by law to administer or prescribe the drug;
(3) is limited by an approved application by Section 505 of the Federal Act to the use under the professional supervision of a practitioner licensed by law to administer or prescribe the drug;
(4) bears the legend “Caution: federal law prohibits dispensing without prescription”;
(5) bears the legend “Caution: federal law restricts this drug to use by or on the order of a licensed veterinarian”;
(6) bears the legend “RX only”; or
(7) has been declared a dangerous drug by the board of pharmacy.
An individual designated by the wholesale distributor, third-party logistics provider, or repackager who will serve as the responsible individual of the wholesale distributor, third-party logistics provider, or repackager with the board who is actively involved in and aware of the actual daily operation of the wholesale distributor, third-party logistics provider, or repackager. The designated representative is responsible for all aspects of the facility operations.
(1) a retail pharmacy, hospital pharmacy, a group of chain pharmacies under common ownership and control that do not act as a wholesale distributor, or other person authorized by law to dispense or administer prescription drugs, and the affiliated warehouses or distribution centers of such entities under common ownership and control that do not act as a wholesale distributor; and
(2) does not include a person who dispenses only products to be used in animals in accordance with Section 512(a)(5) of the Federal Act.
With respect to a product within the possession or control of an entity, means the removal of such product from the pharmaceutical distribution supply chain, which may include disposal or return of the product for disposal or other appropriate handling and other actions, such as retaining a sample of the product for further additional physical examination or laboratory analysis of the product by a manufacturer or regulatory or law enforcement agency.
Distribute or distribution
The sale, purchase, trade, delivery, handling, storage, or receipt of a product, and does not include the dispensing of a drug pursuant to a prescription.
(1) recognized as drugs in any official compendium or supplement thereto, designated from time to time by the board for use in the diagnosis, cure, mitigation, treatment or prevention of disease in humans or other animals;
(2) intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in humans or other animals;
(3) other than food, intended to affect the structure or any function of the body of humans or other animals;
(4) intended for use as a component of any articles specified in Paragraphs (1), (2), (3) or (4) of this subsection.
A unit of a prescription drug that is not intended to be sold and is intended to promote the sale of the drug as defined by the Prescription Drug Marketing Act of 1987.
The Drug Supply Chain Security Act.
Emergency medical reasons
include, but are not limited to:
(1) the transfer or sales by a pharmacy to nearby emergency medical services, i.e. ambulance companies and firefighting organizations in the same state or same marketing or service area or nearby licensed practitioners of prescription drugs for use in the treatment of acutely ill or injured persons, consistent with the DSCSA and successor FDA regulations;
(2) the provision of minimal emergency supplies of prescription drugs by a pharmacy to nearby nursing homes for use in emergencies or during hours of the day when necessary prescription drugs cannot be obtained;
(3) the transfer or sale of naloxone by a dispenser for rescue use in accordance with Section 24-23-1 NMSA 1978 of the Public Health Act;
(4) the transfer or sale of a drug pursuant to a specific patient need.
The wholesale distributor that directly purchased the product from the manufacturer and is the sole distributor of that manufacturer's product to a subsequent repackager, wholesale distributor, or dispenser.
Facility of a wholesale distributor, repackager, or third-party logistics provider where prescription drugs are stored, handled, repackaged or offered for sale.
Food and drug administration, a federal agency within the United States department of health and human services, established to set safety and quality standards for drugs, food, cosmetics and other consumer products.
The Federal Food, Drug and Cosmetic Act.
A sealed case containing only product that has a single NDC number belonging to a single lot.
A product for which credible evidence shows that the product:
(1) is counterfeit, diverted, or stolen;
(2) is intentionally adulterated such that the product would result in serious adverse health consequences or death to humans;
(3) is the subject of a fraudulent transaction; or
(4) appears otherwise unfit for distribution such that the product would be reasonably likely to result in serious adverse health consequences or death to humans.
A container and does not include package liners.
(1) in the case of a wholesale distributor: (a) having valid licensure with the board; and (b) for facilities located outside of New Mexico: (i) having valid licensure by the state from which the drug is distributed; or (ii) if the state from which the drug is distributed has not established a licensure requirement, is licensed by the FDA (beginning at such time as federal regulations are promulgated to implement Section 583 of the Federal Act).
(2) in the case of a third-party logistics provider: (a) for facilities located outside of New Mexico: (i) having valid licensure by the state from which the drug is distributed when required by that state; and (ii) having a valid registration with the FDA (beginning at such time as federal regulations are promulgated to implement Section 584 of the Federal Act), unless the FDA has made a finding that the third-party logistics provider does not utilize good handling and distribution practices and publishes notice thereof; or (iii) having valid licensure with the board. (b) for facilities located in New Mexico: having valid licensure with the board.
(1) a person that holds an application approved under Section 505 of the Federal Act or a license issued under Section 351 of the Federal Public Health Service Act for such drug, or if such drug is not the subject of an approved application or license, the person who manufactured the drug;
(2) a co-licensed partner of the person described in Paragraph (1) that obtains the drug directly from a person described in Paragraph (1) or (3) of this subsection; or
(3) an affiliate of a person described in Paragraph (1) or (2) of this subsection that receives the product directly from a person described in Paragraph (1) or (2) of this subsection.
The production, preparation, propagation, conversion or processing of a drug or device, either directly or indirectly, by extraction from substances of natural origin or independently by means of chemical or biological synthesis; and includes packaging or repackaging, labeling or relabeling and the promotion and marketing of such drugs or devices; also included is the preparation and promotion of commercially available products from bulk compounds for resale by pharmacies, licensed practitioners or other persons.