Ch 19 P 8 Wholesale Distributors; Third-party logistics providers; Repackagers; Drug supply chain security

Question 1

Adulterated

Answer 1

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.

Question 2

Affiliate

Answer 2

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

Question 3

Authorized

Answer 3

(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.

Question 4

Blood

Answer 4

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

Question 5

Blood component

Answer 5

That part of blood separated by physical or mechanical means.

Question 6

Co-licensed partner or product

Answer 6

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).

Question 7

Common carrier

Answer 7

Any person or entity who undertakes, whether directly or by any other arrangement, to transport property including prescription drugs for compensation.

Question 8

Counterfeiting

Answer 8

Engaging in activities that create a counterfeit drug.

Question 9

Counterfeit drug

Answer 9

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.

Question 10

Counterfeit prescription drug

Answer 10

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.

Question 11

Dangerous drug

Answer 11

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.

Question 12

Designated respresentative

Answer 12

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.

Question 13

Dispenser

Answer 13

(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.

Question 14

Disposition

Answer 14

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.

Question 15

Distribute or distribution

Answer 15

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.

Question 16

Drug

Answer 16

(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.

Question 17

Drug sample

Answer 17

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.

Question 18

DSCSA

Answer 18

The Drug Supply Chain Security Act.

Question 19

Emergency medical reasons

Answer 19

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.

Question 20

Exclusive distributor

Answer 20

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.

Question 21

Facility

Answer 21

Facility of a wholesale distributor, repackager, or third-party logistics provider where prescription drugs are stored, handled, repackaged or offered for sale.

Question 22

FDA

Answer 22

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.

Question 23

Federal act

Answer 23

The Federal Food, Drug and Cosmetic Act.

Question 24

Homogeneous case

Answer 24

A sealed case containing only product that has a single NDC number belonging to a single lot.

Question 25

Illegitimate product

Answer 25

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.

Question 26

Immediate container

Answer 26

A container and does not include package liners.

Question 27

Licensed

Answer 27

(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.

Question 28

Manufacturer

Answer 28

(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.

Question 29

Manufacturing

Answer 29

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.

Question 30

Misbranded

Answer 30

A label to an article that is misleading. In determining whether the label is misleading there shall be taken into account, among other things, not only representations made or suggested by statement, word, design, device or any combination of the foregoing, but also the extent to which the label fails to reveal facts material in the light of such representations or material with respect to consequences that may result from the use of the article to which the label relates under the conditions of use prescribed in the label or under such conditions of use as are customary or usual.

Question 31

NDC

Answer 31

National drug code

Question 32

Official compendium

Answer 32

The official USP-NF or the official homeopathic pharmacopoeia of the United States or any supplement to either of them.

Question 33

Package

Answer 33

The smallest individual saleable unit of product for distribution by a manufacturer or repackager that is intended by the manufacturer for ultimate sale to the dispenser of such product. An individual saleable unit is the smallest container of product introduced into commerce by the manufacturer or repackager that is intended by the manufacturer or repackager for individual sale to a dispenser.

Question 34

Prescription drug

Answer 34

Any human drug required by federal or state law or regulation to be dispensed only by a prescription, including finished dosage forms and active ingredients subject to Section 503(b) of the Federal Food, Drug and Cosmetic Act.

Question 35

Product

Answer 35

a prescription drug in a finished dosage form for administration to a patient without substantial further manufacturing (such as capsules, tablets, and lyophilized products before reconstitution), but does not include:

(1) blood or blood components intended for transfusion;
(2) radioactive drugs or radioactive biological products (as defined in Section 600.3(ee) of title 21, Code of Federal Regulations) that are regulated by the Nuclear Regulatory Commission or by the state pursuant to an agreement with such commission under Section 274 of the Atomic Energy Act of 1954 (42 U.S.C. 2021);
(3) imaging drugs;
(4) an intravenous product described in Paragraph (14), (15), or (16) of definition XX. (“transaction”);
(5) any medical gas as defined in Section 575 of the Federal Act;
(6) homeopathic drugs marketed in accordance with applicable guidance under the federal act; or
(7) a drug compounded in compliance with Section 503A or 503B of the Federal Act.

Question 36

Product identifier

Answer 36

A standardized graphic that includes, in both human-readable form and on a machine-readable data carrier that conforms to the standards developed by a widely recognized international standards development organization, the standardized numerical identifier, lot number, and expiration date of the product, meeting the requirements of the DSCSA.

Question 37

Product tracing information

Answer 37

For each transaction: the recorded transaction history, transaction information, and transaction statement meeting the requirements of the DSCSA.

Question 38

Quarentine

Answer 38

The storage or identification of a product, to prevent distribution or transfer of the product, in a physically separate area clearly identified for such use or through other procedures.

Question 39

Repackage

Answer 39

Repackaging or otherwise changing the container, wrapper or labeling to further the distribution of a prescription drug excluding that completed by the pharmacists responsible for dispensing product to the patient.

Question 40

Repackager

Answer 40

a person who owns or operates a facility that repackages and re-labels a product or package for:

(1) further sale; or
(2) distribution without a further transaction.

Question 41

Return

Answer 41

Providing product to the authorized immediate trading partner from which such product was purchased or received, or to a returns processor or reverse logistics provider for handling of such product.

Question 42

Returns processor or reverse logistics provider

Answer 42

a person who owns or operates an establishment that dispositions or otherwise processes saleable or non-saleable product received from an authorized trading partner such that the product may be processed for credit to the purchaser, manufacturer, or seller or disposed of for no further distribution.

Question 43

Selling of drugs, devices or cosmetics

Answer 43

Shall be considered to include the manufacture, production, processing, packing, exposure, offer, possession and holding of any such article for sale and the sale and the sale and the supplying or applying of any such article in the conduct of a drug or cosmetic establishment.

Question 44

Significant loss

Answer 44

Any loss of a prescription drug that exceeds a reasonable level established by like persons which requires that loss to be reported to the board or as required by the DEA or other state or federal agencies for prescription drugs and controlled substances.

Question 45

Specified patient need

Answer 45

The transfer of a product from one pharmacy to another to fill a prescription for an identified patient. Such term does not include the transfer of a product from one pharmacy to another for the purpose of increasing or replenishing stock in anticipation of a potential need.

Question 46

Standardized numerical identifier

Answer 46

A set of numbers or characters used to uniquely identify each package or homogenous case that is composed of the NDC that corresponds to the specific product (including the particular package configuration) combined with a unique alphanumeric serial number of up to 20 characters.

Question 47

Suspect product

Answer 47

A product for which there is reason to believe:

(1) is potentially counterfeit, diverted, or stolen;
(2) is potentially intentionally adulterated such that the product would result in serious adverse health consequences or death to humans;
(3) is potentially the subject of a fraudulent transaction; or
(4) appears otherwise unfit for distribution such that the product would result in serious adverse health consequences or death to humans.

Question 48

Third-party logistics provider

Answer 48

An entity that provides or coordinates warehousing, or other logistics services of a product in interstate commerce on behalf of a manufacturer, wholesale distributor, or dispenser of a product, but does not take ownership of the product, nor have responsibility to direct the sale or disposition of the product.

Question 49

Trading partner

Answer 49

(1) a manufacturer, repackager, wholesale distributor, or dispenser from whom a manufacturer, repackager, wholesale distributor, or dispenser accepts direct ownership of a product or to whom a manufacturer, repackager, wholesale distributor, or dispenser transfers direct ownership of a product; or
(2) a third-party logistics provider from whom a manufacturer, repackager, wholesale distributor, or dispenser accepts direct possession of a product or to whom a manufacturer, repackager, wholesale distributor, or dispenser transfers direct possession of a product.

Question 50

Transaction

Answer 50

The transfer of product between persons in which a change of ownership occurs, but does not include:

(1) intracompany distribution of any product between members of an affiliate or within a manufacturer;
(2) he distribution of a product among hospitals or other health care entities that are under common control; for the purposes of this section “common control” means the power to direct or cause the direction of the management and policies of a person or an organization, whether by ownership of stock, voting rights, by contract, or otherwise;
(3) the distribution of a product for emergency medical reasons including a federal or state declared public health emergency, except that a drug shortage not caused by a public health emergency shall not constitute an emergency medical reason;
(4) the dispensing of a product pursuant to a prescription executed in accordance with Section 503(b)(1) of the Federal Act;
(5) the distribution of product samples by a manufacturer or a licensed wholesale distributor in accordance with Section 503(d) of the Federal Act;
(6) the distribution of blood or blood components intended for transfusion;
(7) the distribution of minimal quantities of product by a licensed retail pharmacy to a licensed practitioner for office use;
(8) the sale, purchase, or trade of a drug or an offer to sell, purchase, or trade a drug by a charitable organization described in Section 501(c)(3) of the Internal Revenue Code of 1986 to a nonprofit affiliate of the organization to the extent otherwise permitted by law;
(9) the distribution of a product pursuant to the sale or merger of a pharmacy or pharmacies or a wholesale distributor or wholesale distributors, except that any records required to be maintained for the product shall be transferred to the new owner of the pharmacy or pharmacies or wholesale distributor or wholesale distributors;
(10) the dispensing of an approved animal drug product approved under Section 512(c) of the Federal Act;
(11) products transferred to or from any location that is licensed by the Nuclear Regulatory Commission or by the state pursuant to an agreement with such commission under Section 274 of the Atomic Energy Act of 1954 (42 U.S.C. 2021);
(12) a combination product that is not subject to approval under Section 505 or licensure under Section 351 of the Public Health Service Act, and that is:
(a) a product comprised of a device and one or more other regulated components (such as a device and a drug, biologic, or drug and biologic) that are physically, chemically, or otherwise combined or mixed and produced as a single entity;
(b) two or more separate products packaged together in a single package or as a unit and comprised of a drug and device or device and biological product; or
(c) two or more finished medical devices plus one or more drug or biological products that are packaged together in what is referred to as a “medical convenience kit” as described in Paragraph (13) below;
(13) the distribution of a collection of finished medical devices, which may include a product or biological product, assembled in kit form strictly for the convenience of the purchaser or user (referred to in this paragraph as a “medical convenience kit”) if:
(a) the medical convenience kit is assembled in an establishment that is registered with the FDA as a device manufacturer in accordance with Section 510(b)(2) of the Federal Act;
(b) the medical convenience kit does not contain a controlled substance that appears in a schedule contained in the Comprehensive Drug Abuse Prevention and Control Act of 1970;
(c) in the case of a medical convenience kit that includes a product, the person that manufacturers the kit:
(i) purchased such product directly from the pharmaceutical manufacturer or from a wholesale distributor that purchased the product directly from the pharmaceutical manufacturer; and
(ii) does not alter the primary container or label of the product as purchased from the manufacturer or wholesale distributor; and
(d) in the case of a medical convenience kit that includes a product, the product is:
(i) an intravenous solution intended for the replenishment of fluids and electrolytes;
(ii) a product intended to maintain the equilibrium of water and minerals in the body;
(iii) a product intended for irrigation or reconstitution;
(iv) an anesthetic;
(v) an anticoagulant;
(vi) a vasopressor; or
(vii) a sympathomimetic;
(14) the distribution of an intravenous product that, by its formulation, is intended for the replenishment of fluids and electrolytes (such as sodium, chloride, and potassium) or calories (such as dextrose and amino acids);
(15) the distribution of an intravenous product used to maintain the equilibrium of water and minerals in the body, such as dialysis solutions;
(16) the distribution of a product that is intended for irrigation, or sterile water, whether intended for such purposes or for injection;
(17) the distribution of a medical gas (as defined in Section 575 of the Federal Act); or
(18) the distribution or sale of any licensed product under section 351 of the Public Health Service Act that meets the definition of a medical device under Section 201(h) of the Federal Act.

Question 51

Transaction history

Answer 51

A statement in paper or electronic form, including the transaction information for each prior transaction going back to the manufacturer of the product.

Question 52

Transaction information

Answer 52

(1) the proprietary or established name or names of the product;
(2) the strength and dosage form of the product;
(3) the NDC number of the product;
(4) the container size;
(5) the number of containers;
(6) the lot number of the product;
(7) the date of the transaction;
(8) the date of the shipment, if more than 24 hours after the date of the transaction;
(9) the business name and address of the person from whom ownership is being transferred; and
(10) the business name and address of the person to whom ownership is being transferred.

Question 53

Transaction statement

Answer 53

a statement, in paper or electronic form, that the entity transferring ownership in a transaction:

(1) is authorized as required under the DSCSA;
(2) received the product from a person that is authorized as required under the DSCSA;
(3) received transaction information and a transaction statement from the prior owner of the product, as required under Section 582 of the Federal Act;
(4) did not knowingly ship a suspect or illegitimate product;
(5) had systems and processes in place to comply with verification requirements under Section 582 of the Federal Act;
(6) did not knowingly provide false transaction information; and
(7) did not knowingly alter the transaction history.

Question 54

USP-NF Standards

Answer 54

Standards published in the current official United States Pharmacopeia-National Formulary.

Question 55

Verification or verify

Answer 55

Determining whether the product identifier affixed to, or imprinted upon, a package or homogeneous case corresponds to the standardized numerical identifier or lot number and expiration date assigned to the product by the manufacturer or the repackager, as applicable in accordance with Section 582 of the Federal Act?

Question 56

Wholesale drug distribution

Answer 56

The distribution of a prescription drug to a person other than a consumer or patient, or receipt of a prescription drug by a person other than the consumer or patient, but does not include:

(1) intracompany distribution of any drug between members of an affiliate or within a manufacturer;
(2) the distribution of a drug, or an offer to distribute a drug among hospitals or other health care entities which are under common control;
(3) the distribution of a drug or an offer to distribute a drug for emergency medical reasons, including a federal or state declared public health emergency, except that, a drug shortage not caused by a public health emergency shall not constitute an emergency medical reason;
(4) the dispensing of a drug pursuant to a prescription;
(5) the distribution of minimal quantities of drug by a licensed retail pharmacy to a licensed practitioner for office use;
(6) the distribution of a drug or an offer to distribute a drug by a charitable organization to a nonprofit affiliate of the organization to the extent otherwise permitted by law;
(7) the purchase or other acquisition by a dispenser, hospital, or other health care entity of a drug for use by such dispenser, hospital, or other health care entity;
(8) the distribution of a drug by the manufacturer of such drug;
(9) the receipt or transfer of a drug by an authorized third-party logistics provider provided that such third-party logistics provider does not take ownership of the drug;
(10) a common carrier that transports a drug, provided that the common carrier does not take ownership of the drug;
(11) the distribution of a drug, or an offer to distribute a drug by an authorized repackager that has taken ownership or possession of the drug and repacks it in accordance with Section 582(e) of the Federal Act;
(12) saleable drug returns when conducted by a dispenser;
(13) the distribution of a collection of finished medical devices, which may include a product or biological product, assembled in kit form strictly for the convenience of the purchaser or user (referred to as a “medical convenience kit”) if:
(a) the medical convenience kit is assembled in an establishment that is registered with the FDA as a device manufacturer in accordance with Section 501(b)(2) of the federal act;
(b) the medical convenience kit does not contain a controlled substance that appears in a schedule contained in the Comprehensive Drug Abuse Prevention and Control Act of 1970 [21 U.S.C. 801 et seq.];
(c) in the case of a medical convenience kit that includes a product, the person that manufacturers the kit:
(i) purchased such product directly from the pharmaceutical manufacturer or from a wholesale distributor that purchased the product directly from the pharmaceutical manufacturer; and
(ii) does not alter the primary container or label of the product as purchased from the manufacturer or wholesale distributor; and
(d) in the case of a medical convenience kit that includes a product, the product is
(i) an intravenous solution intended for the replenishment of fluids and electrolytes;
(ii) a product intended to maintain the equilibrium of water and minerals in the body;
(iii) a product intended for irrigation or reconstitution;
(iv) an anesthetic;
(v) an anticoagulant;
(vi) a vasopressor; or
(vii) a sympathomimetic;
(14) the distribution of an intravenous drug that, by its formulation, is intended for the replenishment of fluids and electrolytes (such as sodium, chloride, and potassium) or calories (such as dextrose and amino acids);
(15) the distribution of an intravenous drug used to maintain the equilibrium of water and minerals in the body, such as dialysis solutions;
(16) the distribution of a drug that is intended for irrigation, or sterile water, whether intended for such purposes or for injection;
(17) the distribution of medical gas, as defined in Section 575 of the Federal Act;
(18) facilitating the distribution of a product by providing solely administrative services, including processing of orders and payments; or
(19) the transfer of a product by a hospital or other health care entity, or by a wholesale distributor or manufacturer operating at the direction of the hospital or other health care entity, to a repackager described in Section 581(16)(B) and registered under Section 510 of the Federal Act for the purpose of repackaging the drug for use by that hospital, or other health care entity and other health care entities that are under common control, if ownership of the drug remains with the hospital or other health care entity at all times.

Question 57

Wholesale distributor

Answer 57

A person or entity (other than a manufacturer, a manufacturer’s co-licensed partner, a third-party logistics provider, or repackager) engaged in wholesale drug distribution.