21 USC 360 - Definitions

View all text of Part H [§ 360eee - § 360eee-4]

§ 360eee. DefinitionsIn this part:

(1) AffiliateThe term “affiliate” means a business entity that has a relationship with a second business entity if, directly or indirectly—

(A) one business entity controls, or has the power to control, the other business entity; or

(B) a third party controls, or has the power to control, both of the business entities.

(2) AuthorizedThe term “authorized” means—

(A) in the case of a manufacturer or repackager, having a valid registration in accordance with section 360 of this title;

(B) in the case of a wholesale distributor, having a valid license under State law or section 360eee–2 of this title, in accordance with section 360eee–1(a)(6) of this title, and complying with the licensure reporting requirements under section 353(e) of this title;

(C) in the case of a third-party logistics provider, having a valid license under State law or section 360eee–3(a)(1) of this title, in accordance with section 360eee–1(a)(7) of this title, and complying with the licensure reporting requirements under section 360eee–3(b) of this title; and

(D) in the case of a dispenser, having a valid license under State law.

(3) DispenserThe term “dispenser”—

(A) means a retail pharmacy, hospital pharmacy, a group of chain pharmacies under common ownership and control that do not act as a wholesale distributor, or any 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

(B) does not include a person who dispenses only products to be used in animals in accordance with section 360b(a)(5) of this title.

(4) Disposition

(5) Distribute or distribution

(6) Exclusive distributor

(7) Homogeneous case

(8) Illegitimate productThe term “illegitimate product” means a product for which credible evidence shows that the product—

(A) is counterfeit, diverted, or stolen;

(B) is intentionally adulterated such that the product would result in serious adverse health consequences or death to humans;

(D) appears otherwise unfit for distribution such that the product would be reasonably likely to result in serious adverse health consequences or death to humans.

(9) LicensedThe term “licensed” means—

(A) in the case of a wholesale distributor, having a valid license in accordance with section 353(e) of this title or section 360eee–1(a)(6) of this title, as applicable;

(B) in the case of a third-party logistics provider, having a valid license in accordance with section 360eee–3(a) of this title or section 360eee–1(a)(7) of this title, as applicable; and

(10) ManufacturerThe term “manufacturer” means, with respect to a product—

(A) a person that holds an application approved under section 355 of this title or a license issued under section 262 of title 42 for such product, or if such product is not the subject of an approved application or license, the person who manufactured the product;

(B) a co-licensed partner of the person described in subparagraph (A) that obtains the product directly from a person described in this subparagraph or subparagraph (A) or (C); or

(C) an affiliate of a person described in subparagraph (A) or (B) that receives the product directly from a person described in this subparagraph or subparagraph (A) or (B).

(11) Package

(A) In general

(B) Individual saleable unit

(12) Prescription drug

(13) Product

(14) Product identifier

(15) Quarantine

(16) RepackagerThe term “repackager” means a person who owns or operates an establishment that repacks and relabels a product or package for—

(A) further sale; or

(B) distribution without a further transaction.

(17) Return

(18) Returns processor or reverse logistics provider

(19) Specific patient need

(20) Standardized numerical identifier

(21) Suspect productThe term “suspect product” means a product for which there is reason to believe that such product—

(A) is potentially counterfeit, diverted, or stolen;

(B) is potentially intentionally adulterated such that the product would result in serious adverse health consequences or death to humans;

(D) appears otherwise unfit for distribution such that the product would result in serious adverse health consequences or death to humans.

(22) Third-party logistics provider

(23) Trading partnerThe term “trading partner” means—

(A) 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

(B) 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.

(24) Transaction

(A) In general

(B) ExemptionsThe term “transaction” does not include—

(i) intracompany distribution of any product between members of an affiliate or within a manufacturer;

(ii) the distribution of a product among hospitals or other health care entities that are under common control;

(iii) the distribution of a product for emergency medical reasons including a public health emergency declaration pursuant to section 247d of title 42, except that a drug shortage not caused by a public health emergency shall not constitute an emergency medical reason;

(iv) the dispensing of a product pursuant to a prescription executed in accordance with section 353(b)(1) of this title;

(v) the distribution of product samples by a manufacturer or a licensed wholesale distributor in accordance with section 353(d) of this title;

(vi) the distribution of blood or blood components intended for transfusion;

(vii) the distribution of minimal quantities of product by a licensed retail pharmacy to a licensed practitioner for office use;

(viii) 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 title 26 to a nonprofit affiliate of the organization to the extent otherwise permitted by law;

(ix) 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;

(x) the dispensing of a product approved under section 360b(c) of this title;

(xi) products transferred to or from any facility that is licensed by the Nuclear Regulatory Commission or by a State pursuant to an agreement with such Commission under section 2021 of title 42;

(xii) a combination product that is not subject to approval under section 355 of this title or licensure under section 262 of title 42, and that is—(I) a product comprised of a device and 1 or more other regulated components (such as a drug/device, biologic/device, or drug/device/biologic) that are physically, chemically, or otherwise combined or mixed and produced as a single entity;(II) 2 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(III) 2 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 clause (xiii);

(xiii) 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 clause as a “medical convenience kit”) if—(I) the medical convenience kit is assembled in an establishment that is registered with the Food and Drug Administration as a device manufacturer in accordance with section 360(b)(2) of this title;(II) 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.];(III) in the case of a medical convenience kit that includes a product, the person that manufacturers the kit—(aa) purchased such product directly from the pharmaceutical manufacturer or from a wholesale distributor that purchased the product directly from the pharmaceutical manufacturer; and(bb) does not alter the primary container or label of the product as purchased from the manufacturer or wholesale distributor; and(IV) in the case of a medical convenience kit that includes a product, the product is—(aa) an intravenous solution intended for the replenishment of fluids and electrolytes;(bb) a product intended to maintain the equilibrium of water and minerals in the body;(cc) a product intended for irrigation or reconstitution;(dd) an anesthetic;(ee) an anticoagulant;(ff) a vasopressor; or(gg) a sympathomimetic;

(xiv) 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);

(xv) the distribution of an intravenous product used to maintain the equilibrium of water and minerals in the body, such as dialysis solutions;

(xvi) the distribution of a product that is intended for irrigation, or sterile water, whether intended for such purposes or for injection;

(xvii) the distribution of a medical gas (as defined in section 360ddd of this title); or

(xviii) the distribution or sale of any licensed product under section 262 of title 42 that meets the definition of a device under section 321(h) of this title.

(25) Transaction history

(26) Transaction informationThe term “transaction information” means—

(A) the proprietary or established name or names of the product;

(B) the strength and dosage form of the product;

(D) the container size;

(E) the number of containers;

(F) the lot number of the product;

(G) the date of the transaction;

(H) the date of the shipment, if more than 24 hours after the date of the transaction;

(I) the business name and address of the person from whom ownership is being transferred; and

(J) the business name and address of the person to whom ownership is being transferred.

(27) Transaction statementThe “transaction statement” is a statement, in paper or electronic form, that the entity transferring ownership in a transaction—

(A) is authorized as required under the Drug Supply Chain Security Act;

(B) received the product from a person that is authorized as required under the Drug Supply Chain Security Act;

(C) received transaction information and a transaction statement from the prior owner of the product, as required under section 360eee–1 of this title;

(D) did not knowingly ship a suspect or illegitimate product;

(E) had systems and processes in place to comply with verification requirements under section 360eee–1 of this title;

(F) did not knowingly provide false transaction information; and

(G) did not knowingly alter the transaction history.

(28) Verification or verify

(29) Wholesale distributor

(June 25, 1938, ch. 675, § 581, as added Pub. L. 113–54, title II, § 202, Nov. 27, 2013, 127 Stat. 599.)