21 U.S.C. § 360eee — Definitions

Page 452 TITLE 21—FOOD AND DRUGS § 360ddd–2 (June 25, 1938, ch. 675, § 576, as added Pub. L. 112–144, title XI, § 1111, July 9, 2012, 126 Stat. 1109; amended Pub. L. 114–255, div. A, title III, § 3101(a)(2)(S), Dec. 13, 2016, 130 Stat. 1155.) Editorial Notes AMENDMENTS 2016—Subsec. (a)(1). Pub. L. 114–255, § 3101(a)(2)(S)(i), inserted ‘‘who seeks to initially introduce or deliver for introduction a designated medical gas into interstate commerce’’ after ‘‘any person’’ in introductory provi- sions. Subsec. (a)(3)(A)(i)(VIII). Pub. L. 114–255, § 3101(a)(2)(S)(ii)(I)(aa), inserted ‘‘for a new drug’’ after ‘‘any period of exclusivity’’. Subsec. (a)(3)(A)(ii). Pub. L. 114–255, § 3101(a)(2)(S)(ii)(I)(bb), inserted ‘‘the’’ before ‘‘final use’’ in introductory provisions. Subsec. (a)(3)(B)(i). Pub. L. 114–255, § 3101(a)(2)(S)(ii)(II)(aa), inserted ‘‘for a new drug’’ after ‘‘any period of exclusivity’’. Subsec. (a)(3)(B)(ii). Pub. L. 114–255, § 3101(a)(2)(S)(ii)(II)(bb), inserted comma after ‘‘drug product’’. § 360ddd–2. Inapplicability of drug fees to des- ignated medical gases A designated medical gas, alone or in com- bination with another designated gas or gases (as medically appropriate) deemed under section 360ddd–1 of this title to have in effect an ap- proved application shall not be assessed fees under section 379h(a) or 379j–12(a) of this title on the basis of such deemed approval. (June 25, 1938, ch. 675, § 577, as added Pub. L. 112–144, title XI, § 1111, July 9, 2012, 126 Stat. 1111; amended Pub. L. 114–255, div. A, title III, § 3101(a)(2)(T), Dec. 13, 2016, 130 Stat. 1155.) Editorial Notes AMENDMENTS 2016—Pub. L. 114–255 inserted ‘‘or 379j–12(a)’’ after ‘‘section 379h(a)’’. PART H—PHARMACEUTICAL DISTRIBUTION SUPPLY CHAIN § 360eee. Definitions In this part: (1) Affiliate The 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) Authorized The term ‘‘authorized’’ means— (A) in the case of a manufacturer or re- packager, having a valid registration in ac- cordance 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 re- quirements 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 re- porting 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) Dispenser The 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 af- filiated 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 dis- penses only products to be used in animals in accordance with section 360b(a)(5) of this title. (4) Disposition The term ‘‘disposition’’, 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. (5) Distribute or distribution The term ‘‘distribute’’ or ‘‘distribution’’ means the sale, purchase, trade, delivery, han- dling, storage, or receipt of a product, and does not include the dispensing of a product pursuant to a prescription executed in accord- ance with section 353(b)(1) of this title or the dispensing of a product approved under section 360b(b) of this title. (6) Exclusive distributor The term ‘‘exclusive distributor’’ means the wholesale distributor that directly purchased the product from the manufacturer and is the sole distributor of that manufacturer’s prod- uct to a subsequent repackager, wholesale dis- tributor, or dispenser. (7) Homogeneous case The term ‘‘homogeneous case’’ means a sealed case containing only product that has a single National Drug Code number belonging to a single lot. (8) Illegitimate product The 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; (C) is the subject of a fraudulent trans- action; or Page 453 TITLE 21—FOOD AND DRUGS § 360eee (D) appears otherwise unfit for distribu- tion such that the product would be reason- ably likely to result in serious adverse health consequences or death to humans. (9) Licensed The 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 accord- ance with section 360eee–3(a) of this title or section 360eee–1(a)(7) of this title, as applica- ble; and (C) in the case of a dispenser, having a valid license under State law. (10) Manufacturer The term ‘‘manufacturer’’ means, with re- spect to a product— (A) a person that holds an application ap- proved under section 355 of this title or a li- cense issued under section 262 of title 42 for such product, or if such product is not the subject of an approved application or li- cense, the person who manufactured the product; (B) a co-licensed partner of the person de- scribed 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 The term ‘‘package’’ means the smallest individual saleable unit of product for dis- tribution by a manufacturer or repackager that is intended by the manufacturer for ul- timate sale to the dispenser of such product. (B) Individual saleable unit For purposes of this paragraph, an ‘‘indi- vidual saleable unit’’ is the smallest con- tainer of product introduced into commerce by the manufacturer or repackager that is intended by the manufacturer or repackager for individual sale to a dispenser. (12) Prescription drug The term ‘‘prescription drug’’ means a drug for human use subject to section 353(b)(1) of this title. (13) Product The term ‘‘product’’ means a prescription drug in a finished dosage form for administra- tion to a patient without substantial further manufacturing (such as capsules, tablets, and lyophilized products before reconstitution), but for purposes of section 360eee–1 of this title, does not include blood or blood compo- nents intended for transfusion, radioactive drugs or radioactive biological products (as de- fined in section 600.3(ee) of title 21, Code of Federal Regulations) that are regulated by the Nuclear Regulatory Commission or by a State pursuant to an agreement with such Commis- sion under section 2021 of title 42, imaging drugs, an intravenous product described in clause (xiv), (xv), or (xvi) of paragraph (24)(B), any medical gas (as defined in section 360ddd of this title), homeopathic drugs marketed in accordance with applicable guidance under this chapter, or a drug compounded in compli- ance with section 353a or 353b of this title. (14) Product identifier The term ‘‘product identifier’’ means a standardized graphic that includes, in both human-readable form and on a machine-read- able data carrier that conforms to the stand- ards developed by a widely recognized inter- national standards development organization, the standardized numerical identifier, lot number, and expiration date of the product. (15) Quarantine The term ‘‘quarantine’’ means the storage or identification of a product, to prevent dis- tribution or transfer of the product, in a phys- ically separate area clearly identified for such use or through other procedures. (16) Repackager The term ‘‘repackager’’ means a person who owns or operates an establishment that re- packs and relabels a product or package for— (A) further sale; or (B) distribution without a further trans- action. (17) Return The term ‘‘return’’ means providing product to the authorized immediate trading partner from which such product was purchased or re- ceived, or to a returns processor or reverse lo- gistics provider for handling of such product. (18) Returns processor or reverse logistics pro- vider The term ‘‘returns processor’’ or ‘‘reverse lo- gistics provider’’ means a person who owns or operates an establishment that dispositions or otherwise processes saleable or nonsaleable product received from an authorized trading partner such that the product may be proc- essed for credit to the purchaser, manufac- turer, or seller or disposed of for no further distribution. (19) Specific patient need The term ‘‘specific patient need’’ refers to the transfer of a product from one pharmacy to another to fill a prescription for an identi- fied patient. Such term does not include the transfer of a product from one pharmacy to another for the purpose of increasing or re- plenishing stock in anticipation of a potential need. (20) Standardized numerical identifier The term ‘‘standardized numerical identi- fier’’ means a set of numbers or characters used to uniquely identify each package or ho- mogenous case that is composed of the Na- tional Drug Code that corresponds to the spe- cific product (including the particular package configuration) combined with a unique alpha- numeric serial number of up to 20 characters. Page 454 TITLE 21—FOOD AND DRUGS § 360eee (21) Suspect product The term ‘‘suspect product’’ means a prod- uct for which there is reason to believe that such product— (A) is potentially counterfeit, diverted, or stolen; (B) is potentially intentionally adulter- ated such that the product would result in serious adverse health consequences or death to humans; (C) is potentially the subject of a fraudu- lent transaction; or (D) appears otherwise unfit for distribu- tion such that the product would result in serious adverse health consequences or death to humans. (22) Third-party logistics provider The term ‘‘third-party logistics provider’’ means 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 dis- penser of a product, but does not take owner- ship of the product, nor have responsibility to direct the sale or disposition of the product. (23) Trading partner The term ‘‘trading partner’’ means— (A) a manufacturer, repackager, wholesale distributor, or dispenser from whom a manu- facturer, repackager, wholesale distributor, or dispenser accepts direct ownership of a product or to whom a manufacturer, repack- ager, wholesale distributor, or dispenser transfers direct ownership of a product; or (B) a third-party logistics provider from whom a manufacturer, repackager, whole- sale distributor, or dispenser accepts direct possession of a product or to whom a manu- facturer, repackager, wholesale distributor, or dispenser transfers direct possession of a product. (24) Transaction (A) In general The term ‘‘transaction’’ means the trans- fer of product between persons in which a change of ownership occurs. (B) Exemptions The 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 pur- suant to section 247d of title 42, except that a drug shortage not caused by a pub- lic 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 quan- tities of product by a licensed retail phar- macy 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 de- scribed 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 pursu- ant 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 dis- tributors; (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 pur- suant to an agreement with such Commis- sion 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 pack- aged 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 prod- ucts 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 in- clude a product or biological product, as- sembled in kit form strictly for the con- venience of the purchaser or user (referred to in this clause as a ‘‘medical convenience kit’’) if— (I) the medical convenience kit is as- sembled in an establishment that is reg- istered with the Food and Drug Adminis- tration as a device manufacturer in ac- cordance 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 conven- ience kit that includes a product, the person that manufacturers the kit— (aa) purchased such product directly from the pharmaceutical manufacturer Page 455 TITLE 21—FOOD AND DRUGS § 360eee–1 or from a wholesale distributor that purchased the product directly from the pharmaceutical manufacturer; and (bb) does not alter the primary con- tainer or label of the product as pur- chased from the manufacturer or wholesale distributor; and (IV) in the case of a medical conven- ience 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 in- tended 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 li- censed product under section 262 of title 42 that meets the definition of a device under section 321(h) of this title. (25) Transaction history The term ‘‘transaction history’’ means a statement in paper or electronic form, includ- ing the transaction information for each prior transaction going back to the manufacturer of the product. (26) Transaction information The term ‘‘transaction information’’ means— (A) the proprietary or established name or names of the product; (B) the strength and dosage form of the product; (C) the National Drug Code number 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 trans- ferred; and (J) the business name and address of the person to whom ownership is being trans- ferred. (27) Transaction statement The ‘‘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 il- legitimate 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 trans- action information; and (G) did not knowingly alter the trans- action history. (28) Verification or verify The term ‘‘verification’’ or ‘‘verify’’ means determining whether the product identifier af- fixed to, or imprinted upon, a package or ho- mogeneous case corresponds to the standard- ized numerical identifier or lot number and ex- piration date assigned to the product by the manufacturer or the repackager, as applicable in accordance with section 360eee–1 of this title. (29) Wholesale distributor The term ‘‘wholesale distributor’’ means a person (other than a manufacturer, a manu- facturer’s co-licensed partner, a third-party logistics provider, or repackager) engaged in wholesale distribution (as defined in section 353(e)(4) of this title). (June 25, 1938, ch. 675, § 581, as added Pub. L. 113–54, title II, § 202, Nov. 27, 2013, 127 Stat. 599.) Editorial Notes REFERENCES IN TEXT The Comprehensive Drug Abuse Prevention and Con- trol Act of 1970, referred to in par. (24)(B)(xiii)(II), is Pub. L. 91–513, Oct. 27, 1970, 84 Stat. 1236, which is clas- sified principally to chapter 13 (§ 801 et seq.) of this title. For complete classification of this Act to the Code, see Short Title note set out under section 801 of this title and Tables. The Drug Supply Chain Security Act, referred to in par. (27)(A), (B), is Pub. L. 113–54, title II, Nov. 27, 2013, 127 Stat. 599. For complete classification of this Act to the Code, see Short Title note set out under section 301 of this title and Tables. § 360eee–1. Requirements (a) In general (1) Other activities Each manufacturer, repackager, wholesale distributor, and dispenser shall comply with the requirements set forth in this section with respect to the role of such manufacturer, re- packager, wholesale distributor, or dispenser in a transaction involving product. If an enti- ty meets the definition of more than one of the entities listed in the preceding sentence,