---
kind: "section"
citation: "21 U.S.C. § 360eee"
title: "21"
title_heading: "Food and Drugs"
number: "360eee"
heading: "Definitions"
release: "119-102"
date: "2026-07-12"
url: "https://uscodex.org/usc/21/360eee"
units:
  - "Chapter 9 — Federal Food, Drug, and Cosmetic Act"
  - "Subchapter V — Drugs and Devices"
  - "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](/usc/21/360hh.md?p=3) or [repackager](#16), having a valid registration in accordance with [section 360 of this title](/usc/21/360.md);
  - (B) in the case of a [wholesale distributor](#29), having a valid license under [State](/usc/21/321.md?p=a-1) law or [section 360eee–2 of this title](/usc/21/360eee–2.md), in accordance with [section 360eee–1(a)(6) of this title](/usc/21/360eee–1.md?p=a-6), and complying with the licensure reporting requirements under [section 353(e) of this title](/usc/21/353.md?p=e);
  - (C) in the case of a [third-party logistics provider](#22), having a valid license under [State](/usc/21/321.md?p=a-1) law or [section 360eee–3(a)(1) of this title](/usc/21/360eee–3.md?p=a-1), in accordance with [section 360eee–1(a)(7) of this title](/usc/21/360eee–1.md?p=a-7), and complying with the licensure reporting requirements under [section 360eee–3(b) of this title](/usc/21/360eee–3.md?p=b); and
  - (D) in the case of a [dispenser](#3), having a valid license under [State](/usc/21/321.md?p=a-1) 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](#29), or any other [person](/usc/21/321.md?p=e) [authorized](#2) by law to dispense or administer [prescription drugs](#12), and the affiliated warehouses or [distribution](#5) centers of such entities under common ownership and control that do not act as a [wholesale distributor](#29); and
  - (B) does not include a [person](/usc/21/321.md?p=e) who dispenses only [products](#13) to be used in animals in accordance with [section 360b(a)(5) of this title](/usc/21/360b.md?p=a-5).
- (4) **Disposition—** The term “disposition”, with respect to a [product](#13) within the possession or control of an entity, means the removal of such [product](#13) from the pharmaceutical [distribution](#5) supply chain, which may include disposal or [return](#17) of the [product](#13) for disposal or other appropriate handling and other actions, such as retaining a sample of the [product](#13) for further additional physical examination or laboratory analysis of the [product](#13) by a [manufacturer](/usc/21/360hh.md?p=3) or regulatory or law enforcement agency.
- (5) **Distribute or distribution—** The term “distribute” or “distribution” means the sale, purchase, trade, delivery, handling, storage, or receipt of a [product](#13), and does not include the dispensing of a [product](#13) pursuant to a prescription executed in accordance with [section 353(b)(1) of this title](/usc/21/353.md?p=b-1) or the dispensing of a [product](#13) approved under [section 360b(b) of this title](/usc/21/360b.md?p=b).
- (6) **Exclusive distributor—** The term “exclusive distributor” means the [wholesale distributor](#29) that directly purchased the [product](#13) from the [manufacturer](/usc/21/360hh.md?p=3) and is the sole distributor of that [manufacturer](/usc/21/360hh.md?p=3)’s [product](#13) to a subsequent [repackager](#16), [wholesale distributor](#29), or [dispenser](#3).
- (7) **Homogeneous case—** The term “homogeneous case” means a sealed case containing only [product](#13) that has a single National Drug Code number belonging to a single lot.
- (8) **Illegitimate product—** The term “illegitimate product” means a [product](#13) for which credible evidence shows that the [product](#13)—
  - (A) is counterfeit, diverted, or stolen;
  - (B) is intentionally adulterated such that the [product](#13) would result in serious adverse health consequences or death to humans;
  - (C) is the subject of a fraudulent [transaction](#24-A); or
  - (D) appears otherwise unfit for [distribution](#5) such that the [product](#13) would be reasonably 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](#29), having a valid license in accordance with [section 353(e) of this title](/usc/21/353.md?p=e) or [section 360eee–1(a)(6) of this title](/usc/21/360eee–1.md?p=a-6), as applicable;
  - (B) in the case of a [third-party logistics provider](#22), having a valid license in accordance with [section 360eee–3(a) of this title](/usc/21/360eee–3.md?p=a) or [section 360eee–1(a)(7) of this title](/usc/21/360eee–1.md?p=a-7), as applicable; and
  - (C) in the case of a [dispenser](#3), having a valid license under [State](/usc/21/321.md?p=a-1) law.
- (10) **Manufacturer—** The term “[manufacturer](/usc/21/360hh.md?p=3)” means, with respect to a [product](#13)—
  - (A) a [person](/usc/21/321.md?p=e) that holds an application approved under [section 355 of this title](/usc/21/355.md) or a license issued under [section 262 of title 42](/usc/42/262.md) for such [product](#13), or if such [product](#13) is not the subject of an approved application or license, the [person](/usc/21/321.md?p=e) who manufactured the [product](#13);
  - (B) a co-[licensed](#9) partner of the [person](/usc/21/321.md?p=e) described in [subparagraph (A)](#10-A) that obtains the [product](#13) directly from a [person](/usc/21/321.md?p=e) described in this subparagraph or subparagraph [(A)](#10-A) or [(C)](#10-C); or
  - (C) an [affiliate](#1) of a [person](/usc/21/321.md?p=e) described in subparagraph [(A)](#10-A) or [(B)](#10-B) that receives the [product](#13) directly from a [person](/usc/21/321.md?p=e) described in this subparagraph or subparagraph [(A)](#10-A) or [(B)](#10-B).
- (11) **Package—**
  - (A) **In general—** The term “package” means the smallest individual saleable unit of [product](#13) for [distribution](#5) by a [manufacturer](/usc/21/360hh.md?p=3) or [repackager](#16) that is intended by the [manufacturer](/usc/21/360hh.md?p=3) for ultimate sale to the [dispenser](#3) of such [product](#13).
  - (B) **Individual saleable unit—** For purposes of this paragraph, an “individual saleable unit” is the smallest container of [product](#13) introduced into [commerce](/usc/21/360hh.md?p=4) by the [manufacturer](/usc/21/360hh.md?p=3) or [repackager](#16) that is intended by the [manufacturer](/usc/21/360hh.md?p=3) or [repackager](#16) for individual sale to a [dispenser](#3).
- (12) **Prescription drug—** The term “prescription drug” means a [drug](/usc/21/321.md?p=g-1) for human use subject to [section 353(b)(1) of this title](/usc/21/353.md?p=b-1).
- (13) **Product—** The term “product” means a [prescription drug](#12) in a finished dosage form for administration 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](/usc/21/360eee–1.md), does not include blood or blood components intended for transfusion, radioactive [drugs](/usc/21/321.md?p=g-1) 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 a [State](/usc/21/321.md?p=a-1) pursuant to an agreement with such Commission under [section 2021 of title 42](/usc/42/2021.md), imaging [drugs](/usc/21/321.md?p=g-1), an intravenous product described in clause [(xiv)](#24-B-xiv), [(xv)](#24-B-xv), or [(xvi)](#24-B-xvi) of paragraph (24)(B), any [medical gas](/usc/21/360ddd.md?p=2) (as defined in [section 360ddd of this title](/usc/21/360ddd.md)), homeopathic [drugs](/usc/21/321.md?p=g-1) marketed in accordance with applicable guidance under this chapter, or a [drug](/usc/21/321.md?p=g-1) compounded in compliance with section [353a](/usc/21/353a.md) or [353b](/usc/21/353b.md) 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-readable data carrier that conforms to the standards developed by a widely recognized international standards development organization, the [standardized numerical identifier](#20), lot number, and expiration date of the [product](#13).
- (15) **Quarantine—** The term “quarantine” means the storage or identification of a [product](#13), to prevent [distribution](#5) or transfer of the [product](#13), in a physically separate area clearly identified for such use or through other procedures.
- (16) **Repackager—** The term “repackager” means a [person](/usc/21/321.md?p=e) who owns or operates an establishment that repacks and relabels a [product](#13) or [package](#11-A) for—
  - (A) further sale; or
  - (B) [distribution](#5) without a further [transaction](#24-A).
- (17) **Return—** The term “return” means providing [product](#13) to the [authorized](#2) immediate [trading partner](#23) from which such [product](#13) was purchased or received, or to a [returns processor](#18) or [reverse logistics provider](#18) for handling of such [product](#13).
- (18) **Returns processor or reverse logistics provider—** The term “returns processor” or “reverse logistics provider” means a [person](/usc/21/321.md?p=e) who owns or operates an establishment that [dispositions](#4) or otherwise processes saleable or nonsaleable [product](#13) received from an [authorized](#2) [trading partner](#23) such that the [product](#13) may be processed for credit to the purchaser, [manufacturer](/usc/21/360hh.md?p=3), or seller or disposed of for no further [distribution](#5).
- (19) **Specific patient need—** The term “specific patient need” refers to the transfer of a [product](#13) from one pharmacy to another to fill a prescription for an identified patient. Such term does not include the transfer of a [product](#13) from one pharmacy to another for the purpose of increasing or replenishing stock in anticipation of a potential need.
- (20) **Standardized numerical identifier—** The term “standardized numerical identifier” means a set of numbers or characters used to uniquely identify each [package](#11-A) or homogenous case that is composed of the National Drug Code that corresponds to the specific [product](#13) (including the particular [package](#11-A) configuration) combined with a unique alphanumeric serial number of up to 20 characters.
- (21) **Suspect product—** The term “suspect product” means a [product](#13) for which there is reason to believe that such [product](#13)—
  - (A) is potentially counterfeit, diverted, or stolen;
  - (B) is potentially intentionally adulterated such that the [product](#13) would result in serious adverse health consequences or death to humans;
  - (C) is potentially the subject of a fraudulent [transaction](#24-A); or
  - (D) appears otherwise unfit for [distribution](#5) such that the [product](#13) 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](#13) in [interstate commerce](/usc/21/321.md?p=b) on behalf of a [manufacturer](/usc/21/360hh.md?p=3), [wholesale distributor](#29), or [dispenser](#3) of a [product](#13), but does not take ownership of the [product](#13), nor have responsibility to direct the sale or [disposition](#4) of the [product](#13).
- (23) **Trading partner—** The term “trading partner” means—
  - (A) a [manufacturer](/usc/21/360hh.md?p=3), [repackager](#16), [wholesale distributor](#29), or [dispenser](#3) from whom a [manufacturer](/usc/21/360hh.md?p=3), [repackager](#16), [wholesale distributor](#29), or [dispenser](#3) accepts direct ownership of a [product](#13) or to whom a [manufacturer](/usc/21/360hh.md?p=3), [repackager](#16), [wholesale distributor](#29), or [dispenser](#3) transfers direct ownership of a [product](#13); or
  - (B) a [third-party logistics provider](#22) from whom a [manufacturer](/usc/21/360hh.md?p=3), [repackager](#16), [wholesale distributor](#29), or [dispenser](#3) accepts direct possession of a [product](#13) or to whom a [manufacturer](/usc/21/360hh.md?p=3), [repackager](#16), [wholesale distributor](#29), or [dispenser](#3) transfers direct possession of a [product](#13).
- (24) **Transaction—**
  - (A) **In general—** The term “transaction” means the transfer of [product](#13) between [persons](/usc/21/321.md?p=e) in which a change of ownership occurs.
  - (B) **Exemptions—** The term “[transaction](#24-A)” does not include—
    - (i) intracompany [distribution](#5) of any [product](#13) between members of an [affiliate](#1) or within a [manufacturer](/usc/21/360hh.md?p=3);
    - (ii) the [distribution](#5) of a [product](#13) among hospitals or other health care entities that are under common control;
    - (iii) the [distribution](#5) of a [product](#13) for emergency medical reasons including a public health emergency declaration pursuant to [section 247d of title 42](/usc/42/247d.md), except that a [drug](/usc/21/321.md?p=g-1) shortage not caused by a public health emergency shall not constitute an emergency medical reason;
    - (iv) the dispensing of a [product](#13) pursuant to a prescription executed in accordance with [section 353(b)(1) of this title](/usc/21/353.md?p=b-1);
    - (v) the [distribution](#5) of [product](#13) samples by a [manufacturer](/usc/21/360hh.md?p=3) or a [licensed](#9) [wholesale distributor](#29) in accordance with [section 353(d) of this title](/usc/21/353.md?p=d);
    - (vi) the [distribution](#5) of blood or blood components intended for transfusion;
    - (vii) the [distribution](#5) of minimal quantities of [product](#13) by a [licensed](#9) retail pharmacy to a [licensed](#9) practitioner for office use;
    - (viii) the sale, purchase, or trade of a [drug](/usc/21/321.md?p=g-1) or an offer to sell, purchase, or trade a [drug](/usc/21/321.md?p=g-1) by a charitable organization described in [section 501(c)(3) of title 26](/usc/26/501.md?p=c-3) to a nonprofit [affiliate](#1) of the organization to the extent otherwise permitted by law;
    - (ix) the [distribution](#5) of a [product](#13) pursuant to the sale or merger of a pharmacy or pharmacies or a [wholesale distributor](#29) or [wholesale distributors](#29), except that any records required to be maintained for the [product](#13) shall be transferred to the new owner of the pharmacy or pharmacies or [wholesale distributor](#29) or [wholesale distributors](#29);
    - (x) the dispensing of a [product](#13) approved under [section 360b(c) of this title](/usc/21/360b.md?p=c);
    - (xi) [products](#13) transferred to or from any facility that is [licensed](#9) by the Nuclear Regulatory Commission or by a [State](/usc/21/321.md?p=a-1) pursuant to an agreement with such Commission under [section 2021 of title 42](/usc/42/2021.md);
    - (xii) a combination [product](#13) that is not subject to approval under [section 355 of this title](/usc/21/355.md) or licensure under [section 262 of title 42](/usc/42/262.md), and that is—
      - (I) a [product](#13) comprised of a [device](/usc/21/321.md?p=h-1) and 1 or more other regulated components (such as a [drug](/usc/21/321.md?p=g-1)/[device](/usc/21/321.md?p=h-1), biologic/[device](/usc/21/321.md?p=h-1), or [drug](/usc/21/321.md?p=g-1)/[device](/usc/21/321.md?p=h-1)/biologic) that are physically, chemically, or otherwise combined or mixed and produced as a single entity;
      - (II) 2 or more separate [products](#13) packaged together in a single [package](#11-A) or as a unit and comprised of a [drug](/usc/21/321.md?p=g-1) and [device](/usc/21/321.md?p=h-1) or [device](/usc/21/321.md?p=h-1) and biological [product](#13); or
      - (III) 2 or more finished medical [devices](/usc/21/321.md?p=h-1) plus one or more [drug](/usc/21/321.md?p=g-1) or biological [products](#13) that are packaged together in what is referred to as a “medical convenience kit” as described in [clause (xiii)](#24-B-xiii);
    - (xiii) the [distribution](#5) of a collection of finished medical [devices](/usc/21/321.md?p=h-1), which may include a [product](#13) or biological [product](#13), 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](/usc/21/321.md?p=f) and [Drug](/usc/21/321.md?p=g-1) Administration as a [device](/usc/21/321.md?p=h-1) [manufacturer](/usc/21/360hh.md?p=3) in accordance with [section 360(b)(2) of this title](/usc/21/360.md?p=b-2);
      - (II) the medical convenience kit does not contain a controlled substance that appears in a schedule contained in the Comprehensive [Drug](/usc/21/321.md?p=g-1) Abuse Prevention and Control Act of 1970 [[21 U.S.C. 801](/usc/21/801.md) et seq.];
      - (III) in the case of a medical convenience kit that includes a [product](#13), the [person](/usc/21/321.md?p=e) that [manufacturers](/usc/21/360hh.md?p=3) the kit—
        - (aa) purchased such [product](#13) directly from the pharmaceutical [manufacturer](/usc/21/360hh.md?p=3) or from a [wholesale distributor](#29) that purchased the [product](#13) directly from the pharmaceutical [manufacturer](/usc/21/360hh.md?p=3); and
        - (bb) does not alter the primary container or [label](/usc/21/321.md?p=k) of the [product](#13) as purchased from the [manufacturer](/usc/21/360hh.md?p=3) or [wholesale distributor](#29); and
      - (IV) in the case of a medical convenience kit that includes a [product](#13), the [product](#13) is—
        - (aa) an intravenous solution intended for the replenishment of fluids and electrolytes;
        - (bb) a [product](#13) intended to maintain the equilibrium of water and minerals in the body;
        - (cc) a [product](#13) intended for irrigation or reconstitution;
        - (dd) an anesthetic;
        - (ee) an anticoagulant;
        - (ff) a vasopressor; or
        - (gg) a sympathomimetic;
    - (xiv) the [distribution](#5) of an intravenous [product](#13) 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](#5) of an intravenous [product](#13) used to maintain the equilibrium of water and minerals in the body, such as dialysis solutions;
    - (xvi) the [distribution](#5) of a [product](#13) that is intended for irrigation, or sterile water, whether intended for such purposes or for injection;
    - (xvii) the [distribution](#5) of a [medical gas](/usc/21/360ddd.md?p=2) (as defined in [section 360ddd of this title](/usc/21/360ddd.md)); or
    - (xviii) the [distribution](#5) or sale of any [licensed](#9) [product](#13) under [section 262 of title 42](/usc/42/262.md) that meets the definition of a [device](/usc/21/321.md?p=h-1) under [section 321(h) of this title](/usc/21/321.md?p=h).
- (25) **Transaction history—** The term “transaction history” means a statement in paper or electronic form, including the [transaction information](#26) for each prior [transaction](#24-A) going back to the [manufacturer](/usc/21/360hh.md?p=3) of the [product](#13).
- (26) **Transaction information—** The term “transaction information” means—
  - (A) the proprietary or established name or names of the [product](#13);
  - (B) the strength and dosage form of the [product](#13);
  - (C) the National Drug Code number of the [product](#13);
  - (D) the container size;
  - (E) the number of containers;
  - (F) the lot number of the [product](#13);
  - (G) the date of the [transaction](#24-A);
  - (H) the date of the shipment, if more than 24 hours after the date of the [transaction](#24-A);
  - (I) the business name and address of the [person](/usc/21/321.md?p=e) from whom ownership is being transferred; and
  - (J) the business name and address of the [person](/usc/21/321.md?p=e) to whom ownership is being transferred.
- (27) **Transaction statement—** The “[transaction](#24-A) statement” is a statement, in paper or electronic form, that the entity transferring ownership in a [transaction](#24-A)—
  - (A) is [authorized](#2) as required under the [Drug](/usc/21/321.md?p=g-1) Supply Chain Security Act;
  - (B) received the [product](#13) from a [person](/usc/21/321.md?p=e) that is [authorized](#2) as required under the [Drug](/usc/21/321.md?p=g-1) Supply Chain Security Act;
  - (C) received [transaction information](#26) and a [transaction](#24-A) statement from the prior owner of the [product](#13), as required under [section 360eee–1 of this title](/usc/21/360eee–1.md);
  - (D) did not [knowingly](/usc/21/321.md?p=bb) ship a suspect or [illegitimate product](#8);
  - (E) had systems and processes in place to comply with [verification](#28) requirements under [section 360eee–1 of this title](/usc/21/360eee–1.md);
  - (F) did not [knowingly](/usc/21/321.md?p=bb) provide false [transaction information](#26); and
  - (G) did not [knowingly](/usc/21/321.md?p=bb) alter the [transaction history](#25).
- (28) **Verification or verify—** The term “verification” or “verify” means determining whether the [product identifier](#14) affixed to, or imprinted upon, a [package](#11-A) or [homogeneous case](#7) corresponds to the [standardized numerical identifier](#20) or lot number and expiration date assigned to the [product](#13) by the [manufacturer](/usc/21/360hh.md?p=3) or the [repackager](#16), as applicable in accordance with [section 360eee–1 of this title](/usc/21/360eee–1.md).
- (29) **Wholesale distributor—** The term “wholesale distributor” means a [person](/usc/21/321.md?p=e) (other than a [manufacturer](/usc/21/360hh.md?p=3), a [manufacturer](/usc/21/360hh.md?p=3)’s co-[licensed](#9) partner, a [third-party logistics provider](#22), or [repackager](#16)) engaged in wholesale [distribution](#5) (as defined in [section 353(e)(4) of this title](/usc/21/353.md?p=e-4)).

## Source credit

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

## Notes

### Editorial Notes

### References in Text

The Comprehensive Drug Abuse Prevention and Control Act of 1970, referred to in par. (24)(B)(xiii)(II), is Pub. L. 91–513, Oct. 27, 1970, 84 Stat. 1236, which is classified 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.