---
kind: "section"
citation: "21 U.S.C. § 360eee–1"
title: "21"
title_heading: "Food and Drugs"
number: "360eee–1"
heading: "Requirements"
release: "119-102"
date: "2026-07-12"
url: "https://uscodex.org/usc/21/360eee-1"
units:
  - "Chapter 9 — Federal Food, Drug, and Cosmetic Act"
  - "Subchapter V — Drugs and Devices"
  - "Part H — Pharmaceutical Distribution Supply Chain"
---

# §360eee–1. Requirements

- (a) **In general—**
  - (1) **Other activities—** Each [manufacturer](/usc/21/360hh.md?p=3), [repackager](/usc/21/360eee.md?p=16), [wholesale distributor](/usc/21/360eee.md?p=29), and [dispenser](/usc/21/360eee.md?p=3) shall comply with the requirements set forth in this section with respect to the role of such [manufacturer](/usc/21/360hh.md?p=3), [repackager](/usc/21/360eee.md?p=16), [wholesale distributor](/usc/21/360eee.md?p=29), or [dispenser](/usc/21/360eee.md?p=3) in a [transaction](/usc/21/360eee.md?p=24-A) involving [product](/usc/21/360eee.md?p=13). If an entity meets the definition of more than one of the entities listed in the preceding sentence, such entity shall comply with all applicable requirements in this section, but shall not be required to duplicate requirements.
  - (2) **Initial standards—**
    - (A) **In general—** The [Secretary](/usc/21/321.md?p=d) shall, in consultation with other appropriate Federal officials, [manufacturers](/usc/21/360hh.md?p=3), [repackagers](/usc/21/360eee.md?p=16), [wholesale distributors](/usc/21/360eee.md?p=29), [dispensers](/usc/21/360eee.md?p=3), and other pharmaceutical [distribution](/usc/21/360eee.md?p=5) supply chain stakeholders, issue a draft guidance document that establishes standards for the interoperable exchange of [transaction information](/usc/21/360eee.md?p=26), [transaction history](/usc/21/360eee.md?p=25), and [transaction](/usc/21/360eee.md?p=24-A) statements, in paper or electronic format, for compliance with this subsection and subsections [(b)](#b), [(c)](#c), [(d)](#d), and [(e)](#e). In establishing such standards, the [Secretary](/usc/21/321.md?p=d) shall consider the feasibility of establishing standardized documentation to be used by members of the pharmaceutical [distribution](/usc/21/360eee.md?p=5) supply chain to convey the [transaction information](/usc/21/360eee.md?p=26), [transaction history](/usc/21/360eee.md?p=25), and [transaction](/usc/21/360eee.md?p=24-A) statement to the subsequent purchaser of a [product](/usc/21/360eee.md?p=13) and to facilitate the exchange of lot level data. The standards established under this paragraph shall take into consideration the standards established under [section 355e of this title](/usc/21/355e.md) and shall comply with a form and format developed by a widely recognized international standards development organization.
    - (B) **Public input—** Prior to issuing the draft guidance under [subparagraph (A)](#a-2-A), the [Secretary](/usc/21/321.md?p=d) shall gather comments and information from stakeholders and maintain such comments and information in a public docket for at least 60 days prior to issuing such guidance.
    - (C) **Publication—** The [Secretary](/usc/21/321.md?p=d) shall publish the standards established under [subparagraph (A)](#a-2-A) not later than 1 year after November 27, 2013.
  - (3) **Waivers, exceptions, and exemptions—**
    - (A) **In general—** Not later than 2 years after November 27, 2013, the [Secretary](/usc/21/321.md?p=d) shall, by guidance—
      - (i) establish a process by which an [authorized](/usc/21/360eee.md?p=2) [manufacturer](/usc/21/360hh.md?p=3), [repackager](/usc/21/360eee.md?p=16), [wholesale distributor](/usc/21/360eee.md?p=29), or [dispenser](/usc/21/360eee.md?p=3) may request a waiver from any of the requirements set forth in this section, which the [Secretary](/usc/21/321.md?p=d) may grant if the [Secretary](/usc/21/321.md?p=d) determines that such requirements would result in an undue economic hardship or for emergency medical reasons, including a public health emergency declaration pursuant to [section 247d of title 42](/usc/42/247d.md);
      - (ii) establish a process by which the [Secretary](/usc/21/321.md?p=d) determines exceptions, and a process through which a [manufacturer](/usc/21/360hh.md?p=3) or [repackager](/usc/21/360eee.md?p=16) may request such an exception, to the requirements relating to [product identifiers](/usc/21/360eee.md?p=14) if a [product](/usc/21/360eee.md?p=13) is packaged in a container too small or otherwise unable to accommodate a [label](/usc/21/321.md?p=k) with sufficient space to bear the information required for compliance with this section; and
      - (iii) establish a process by which the [Secretary](/usc/21/321.md?p=d) may determine other [products](/usc/21/360eee.md?p=13) or [transactions](/usc/21/360eee.md?p=24-A) that shall be exempt from the requirements of this section.
    - (B) **Content—** The guidance issued under [subparagraph (A)](#a-3-A) shall include a process for the biennial review and renewal of such waivers, exceptions, and exemptions, as applicable.
    - (C) **Process—** In issuing the guidance under this paragraph, the [Secretary](/usc/21/321.md?p=d) shall provide an effective date that is not later than 180 days prior to the date on which [manufacturers](/usc/21/360hh.md?p=3) are required to affix or imprint a [product identifier](/usc/21/360eee.md?p=14) to each [package](/usc/21/360eee.md?p=11-A) and homogenous case of [product](/usc/21/360eee.md?p=13) intended to be introduced in a [transaction](/usc/21/360eee.md?p=24-A) into [commerce](/usc/21/360hh.md?p=4) consistent with this section.
  - (4) **Self-executing requirements—** Except where otherwise specified, the requirements of this section may be enforced without further regulations or guidance from the [Secretary](/usc/21/321.md?p=d).
  - (5) **Grandfathering product—**
    - (A) **Product identifier—** Not later than 2 years after November 27, 2013, the [Secretary](/usc/21/321.md?p=d) shall finalize guidance specifying whether and under what circumstances [product](/usc/21/360eee.md?p=13) that is not labeled with a [product identifier](/usc/21/360eee.md?p=14) and that is in the pharmaceutical [distribution](/usc/21/360eee.md?p=5) supply chain at the time of the effective date of the requirements of this section shall be exempted from the requirements of this section.
    - (B) **Tracing—** For a [product](/usc/21/360eee.md?p=13) that entered the pharmaceutical [distribution](/usc/21/360eee.md?p=5) supply chain prior to January 1, 2015—
      - (i) [authorized](/usc/21/360eee.md?p=2) [trading partners](/usc/21/360eee.md?p=23) shall be exempt from providing [transaction information](/usc/21/360eee.md?p=26) as required under subsections [(b)(1)(A)(i)](#b-1-A-i), [(c)(1)(A)(ii)](#c-1-A-ii), [(d)(1)(A)(ii)](#d-1-A-ii), and [(e)(1)(A)(ii)](#e-1-A-ii);
      - (ii) [transaction history](/usc/21/360eee.md?p=25) required under this section shall begin with the owner of such [product](/usc/21/360eee.md?p=13) on such date; and
      - (iii) the owners of such [product](/usc/21/360eee.md?p=13) on such date shall be exempt from asserting receipt of [transaction information](/usc/21/360eee.md?p=26) and [transaction](/usc/21/360eee.md?p=24-A) statement from the prior owner as required under this section.
  - (6) **Wholesale distributor licenses—** Notwithstanding [section 360eee(9)(A) of this title](/usc/21/360eee.md?p=9-A), until the effective date of the [wholesale distributor](/usc/21/360eee.md?p=29) licensing regulations under [section 360eee–2 of this title](/usc/21/360eee–2.md), the term “[licensed](/usc/21/360eee.md?p=9)” or “[authorized](/usc/21/360eee.md?p=2)”, as it relates to a [wholesale distributor](/usc/21/360eee.md?p=29) with respect to [prescription drugs](/usc/21/360eee.md?p=12), shall mean a [wholesale distributor](/usc/21/360eee.md?p=29) with a valid license under [State](/usc/21/321.md?p=a-1) law.
  - (7) **Third-party logistics provider licenses—** Until the effective date of the [third-party logistics provider](/usc/21/360eee.md?p=22) licensing regulations under [section 360eee–3 of this title](/usc/21/360eee–3.md), a [third-party logistics provider](/usc/21/360eee.md?p=22) shall be considered “[licensed](/usc/21/360eee.md?p=9)” under [section 360eee(9)(B) of this title](/usc/21/360eee.md?p=9-B) unless the [Secretary](/usc/21/321.md?p=d) has made a finding that the [third-party logistics provider](/usc/21/360eee.md?p=22) does not utilize good handling and [distribution](/usc/21/360eee.md?p=5) practices and publishes notice thereof.
  - (8) **Label changes—** Changes made to [package](/usc/21/360eee.md?p=11-A) [labels](/usc/21/321.md?p=k) solely to incorporate the [product identifier](/usc/21/360eee.md?p=14) may be submitted to the [Secretary](/usc/21/321.md?p=d) in the annual report of an establishment, in accordance with section 314.70(d) of chapter[^1] 21, Code of Federal Regulations (or any successor regulation).
  - (9) **Product identifiers—** With respect to any requirement relating to [product identifiers](/usc/21/360eee.md?p=14) under this part—
    - (A) unless the [Secretary](/usc/21/321.md?p=d) allows, through guidance, the use of other technologies for data instead of or in addition to the technologies described in clauses [(i)](#a-9-A-i) and [(ii)](#a-9-A-ii), the applicable data—
      - (i) shall be included in a 2-dimensional data matrix barcode when affixed to, or imprinted upon, a [package](/usc/21/360eee.md?p=11-A); and
      - (ii) shall be included in a linear or 2-dimensional data matrix barcode when affixed to, or imprinted upon, a [homogeneous case](/usc/21/360eee.md?p=7); and
    - (B) [verification](/usc/21/360eee.md?p=28) of the [product identifier](/usc/21/360eee.md?p=14) may occur by using human-readable or machine-readable methods.
- (b) **Manufacturer requirements—**
  - (1) **Product tracing—**
    - (A) **In general—** Beginning not later than January 1, 2015, a [manufacturer](/usc/21/360hh.md?p=3) shall—
      - (i) prior to, or at the time of, each [transaction](/usc/21/360eee.md?p=24-A) in which such [manufacturer](/usc/21/360hh.md?p=3) transfers ownership of a [product](/usc/21/360eee.md?p=13), provide the subsequent owner with [transaction history](/usc/21/360eee.md?p=25), [transaction information](/usc/21/360eee.md?p=26), and a [transaction](/usc/21/360eee.md?p=24-A) statement, in a single document in an[^2] paper or electronic format; and
      - (ii) capture the [transaction information](/usc/21/360eee.md?p=26) (including lot level information), [transaction history](/usc/21/360eee.md?p=25), and [transaction](/usc/21/360eee.md?p=24-A) statement for each [transaction](/usc/21/360eee.md?p=24-A) and maintain such information, history, and statement for not less than 6 years after the date of the [transaction](/usc/21/360eee.md?p=24-A).
    - (B) **Requests for information—** Upon a request by the [Secretary](/usc/21/321.md?p=d) or other appropriate Federal or [State](/usc/21/321.md?p=a-1) official, in the event of a recall or for the purpose of investigating a [suspect product](/usc/21/360eee.md?p=21) or an [illegitimate product](/usc/21/360eee.md?p=8), a [manufacturer](/usc/21/360hh.md?p=3) shall, not later than 1 business day, and not to exceed 48 hours, after receiving the request, or in other such reasonable time as determined by the [Secretary](/usc/21/321.md?p=d), based on the circumstances of the request, provide the applicable [transaction information](/usc/21/360eee.md?p=26), [transaction history](/usc/21/360eee.md?p=25), and [transaction](/usc/21/360eee.md?p=24-A) statement for the [product](/usc/21/360eee.md?p=13).
    - (C) **Electronic format—**
      - (i) **In general—** Beginning not later than 4 years after November 27, 2013, except as provided under [clause (ii)](#b-1-C-ii), a [manufacturer](/usc/21/360hh.md?p=3) shall provide the [transaction information](/usc/21/360eee.md?p=26), [transaction history](/usc/21/360eee.md?p=25), and [transaction](/usc/21/360eee.md?p=24-A) statement required under [subparagraph (A)(i)](#b-1-A-i) in electronic format.
      - (ii) **Exception—** A [manufacturer](/usc/21/360hh.md?p=3) may continue to provide the [transaction information](/usc/21/360eee.md?p=26), [transaction history](/usc/21/360eee.md?p=25), and [transaction](/usc/21/360eee.md?p=24-A) statement required under [subparagraph (A)(i)](#b-1-A-i) in a paper format to a [licensed](/usc/21/360eee.md?p=9) health care practitioner [authorized](/usc/21/360eee.md?p=2) to prescribe medication under [State](/usc/21/321.md?p=a-1) law or other [licensed](/usc/21/360eee.md?p=9) individual under the supervision or direction of such a practitioner who dispenses [product](/usc/21/360eee.md?p=13) in the usual course of professional practice.
  - (2) **Product identifier—**
    - (A) **In general—** Beginning not later than 4 years after November 27, 2013, a [manufacturer](/usc/21/360hh.md?p=3) shall affix or imprint a [product identifier](/usc/21/360eee.md?p=14) to each [package](/usc/21/360eee.md?p=11-A) and homogenous case of a [product](/usc/21/360eee.md?p=13) intended to be introduced in a [transaction](/usc/21/360eee.md?p=24-A) into [commerce](/usc/21/360hh.md?p=4). Such [manufacturer](/usc/21/360hh.md?p=3) shall maintain the [product identifier](/usc/21/360eee.md?p=14) information for such [product](/usc/21/360eee.md?p=13) for not less than 6 years after the date of the [transaction](/usc/21/360eee.md?p=24-A).
    - (B) **Exception—** A [package](/usc/21/360eee.md?p=11-A) that is required to have a [standardized numerical identifier](/usc/21/360eee.md?p=20) is not required to have a unique [device](/usc/21/321.md?p=h-1) identifier.
  - (3) **Authorized trading partners—** Beginning not later than January 1, 2015, the [trading partners](/usc/21/360eee.md?p=23) of a [manufacturer](/usc/21/360hh.md?p=3) may be only [authorized](/usc/21/360eee.md?p=2) [trading partners](/usc/21/360eee.md?p=23).
  - (4) **Verification—** Beginning not later than January 1, 2015, a [manufacturer](/usc/21/360hh.md?p=3) shall have systems in place to enable the [manufacturer](/usc/21/360hh.md?p=3) to comply with the following requirements:
    - (A) **Suspect product—**
      - (i) **In general—** Upon making a determination that a [product](/usc/21/360eee.md?p=13) in the possession or control of the [manufacturer](/usc/21/360hh.md?p=3) is a [suspect product](/usc/21/360eee.md?p=21), or upon receiving a request for [verification](/usc/21/360eee.md?p=28) from the [Secretary](/usc/21/321.md?p=d) that has made a determination that a [product](/usc/21/360eee.md?p=13) within the possession or control of a [manufacturer](/usc/21/360hh.md?p=3) is a [suspect product](/usc/21/360eee.md?p=21), a [manufacturer](/usc/21/360hh.md?p=3) shall—
        - (I) [quarantine](/usc/21/360eee.md?p=15) such [product](/usc/21/360eee.md?p=13) within the possession or control of the [manufacturer](/usc/21/360hh.md?p=3) from [product](/usc/21/360eee.md?p=13) intended for [distribution](/usc/21/360eee.md?p=5) until such [product](/usc/21/360eee.md?p=13) is cleared or dispositioned; and
        - (II) promptly conduct an investigation in coordination with [trading partners](/usc/21/360eee.md?p=23), as applicable, to determine whether the [product](/usc/21/360eee.md?p=13) is an [illegitimate product](/usc/21/360eee.md?p=8), which shall include validating any applicable [transaction history](/usc/21/360eee.md?p=25) and [transaction information](/usc/21/360eee.md?p=26) in the possession of the [manufacturer](/usc/21/360hh.md?p=3) and otherwise investigating to determine whether the [product](/usc/21/360eee.md?p=13) is an [illegitimate product](/usc/21/360eee.md?p=8), and, beginning 4 years after November 27, 2013, verifying the [product](/usc/21/360eee.md?p=13) at the [package](/usc/21/360eee.md?p=11-A) level, including the [standardized numerical identifier](/usc/21/360eee.md?p=20).
      - (ii) **Cleared product—** If the [manufacturer](/usc/21/360hh.md?p=3) makes the determination that a [suspect product](/usc/21/360eee.md?p=21) is not an [illegitimate product](/usc/21/360eee.md?p=8), the [manufacturer](/usc/21/360hh.md?p=3) shall promptly notify the [Secretary](/usc/21/321.md?p=d), if applicable, of such determination and such [product](/usc/21/360eee.md?p=13) may be further distributed.
      - (iii) **Records—** A [manufacturer](/usc/21/360hh.md?p=3) shall keep records of the investigation of a [suspect product](/usc/21/360eee.md?p=21) for not less than 6 years after the conclusion of the investigation.
    - (B) **Illegitimate product—**
      - (i) **In general—** Upon determining that a [product](/usc/21/360eee.md?p=13) in the possession or control of a [manufacturer](/usc/21/360hh.md?p=3) is an [illegitimate product](/usc/21/360eee.md?p=8), the [manufacturer](/usc/21/360hh.md?p=3) shall, in a manner consistent with the systems and processes of such [manufacturer](/usc/21/360hh.md?p=3)—
        - (I) [quarantine](/usc/21/360eee.md?p=15) such [product](/usc/21/360eee.md?p=13) within the possession or control of the [manufacturer](/usc/21/360hh.md?p=3) from [product](/usc/21/360eee.md?p=13) intended for [distribution](/usc/21/360eee.md?p=5) until such [product](/usc/21/360eee.md?p=13) is dispositioned;
        - (II) [disposition](/usc/21/360eee.md?p=4) the [illegitimate product](/usc/21/360eee.md?p=8) within the possession or control of the [manufacturer](/usc/21/360hh.md?p=3);
        - (III) take reasonable and appropriate steps to assist a [trading partner](/usc/21/360eee.md?p=23) to [disposition](/usc/21/360eee.md?p=4) an [illegitimate product](/usc/21/360eee.md?p=8) not in the possession or control of the [manufacturer](/usc/21/360hh.md?p=3); and
        - (IV) retain a sample of the [product](/usc/21/360eee.md?p=13) for further physical examination or laboratory analysis of the [product](/usc/21/360eee.md?p=13) by the [manufacturer](/usc/21/360hh.md?p=3) or [Secretary](/usc/21/321.md?p=d) (or other appropriate Federal or [State](/usc/21/321.md?p=a-1) official) upon request by the [Secretary](/usc/21/321.md?p=d) (or other appropriate Federal or [State](/usc/21/321.md?p=a-1) official), as necessary and appropriate.
      - (ii) **Making a notification—**
        - (I) **Illegitimate product—** Upon determining that a [product](/usc/21/360eee.md?p=13) in the possession or control of the [manufacturer](/usc/21/360hh.md?p=3) is an [illegitimate product](/usc/21/360eee.md?p=8), the [manufacturer](/usc/21/360hh.md?p=3) shall notify the [Secretary](/usc/21/321.md?p=d) and all immediate [trading partners](/usc/21/360eee.md?p=23) that the [manufacturer](/usc/21/360hh.md?p=3) has reason to believe may have received such [illegitimate product](/usc/21/360eee.md?p=8) of such determination not later than 24 hours after making such determination.
        - (II) **High risk of illegitimacy—** A [manufacturer](/usc/21/360hh.md?p=3) shall notify the [Secretary](/usc/21/321.md?p=d) and immediate [trading partners](/usc/21/360eee.md?p=23) that the [manufacturer](/usc/21/360hh.md?p=3) has reason to believe may have in the [trading partner](/usc/21/360eee.md?p=23)’s possession a [product](/usc/21/360eee.md?p=13) manufactured by, or purported to be a [product](/usc/21/360eee.md?p=13) manufactured by, the [manufacturer](/usc/21/360hh.md?p=3) not later than 24 hours after determining or being notified by the [Secretary](/usc/21/321.md?p=d) or a [trading partner](/usc/21/360eee.md?p=23) that there is a high risk that such [product](/usc/21/360eee.md?p=13) is an [illegitimate product](/usc/21/360eee.md?p=8). For purposes of this subclause, a “high risk” may include a specific high risk that could increase the likelihood that [illegitimate product](/usc/21/360eee.md?p=8) will enter the pharmaceutical [distribution](/usc/21/360eee.md?p=5) supply chain and other high risks as determined by the [Secretary](/usc/21/321.md?p=d) in guidance pursuant to [subsection (h)](#h).
      - (iii) **Responding to a notification—** Upon the receipt of a notification from the [Secretary](/usc/21/321.md?p=d) or a [trading partner](/usc/21/360eee.md?p=23) that a determination has been made that a [product](/usc/21/360eee.md?p=13) is an [illegitimate product](/usc/21/360eee.md?p=8), a [manufacturer](/usc/21/360hh.md?p=3) shall identify all [illegitimate product](/usc/21/360eee.md?p=8) subject to such notification that is in the possession or control of the [manufacturer](/usc/21/360hh.md?p=3), including any [product](/usc/21/360eee.md?p=13) that is subsequently received, and shall perform the activities described in [subparagraph (A)](#b-4-A).
      - (iv) **Terminating a notification—** Upon making a determination, in consultation with the [Secretary](/usc/21/321.md?p=d), that a notification is no longer necessary, a [manufacturer](/usc/21/360hh.md?p=3) shall promptly notify immediate [trading partners](/usc/21/360eee.md?p=23) that the [manufacturer](/usc/21/360hh.md?p=3) notified pursuant to [clause (ii)](#b-4-B-ii) that such notification has been terminated.
      - (v) **Records—** A [manufacturer](/usc/21/360hh.md?p=3) shall keep records of the [disposition](/usc/21/360eee.md?p=4) of an [illegitimate product](/usc/21/360eee.md?p=8) for not less than 6 years after the conclusion of the [disposition](/usc/21/360eee.md?p=4).
    - (C) **Requests for verification—** Beginning 4 years after November 27, 2013, upon receiving a request for [verification](/usc/21/360eee.md?p=28) from an [authorized](/usc/21/360eee.md?p=2) [repackager](/usc/21/360eee.md?p=16), [wholesale distributor](/usc/21/360eee.md?p=29), or [dispenser](/usc/21/360eee.md?p=3) that is in possession or control of a [product](/usc/21/360eee.md?p=13) such [person](/usc/21/321.md?p=e) believes to be manufactured by such [manufacturer](/usc/21/360hh.md?p=3), a [manufacturer](/usc/21/360hh.md?p=3) shall, not later than 24 hours after receiving the request for [verification](/usc/21/360eee.md?p=28) or in other such reasonable time as determined by the [Secretary](/usc/21/321.md?p=d), based on the circumstances of the request, notify the [person](/usc/21/321.md?p=e) making the request whether the [product identifier](/usc/21/360eee.md?p=14), including the [standardized numerical identifier](/usc/21/360eee.md?p=20), that is the subject of the request corresponds to the [product identifier](/usc/21/360eee.md?p=14) affixed or imprinted by the [manufacturer](/usc/21/360hh.md?p=3). If a [manufacturer](/usc/21/360hh.md?p=3) responding to a request for [verification](/usc/21/360eee.md?p=28) identifies a [product identifier](/usc/21/360eee.md?p=14) that does not correspond to that affixed or imprinted by the [manufacturer](/usc/21/360hh.md?p=3), the [manufacturer](/usc/21/360hh.md?p=3) shall treat such [product](/usc/21/360eee.md?p=13) as [suspect product](/usc/21/360eee.md?p=21) and conduct an investigation as described in [subparagraph (A)](#b-4-A). If the [manufacturer](/usc/21/360hh.md?p=3) has reason to believe the [product](/usc/21/360eee.md?p=13) is an [illegitimate product](/usc/21/360eee.md?p=8), the [manufacturer](/usc/21/360hh.md?p=3) shall advise the [person](/usc/21/321.md?p=e) making the request of such belief at the time such [manufacturer](/usc/21/360hh.md?p=3) responds to the request for [verification](/usc/21/360eee.md?p=28).
    - (D) **Electronic database—** A [manufacturer](/usc/21/360hh.md?p=3) may satisfy the requirements of this paragraph by developing a secure electronic database or utilizing a secure electronic database developed or operated by another entity. The owner of such database shall establish the requirements and processes to respond to requests and may provide for data access to other members of the pharmaceutical [distribution](/usc/21/360eee.md?p=5) supply chain, as appropriate. The development and operation of such a database shall not relieve a [manufacturer](/usc/21/360hh.md?p=3) of the requirement under this paragraph to respond to a request for [verification](/usc/21/360eee.md?p=28) submitted by means other than a secure electronic database.
    - (E) **Saleable returned product—** Beginning 4 years after November 27, 2013 (except as provided pursuant to [subsection (a)(5)](#a-5)), upon receipt of a returned [product](/usc/21/360eee.md?p=13) that the [manufacturer](/usc/21/360hh.md?p=3) intends to further [distribute](/usc/21/360eee.md?p=5), before further distributing such [product](/usc/21/360eee.md?p=13), the [manufacturer](/usc/21/360hh.md?p=3) shall [verify](/usc/21/360eee.md?p=28) the [product identifier](/usc/21/360eee.md?p=14), including the [standardized numerical identifier](/usc/21/360eee.md?p=20), for each sealed [homogeneous case](/usc/21/360eee.md?p=7) of such [product](/usc/21/360eee.md?p=13) or, if such [product](/usc/21/360eee.md?p=13) is not in a sealed [homogeneous case](/usc/21/360eee.md?p=7), [verify](/usc/21/360eee.md?p=28) the [product identifier](/usc/21/360eee.md?p=14), including the [standardized numerical identifier](/usc/21/360eee.md?p=20), on each [package](/usc/21/360eee.md?p=11-A).
    - (F) **Nonsaleable returned product—** A [manufacturer](/usc/21/360hh.md?p=3) may [return](/usc/21/360eee.md?p=17) a nonsaleable [product](/usc/21/360eee.md?p=13) to the [manufacturer](/usc/21/360hh.md?p=3) or [repackager](/usc/21/360eee.md?p=16), to the [wholesale distributor](/usc/21/360eee.md?p=29) from whom such [product](/usc/21/360eee.md?p=13) was purchased, or to a [person](/usc/21/321.md?p=e) acting on behalf of such a [person](/usc/21/321.md?p=e), including a [returns processor](/usc/21/360eee.md?p=18), without providing the information described in [paragraph (1)(A)(i)](#b-1-A-i).
- (c) **Wholesale distributor requirements—**
  - (1) **Product tracing—**
    - (A) **In general—** Beginning not later than January 1, 2015, the following requirements shall apply to [wholesale distributors](/usc/21/360eee.md?p=29):
      - (i) A [wholesale distributor](/usc/21/360eee.md?p=29) shall not accept ownership of a [product](/usc/21/360eee.md?p=13) unless the previous owner prior to, or at the time of, the [transaction](/usc/21/360eee.md?p=24-A) provides the [transaction history](/usc/21/360eee.md?p=25), [transaction information](/usc/21/360eee.md?p=26), and a [transaction](/usc/21/360eee.md?p=24-A) statement for the [product](/usc/21/360eee.md?p=13), as applicable under this subparagraph.
      - (ii)
        - (I)
          - (aa) If the [wholesale distributor](/usc/21/360eee.md?p=29) purchased a [product](/usc/21/360eee.md?p=13) directly from the [manufacturer](/usc/21/360hh.md?p=3), the [exclusive distributor](/usc/21/360eee.md?p=6) of the [manufacturer](/usc/21/360hh.md?p=3), or a [repackager](/usc/21/360eee.md?p=16) that purchased directly from the [manufacturer](/usc/21/360hh.md?p=3), then prior to, or at the time of, each [transaction](/usc/21/360eee.md?p=24-A) in which the [wholesale distributor](/usc/21/360eee.md?p=29) transfers ownership of a [product](/usc/21/360eee.md?p=13), the [wholesale distributor](/usc/21/360eee.md?p=29) shall provide to the subsequent purchaser—
            - (AA) a [transaction](/usc/21/360eee.md?p=24-A) statement, which shall [state](/usc/21/321.md?p=a-1) that such [wholesale distributor](/usc/21/360eee.md?p=29), or a member of the [affiliate](/usc/21/360eee.md?p=1) of such [wholesale distributor](/usc/21/360eee.md?p=29), purchased the [product](/usc/21/360eee.md?p=13) directly from the [manufacturer](/usc/21/360hh.md?p=3), [exclusive distributor](/usc/21/360eee.md?p=6) of the [manufacturer](/usc/21/360hh.md?p=3), or [repackager](/usc/21/360eee.md?p=16) that purchased the [product](/usc/21/360eee.md?p=13) directly from the [manufacturer](/usc/21/360hh.md?p=3); and
            - (BB) subject to [subclause (II)](#c-1-A-ii-II), the [transaction history](/usc/21/360eee.md?p=25) and [transaction information](/usc/21/360eee.md?p=26).
          - (bb) The [wholesale distributor](/usc/21/360eee.md?p=29) shall provide the [transaction history](/usc/21/360eee.md?p=25), [transaction information](/usc/21/360eee.md?p=26), and [transaction](/usc/21/360eee.md?p=24-A) statement under [item (aa)](#c-1-A-ii-I-aa)—
            - (AA) if provided to a [dispenser](/usc/21/360eee.md?p=3), on a single document in a paper or electronic format; and
            - (BB) if provided to a [wholesale distributor](/usc/21/360eee.md?p=29), through any combination of self-generated paper, electronic data, or [manufacturer](/usc/21/360hh.md?p=3)-provided information on the [product](/usc/21/360eee.md?p=13) [package](/usc/21/360eee.md?p=11-A).
        - (II) For purposes of [transactions](/usc/21/360eee.md?p=24-A) described in [subclause (I)](#c-1-A-ii-I), [transaction history](/usc/21/360eee.md?p=25) and [transaction information](/usc/21/360eee.md?p=26) shall not be required to include the lot number of the [product](/usc/21/360eee.md?p=13), the initial [transaction](/usc/21/360eee.md?p=24-A) date, or the initial shipment date from the [manufacturer](/usc/21/360hh.md?p=3) (as defined in subparagraphs (F), (G), and (H) of [section 360eee(26) of this title](/usc/21/360eee.md?p=26)).
      - (iii) If the [wholesale distributor](/usc/21/360eee.md?p=29) did not purchase a [product](/usc/21/360eee.md?p=13) directly from the [manufacturer](/usc/21/360hh.md?p=3), the [exclusive distributor](/usc/21/360eee.md?p=6) of the [manufacturer](/usc/21/360hh.md?p=3), or a [repackager](/usc/21/360eee.md?p=16) that purchased directly from the [manufacturer](/usc/21/360hh.md?p=3), as described in [clause (ii)](#c-1-A-ii), then prior to, or at the time of, each [transaction](/usc/21/360eee.md?p=24-A) or subsequent [transaction](/usc/21/360eee.md?p=24-A), the [wholesale distributor](/usc/21/360eee.md?p=29) shall provide to the subsequent purchaser a [transaction](/usc/21/360eee.md?p=24-A) statement, [transaction history](/usc/21/360eee.md?p=25), and [transaction information](/usc/21/360eee.md?p=26), in a paper or electronic format that complies with the guidance document issued under [subsection (a)(2)](#a-2).
      - (iv) For the purposes of [clause (iii)](#c-1-A-iii), the [transaction history](/usc/21/360eee.md?p=25) supplied shall begin only with the [wholesale distributor](/usc/21/360eee.md?p=29) described in [clause (ii)(I)](#c-1-A-ii-I), but the [wholesale distributor](/usc/21/360eee.md?p=29) described in [clause (iii)](#c-1-A-iii) shall inform the subsequent purchaser that such [wholesale distributor](/usc/21/360eee.md?p=29) received a direct purchase statement from a [wholesale distributor](/usc/21/360eee.md?p=29) described in [clause (ii)(I)](#c-1-A-ii-I).
      - (v) A [wholesale distributor](/usc/21/360eee.md?p=29) shall—
        - (I) capture the [transaction information](/usc/21/360eee.md?p=26) (including lot level information) consistent with the requirements of this section, [transaction history](/usc/21/360eee.md?p=25), and [transaction](/usc/21/360eee.md?p=24-A) statement for each [transaction](/usc/21/360eee.md?p=24-A) described in clauses [(i)](#c-1-A-i), [(ii)](#c-1-A-ii), and [(iii)](#c-1-A-iii) and maintain such information, history, and statement for not less than 6 years after the date of the [transaction](/usc/21/360eee.md?p=24-A); and
        - (II) maintain the confidentiality of the [transaction information](/usc/21/360eee.md?p=26) (including any lot level information consistent with the requirements of this section), [transaction history](/usc/21/360eee.md?p=25), and [transaction](/usc/21/360eee.md?p=24-A) statement for a [product](/usc/21/360eee.md?p=13) in a manner that prohibits disclosure to any [person](/usc/21/321.md?p=e) other than the [Secretary](/usc/21/321.md?p=d) or other appropriate Federal or [State](/usc/21/321.md?p=a-1) official, except to comply with clauses [(ii)](#c-1-A-ii) and [(iii)](#c-1-A-iii), and, as applicable, pursuant to an agreement under [subparagraph (D)](#c-1-D).
    - (B) **Returns—**
      - (i) **Saleable returns—** Notwithstanding [subparagraph (A)(i)](#c-1-A-i), the following shall apply:
        - (I) **Requirements—** Until the date that is 6 years after November 27, 2013 (except as provided pursuant to [subsection (a)(5)](#a-5)), a [wholesale distributor](/usc/21/360eee.md?p=29) may accept returned [product](/usc/21/360eee.md?p=13) from a [dispenser](/usc/21/360eee.md?p=3) or [repackager](/usc/21/360eee.md?p=16) pursuant to the terms and conditions of any agreement between the parties, and, notwithstanding [subparagraph (A)(ii)](#c-1-A-ii), may [distribute](/usc/21/360eee.md?p=5) such returned [product](/usc/21/360eee.md?p=13) without providing the [transaction history](/usc/21/360eee.md?p=25). For [transactions](/usc/21/360eee.md?p=24-A) subsequent to the [return](/usc/21/360eee.md?p=17), the [transaction history](/usc/21/360eee.md?p=25) of such [product](/usc/21/360eee.md?p=13) shall begin with the [wholesale distributor](/usc/21/360eee.md?p=29) that accepted the returned [product](/usc/21/360eee.md?p=13), consistent with the requirements of this subsection.
        - (II) **Enhanced requirements—** Beginning 6 years after November 27, 2013 (except as provided pursuant to [subsection (a)(5)](#a-5)), a [wholesale distributor](/usc/21/360eee.md?p=29) may accept returned [product](/usc/21/360eee.md?p=13) from a [dispenser](/usc/21/360eee.md?p=3) or [repackager](/usc/21/360eee.md?p=16) only if the [wholesale distributor](/usc/21/360eee.md?p=29) can associate returned [product](/usc/21/360eee.md?p=13) with the [transaction information](/usc/21/360eee.md?p=26) and [transaction](/usc/21/360eee.md?p=24-A) statement associated with that [product](/usc/21/360eee.md?p=13). For all [transactions](/usc/21/360eee.md?p=24-A) after such date, the [transaction history](/usc/21/360eee.md?p=25), as applicable, of such [product](/usc/21/360eee.md?p=13) shall begin with the [wholesale distributor](/usc/21/360eee.md?p=29) that accepted and verified the returned [product](/usc/21/360eee.md?p=13). For purposes of this subparagraph, the [transaction information](/usc/21/360eee.md?p=26) and [transaction history](/usc/21/360eee.md?p=25), as applicable, need not include [transaction](/usc/21/360eee.md?p=24-A) dates if it is not reasonably practicable to obtain such dates.
      - (ii) **Nonsaleable returns—** A [wholesale distributor](/usc/21/360eee.md?p=29) may [return](/usc/21/360eee.md?p=17) a nonsaleable [product](/usc/21/360eee.md?p=13) to the [manufacturer](/usc/21/360hh.md?p=3) or [repackager](/usc/21/360eee.md?p=16), to the [wholesale distributor](/usc/21/360eee.md?p=29) from whom such [product](/usc/21/360eee.md?p=13) was purchased, or to a [person](/usc/21/321.md?p=e) acting on behalf of such a [person](/usc/21/321.md?p=e), including a [returns processor](/usc/21/360eee.md?p=18), without providing the information required under [subparagraph (A)(i)](#c-1-A-i).
    - (C) **Requests for information—** Upon a request by the [Secretary](/usc/21/321.md?p=d) or other appropriate Federal or [State](/usc/21/321.md?p=a-1) official, in the event of a recall or for the purpose of investigating a [suspect product](/usc/21/360eee.md?p=21) or an [illegitimate product](/usc/21/360eee.md?p=8), a [wholesale distributor](/usc/21/360eee.md?p=29) shall, not later than 1 business day, and not to exceed 48 hours, after receiving the request or in other such reasonable time as determined by the [Secretary](/usc/21/321.md?p=d), based on the circumstances of the request, provide the applicable [transaction information](/usc/21/360eee.md?p=26), [transaction history](/usc/21/360eee.md?p=25), and [transaction](/usc/21/360eee.md?p=24-A) statement for the [product](/usc/21/360eee.md?p=13).
    - (D) **Trading partner agreements—** Beginning 6 years after November 27, 2013, a [wholesale distributor](/usc/21/360eee.md?p=29) may disclose the [transaction information](/usc/21/360eee.md?p=26), including lot level information, [transaction history](/usc/21/360eee.md?p=25), or [transaction](/usc/21/360eee.md?p=24-A) statement of a [product](/usc/21/360eee.md?p=13) to the subsequent purchaser of the [product](/usc/21/360eee.md?p=13), pursuant to a written agreement between such [wholesale distributor](/usc/21/360eee.md?p=29) and such subsequent purchaser. Nothing in this subparagraph shall be construed to limit the applicability of subparagraphs [(A)](#c-1-A) through [(C)](#c-1-C).
  - (2) **Product identifier—** Beginning 6 years after November 27, 2013, a [wholesale distributor](/usc/21/360eee.md?p=29) may engage in [transactions](/usc/21/360eee.md?p=24-A) involving a [product](/usc/21/360eee.md?p=13) only if such [product](/usc/21/360eee.md?p=13) is encoded with a [product identifier](/usc/21/360eee.md?p=14) (except as provided pursuant to [subsection (a)(5)](#a-5)).
  - (3) **Authorized trading partners—** Beginning not later than January 1, 2015, the [trading partners](/usc/21/360eee.md?p=23) of a [wholesale distributor](/usc/21/360eee.md?p=29) may be only [authorized](/usc/21/360eee.md?p=2) [trading partners](/usc/21/360eee.md?p=23).
  - (4) **Verification—** Beginning not later than January 1, 2015, a [wholesale distributor](/usc/21/360eee.md?p=29) shall have systems in place to enable the [wholesale distributor](/usc/21/360eee.md?p=29) to comply with the following requirements:
    - (A) **Suspect product—**
      - (i) **In general—** Upon making a determination that a [product](/usc/21/360eee.md?p=13) in the possession or control of a [wholesale distributor](/usc/21/360eee.md?p=29) is a [suspect product](/usc/21/360eee.md?p=21), or upon receiving a request for [verification](/usc/21/360eee.md?p=28) from the [Secretary](/usc/21/321.md?p=d) that has made a determination that a [product](/usc/21/360eee.md?p=13) within the possession or control of a [wholesale distributor](/usc/21/360eee.md?p=29) is a [suspect product](/usc/21/360eee.md?p=21), a [wholesale distributor](/usc/21/360eee.md?p=29) shall—
        - (I) [quarantine](/usc/21/360eee.md?p=15) such [product](/usc/21/360eee.md?p=13) within the possession or control of the [wholesale distributor](/usc/21/360eee.md?p=29) from [product](/usc/21/360eee.md?p=13) intended for [distribution](/usc/21/360eee.md?p=5) until such [product](/usc/21/360eee.md?p=13) is cleared or dispositioned; and
        - (II) promptly conduct an investigation in coordination with [trading partners](/usc/21/360eee.md?p=23), as applicable, to determine whether the [product](/usc/21/360eee.md?p=13) is an [illegitimate product](/usc/21/360eee.md?p=8), which shall include validating any applicable [transaction history](/usc/21/360eee.md?p=25) and [transaction information](/usc/21/360eee.md?p=26) in the possession of the [wholesale distributor](/usc/21/360eee.md?p=29) and otherwise investigating to determine whether the [product](/usc/21/360eee.md?p=13) is an [illegitimate product](/usc/21/360eee.md?p=8), and, beginning 6 years after November 27, 2013 (except as provided pursuant to [subsection (a)(5)](#a-5)), verifying the [product](/usc/21/360eee.md?p=13) at the [package](/usc/21/360eee.md?p=11-A) level, including the [standardized numerical identifier](/usc/21/360eee.md?p=20).
      - (ii) **Cleared product—** If the [wholesale distributor](/usc/21/360eee.md?p=29) determines that a [suspect product](/usc/21/360eee.md?p=21) is not an [illegitimate product](/usc/21/360eee.md?p=8), the [wholesale distributor](/usc/21/360eee.md?p=29) shall promptly notify the [Secretary](/usc/21/321.md?p=d), if applicable, of such determination and such [product](/usc/21/360eee.md?p=13) may be further distributed.
      - (iii) **Records—** A [wholesale distributor](/usc/21/360eee.md?p=29) shall keep records of the investigation of a [suspect product](/usc/21/360eee.md?p=21) for not less than 6 years after the conclusion of the investigation.
    - (B) **Illegitimate product—**
      - (i) **In general—** Upon determining, in coordination with the [manufacturer](/usc/21/360hh.md?p=3), that a [product](/usc/21/360eee.md?p=13) in the possession or control of a [wholesale distributor](/usc/21/360eee.md?p=29) is an [illegitimate product](/usc/21/360eee.md?p=8), the [wholesale distributor](/usc/21/360eee.md?p=29) shall, in a manner that is consistent with the systems and processes of such [wholesale distributor](/usc/21/360eee.md?p=29)—
        - (I) [quarantine](/usc/21/360eee.md?p=15) such [product](/usc/21/360eee.md?p=13) within the possession or control of the [wholesale distributor](/usc/21/360eee.md?p=29) from [product](/usc/21/360eee.md?p=13) intended for [distribution](/usc/21/360eee.md?p=5) until such [product](/usc/21/360eee.md?p=13) is dispositioned;
        - (II) [disposition](/usc/21/360eee.md?p=4) the [illegitimate product](/usc/21/360eee.md?p=8) within the possession or control of the [wholesale distributor](/usc/21/360eee.md?p=29);
        - (III) take reasonable and appropriate steps to assist a [trading partner](/usc/21/360eee.md?p=23) to [disposition](/usc/21/360eee.md?p=4) an [illegitimate product](/usc/21/360eee.md?p=8) not in the possession or control of the [wholesale distributor](/usc/21/360eee.md?p=29); and
        - (IV) retain a sample of the [product](/usc/21/360eee.md?p=13) for further physical examination or laboratory analysis of the [product](/usc/21/360eee.md?p=13) by the [manufacturer](/usc/21/360hh.md?p=3) or [Secretary](/usc/21/321.md?p=d) (or other appropriate Federal or [State](/usc/21/321.md?p=a-1) official) upon request by the [manufacturer](/usc/21/360hh.md?p=3) or [Secretary](/usc/21/321.md?p=d) (or other appropriate Federal or [State](/usc/21/321.md?p=a-1) official), as necessary and appropriate.
      - (ii) **Making a notification—** Upon determining that a [product](/usc/21/360eee.md?p=13) in the possession or control of the [wholesale distributor](/usc/21/360eee.md?p=29) is an [illegitimate product](/usc/21/360eee.md?p=8), the [wholesale distributor](/usc/21/360eee.md?p=29) shall notify the [Secretary](/usc/21/321.md?p=d) and all immediate [trading partners](/usc/21/360eee.md?p=23) that the [wholesale distributor](/usc/21/360eee.md?p=29) has reason to believe may have received such [illegitimate product](/usc/21/360eee.md?p=8) of such determination not later than 24 hours after making such determination.
      - (iii) **Responding to a notification—** Upon the receipt of a notification from the [Secretary](/usc/21/321.md?p=d) or a [trading partner](/usc/21/360eee.md?p=23) that a determination has been made that a [product](/usc/21/360eee.md?p=13) is an [illegitimate product](/usc/21/360eee.md?p=8), a [wholesale distributor](/usc/21/360eee.md?p=29) shall identify all [illegitimate product](/usc/21/360eee.md?p=8) subject to such notification that is in the possession or control of the [wholesale distributor](/usc/21/360eee.md?p=29), including any [product](/usc/21/360eee.md?p=13) that is subsequently received, and shall perform the activities described in [subparagraph (A)](#c-4-A).
      - (iv) **Terminating a notification—** Upon making a determination, in consultation with the [Secretary](/usc/21/321.md?p=d), that a notification is no longer necessary, a [wholesale distributor](/usc/21/360eee.md?p=29) shall promptly notify immediate [trading partners](/usc/21/360eee.md?p=23) that the [wholesale distributor](/usc/21/360eee.md?p=29) notified pursuant to [clause (ii)](#c-4-B-ii) that such notification has been terminated.
      - (v) **Records—** A [wholesale distributor](/usc/21/360eee.md?p=29) shall keep records of the [disposition](/usc/21/360eee.md?p=4) of an [illegitimate product](/usc/21/360eee.md?p=8) for not less than 6 years after the conclusion of the [disposition](/usc/21/360eee.md?p=4).
    - (C) **Electronic database—** A [wholesale distributor](/usc/21/360eee.md?p=29) may satisfy the requirements of this paragraph by developing a secure electronic database or utilizing a secure electronic database developed or operated by another entity. The owner of such database shall establish the requirements and processes to respond to requests and may provide for data access to other members of the pharmaceutical [distribution](/usc/21/360eee.md?p=5) supply chain, as appropriate. The development and operation of such a database shall not relieve a [wholesale distributor](/usc/21/360eee.md?p=29) of the requirement under this paragraph to respond to a [verification](/usc/21/360eee.md?p=28) request submitted by means other than a secure electronic database.
    - (D) **Verification of saleable returned product—** Beginning 6 years after November 27, 2013, upon receipt of a returned [product](/usc/21/360eee.md?p=13) that the [wholesale distributor](/usc/21/360eee.md?p=29) intends to further [distribute](/usc/21/360eee.md?p=5), before further distributing such [product](/usc/21/360eee.md?p=13), the [wholesale distributor](/usc/21/360eee.md?p=29) shall [verify](/usc/21/360eee.md?p=28) the [product identifier](/usc/21/360eee.md?p=14), including the [standardized numerical identifier](/usc/21/360eee.md?p=20), for each sealed [homogeneous case](/usc/21/360eee.md?p=7) of such [product](/usc/21/360eee.md?p=13) or, if such [product](/usc/21/360eee.md?p=13) is not in a sealed [homogeneous case](/usc/21/360eee.md?p=7), [verify](/usc/21/360eee.md?p=28) the [product identifier](/usc/21/360eee.md?p=14), including the [standardized numerical identifier](/usc/21/360eee.md?p=20), on each [package](/usc/21/360eee.md?p=11-A).
- (d) **Dispenser requirements—**
  - (1) **Product tracing—**
    - (A) **In general—** Beginning July 1, 2015, a [dispenser](/usc/21/360eee.md?p=3)—
      - (i) shall not accept ownership of a [product](/usc/21/360eee.md?p=13), unless the previous owner prior to, or at the time of, the [transaction](/usc/21/360eee.md?p=24-A), provides [transaction history](/usc/21/360eee.md?p=25), [transaction information](/usc/21/360eee.md?p=26), and a [transaction](/usc/21/360eee.md?p=24-A) statement;
      - (ii) prior to, or at the time of, each [transaction](/usc/21/360eee.md?p=24-A) in which the [dispenser](/usc/21/360eee.md?p=3) transfers ownership of a [product](/usc/21/360eee.md?p=13) (but not including dispensing to a patient or [returns](/usc/21/360eee.md?p=17)) shall provide the subsequent owner with [transaction history](/usc/21/360eee.md?p=25), [transaction information](/usc/21/360eee.md?p=26), and a [transaction](/usc/21/360eee.md?p=24-A) statement for the [product](/usc/21/360eee.md?p=13), except that the requirements of this clause shall not apply to sales by a [dispenser](/usc/21/360eee.md?p=3) to another [dispenser](/usc/21/360eee.md?p=3) to fulfill a [specific patient need](/usc/21/360eee.md?p=19); and
      - (iii) shall capture [transaction information](/usc/21/360eee.md?p=26) (including lot level information, if provided), [transaction history](/usc/21/360eee.md?p=25), and [transaction](/usc/21/360eee.md?p=24-A) statements, as necessary to investigate a [suspect product](/usc/21/360eee.md?p=21), and maintain such information, history, and statements for not less than 6 years after the [transaction](/usc/21/360eee.md?p=24-A).
    - (B) **Agreements with third parties—** A [dispenser](/usc/21/360eee.md?p=3) may enter into a written agreement with a third party, including an [authorized](/usc/21/360eee.md?p=2) [wholesale distributor](/usc/21/360eee.md?p=29), under which the third party confidentially maintains the [transaction information](/usc/21/360eee.md?p=26), [transaction history](/usc/21/360eee.md?p=25), and [transaction](/usc/21/360eee.md?p=24-A) statements required to be maintained under this subsection on behalf of the [dispenser](/usc/21/360eee.md?p=3). If a [dispenser](/usc/21/360eee.md?p=3) enters into such an agreement, the [dispenser](/usc/21/360eee.md?p=3) shall maintain a copy of the written agreement and shall not be relieved of the obligations of the [dispenser](/usc/21/360eee.md?p=3) under this subsection.
    - (C) **Returns—**
      - (i) **Saleable returns—** A [dispenser](/usc/21/360eee.md?p=3) may [return](/usc/21/360eee.md?p=17) [product](/usc/21/360eee.md?p=13) to the [trading partner](/usc/21/360eee.md?p=23) from which the [dispenser](/usc/21/360eee.md?p=3) obtained the [product](/usc/21/360eee.md?p=13) without providing the information required under [subparagraph (A)](#d-1-A).
      - (ii) **Nonsaleable returns—** A [dispenser](/usc/21/360eee.md?p=3) may [return](/usc/21/360eee.md?p=17) a nonsaleable [product](/usc/21/360eee.md?p=13) to the [manufacturer](/usc/21/360hh.md?p=3) or [repackager](/usc/21/360eee.md?p=16), to the [wholesale distributor](/usc/21/360eee.md?p=29) from whom such [product](/usc/21/360eee.md?p=13) was purchased, to a [returns processor](/usc/21/360eee.md?p=18), or to a [person](/usc/21/321.md?p=e) acting on behalf of such a [person](/usc/21/321.md?p=e) without providing the information required under [subparagraph (A)](#d-1-A).
    - (D) **Requests for information—** Upon a request by the [Secretary](/usc/21/321.md?p=d) or other appropriate Federal or [State](/usc/21/321.md?p=a-1) official, in the event of a recall or for the purpose of investigating a suspect or an [illegitimate product](/usc/21/360eee.md?p=8), a [dispenser](/usc/21/360eee.md?p=3) shall, not later than 2 business days after receiving the request or in another such reasonable time as determined by the [Secretary](/usc/21/321.md?p=d), based on the circumstances of the request, provide the applicable [transaction information](/usc/21/360eee.md?p=26), [transaction](/usc/21/360eee.md?p=24-A) statement, and [transaction history](/usc/21/360eee.md?p=25) which the [dispenser](/usc/21/360eee.md?p=3) received from the previous owner, which shall not include the lot number of the [product](/usc/21/360eee.md?p=13), the initial [transaction](/usc/21/360eee.md?p=24-A) date, or the initial shipment date from the [manufacturer](/usc/21/360hh.md?p=3) unless such information was included in the [transaction information](/usc/21/360eee.md?p=26), [transaction](/usc/21/360eee.md?p=24-A) statement, and [transaction history](/usc/21/360eee.md?p=25) provided by the [manufacturer](/usc/21/360hh.md?p=3) or [wholesale distributor](/usc/21/360eee.md?p=29) to the [dispenser](/usc/21/360eee.md?p=3). The [dispenser](/usc/21/360eee.md?p=3) may respond to the request by providing the applicable information in either paper or electronic format. Until the date that is 4 years after November 27, 2013, the [Secretary](/usc/21/321.md?p=d) or other appropriate Federal or [State](/usc/21/321.md?p=a-1) official shall grant a [dispenser](/usc/21/360eee.md?p=3) additional time, as necessary, only with respect to a request to provide lot level information described in subparagraph (F) of [section 360eee(26) of this title](/usc/21/360eee.md?p=26) that was provided to the [dispenser](/usc/21/360eee.md?p=3) in paper format, limit the request time period to the 6 months preceding the request or other relevant date, and, in the event of a recall, the [Secretary](/usc/21/321.md?p=d), or other appropriate Federal or [State](/usc/21/321.md?p=a-1) official may request information only if such recall involves a serious adverse health consequence or death to humans.
  - (2) **Product identifier—** Beginning not later than 7 years after November 27, 2013, a [dispenser](/usc/21/360eee.md?p=3) may engage in [transactions](/usc/21/360eee.md?p=24-A) involving a [product](/usc/21/360eee.md?p=13) only if such [product](/usc/21/360eee.md?p=13) is encoded with a [product identifier](/usc/21/360eee.md?p=14) (except as provided pursuant to [subsection (a)(5)](#a-5)).
  - (3) **Authorized trading partners—** Beginning not later than January 1, 2015, the [trading partners](/usc/21/360eee.md?p=23) of a [dispenser](/usc/21/360eee.md?p=3) may be only [authorized](/usc/21/360eee.md?p=2) [trading partners](/usc/21/360eee.md?p=23).
  - (4) **Verification—** Beginning not later than January 1, 2015, a [dispenser](/usc/21/360eee.md?p=3) shall have systems in place to enable the [dispenser](/usc/21/360eee.md?p=3) to comply with the following requirements:
    - (A) **Suspect product—**
      - (i) **In general—** Upon making a determination that a [product](/usc/21/360eee.md?p=13) in the possession or control of the [dispenser](/usc/21/360eee.md?p=3) is a [suspect product](/usc/21/360eee.md?p=21), or upon receiving a request for [verification](/usc/21/360eee.md?p=28) from the [Secretary](/usc/21/321.md?p=d) that has made a determination that a [product](/usc/21/360eee.md?p=13) within the possession or control of a [dispenser](/usc/21/360eee.md?p=3) is a [suspect product](/usc/21/360eee.md?p=21), a [dispenser](/usc/21/360eee.md?p=3) shall—
        - (I) [quarantine](/usc/21/360eee.md?p=15) such [product](/usc/21/360eee.md?p=13) within the possession or control of the [dispenser](/usc/21/360eee.md?p=3) from [product](/usc/21/360eee.md?p=13) intended for [distribution](/usc/21/360eee.md?p=5) until such [product](/usc/21/360eee.md?p=13) is cleared or dispositioned; and
        - (II) promptly conduct an investigation in coordination with [trading partners](/usc/21/360eee.md?p=23), as applicable, to determine whether the [product](/usc/21/360eee.md?p=13) is an [illegitimate product](/usc/21/360eee.md?p=8).
      - (ii) **Investigation—** An investigation conducted under [clause (i)(II)](#d-4-A-i-II) shall include—
        - (I) beginning 7 years after November 27, 2013, verifying whether the lot number of a [suspect product](/usc/21/360eee.md?p=21) corresponds with the lot number for such [product](/usc/21/360eee.md?p=13);
        - (II) beginning 7 years after November 27, 2013, verifying that the [product identifier](/usc/21/360eee.md?p=14), including the [standardized numerical identifier](/usc/21/360eee.md?p=20), of at least 3 [packages](/usc/21/360eee.md?p=11-A) or 10 percent of such [suspect product](/usc/21/360eee.md?p=21), whichever is greater, or all [packages](/usc/21/360eee.md?p=11-A), if there are fewer than 3, corresponds with the [product identifier](/usc/21/360eee.md?p=14) for such [product](/usc/21/360eee.md?p=13);
        - (III) validating any applicable [transaction history](/usc/21/360eee.md?p=25) and [transaction information](/usc/21/360eee.md?p=26) in the possession of the [dispenser](/usc/21/360eee.md?p=3); and
        - (IV) otherwise investigating to determine whether the [product](/usc/21/360eee.md?p=13) is an [illegitimate product](/usc/21/360eee.md?p=8).
      - (iii) **Cleared product—** If the [dispenser](/usc/21/360eee.md?p=3) makes the determination that a [suspect product](/usc/21/360eee.md?p=21) is not an [illegitimate product](/usc/21/360eee.md?p=8), the [dispenser](/usc/21/360eee.md?p=3) shall promptly notify the [Secretary](/usc/21/321.md?p=d), if applicable, of such determination and such [product](/usc/21/360eee.md?p=13) may be further distributed or dispensed.
      - (iv) **Records—** A [dispenser](/usc/21/360eee.md?p=3) shall keep records of the investigation of a [suspect product](/usc/21/360eee.md?p=21) for not less than 6 years after the conclusion of the investigation.
    - (B) **Illegitimate product—**
      - (i) **In general—** Upon determining, in coordination with the [manufacturer](/usc/21/360hh.md?p=3), that a [product](/usc/21/360eee.md?p=13) in the possession or control of a [dispenser](/usc/21/360eee.md?p=3) is an [illegitimate product](/usc/21/360eee.md?p=8), the [dispenser](/usc/21/360eee.md?p=3) shall—
        - (I) [disposition](/usc/21/360eee.md?p=4) the [illegitimate product](/usc/21/360eee.md?p=8) within the possession or control of the [dispenser](/usc/21/360eee.md?p=3);
        - (II) take reasonable and appropriate steps to assist a [trading partner](/usc/21/360eee.md?p=23) to [disposition](/usc/21/360eee.md?p=4) an [illegitimate product](/usc/21/360eee.md?p=8) not in the possession or control of the [dispenser](/usc/21/360eee.md?p=3); and
        - (III) retain a sample of the [product](/usc/21/360eee.md?p=13) for further physical examination or laboratory analysis of the [product](/usc/21/360eee.md?p=13) by the [manufacturer](/usc/21/360hh.md?p=3) or [Secretary](/usc/21/321.md?p=d) (or other appropriate Federal or [State](/usc/21/321.md?p=a-1) official) upon request by the [manufacturer](/usc/21/360hh.md?p=3) or [Secretary](/usc/21/321.md?p=d) (or other appropriate Federal or [State](/usc/21/321.md?p=a-1) official), as necessary and appropriate.
      - (ii) **Making a notification—** Upon determining that a [product](/usc/21/360eee.md?p=13) in the possession or control of the [dispenser](/usc/21/360eee.md?p=3) is an [illegitimate product](/usc/21/360eee.md?p=8), the [dispenser](/usc/21/360eee.md?p=3) shall notify the [Secretary](/usc/21/321.md?p=d) and all immediate [trading partners](/usc/21/360eee.md?p=23) that the [dispenser](/usc/21/360eee.md?p=3) has reason to believe may have received such [illegitimate product](/usc/21/360eee.md?p=8) of such determination not later than 24 hours after making such determination.
      - (iii) **Responding to a notification—** Upon the receipt of a notification from the [Secretary](/usc/21/321.md?p=d) or a [trading partner](/usc/21/360eee.md?p=23) that a determination has been made that a [product](/usc/21/360eee.md?p=13) is an [illegitimate product](/usc/21/360eee.md?p=8), a [dispenser](/usc/21/360eee.md?p=3) shall identify all [illegitimate product](/usc/21/360eee.md?p=8) subject to such notification that is in the possession or control of the [dispenser](/usc/21/360eee.md?p=3), including any [product](/usc/21/360eee.md?p=13) that is subsequently received, and shall perform the activities described in [subparagraph (A)](#d-4-A).
      - (iv) **Terminating a notification—** Upon making a determination, in consultation with the [Secretary](/usc/21/321.md?p=d), that a notification is no longer necessary, a [dispenser](/usc/21/360eee.md?p=3) shall promptly notify immediate [trading partners](/usc/21/360eee.md?p=23) that the [dispenser](/usc/21/360eee.md?p=3) notified pursuant to [clause (ii)](#d-4-B-ii) that such notification has been terminated.
      - (v) **Records—** A [dispenser](/usc/21/360eee.md?p=3) shall keep records of the [disposition](/usc/21/360eee.md?p=4) of an [illegitimate product](/usc/21/360eee.md?p=8) for not less than 6 years after the conclusion of the [disposition](/usc/21/360eee.md?p=4).
    - (C) **Electronic database—** A [dispenser](/usc/21/360eee.md?p=3) may satisfy the requirements of this paragraph by developing a secure electronic database or utilizing a secure electronic database developed or operated by another entity.
  - (5) **Exception—** Notwithstanding any other provision of law, the requirements under paragraphs [(1)](#d-1) and [(4)](#d-4) shall not apply to [licensed](/usc/21/360eee.md?p=9) health care practitioners [authorized](/usc/21/360eee.md?p=2) to prescribe or administer medication under [State](/usc/21/321.md?p=a-1) law or other [licensed](/usc/21/360eee.md?p=9) individuals under the supervision or direction of such practitioners who dispense or administer [product](/usc/21/360eee.md?p=13) in the usual course of professional practice.
- (e) **Repackager requirements—**
  - (1) **Product tracing—**
    - (A) **In general—** Beginning not later than January 1, 2015, a [repackager](/usc/21/360eee.md?p=16) described in [section 360eee(16)(A) of this title](/usc/21/360eee.md?p=16-A) shall—
      - (i) not accept ownership of a [product](/usc/21/360eee.md?p=13) unless the previous owner, prior to, or at the time of, the [transaction](/usc/21/360eee.md?p=24-A), provides [transaction history](/usc/21/360eee.md?p=25), [transaction information](/usc/21/360eee.md?p=26), and a [transaction](/usc/21/360eee.md?p=24-A) statement for the [product](/usc/21/360eee.md?p=13);
      - (ii) prior to, or at the time of, each [transaction](/usc/21/360eee.md?p=24-A) in which the [repackager](/usc/21/360eee.md?p=16) transfers ownership of a [product](/usc/21/360eee.md?p=13), provide the subsequent owner with [transaction history](/usc/21/360eee.md?p=25), [transaction information](/usc/21/360eee.md?p=26), and a [transaction](/usc/21/360eee.md?p=24-A) statement for the [product](/usc/21/360eee.md?p=13); and
      - (iii) capture the [transaction information](/usc/21/360eee.md?p=26) (including lot level information), [transaction history](/usc/21/360eee.md?p=25), and [transaction](/usc/21/360eee.md?p=24-A) statement for each [transaction](/usc/21/360eee.md?p=24-A) described in clauses [(i)](#e-1-A-i) and [(ii)](#e-1-A-ii) and maintain such information, history, and statement for not less than 6 years after the [transaction](/usc/21/360eee.md?p=24-A).
    - (B) **Returns—**
      - (i) **Nonsaleable product—** A [repackager](/usc/21/360eee.md?p=16) described in [section 360eee(16)(A) of this title](/usc/21/360eee.md?p=16-A) may [return](/usc/21/360eee.md?p=17) a nonsaleable [product](/usc/21/360eee.md?p=13) to the [manufacturer](/usc/21/360hh.md?p=3) or [repackager](/usc/21/360eee.md?p=16), or to the [wholesale distributor](/usc/21/360eee.md?p=29) from whom such [product](/usc/21/360eee.md?p=13) was purchased, or to a [person](/usc/21/321.md?p=e) acting on behalf of such a [person](/usc/21/321.md?p=e), including a [returns processor](/usc/21/360eee.md?p=18), without providing the information required under [subparagraph (A)(ii)](#e-1-A-ii).
      - (ii) **Saleable or nonsaleable product—** A [repackager](/usc/21/360eee.md?p=16) described in [section 360eee(16)(B) of this title](/usc/21/360eee.md?p=16-B) may [return](/usc/21/360eee.md?p=17) a saleable or nonsaleable [product](/usc/21/360eee.md?p=13) to the [manufacturer](/usc/21/360hh.md?p=3), [repackager](/usc/21/360eee.md?p=16), or to the [wholesale distributor](/usc/21/360eee.md?p=29) from whom such [product](/usc/21/360eee.md?p=13) was received without providing the information required under [subparagraph (A)(ii)](#e-1-A-ii) on behalf of the hospital or other health care entity that took ownership of such [product](/usc/21/360eee.md?p=13) pursuant to the terms and conditions of any agreement between such [repackager](/usc/21/360eee.md?p=16) and the entity that owns the [product](/usc/21/360eee.md?p=13).
    - (C) **Requests for information—** Upon a request by the [Secretary](/usc/21/321.md?p=d) or other appropriate Federal or [State](/usc/21/321.md?p=a-1) official, in the event of a recall or for the purpose of investigating a [suspect product](/usc/21/360eee.md?p=21) or an [illegitimate product](/usc/21/360eee.md?p=8), a [repackager](/usc/21/360eee.md?p=16) described in [section 360eee(16)(A) of this title](/usc/21/360eee.md?p=16-A) shall, not later than 1 business day, and not to exceed 48 hours, after receiving the request or in other such reasonable time as determined by the [Secretary](/usc/21/321.md?p=d), provide the applicable [transaction information](/usc/21/360eee.md?p=26), [transaction history](/usc/21/360eee.md?p=25), and [transaction](/usc/21/360eee.md?p=24-A) statement for the [product](/usc/21/360eee.md?p=13).
  - (2) **Product identifier—**
    - (A) **In general—** Beginning not later than 5 years after November 27, 2013, a [repackager](/usc/21/360eee.md?p=16) described in [section 360eee(16)(A) of this title](/usc/21/360eee.md?p=16-A)—
      - (i) shall affix or imprint a [product identifier](/usc/21/360eee.md?p=14) to each [package](/usc/21/360eee.md?p=11-A) and homogenous case of [product](/usc/21/360eee.md?p=13) intended to be introduced in a [transaction](/usc/21/360eee.md?p=24-A) in [commerce](/usc/21/360hh.md?p=4);
      - (ii) shall maintain the [product identifier](/usc/21/360eee.md?p=14) information for such [product](/usc/21/360eee.md?p=13) for not less than 6 years after the date of the [transaction](/usc/21/360eee.md?p=24-A);
      - (iii) may engage in [transactions](/usc/21/360eee.md?p=24-A) involving a [product](/usc/21/360eee.md?p=13) only if such [product](/usc/21/360eee.md?p=13) is encoded with a [product identifier](/usc/21/360eee.md?p=14) (except as provided pursuant to [subsection (a)(5)](#a-5)); and
      - (iv) shall maintain records for not less than 6 years to allow the [repackager](/usc/21/360eee.md?p=16) to associate the [product identifier](/usc/21/360eee.md?p=14) the [repackager](/usc/21/360eee.md?p=16) affixes or imprints with the [product identifier](/usc/21/360eee.md?p=14) assigned by the original [manufacturer](/usc/21/360hh.md?p=3) of the [product](/usc/21/360eee.md?p=13).
    - (B) **Exception—** A [package](/usc/21/360eee.md?p=11-A) that is required to have a [standardized numerical identifier](/usc/21/360eee.md?p=20) is not required to have a unique [device](/usc/21/321.md?p=h-1) identifier.
  - (3) **Authorized trading partners—** Beginning January 1, 2015, the [trading partners](/usc/21/360eee.md?p=23) of a [repackager](/usc/21/360eee.md?p=16) described in [section 360eee(16) of this title](/usc/21/360eee.md?p=16) may be only [authorized](/usc/21/360eee.md?p=2) [trading partners](/usc/21/360eee.md?p=23).
  - (4) **Verification—** Beginning not later than January 1, 2015, a [repackager](/usc/21/360eee.md?p=16) described in [section 360eee(16)(A) of this title](/usc/21/360eee.md?p=16-A) shall have systems in place to enable the [repackager](/usc/21/360eee.md?p=16) to comply with the following requirements:
    - (A) **Suspect product—**
      - (i) **In general—** Upon making a determination that a [product](/usc/21/360eee.md?p=13) in the possession or control of the [repackager](/usc/21/360eee.md?p=16) is a [suspect product](/usc/21/360eee.md?p=21), or upon receiving a request for [verification](/usc/21/360eee.md?p=28) from the [Secretary](/usc/21/321.md?p=d) that has made a determination that a [product](/usc/21/360eee.md?p=13) within the possession or control of a [repackager](/usc/21/360eee.md?p=16) is a [suspect product](/usc/21/360eee.md?p=21), a [repackager](/usc/21/360eee.md?p=16) shall—
        - (I) [quarantine](/usc/21/360eee.md?p=15) such [product](/usc/21/360eee.md?p=13) within the possession or control of the [repackager](/usc/21/360eee.md?p=16) from [product](/usc/21/360eee.md?p=13) intended for [distribution](/usc/21/360eee.md?p=5) until such [product](/usc/21/360eee.md?p=13) is cleared or dispositioned; and
        - (II) promptly conduct an investigation in coordination with [trading partners](/usc/21/360eee.md?p=23), as applicable, to determine whether the [product](/usc/21/360eee.md?p=13) is an [illegitimate product](/usc/21/360eee.md?p=8), which shall include validating any applicable [transaction history](/usc/21/360eee.md?p=25) and [transaction information](/usc/21/360eee.md?p=26) in the possession of the [repackager](/usc/21/360eee.md?p=16) and otherwise investigating to determine whether the [product](/usc/21/360eee.md?p=13) is an [illegitimate product](/usc/21/360eee.md?p=8), and, beginning 5 years after November 27, 2013 (except as provided pursuant to [subsection (a)(5)](#a-5)), verifying the [product](/usc/21/360eee.md?p=13) at the [package](/usc/21/360eee.md?p=11-A) level, including the [standardized numerical identifier](/usc/21/360eee.md?p=20).
      - (ii) **Cleared product—** If the [repackager](/usc/21/360eee.md?p=16) makes the determination that a [suspect product](/usc/21/360eee.md?p=21) is not an [illegitimate product](/usc/21/360eee.md?p=8), the [repackager](/usc/21/360eee.md?p=16) shall promptly notify the [Secretary](/usc/21/321.md?p=d), if applicable, of such determination and such [product](/usc/21/360eee.md?p=13) may be further distributed.
      - (iii) **Records—** A [repackager](/usc/21/360eee.md?p=16) shall keep records of the investigation of a [suspect product](/usc/21/360eee.md?p=21) for not less than 6 years after the conclusion of the investigation.
    - (B) **Illegitimate product—**
      - (i) **In general—** Upon determining, in coordination with the [manufacturer](/usc/21/360hh.md?p=3), that a [product](/usc/21/360eee.md?p=13) in the possession or control of a [repackager](/usc/21/360eee.md?p=16) is an [illegitimate product](/usc/21/360eee.md?p=8), the [repackager](/usc/21/360eee.md?p=16) shall, in a manner that is consistent with the systems and processes of such [repackager](/usc/21/360eee.md?p=16)—
        - (I) [quarantine](/usc/21/360eee.md?p=15) such [product](/usc/21/360eee.md?p=13) within the possession or control of the [repackager](/usc/21/360eee.md?p=16) from [product](/usc/21/360eee.md?p=13) intended for [distribution](/usc/21/360eee.md?p=5) until such [product](/usc/21/360eee.md?p=13) is dispositioned;
        - (II) [disposition](/usc/21/360eee.md?p=4) the [illegitimate product](/usc/21/360eee.md?p=8) within the possession or control of the [repackager](/usc/21/360eee.md?p=16);
        - (III) take reasonable and appropriate steps to assist a [trading partner](/usc/21/360eee.md?p=23) to [disposition](/usc/21/360eee.md?p=4) an [illegitimate product](/usc/21/360eee.md?p=8) not in the possession or control of the [repackager](/usc/21/360eee.md?p=16); and
        - (IV) retain a sample of the [product](/usc/21/360eee.md?p=13) for further physical examination or laboratory analysis of the [product](/usc/21/360eee.md?p=13) by the [manufacturer](/usc/21/360hh.md?p=3) or [Secretary](/usc/21/321.md?p=d) (or other appropriate Federal or [State](/usc/21/321.md?p=a-1) official) upon request by the [manufacturer](/usc/21/360hh.md?p=3) or [Secretary](/usc/21/321.md?p=d) (or other appropriate Federal or [State](/usc/21/321.md?p=a-1) official), as necessary and appropriate.
      - (ii) **Making a notification—** Upon determining that a [product](/usc/21/360eee.md?p=13) in the possession or control of the [repackager](/usc/21/360eee.md?p=16) is an [illegitimate product](/usc/21/360eee.md?p=8), the [repackager](/usc/21/360eee.md?p=16) shall notify the [Secretary](/usc/21/321.md?p=d) and all immediate [trading partners](/usc/21/360eee.md?p=23) that the [repackager](/usc/21/360eee.md?p=16) has reason to believe may have received the [illegitimate product](/usc/21/360eee.md?p=8) of such determination not later than 24 hours after making such determination.
      - (iii) **Responding to a notification—** Upon the receipt of a notification from the [Secretary](/usc/21/321.md?p=d) or a [trading partner](/usc/21/360eee.md?p=23), a [repackager](/usc/21/360eee.md?p=16) shall identify all [illegitimate product](/usc/21/360eee.md?p=8) subject to such notification that is in the possession or control of the [repackager](/usc/21/360eee.md?p=16), including any [product](/usc/21/360eee.md?p=13) that is subsequently received, and shall perform the activities described in [subparagraph (A)](#e-4-A).
      - (iv) **Terminating a notification—** Upon making a determination, in consultation with the [Secretary](/usc/21/321.md?p=d), that a notification is no longer necessary, a [repackager](/usc/21/360eee.md?p=16) shall promptly notify immediate [trading partners](/usc/21/360eee.md?p=23) that the [repackager](/usc/21/360eee.md?p=16) notified pursuant to [clause (ii)](#e-4-B-ii) that such notification has been terminated.
      - (v) **Records—** A [repackager](/usc/21/360eee.md?p=16) shall keep records of the [disposition](/usc/21/360eee.md?p=4) of an [illegitimate product](/usc/21/360eee.md?p=8) for not less than 6 years after the conclusion of the [disposition](/usc/21/360eee.md?p=4).
    - (C) **Requests for verification—** Beginning 5 years after November 27, 2013, upon receiving a request for [verification](/usc/21/360eee.md?p=28) from an [authorized](/usc/21/360eee.md?p=2) [manufacturer](/usc/21/360hh.md?p=3), [wholesale distributor](/usc/21/360eee.md?p=29), or [dispenser](/usc/21/360eee.md?p=3) that is in possession or control of a [product](/usc/21/360eee.md?p=13) they believe to be repackaged by such [repackager](/usc/21/360eee.md?p=16), a [repackager](/usc/21/360eee.md?p=16) shall, not later than 24 hours after receiving the [verification](/usc/21/360eee.md?p=28) request or in other such reasonable time as determined by the [Secretary](/usc/21/321.md?p=d), based on the circumstances of the request, notify the [person](/usc/21/321.md?p=e) making the request whether the [product identifier](/usc/21/360eee.md?p=14), including the [standardized numerical identifier](/usc/21/360eee.md?p=20), that is the subject of the request corresponds to the [product identifier](/usc/21/360eee.md?p=14) affixed or imprinted by the [repackager](/usc/21/360eee.md?p=16). If a [repackager](/usc/21/360eee.md?p=16) responding to a [verification](/usc/21/360eee.md?p=28) request identifies a [product identifier](/usc/21/360eee.md?p=14) that does not correspond to that affixed or imprinted by the [repackager](/usc/21/360eee.md?p=16), the [repackager](/usc/21/360eee.md?p=16) shall treat such [product](/usc/21/360eee.md?p=13) as [suspect product](/usc/21/360eee.md?p=21) and conduct an investigation as described in [subparagraph (A)](#e-4-A). If the [repackager](/usc/21/360eee.md?p=16) has reason to believe the [product](/usc/21/360eee.md?p=13) is an [illegitimate product](/usc/21/360eee.md?p=8), the [repackager](/usc/21/360eee.md?p=16) shall advise the [person](/usc/21/321.md?p=e) making the request of such belief at the time such [repackager](/usc/21/360eee.md?p=16) responds to the [verification](/usc/21/360eee.md?p=28) request.
    - (D) **Electronic database—** A [repackager](/usc/21/360eee.md?p=16) may satisfy the requirements of [paragraph (4)](#e-4) by developing a secure electronic database or utilizing a secure electronic database developed or operated by another entity. The owner of such database shall establish the requirements and processes to respond to requests and may provide for data access to other members of the pharmaceutical [distribution](/usc/21/360eee.md?p=5) supply chain, as appropriate. The development and operation of such a database shall not relieve a [repackager](/usc/21/360eee.md?p=16) of the requirement under [subparagraph (C)](#e-4-C) to respond to a [verification](/usc/21/360eee.md?p=28) request submitted by means other than a secure electronic database.
    - (E) **Verification of saleable returned product—** Beginning 5 years after November 27, 2013, upon receipt of a returned [product](/usc/21/360eee.md?p=13) that the [repackager](/usc/21/360eee.md?p=16) intends to further [distribute](/usc/21/360eee.md?p=5), before further distributing such [product](/usc/21/360eee.md?p=13), the [repackager](/usc/21/360eee.md?p=16) shall [verify](/usc/21/360eee.md?p=28) the [product identifier](/usc/21/360eee.md?p=14) for each sealed [homogeneous case](/usc/21/360eee.md?p=7) of such [product](/usc/21/360eee.md?p=13) or, if such [product](/usc/21/360eee.md?p=13) is not in a sealed [homogeneous case](/usc/21/360eee.md?p=7), [verify](/usc/21/360eee.md?p=28) the [product identifier](/usc/21/360eee.md?p=14) on each [package](/usc/21/360eee.md?p=11-A).
- (f) **Drop shipments—**
  - (1) **In general—** A [wholesale distributor](/usc/21/360eee.md?p=29) that does not physically handle or store [product](/usc/21/360eee.md?p=13) shall be exempt from the provisions of this section, except the notification requirements under clauses [(ii)](#c-4-B-ii), [(iii)](#c-4-B-iii), and [(iv)](#c-4-B-iv) of subsection (c)(4)(B), provided that the [manufacturer](/usc/21/360hh.md?p=3), [repackager](/usc/21/360eee.md?p=16), or other [wholesale distributor](/usc/21/360eee.md?p=29) that [distributes](/usc/21/360eee.md?p=5) the [product](/usc/21/360eee.md?p=13) to the [dispenser](/usc/21/360eee.md?p=3) by means of a drop shipment for such [wholesale distributor](/usc/21/360eee.md?p=29) includes on the [transaction information](/usc/21/360eee.md?p=26) and [transaction history](/usc/21/360eee.md?p=25) to the [dispenser](/usc/21/360eee.md?p=3) the contact information of such [wholesale distributor](/usc/21/360eee.md?p=29) and provides the [transaction information](/usc/21/360eee.md?p=26), [transaction history](/usc/21/360eee.md?p=25), and [transaction](/usc/21/360eee.md?p=24-A) statement directly to the [dispenser](/usc/21/360eee.md?p=3).
  - (2) **Clarification—** For purposes of this subsection, providing administrative services, including processing of orders and payments, shall not by itself, be construed as being involved in the handling, [distribution](/usc/21/360eee.md?p=5), or storage of a [product](/usc/21/360eee.md?p=13).
- (g) **Enhanced drug distribution security—**
  - (1) **In general—** On the date that is 10 years after November 27, 2013, the following interoperable, electronic tracing of [product](/usc/21/360eee.md?p=13) at the [package](/usc/21/360eee.md?p=11-A) level requirements shall go into effect:
    - (A) The [transaction information](/usc/21/360eee.md?p=26) and the [transaction](/usc/21/360eee.md?p=24-A) statements as required under this section shall be exchanged in a secure, interoperable, electronic manner in accordance with the standards established under the guidance issued pursuant to paragraphs [(3)](#h-3) and [(4)](#h-4) of subsection (h), including any revision of such guidance issued in accordance with [paragraph (5)](#h-5) of such subsection.
    - (B) The [transaction information](/usc/21/360eee.md?p=26) required under this section shall include the [product identifier](/usc/21/360eee.md?p=14) at the [package](/usc/21/360eee.md?p=11-A) level for each [package](/usc/21/360eee.md?p=11-A) included in the [transaction](/usc/21/360eee.md?p=24-A).
    - (C) Systems and processes for [verification](/usc/21/360eee.md?p=28) of [product](/usc/21/360eee.md?p=13) at the [package](/usc/21/360eee.md?p=11-A) level, including the [standardized numerical identifier](/usc/21/360eee.md?p=20), shall be required in accordance with the standards established under the guidance issued pursuant to [subsection (a)(2)](#a-2) and the guidances issued pursuant to paragraphs [(2)](#h-2), [(3)](#h-3), and [(4)](#h-4) of subsection (h), including any revision of such guidances issued in accordance with [paragraph (5)](#h-5) of such subsection, which may include the use of aggregation and inference as necessary.
    - (D) The systems and processes necessary to promptly respond with the [transaction information](/usc/21/360eee.md?p=26) and [transaction](/usc/21/360eee.md?p=24-A) statement for a [product](/usc/21/360eee.md?p=13) upon a request by the [Secretary](/usc/21/321.md?p=d) (or other appropriate Federal or [State](/usc/21/321.md?p=a-1) official) in the event of a recall or for the purposes of investigating a [suspect product](/usc/21/360eee.md?p=21) or an [illegitimate product](/usc/21/360eee.md?p=8) shall be required.
    - (E) The systems and processes necessary to promptly facilitate gathering the information necessary to produce the [transaction information](/usc/21/360eee.md?p=26) for each [transaction](/usc/21/360eee.md?p=24-A) going back to the [manufacturer](/usc/21/360hh.md?p=3), as applicable, shall be required—
      - (i) in the event of a request by the [Secretary](/usc/21/321.md?p=d) (or other appropriate Federal or [State](/usc/21/321.md?p=a-1) official), on account of a recall or for the purposes of investigating a [suspect product](/usc/21/360eee.md?p=21) or an [illegitimate product](/usc/21/360eee.md?p=8); or
      - (ii) in the event of a request by an [authorized](/usc/21/360eee.md?p=2) [trading partner](/usc/21/360eee.md?p=23), in a secure manner that ensures the protection of confidential commercial information and trade secrets, for purposes of investigating a [suspect product](/usc/21/360eee.md?p=21) or assisting the [Secretary](/usc/21/321.md?p=d) (or other appropriate Federal or [State](/usc/21/321.md?p=a-1) official) with a request described in [clause (i)](#g-1-E-i).
    - (F) Each [person](/usc/21/321.md?p=e) accepting a saleable [return](/usc/21/360eee.md?p=17) shall have systems and processes in place to allow acceptance of such [product](/usc/21/360eee.md?p=13) and may accept saleable [returns](/usc/21/360eee.md?p=17) only if such [person](/usc/21/321.md?p=e) can associate the saleable [return](/usc/21/360eee.md?p=17) [product](/usc/21/360eee.md?p=13) with the [transaction information](/usc/21/360eee.md?p=26) and [transaction](/usc/21/360eee.md?p=24-A) statement associated with that [product](/usc/21/360eee.md?p=13).
  - (2) **Compliance—**
    - (A) **Information maintenance agreement—** A [dispenser](/usc/21/360eee.md?p=3) may enter into a written agreement with a third party, including an [authorized](/usc/21/360eee.md?p=2) [wholesale distributor](/usc/21/360eee.md?p=29), under which the third party shall confidentially maintain any information and statements required to be maintained under this section. If a [dispenser](/usc/21/360eee.md?p=3) enters into such an agreement, the [dispenser](/usc/21/360eee.md?p=3) shall maintain a copy of the written agreement and shall not be relieved of the obligations of the [dispenser](/usc/21/360eee.md?p=3) under this subsection.
    - (B) **Alternative methods—** The [Secretary](/usc/21/321.md?p=d), taking into consideration the assessment conducted under [paragraph (3)](#g-3), shall provide for alternative methods of compliance with any of the requirements set forth in [paragraph (1)](#g-1), including—
      - (i) establishing timelines for compliance by small businesses (including small business [dispensers](/usc/21/360eee.md?p=3) with 25 or fewer full-time employees) with such requirements, in order to ensure that such requirements do not impose undue economic hardship for small businesses, including small business [dispensers](/usc/21/360eee.md?p=3) for whom the criteria set forth in the assessment under [paragraph (3)](#g-3) is not met, if the [Secretary](/usc/21/321.md?p=d) determines that such requirements under [paragraph (1)](#g-1) would result in undue economic hardship; and
      - (ii) establishing a process by which a [dispenser](/usc/21/360eee.md?p=3) may request a waiver from any of the requirements set forth in [paragraph (1)](#g-1) if the [Secretary](/usc/21/321.md?p=d) determines that such requirements would result in an undue economic hardship, which shall include a process for the biennial review and renewal of any such waiver.
  - (3) **Assessment—**
    - (A) **In general—** Not later than the date that is 18 months after the [Secretary](/usc/21/321.md?p=d) issues the final guidance required under [subsection (h)](#h), the [Secretary](/usc/21/321.md?p=d) shall enter into a contract with a private, independent consulting firm with expertise to conduct a technology and software assessment that looks at the feasibility of [dispensers](/usc/21/360eee.md?p=3) with 25 or fewer full-time employees conducting interoperable, electronic tracing of [products](/usc/21/360eee.md?p=13) at the [package](/usc/21/360eee.md?p=11-A) level. Such assessment shall be completed not later than 8½ years after November 27, 2013.
    - (B) **Condition—** As a condition of the award of the contract under [subparagraph (A)](#g-3-A), the private, independent consulting firm shall agree to consult with [dispensers](/usc/21/360eee.md?p=3) with 25 or fewer full-time employees when conducting the assessment under such subparagraph.
    - (C) **Content—** The assessment under [subparagraph (A)](#g-3-A) shall assess whether—
      - (i) the necessary software and hardware is readily accessible to such [dispensers](/usc/21/360eee.md?p=3);
      - (ii) the necessary software and hardware is prohibitively expensive to obtain, install, and maintain for such [dispensers](/usc/21/360eee.md?p=3); and
      - (iii) the necessary hardware and software can be integrated into business practices, such as interoperability with [wholesale distributors](/usc/21/360eee.md?p=29), for such [dispensers](/usc/21/360eee.md?p=3).
    - (D) **Publication—** The [Secretary](/usc/21/321.md?p=d) shall—
      - (i) publish the statement of work for the assessment under [subparagraph (A)](#g-3-A) for public comment prior to beginning the assessment;
      - (ii) publish the final assessment for public comment not later than 30 calendar days after receiving such assessment; and
      - (iii) hold a public meeting not later than 180 calendar days after receiving the final assessment at which public stakeholders may present their views on the assessment.
  - (4) **Procedure—** Notwithstanding [section 553 of title 5](/usc/5/553.md), the [Secretary](/usc/21/321.md?p=d), in promulgating any regulation pursuant to this section, shall—
    - (A) provide appropriate flexibility by—
      - (i) not requiring the adoption of specific business systems for the maintenance and transmission of data;
      - (ii) prescribing alternative methods of compliance for any of the requirements set forth in [paragraph (1)](#g-1) or set forth in regulations implementing such requirements, including—
        - (I) timelines for small businesses to comply with the requirements set forth in the regulations in order to ensure that such requirements do not impose undue economic hardship for small businesses (including small business [dispensers](/usc/21/360eee.md?p=3) for whom the criteria set forth in the assessment under [paragraph (3)](#g-3) is not met), if the [Secretary](/usc/21/321.md?p=d) determines that such requirements would result in undue economic hardship; and
        - (II) the establishment of a process by which a [dispenser](/usc/21/360eee.md?p=3) may request a waiver from any of the requirements set forth in such regulations if the [Secretary](/usc/21/321.md?p=d) determines that such requirements would result in an undue economic hardship; and
      - (iii) taking into consideration—
        - (I) the results of pilot projects, including pilot projects pursuant to this section and private sector pilot projects, including those involving the use of aggregation and inference;
        - (II) the public meetings held and related guidance documents issued under this section;
        - (III) the public health benefits of any additional regulations in comparison to the cost of compliance with such requirements, including on entities of varying sizes and capabilities;
        - (IV) the diversity of the pharmaceutical [distribution](/usc/21/360eee.md?p=5) supply chain by providing appropriate flexibility for each sector, including both large and small businesses; and
        - (V) the assessment pursuant to [paragraph (3)](#g-3) with respect to small business [dispensers](/usc/21/360eee.md?p=3), including related public comment and the public meeting, and requirements under this section;
    - (B) issue a notice of proposed rulemaking that includes a copy of the proposed regulation;
    - (C) provide a period of not less than 60 days for comments on the proposed regulation; and
    - (D) publish in the Federal Register the final regulation not less than 2 years prior to the effective date of the regulation.
- (h) **Guidance documents—**
  - (1) **In general—** For the purposes of facilitating the successful and efficient adoption of secure, interoperable [product](/usc/21/360eee.md?p=13) tracing at the [package](/usc/21/360eee.md?p=11-A) level in order to enhance [drug](/usc/21/321.md?p=g-1) [distribution](/usc/21/360eee.md?p=5) security and further protect the public health, the [Secretary](/usc/21/321.md?p=d) shall issue the guidance documents as provided for in this subsection.
  - (2) **Suspect and illegitimate product—**
    - (A) **In general—** Not later than 180 days after November 27, 2013, the [Secretary](/usc/21/321.md?p=d) shall issue a guidance document to aid [trading partners](/usc/21/360eee.md?p=23) in the identification of a [suspect product](/usc/21/360eee.md?p=21) and notification termination. Such guidance document shall—
      - (i) identify specific scenarios that could significantly increase the risk of a [suspect product](/usc/21/360eee.md?p=21) entering the pharmaceutical [distribution](/usc/21/360eee.md?p=5) supply chain;
      - (ii) provide recommendation on how [trading partners](/usc/21/360eee.md?p=23) may identify such [product](/usc/21/360eee.md?p=13) and make a determination on whether the [product](/usc/21/360eee.md?p=13) is a [suspect product](/usc/21/360eee.md?p=21) as soon as practicable; and
      - (iii) set forth the process by which [manufacturers](/usc/21/360hh.md?p=3), [repackagers](/usc/21/360eee.md?p=16), [wholesale distributors](/usc/21/360eee.md?p=29), and [dispensers](/usc/21/360eee.md?p=3) shall terminate notifications in consultation with the [Secretary](/usc/21/321.md?p=d) regarding [illegitimate product](/usc/21/360eee.md?p=8) pursuant to subsections [(b)(4)(B)](#b-4-B), [(c)(4)(B)](#c-4-B), [(d)(4)(B)](#d-4-B), and [(e)(4)(B)](#e-4-B).
    - (B) **Revised guidance—** If the [Secretary](/usc/21/321.md?p=d) revises the guidance issued under [subparagraph (A)](#h-2-A), the [Secretary](/usc/21/321.md?p=d) shall follow the procedure set forth in [paragraph (5)](#h-5).
  - (3) **Unit level tracing—**
    - (A) **In general—** In order to enhance [drug](/usc/21/321.md?p=g-1) [distribution](/usc/21/360eee.md?p=5) security at the [package](/usc/21/360eee.md?p=11-A) level, not later than 18 months after conducting a public meeting on the system attributes necessary to enable secure tracing of [product](/usc/21/360eee.md?p=13) at the [package](/usc/21/360eee.md?p=11-A) level, including allowing for the use of [verification](/usc/21/360eee.md?p=28), inference, and aggregation, as necessary, the [Secretary](/usc/21/321.md?p=d) shall issue a final guidance document that outlines and makes recommendations with respect to the system attributes necessary to enable secure tracing at the [package](/usc/21/360eee.md?p=11-A) level as required under the requirements established under [subsection (g)](#g). Such guidance document shall—
      - (i) define the circumstances under which the sectors within the pharmaceutical [distribution](/usc/21/360eee.md?p=5) supply chain may, in the most efficient manner practicable, infer the contents of a case, pallet, tote, or other aggregate of individual [packages](/usc/21/360eee.md?p=11-A) or containers of [product](/usc/21/360eee.md?p=13), from a [product identifier](/usc/21/360eee.md?p=14) associated with the case, pallet, tote, or other aggregate, without opening each case, pallet, tote, or other aggregate or otherwise individually scanning each [package](/usc/21/360eee.md?p=11-A);
      - (ii) identify methods and processes to enhance secure tracing of [product](/usc/21/360eee.md?p=13) at the [package](/usc/21/360eee.md?p=11-A) level, such as secure processes to facilitate the use of inference, enhanced [verification](/usc/21/360eee.md?p=28) activities, the use of aggregation and inference, processes that utilize the [product identifiers](/usc/21/360eee.md?p=14) to enhance tracing of [product](/usc/21/360eee.md?p=13) at the [package](/usc/21/360eee.md?p=11-A) level, including the [standardized numerical identifier](/usc/21/360eee.md?p=20), or [package](/usc/21/360eee.md?p=11-A) security features; and
      - (iii) ensure the protection of confidential commercial information and trade secrets.
    - (B) **Procedure—** In issuing the guidance under [subparagraph (A)](#h-3-A), and in revising such guidance, if applicable, the [Secretary](/usc/21/321.md?p=d) shall follow the procedure set forth in [paragraph (5)](#h-5).
  - (4) **Standards for interoperable data exchange—**
    - (A) **In general—** In order to enhance secure tracing of a [product](/usc/21/360eee.md?p=13) at the [package](/usc/21/360eee.md?p=11-A) level, the [Secretary](/usc/21/321.md?p=d), not later than 18 months after conducting a public meeting on the interoperable standards necessary to enhance the security of the pharmaceutical [distribution](/usc/21/360eee.md?p=5) supply chain, shall update the guidance issued pursuant to [subsection (a)(2)](#a-2), as necessary and appropriate, and finalize such guidance document so that the guidance document—
      - (i) identifies and makes recommendations with respect to the standards necessary for adoption in order to support the secure, interoperable electronic data exchange among the pharmaceutical [distribution](/usc/21/360eee.md?p=5) supply chain that comply with a form and format developed by a widely recognized international standards development organization;
      - (ii) takes into consideration standards established pursuant to [subsection (a)(2)](#a-2) and [section 355e of this title](/usc/21/355e.md);
      - (iii) facilitates the creation of a uniform process or methodology for [product](/usc/21/360eee.md?p=13) tracing; and
      - (iv) ensures the protection of confidential commercial information and trade secrets.
    - (B) **Procedure—** In issuing the guidance under [subparagraph (A)](#h-4-A), and in revising such guidance, if applicable, the [Secretary](/usc/21/321.md?p=d) shall follow the procedure set forth in [paragraph (5)](#h-5).
  - (5) **Procedure—** In issuing or revising any guidance issued pursuant to this subsection or [subsection (g)](#g), except the initial guidance issued under [paragraph (2)(A)](#h-2-A), the [Secretary](/usc/21/321.md?p=d) shall—
    - (A) publish a notice in the Federal Register for a period not less than 30 days announcing that the draft or revised draft guidance is available;
    - (B) post the draft guidance document on the Internet Web site of the [Food](/usc/21/321.md?p=f) and [Drug](/usc/21/321.md?p=g-1) Administration and make such draft guidance document available in hard copy;
    - (C) provide an opportunity for comment and review and take into consideration any comments received;
    - (D) revise the draft guidance, as appropriate;
    - (E) publish a notice in the Federal Register for a period not less than 30 days announcing that the final guidance or final revised guidance is available;
    - (F) post the final guidance document on the Internet Web site of the [Food](/usc/21/321.md?p=f) and [Drug](/usc/21/321.md?p=g-1) Administration and make such final guidance document available in hard copy; and
    - (G) provide for an effective date of not earlier than 1 year after such guidance becomes final.
- (i) **Public meetings—**
  - (1) **In general—** The [Secretary](/usc/21/321.md?p=d) shall hold not less than 5 public meetings to enhance the safety and security of the pharmaceutical [distribution](/usc/21/360eee.md?p=5) supply chain and provide for comment. The [Secretary](/usc/21/321.md?p=d) may hold the first such public meeting not earlier than 1 year after November 27, 2013. In carrying out the public meetings described in this paragraph, the [Secretary](/usc/21/321.md?p=d) shall—
    - (A) prioritize topics necessary to inform the issuance of the guidance described in paragraphs [(3)](#h-3) and [(4)](#h-4) of subsection (h); and
    - (B) take all measures reasonable and practicable to ensure the protection of confidential commercial information and trade secrets.
  - (2) **Content—** Each of the following topics shall be addressed in at least one of the public meetings described in [paragraph (1)](#i-1):
    - (A) An assessment of the steps taken under subsections [(b)](#b) through [(e)](#e) to build capacity for a unit-level system, including the impact of the requirements of such subsections on—
      - (i) the ability of the health care system collectively to maintain patient access to medicines;
      - (ii) the scalability of such requirements, including as it relates to [product](/usc/21/360eee.md?p=13) lines; and
      - (iii) the capability of different sectors and subsectors, including both large and small businesses, to affix and utilize the [product identifier](/usc/21/360eee.md?p=14).
    - (B) The system attributes necessary to support the requirements set forth under [subsection (g)](#g), including the standards necessary for adoption in order to support the secure, interoperable electronic data exchange among sectors within the pharmaceutical [distribution](/usc/21/360eee.md?p=5) supply chain.
    - (C) Best practices in each of the different sectors within the pharmaceutical [distribution](/usc/21/360eee.md?p=5) supply chain to implement the requirements of this section.
    - (D) The costs and benefits of the implementation of this section, including the impact on each pharmaceutical [distribution](/usc/21/360eee.md?p=5) supply chain sector and on public health.
    - (E) Whether electronic tracing requirements, including tracing of [product](/usc/21/360eee.md?p=13) at the [package](/usc/21/360eee.md?p=11-A) level, are feasible, cost effective, and needed to protect the public health.
    - (F) The systems and processes needed to utilize the [product identifiers](/usc/21/360eee.md?p=14) to enhance tracing of [product](/usc/21/360eee.md?p=13) at the [package](/usc/21/360eee.md?p=11-A) level, including allowing for [verification](/usc/21/360eee.md?p=28), aggregation, and inference, as necessary.
    - (G) The technical capabilities and legal authorities, if any, needed to establish an interoperable, electronic system that provides for tracing of [product](/usc/21/360eee.md?p=13) at the [package](/usc/21/360eee.md?p=11-A) level.
    - (H) The impact that such additional requirements would have on patient safety, the [drug](/usc/21/321.md?p=g-1) supply, cost and regulatory burden, and timely patient access to [prescription drugs](/usc/21/360eee.md?p=12).
    - (I) Other topics, as determined appropriate by the [Secretary](/usc/21/321.md?p=d).
- (j) **Pilot projects—**
  - (1) **In general—** The [Secretary](/usc/21/321.md?p=d) shall establish 1 or more pilot projects, in coordination with [authorized](/usc/21/360eee.md?p=2) [manufacturers](/usc/21/360hh.md?p=3), [repackagers](/usc/21/360eee.md?p=16), [wholesale distributors](/usc/21/360eee.md?p=29), and [dispensers](/usc/21/360eee.md?p=3), to explore and evaluate methods to enhance the safety and security of the pharmaceutical [distribution](/usc/21/360eee.md?p=5) supply chain. Such projects shall build upon efforts, in existence as of November 27, 2013, to enhance the safety and security of the pharmaceutical [distribution](/usc/21/360eee.md?p=5) supply chain, take into consideration any pilot projects conducted prior to November 27, 2013, including any pilot projects that use aggregation and inference, and inform the draft and final guidance under paragraphs [(3)](#h-3) and [(4)](#h-4) of subsection (h).
  - (2) **Content—**
    - (A) **In general—** The [Secretary](/usc/21/321.md?p=d) shall ensure that the pilot projects under [paragraph (1)](#j-1) reflect the diversity of the pharmaceutical [distribution](/usc/21/360eee.md?p=5) supply chain and that the pilot projects, when taken as a whole, include participants representative of every sector, including both large and small businesses.
    - (B) **Project design—** The pilot projects under [paragraph (1)](#j-1) shall be designed to—
      - (i) utilize the [product identifier](/usc/21/360eee.md?p=14) for tracing of a [product](/usc/21/360eee.md?p=13), which may include [verification](/usc/21/360eee.md?p=28) of the [product identifier](/usc/21/360eee.md?p=14) of a [product](/usc/21/360eee.md?p=13), including the use of aggregation and inference;
      - (ii) improve the technical capabilities of each sector and subsector to comply with systems and processes needed to utilize the [product identifiers](/usc/21/360eee.md?p=14) to enhance tracing of a [product](/usc/21/360eee.md?p=13);
      - (iii) identify system attributes that are necessary to implement the requirements established under this section; and
      - (iv) complete other activities as determined by the [Secretary](/usc/21/321.md?p=d).
- (k) **Sunset—** The following requirements shall have no force or effect beginning on the date that is 10 years after November 27, 2013:
  - (1) The provision and receipt of [transaction history](/usc/21/360eee.md?p=25) under this section.
  - (2) The requirements set forth for [returns](/usc/21/360eee.md?p=17) under subsections [(b)(4)(E)](#b-4-E), [(c)(1)(B)(i)](#c-1-B-i), [(d)(1)(C)(i)](#d-1-C-i), and [(e)(4)(E)](#e-4-E).
  - (3) The requirements set forth under subparagraphs [(A)(v)(II)](#c-1-A-v-II) and [(D)](#c-1-D) of subsection (c)(1), as applied to lot level information only.
- (l) **Rule of construction—** The requirements set forth in subsections [(g)(4)](#g-4), [(i)](#i), and [(j)](#j) shall not be construed as a condition, prohibition, or precedent for precluding or delaying the provisions becoming effective pursuant to [subsection (g)](#g).
- (m) **Requests for information—** On the date that is 10 years after November 27, 2013, the timeline for responses to requests for information from the [Secretary](/usc/21/321.md?p=d), or other appropriate Federal or [State](/usc/21/321.md?p=a-1) official, as applicable, under subsections [(b)(1)(B)](#b-1-B), [(c)(1)(C)](#c-1-C), and [(e)(1)(C)](#e-1-C) shall be not later than 24 hours after receiving the request from the [Secretary](/usc/21/321.md?p=d) or other appropriate Federal or [State](/usc/21/321.md?p=a-1) official, as applicable, or in such other reasonable time as determined by the [Secretary](/usc/21/321.md?p=d) based on the circumstances of the request.

## Footnotes

[^1]: So in original. Probably should be “title”.
[^2]: So in original. Probably should be “a”.

## Source credit

(June 25, 1938, ch. 675, § 582, as added and amended Pub. L. 113–54, title II, §§ 202, 203, Nov. 27, 2013, 127 Stat. 605, 623.)

## Notes

### Editorial Notes

### Amendments

2013—Subsecs. (g) to (m). Pub. L. 113–54, § 203, added subsecs. (g) to (m).