---
kind: "section"
citation: "21 U.S.C. § 353"
title: "21"
title_heading: "Food and Drugs"
number: "353"
heading: "Exemptions and consideration for certain drugs, devices, and biological products"
release: "119-102"
date: "2026-07-12"
url: "https://uscodex.org/usc/21/353"
units:
  - "Chapter 9 — Federal Food, Drug, and Cosmetic Act"
  - "Subchapter V — Drugs and Devices"
  - "Part A — Drugs and Devices"
---

# §353. Exemptions and consideration for certain drugs, devices, and biological products

- (a) **Regulations for goods to be processed, labeled, or repacked elsewhere—** The [Secretary](/usc/21/321.md?p=d) is directed to promulgate regulations exempting from any [labeling](/usc/21/321.md?p=m) or packaging requirement of this chapter [drugs](/usc/21/321.md?p=g-1) and [devices](/usc/21/321.md?p=h-1) which are, in accordance with the practice of the trade, to be processed, labeled, or repacked in substantial quantities at establishments other than those where originally processed or packed, on condition that such [drugs](/usc/21/321.md?p=g-1) and [devices](/usc/21/321.md?p=h-1) are not adulterated or misbranded under the provisions of this chapter upon removal from such processing, [labeling](/usc/21/321.md?p=m), or repacking establishment.
- (b) **Prescription by physician; exemption from labeling and prescription requirements; misbranded drugs; compliance with narcotic and marihuana laws—**
  - (1) A [drug](/usc/21/321.md?p=g-1) intended for use by man which—
    - (A) because of its toxicity or other potentiality for harmful effect, or the method of its use, or the collateral measures necessary to its use, is not [safe](/usc/21/321.md?p=u) for use except under the supervision of a practitioner [licensed](/usc/21/360eee.md?p=9) by law to administer such [drug](/usc/21/321.md?p=g-1); or
    - (B) is limited by an approved application under [section 355 of this title](/usc/21/355.md) to use under the professional supervision of a practitioner [licensed](/usc/21/360eee.md?p=9) by law to administer such [drug](/usc/21/321.md?p=g-1);

    shall be dispensed only (i) upon a written prescription of a practitioner [licensed](/usc/21/360eee.md?p=9) by law to administer such [drug](/usc/21/321.md?p=g-1), or (ii) upon an oral prescription of such practitioner which is reduced promptly to writing and filed by the pharmacist, or (iii) by refilling any such written or oral prescription if such refilling is [authorized](/usc/21/360eee.md?p=2) by the prescriber either in the original prescription or by oral order which is reduced promptly to writing and filed by the pharmacist. The act of dispensing a [drug](/usc/21/321.md?p=g-1) contrary to the provisions of this paragraph shall be deemed to be an act which results in the [drug](/usc/21/321.md?p=g-1) being misbranded while held for sale.

  - (2) Any [drug](/usc/21/321.md?p=g-1) dispensed by filling or refilling a written or oral prescription of a practitioner [licensed](/usc/21/360eee.md?p=9) by law to administer such [drug](/usc/21/321.md?p=g-1) shall be exempt from the requirements of [section 352 of this title](/usc/21/352.md), except paragraphs (a), (i)(2) and [(3)](#b-3), (k), and (l), and the packaging requirements of paragraphs (g), (h), and (p), if the [drug](/usc/21/321.md?p=g-1) bears a [label](/usc/21/321.md?p=k) containing the name and address of the [dispenser](/usc/21/360eee.md?p=3), the serial number and date of the prescription or of its filling, the name of the prescriber, and, if stated in the prescription, the name of the patient, and the directions for use and cautionary statements, if any, contained in such prescription. This exemption shall not apply to any [drug](/usc/21/321.md?p=g-1) dispensed in the course of the conduct of a business of dispensing [drugs](/usc/21/321.md?p=g-1) pursuant to diagnosis by mail, or to a [drug](/usc/21/321.md?p=g-1) dispensed in violation of paragraph (1) of this subsection.
  - (3) The [Secretary](/usc/21/321.md?p=d) may by regulation remove [drugs](/usc/21/321.md?p=g-1) subject to [section 355 of this title](/usc/21/355.md) from the requirements of paragraph (1) of this subsection when such requirements are not necessary for the protection of the public health.
  - (4)
    - (A) A [drug](/usc/21/321.md?p=g-1) that is subject to [paragraph (1)](#b-1) shall be deemed to be misbranded if at any time prior to dispensing the [label](/usc/21/321.md?p=k) of the [drug](/usc/21/321.md?p=g-1) fails to bear, at a minimum, the symbol “Rx only”.
    - (B) A [drug](/usc/21/321.md?p=g-1) to which [paragraph (1)](#b-1) does not apply shall be deemed to be misbranded if at any time prior to dispensing the [label](/usc/21/321.md?p=k) of the [drug](/usc/21/321.md?p=g-1) bears the symbol described in [subparagraph (A)](#b-4-A).
  - (5) Nothing in this subsection shall be construed to relieve any [person](/usc/21/321.md?p=e) from any requirement prescribed by or under authority of law with respect to [drugs](/usc/21/321.md?p=g-1) now included or which may hereafter be included within the classifications stated in sections 4721, [6001](/usc/26/6001.md), and [6151](/usc/26/6151.md) of title 26, or to marihuana as defined in [section 4761 of title 26](https://uscode.house.gov/view.xhtml?req=(/us/usc/t26/s4761)).
- (c) **Sales restrictions—**
  - (1) No [person](/usc/21/321.md?p=e) may sell, purchase, or trade or offer to sell, purchase, or trade any [drug](/usc/21/321.md?p=g-1) sample. For purposes of this paragraph and [subsection (d)](#d), the term “[drug](/usc/21/321.md?p=g-1) sample” means a unit of a [drug](/usc/21/321.md?p=g-1), subject to [subsection (b)](#b), which is not intended to be sold and is intended to promote the sale of the [drug](/usc/21/321.md?p=g-1). Nothing in this paragraph shall subject an officer or executive of a [drug](/usc/21/321.md?p=g-1) [manufacturer](/usc/21/360hh.md?p=3) or distributor to criminal liability solely because of a sale, purchase, trade, or offer to sell, purchase, or trade in violation of this paragraph by other employees of the [manufacturer](/usc/21/360hh.md?p=3) or distributor.
  - (2) No [person](/usc/21/321.md?p=e) may sell, purchase, or trade, offer to sell, purchase, or trade, or counterfeit any coupon. For purposes of this paragraph, the term “coupon” means a form which may be redeemed, at no cost or at a reduced cost, for a [drug](/usc/21/321.md?p=g-1) which is prescribed in accordance with [subsection (b)](#b).
  - (3)
    - (A) No [person](/usc/21/321.md?p=e) may sell, purchase, or trade, or offer to sell, purchase, or trade, any [drug](/usc/21/321.md?p=g-1)—
      - (i) which is subject to [subsection (b)](#b), and
      - (ii)
        - (I) which was purchased by a public or private hospital or other health care entity, or
        - (II) which was donated or supplied at a reduced price to a charitable organization described in [section 501(c)(3) of title 26](/usc/26/501.md?p=c-3).
    - (B) [Subparagraph (A)](#c-3-A) does not apply to—
      - (i) the purchase or other acquisition by a hospital or other health care entity which is a member of a group purchasing organization of a [drug](/usc/21/321.md?p=g-1) for its own use from the group purchasing organization or from other hospitals or health care entities which are members of such organization,
      - (ii) the sale, purchase, or trade of a [drug](/usc/21/321.md?p=g-1) or an offer to sell, purchase, or trade a [drug](/usc/21/321.md?p=g-1) by an organization described in [subparagraph (A)(ii)(II)](#c-3-A-ii-II) to a nonprofit [affiliate](/usc/21/360eee.md?p=1) of the organization to the extent otherwise permitted by law,
      - (iii) a sale, purchase, or trade of a [drug](/usc/21/321.md?p=g-1) or an offer to sell, purchase, or trade a [drug](/usc/21/321.md?p=g-1) among hospitals or other health care entities which are under common control,
      - (iv) a sale, purchase, or trade of a [drug](/usc/21/321.md?p=g-1) or an offer to sell, purchase, or trade a [drug](/usc/21/321.md?p=g-1) for emergency medical reasons, or
      - (v) a sale, purchase, or trade of a [drug](/usc/21/321.md?p=g-1), an offer to sell, purchase, or trade a [drug](/usc/21/321.md?p=g-1), or the dispensing of a [drug](/usc/21/321.md?p=g-1) pursuant to a prescription executed in accordance with [subsection (b)](#b).

      For purposes of this paragraph, the term “entity” does not include a [wholesale distributor](/usc/21/360eee.md?p=29) of [drugs](/usc/21/321.md?p=g-1) or a retail pharmacy [licensed](/usc/21/360eee.md?p=9) under [State](/usc/21/321.md?p=a-1) law and the term “emergency medical reasons” includes transfers of a [drug](/usc/21/321.md?p=g-1) between health care entities or from a health care entity to a retail pharmacy undertaken to alleviate temporary shortages of the [drug](/usc/21/321.md?p=g-1) arising from delays in or interruptions of regular [distribution](/usc/21/360eee.md?p=5) schedules.

- (d) **Distribution of drug samples—**
  - (1) Except as provided in paragraphs [(2)](#d-2) and [(3)](#d-3), no [person](/usc/21/321.md?p=e) may [distribute](/usc/21/360eee.md?p=5) any [drug](/usc/21/321.md?p=g-1) sample. For purposes of this subsection, the term “[distribute](/usc/21/360eee.md?p=5)” does not include the providing of a [drug](/usc/21/321.md?p=g-1) sample to a patient by a—
    - (A) practitioner [licensed](/usc/21/360eee.md?p=9) to prescribe such [drug](/usc/21/321.md?p=g-1),
    - (B) health care professional acting at the direction and under the supervision of such a practitioner, or
    - (C) pharmacy of a hospital or of another health care entity that is acting at the direction of such a practitioner and that received such sample pursuant to paragraph [(2)](#d-2) or [(3)](#d-3).
  - (2)
    - (A) The [manufacturer](/usc/21/360hh.md?p=3) or [authorized](/usc/21/360eee.md?p=2) distributor of record of a [drug](/usc/21/321.md?p=g-1) subject to [subsection (b)](#b) may, in accordance with this paragraph, [distribute](/usc/21/360eee.md?p=5) [drug](/usc/21/321.md?p=g-1) samples by mail or common carrier to practitioners [licensed](/usc/21/360eee.md?p=9) to prescribe such [drugs](/usc/21/321.md?p=g-1) or, at the request of a [licensed](/usc/21/360eee.md?p=9) practitioner, to pharmacies of hospitals or other health care entities. Such a [distribution](/usc/21/360eee.md?p=5) of [drug](/usc/21/321.md?p=g-1) samples may only be made—
      - (i) in response to a written request for [drug](/usc/21/321.md?p=g-1) samples made on a form which meets the requirements of [subparagraph (B)](#d-2-B), and
      - (ii) under a system which requires the recipient of the [drug](/usc/21/321.md?p=g-1) sample to execute a written receipt for the [drug](/usc/21/321.md?p=g-1) sample upon its delivery and the [return](/usc/21/360eee.md?p=17) of the receipt to the [manufacturer](/usc/21/360hh.md?p=3) or [authorized](/usc/21/360eee.md?p=2) distributor of record.
    - (B) A written request for a [drug](/usc/21/321.md?p=g-1) sample required by [subparagraph (A)(i)](#d-2-A-i) shall contain—
      - (i) the name, address, professional designation, and signature of the practitioner making the request,
      - (ii) the identity of the [drug](/usc/21/321.md?p=g-1) sample requested and the quantity requested,
      - (iii) the name of the [manufacturer](/usc/21/360hh.md?p=3) of the [drug](/usc/21/321.md?p=g-1) sample requested, and
      - (iv) the date of the request.
    - (C) Each [drug](/usc/21/321.md?p=g-1) [manufacturer](/usc/21/360hh.md?p=3) or [authorized](/usc/21/360eee.md?p=2) distributor of record which makes [distributions](/usc/21/360eee.md?p=5) by mail or common carrier under this paragraph shall maintain, for a period of 3 years, the request forms submitted for such [distributions](/usc/21/360eee.md?p=5) and the receipts submitted for such [distributions](/usc/21/360eee.md?p=5) and shall maintain a record of [distributions](/usc/21/360eee.md?p=5) of [drug](/usc/21/321.md?p=g-1) samples which identifies the [drugs](/usc/21/321.md?p=g-1) distributed and the recipients of the [distributions](/usc/21/360eee.md?p=5). Forms, receipts, and records required to be maintained under this subparagraph shall be made available by the [drug](/usc/21/321.md?p=g-1) [manufacturer](/usc/21/360hh.md?p=3) or [authorized](/usc/21/360eee.md?p=2) distributor of record to Federal and [State](/usc/21/321.md?p=a-1) officials engaged in the regulation of [drugs](/usc/21/321.md?p=g-1) and in the enforcement of laws applicable to [drugs](/usc/21/321.md?p=g-1).
  - (3) The [manufacturer](/usc/21/360hh.md?p=3) or [authorized](/usc/21/360eee.md?p=2) distributor of record of a [drug](/usc/21/321.md?p=g-1) subject to [subsection (b)](#b) may, by means other than mail or common carrier, [distribute](/usc/21/360eee.md?p=5) [drug](/usc/21/321.md?p=g-1) samples only if the [manufacturer](/usc/21/360hh.md?p=3) or [authorized](/usc/21/360eee.md?p=2) distributor of record makes the [distributions](/usc/21/360eee.md?p=5) in accordance with [subparagraph (A)](#d-3-A) and carries out the activities described in subparagraphs [(B)](#d-3-B) through [(F)](#d-3-F) as follows:
    - (A) [Drug](/usc/21/321.md?p=g-1) samples may only be distributed—
      - (i) to practitioners [licensed](/usc/21/360eee.md?p=9) to prescribe such [drugs](/usc/21/321.md?p=g-1) if they make a written request for the [drug](/usc/21/321.md?p=g-1) samples, or
      - (ii) at the written request of such a [licensed](/usc/21/360eee.md?p=9) practitioner, to pharmacies of hospitals or other health care entities.

      A written request for [drug](/usc/21/321.md?p=g-1) samples shall be made on a form which contains the practitioner’s name, address, and professional designation, the identity of the [drug](/usc/21/321.md?p=g-1) sample requested, the quantity of [drug](/usc/21/321.md?p=g-1) samples requested, the name of the [manufacturer](/usc/21/360hh.md?p=3) or [authorized](/usc/21/360eee.md?p=2) distributor of record of the [drug](/usc/21/321.md?p=g-1) sample, the date of the request and signature of the practitioner making the request.

    - (B) [Drug](/usc/21/321.md?p=g-1) [manufacturers](/usc/21/360hh.md?p=3) or [authorized](/usc/21/360eee.md?p=2) distributors of record shall store [drug](/usc/21/321.md?p=g-1) samples under conditions that will maintain their stability, integrity, and effectiveness and will assure that the [drug](/usc/21/321.md?p=g-1) samples will be free of contamination, deterioration, and adulteration.
    - (C) [Drug](/usc/21/321.md?p=g-1) [manufacturers](/usc/21/360hh.md?p=3) or [authorized](/usc/21/360eee.md?p=2) distributors of record shall conduct, at least annually, a complete and accurate inventory of all [drug](/usc/21/321.md?p=g-1) samples in the possession of representatives of the [manufacturer](/usc/21/360hh.md?p=3) or [authorized](/usc/21/360eee.md?p=2) distributor of record. [Drug](/usc/21/321.md?p=g-1) [manufacturers](/usc/21/360hh.md?p=3) or [authorized](/usc/21/360eee.md?p=2) distributors of record shall maintain lists of the names and address of each of their representatives who [distribute](/usc/21/360eee.md?p=5) [drug](/usc/21/321.md?p=g-1) samples and of the sites where [drug](/usc/21/321.md?p=g-1) samples are stored. [Drug](/usc/21/321.md?p=g-1) [manufacturers](/usc/21/360hh.md?p=3) or [authorized](/usc/21/360eee.md?p=2) distributors of record shall maintain records for at least 3 years of all [drug](/usc/21/321.md?p=g-1) samples distributed, destroyed, or returned to the [manufacturer](/usc/21/360hh.md?p=3) or [authorized](/usc/21/360eee.md?p=2) distributor of record, of all inventories maintained under this subparagraph, of all thefts or significant losses of [drug](/usc/21/321.md?p=g-1) samples, and of all requests made under [subparagraph (A)](#d-3-A) for [drug](/usc/21/321.md?p=g-1) samples. Records and lists maintained under this subparagraph shall be made available by the [drug](/usc/21/321.md?p=g-1) [manufacturer](/usc/21/360hh.md?p=3) or [authorized](/usc/21/360eee.md?p=2) distributor of record to the [Secretary](/usc/21/321.md?p=d) upon request.
    - (D) [Drug](/usc/21/321.md?p=g-1) [manufacturers](/usc/21/360hh.md?p=3) or [authorized](/usc/21/360eee.md?p=2) distributors of record shall notify the [Secretary](/usc/21/321.md?p=d) of any significant loss of [drug](/usc/21/321.md?p=g-1) samples and any known theft of [drug](/usc/21/321.md?p=g-1) samples.
    - (E) [Drug](/usc/21/321.md?p=g-1) [manufacturers](/usc/21/360hh.md?p=3) or [authorized](/usc/21/360eee.md?p=2) distributors of record shall report to the [Secretary](/usc/21/321.md?p=d) any conviction of their representatives for violations of [subsection (c)(1)](#c-1) or a [State](/usc/21/321.md?p=a-1) law because of the sale, purchase, or trade of a [drug](/usc/21/321.md?p=g-1) sample or the offer to sell, purchase, or trade a [drug](/usc/21/321.md?p=g-1) sample.
    - (F) [Drug](/usc/21/321.md?p=g-1) [manufacturers](/usc/21/360hh.md?p=3) or [authorized](/usc/21/360eee.md?p=2) distributors of record shall provide to the [Secretary](/usc/21/321.md?p=d) the name and telephone number of the individual responsible for responding to a request for information respecting [drug](/usc/21/321.md?p=g-1) samples.
  - (4) In this subsection, the term “[authorized](/usc/21/360eee.md?p=2) distributors of record” means those distributors with whom a [manufacturer](/usc/21/360hh.md?p=3) has established an ongoing relationship to [distribute](/usc/21/360eee.md?p=5) such [manufacturer](/usc/21/360hh.md?p=3)’s [products](/usc/21/360eee.md?p=13).
- (e) **Licensing and reporting requirements for wholesale distributors; fees; definitions—**
  - (1) **Requirement.—** Subject to [section 360eee–2 of this title](/usc/21/360eee–2.md):
    - (A) **In general.—** No [person](/usc/21/321.md?p=e) may engage in wholesale [distribution](/usc/21/360eee.md?p=5) of a [drug](/usc/21/321.md?p=g-1) subject to [subsection (b)(1)](#b-1) in any [State](/usc/21/321.md?p=a-1) unless such [person](/usc/21/321.md?p=e)—
      - (i)
        - (I) is [licensed](/usc/21/360eee.md?p=9) by the [State](/usc/21/321.md?p=a-1) from which the [drug](/usc/21/321.md?p=g-1) is distributed; or
        - (II) if the [State](/usc/21/321.md?p=a-1) from which the [drug](/usc/21/321.md?p=g-1) is distributed has not established a licensure requirement, is [licensed](/usc/21/360eee.md?p=9) by the [Secretary](/usc/21/321.md?p=d); and
      - (ii) if the [drug](/usc/21/321.md?p=g-1) is distributed interstate, is [licensed](/usc/21/360eee.md?p=9) by the [State](/usc/21/321.md?p=a-1) into which the [drug](/usc/21/321.md?p=g-1) is distributed if the [State](/usc/21/321.md?p=a-1) into which the [drug](/usc/21/321.md?p=g-1) is distributed requires the licensure of a [person](/usc/21/321.md?p=e) that [distributes](/usc/21/360eee.md?p=5) [drugs](/usc/21/321.md?p=g-1) into the [State](/usc/21/321.md?p=a-1).
    - (B) **Standards.—** Each Federal and [State](/usc/21/321.md?p=a-1) license described in [subparagraph (A)](#e-1-A) shall meet the standards, terms, and conditions established by the [Secretary](/usc/21/321.md?p=d) under [section 360eee–2 of this title](/usc/21/360eee–2.md).
  - (2) **Reporting and database.—**
    - (A) **Reporting.—** Beginning January 1, 2015, any [person](/usc/21/321.md?p=e) who owns or operates an establishment that engages in wholesale [distribution](/usc/21/360eee.md?p=5) shall—
      - (i) report to the [Secretary](/usc/21/321.md?p=d), on an annual basis pursuant to a schedule determined by the [Secretary](/usc/21/321.md?p=d)—
        - (I) each [State](/usc/21/321.md?p=a-1) by which the [person](/usc/21/321.md?p=e) is [licensed](/usc/21/360eee.md?p=9) and the appropriate identification number of each such license; and
        - (II) the name, address, and contact information of each facility at which, and all trade names under which, the [person](/usc/21/321.md?p=e) conducts business; and
      - (ii) report to the [Secretary](/usc/21/321.md?p=d) within a reasonable period of time and in a reasonable manner, as determined by the [Secretary](/usc/21/321.md?p=d), any significant disciplinary actions, such as the revocation or suspension of a [wholesale distributor](/usc/21/360eee.md?p=29) license, taken by a [State](/usc/21/321.md?p=a-1) or the Federal Government during the reporting period against the [wholesale distributor](/usc/21/360eee.md?p=29).
    - (B) **Database.—** Not later than January 1, 2015, the [Secretary](/usc/21/321.md?p=d) shall establish a database of [authorized](/usc/21/360eee.md?p=2) [wholesale distributors](/usc/21/360eee.md?p=29). Such database shall—
      - (i) identify each [authorized](/usc/21/360eee.md?p=2) [wholesale distributor](/usc/21/360eee.md?p=29) by name, contact information, and each [State](/usc/21/321.md?p=a-1) where such [wholesale distributor](/usc/21/360eee.md?p=29) is appropriately [licensed](/usc/21/360eee.md?p=9) to engage in wholesale [distribution](/usc/21/360eee.md?p=5);
      - (ii) be available to the public 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
      - (iii) be regularly updated on a schedule determined by the [Secretary](/usc/21/321.md?p=d).
    - (C) **Coordination.—** The [Secretary](/usc/21/321.md?p=d) shall establish a format and procedure for appropriate [State](/usc/21/321.md?p=a-1) officials to access the information provided pursuant to [subparagraph (A)](#e-2-A) in a prompt and secure manner.
    - (D) **Confidentiality.—** Nothing in this paragraph shall be construed as authorizing the [Secretary](/usc/21/321.md?p=d) to disclose any information that is a trade secret or confidential information subject to [section 552(b)(4) of title 5](/usc/5/552.md?p=b-4) or [section 1905 of title 18](/usc/18/1905.md).
  - (3) **Costs.—**
    - (A) **Authorized fees of secretary.—** If a [State](/usc/21/321.md?p=a-1) does not establish a licensing program for [persons](/usc/21/321.md?p=e) engaged in the wholesale [distribution](/usc/21/360eee.md?p=5) of a [drug](/usc/21/321.md?p=g-1) subject to [subsection (b)](#b), the [Secretary](/usc/21/321.md?p=d) shall license a [person](/usc/21/321.md?p=e) engaged in wholesale [distribution](/usc/21/360eee.md?p=5) located in such [State](/usc/21/321.md?p=a-1) and may collect a reasonable fee in such amount necessary to reimburse the [Secretary](/usc/21/321.md?p=d) for costs associated with establishing and administering the licensure program and conducting periodic inspections under this section. The [Secretary](/usc/21/321.md?p=d) shall adjust fee rates as needed on an annual basis to generate only the amount of revenue needed to perform this service. Fees [authorized](/usc/21/360eee.md?p=2) under this paragraph shall be collected and available for obligation only to the extent and in the amount provided in advance in appropriations Acts. Such fees are [authorized](/usc/21/360eee.md?p=2) to remain available until expended. Such sums as may be necessary may be transferred from the [Food](/usc/21/321.md?p=f) and [Drug](/usc/21/321.md?p=g-1) Administration salaries and expenses appropriation account without fiscal year limitation to such appropriation account for salaries and expenses with such fiscal year limitation.
    - (B) **State licensing fees.—** Nothing in this chapter shall prohibit [States](/usc/21/321.md?p=a-1) from collecting fees from [wholesale distributors](/usc/21/360eee.md?p=29) in connection with [State](/usc/21/321.md?p=a-1) licensing of such distributors.
  - (4) For the purposes of this subsection and [subsection (d)](#d), the term “wholesale [distribution](/usc/21/360eee.md?p=5)” means the [distribution](/usc/21/360eee.md?p=5) of a [drug](/usc/21/321.md?p=g-1) subject to [subsection (b)](#b) to a [person](/usc/21/321.md?p=e) other than a consumer or patient, or receipt of a [drug](/usc/21/321.md?p=g-1) subject to [subsection (b)](#b) by a [person](/usc/21/321.md?p=e) other than the consumer or patient, but does not include—
    - (A) intracompany [distribution](/usc/21/360eee.md?p=5) of any [drug](/usc/21/321.md?p=g-1) between members of an [affiliate](/usc/21/360eee.md?p=1) or within a [manufacturer](/usc/21/360hh.md?p=3);
    - (B) the [distribution](/usc/21/360eee.md?p=5) of a [drug](/usc/21/321.md?p=g-1), or an offer to [distribute](/usc/21/360eee.md?p=5) a [drug](/usc/21/321.md?p=g-1) among hospitals or other health care entities which are under common control;
    - (C) the [distribution](/usc/21/360eee.md?p=5) of a [drug](/usc/21/321.md?p=g-1) or an offer to [distribute](/usc/21/360eee.md?p=5) a [drug](/usc/21/321.md?p=g-1) for emergency medical reasons, including a public health emergency declaration pursuant to section 319 of the Public Health Service Act [[42 U.S.C. 247d](/usc/42/247d.md)], except that, for purposes of this paragraph, a [drug](/usc/21/321.md?p=g-1) shortage not caused by a public health emergency shall not constitute an emergency medical reason;
    - (D) the dispensing of a [drug](/usc/21/321.md?p=g-1) pursuant to a prescription executed in accordance with [subsection (b)(1)](#b-1);
    - (E) the [distribution](/usc/21/360eee.md?p=5) of minimal quantities of [drug](/usc/21/321.md?p=g-1) by a [licensed](/usc/21/360eee.md?p=9) retail pharmacy to a [licensed](/usc/21/360eee.md?p=9) practitioner for office use;
    - (F) the [distribution](/usc/21/360eee.md?p=5) of a [drug](/usc/21/321.md?p=g-1) or an offer to [distribute](/usc/21/360eee.md?p=5) a [drug](/usc/21/321.md?p=g-1) by a charitable organization to a nonprofit [affiliate](/usc/21/360eee.md?p=1) of the organization to the extent otherwise permitted by law;
    - (G) the purchase or other acquisition by a [dispenser](/usc/21/360eee.md?p=3), hospital, or other health care entity of a [drug](/usc/21/321.md?p=g-1) for use by such [dispenser](/usc/21/360eee.md?p=3), hospital, or other health care entity;
    - (H) the [distribution](/usc/21/360eee.md?p=5) of a [drug](/usc/21/321.md?p=g-1) by the [manufacturer](/usc/21/360hh.md?p=3) of such [drug](/usc/21/321.md?p=g-1);
    - (I) the receipt or transfer of a [drug](/usc/21/321.md?p=g-1) by an [authorized](/usc/21/360eee.md?p=2) [third-party logistics provider](/usc/21/360eee.md?p=22) provided that such [third-party logistics provider](/usc/21/360eee.md?p=22) does not take ownership of the [drug](/usc/21/321.md?p=g-1);
    - (J) a common carrier that transports a [drug](/usc/21/321.md?p=g-1), provided that the common carrier does not take ownership of the [drug](/usc/21/321.md?p=g-1);
    - (K) the [distribution](/usc/21/360eee.md?p=5) of a [drug](/usc/21/321.md?p=g-1), or an offer to [distribute](/usc/21/360eee.md?p=5) a [drug](/usc/21/321.md?p=g-1) by an [authorized](/usc/21/360eee.md?p=2) [repackager](/usc/21/360eee.md?p=16) that has taken ownership or possession of the [drug](/usc/21/321.md?p=g-1) and repacks it in accordance with [section 360eee–1(e) of this title](/usc/21/360eee–1.md?p=e);
    - (L) salable [drug](/usc/21/321.md?p=g-1) [returns](/usc/21/360eee.md?p=17) when conducted by a [dispenser](/usc/21/360eee.md?p=3);
    - (M) the [distribution](/usc/21/360eee.md?p=5) of a collection of finished medical [devices](/usc/21/321.md?p=h-1), which may include a [product](/usc/21/360eee.md?p=13) or biological [product](/usc/21/360eee.md?p=13), assembled in kit form strictly for the convenience of the purchaser or user (referred to in this subparagraph as a “medical convenience kit”) if—
      - (i) the medical convenience kit is assembled in an establishment that is registered with the [Food](/usc/21/321.md?p=f) and [Drug](/usc/21/321.md?p=g-1) Administration as a [device](/usc/21/321.md?p=h-1) [manufacturer](/usc/21/360hh.md?p=3) in accordance with [section 360(b)(2) of this title](/usc/21/360.md?p=b-2);
      - (ii) the medical convenience kit does not contain a controlled substance that appears in a schedule contained in the Comprehensive [Drug](/usc/21/321.md?p=g-1) Abuse Prevention and Control Act of 1970 [[21 U.S.C. 801](/usc/21/801.md) et seq.];
      - (iii) in the case of a medical convenience kit that includes a [product](/usc/21/360eee.md?p=13), the [person](/usc/21/321.md?p=e) that [manufacturers](/usc/21/360hh.md?p=3) the kit—
        - (I) purchased such [product](/usc/21/360eee.md?p=13) directly from the pharmaceutical [manufacturer](/usc/21/360hh.md?p=3) or from a [wholesale distributor](/usc/21/360eee.md?p=29) that purchased the [product](/usc/21/360eee.md?p=13) directly from the pharmaceutical [manufacturer](/usc/21/360hh.md?p=3); and
        - (II) does not alter the primary container or [label](/usc/21/321.md?p=k) of the [product](/usc/21/360eee.md?p=13) as purchased from the [manufacturer](/usc/21/360hh.md?p=3) or [wholesale distributor](/usc/21/360eee.md?p=29); and
      - (iv) in the case of a medical convenience kit that includes a [product](/usc/21/360eee.md?p=13), the [product](/usc/21/360eee.md?p=13) is—
        - (I) an intravenous solution intended for the replenishment of fluids and electrolytes;
        - (II) a [product](/usc/21/360eee.md?p=13) intended to maintain the equilibrium of water and minerals in the body;
        - (III) a [product](/usc/21/360eee.md?p=13) intended for irrigation or reconstitution;
        - (IV) an anesthetic;
        - (V) an anticoagulant;
        - (VI) a vasopressor; or
        - (VII) a sympathomimetic;
    - (N) the [distribution](/usc/21/360eee.md?p=5) of an intravenous [drug](/usc/21/321.md?p=g-1) that, by its formulation, is intended for the replenishment of fluids and electrolytes (such as sodium, chloride, and potassium) or calories (such as dextrose and amino acids);
    - (O) the [distribution](/usc/21/360eee.md?p=5) of an intravenous [drug](/usc/21/321.md?p=g-1) used to maintain the equilibrium of water and minerals in the body, such as dialysis solutions;
    - (P) the [distribution](/usc/21/360eee.md?p=5) of a [drug](/usc/21/321.md?p=g-1) that is intended for irrigation, or sterile water, whether intended for such purposes or for injection;
    - (Q) the [distribution](/usc/21/360eee.md?p=5) of [medical gas](/usc/21/360ddd.md?p=2), as defined in [section 360ddd of this title](/usc/21/360ddd.md);
    - (R) facilitating the [distribution](/usc/21/360eee.md?p=5) of a [product](/usc/21/360eee.md?p=13) by providing solely administrative services, including processing of orders and payments; or
    - (S) the transfer of a [product](/usc/21/360eee.md?p=13) by a hospital or other health care entity, or by a [wholesale distributor](/usc/21/360eee.md?p=29) or [manufacturer](/usc/21/360hh.md?p=3) operating at the direction of the hospital or other health care entity, to a [repackager](/usc/21/360eee.md?p=16) described in [section 360eee(16)(B) of this title](/usc/21/360eee.md?p=16-B) and registered under [section 360 of this title](/usc/21/360.md) for the purpose of repackaging the [drug](/usc/21/321.md?p=g-1) for use by that hospital, or other health care entity and other health care entities that are under common control, if ownership of the [drug](/usc/21/321.md?p=g-1) remains with the hospital or other health care entity at all times.
  - (5) **Third-party logistics providers.—** Notwithstanding paragraphs [(1)](#e-1) through [(4)](#e-4), each entity that meets the definition of a [third-party logistics provider](/usc/21/360eee.md?p=22) under [section 360eee(22) of this title](/usc/21/360eee.md?p=22) shall obtain a license as a [third-party logistics provider](/usc/21/360eee.md?p=22) as described in [section 360eee–3(a) of this title](/usc/21/360eee–3.md?p=a) and is not required to obtain a license as a [wholesale distributor](/usc/21/360eee.md?p=29) if the entity never assumes an ownership interest in the [product](/usc/21/360eee.md?p=13) it handles.
  - (6) **Affiliate.—** For purposes of this subsection, the term “[affiliate](/usc/21/360eee.md?p=1)” means a business entity that has a relationship with a second business entity if, directly or indirectly—
    - (A) one business entity controls, or has the power to control, the other business entity; or
    - (B) a third party controls, or has the power to control, both of the business entities.
- (f) **Veterinary prescription drugs—**
  - (1)
    - (A) A [drug](/usc/21/321.md?p=g-1) intended for use by animals other than man, other than a veterinary feed directive [drug](/usc/21/321.md?p=g-1) intended for use in [animal feed](/usc/21/321.md?p=w) or an [animal feed](/usc/21/321.md?p=w) bearing or containing a veterinary feed directive [drug](/usc/21/321.md?p=g-1), which—
      - (i) because of its toxicity or other potentiality for harmful effect, or the method of its use, or the collateral measures necessary for its use, is not [safe](/usc/21/321.md?p=u) for animal use except under the professional supervision of a [licensed](/usc/21/360eee.md?p=9) veterinarian, or
      - (ii) is limited by an approved application under subsection (b) of [section 360b of this title](/usc/21/360b.md), a conditionally-approved application under [section 360ccc of this title](/usc/21/360ccc.md), or an index listing under [section 360ccc–1 of this title](/usc/21/360ccc–1.md) to use under the professional supervision of a [licensed](/usc/21/360eee.md?p=9) veterinarian,

      shall be dispensed only by or upon the lawful written or oral order of a [licensed](/usc/21/360eee.md?p=9) veterinarian in the course of the veterinarian’s professional practice.

    - (B) For purposes of [subparagraph (A)](#f-1-A), an order is lawful if the order—
      - (i) is a prescription or other order [authorized](/usc/21/360eee.md?p=2) by law,
      - (ii) is, if an oral order, promptly reduced to writing by the [person](/usc/21/321.md?p=e) lawfully filling the order, and filed by that [person](/usc/21/321.md?p=e), and
      - (iii) is refilled only if [authorized](/usc/21/360eee.md?p=2) in the original order or in a subsequent oral order promptly reduced to writing by the [person](/usc/21/321.md?p=e) lawfully filling the order, and filed by that [person](/usc/21/321.md?p=e).
    - (C) The act of dispensing a [drug](/usc/21/321.md?p=g-1) contrary to the provisions of this paragraph shall be deemed to be an act which results in the [drug](/usc/21/321.md?p=g-1) being misbranded while held for sale.
  - (2) Any [drug](/usc/21/321.md?p=g-1) when dispensed in accordance with paragraph (1) of this subsection—
    - (A) shall be exempt from the requirements of [section 352 of this title](/usc/21/352.md), except subsections [(a)](/usc/21/352.md?p=a), [(g)](/usc/21/352.md?p=g), [(h)](/usc/21/352.md?p=h), [(i)(2)](/usc/21/352.md), [(i)(3)](/usc/21/352.md), and [(p)](/usc/21/352.md?p=p) of such section, and
    - (B) shall be exempt from the packaging requirements of subsections [(g)](#g), [(h)](#h), and (p) of such section, if—
      - (i) when dispensed by a [licensed](/usc/21/360eee.md?p=9) veterinarian, the [drug](/usc/21/321.md?p=g-1) bears a [label](/usc/21/321.md?p=k) containing the name and address of the practitioner and any directions for use and cautionary statements specified by the practitioner, or
      - (ii) when dispensed by filling the lawful order of a [licensed](/usc/21/360eee.md?p=9) veterinarian, the [drug](/usc/21/321.md?p=g-1) bears a [label](/usc/21/321.md?p=k) containing the name and address of the [dispenser](/usc/21/360eee.md?p=3), the serial number and date of the order or of its filling, the name of the [licensed](/usc/21/360eee.md?p=9) veterinarian, and the directions for use and cautionary statements, if any, contained in such order.

    The preceding sentence shall not apply to any [drug](/usc/21/321.md?p=g-1) dispensed in the course of the conduct of a business of dispensing [drugs](/usc/21/321.md?p=g-1) pursuant to diagnosis by mail.

  - (3) The [Secretary](/usc/21/321.md?p=d) may by regulation exempt [drugs](/usc/21/321.md?p=g-1) for animals other than man subject to section [360b](/usc/21/360b.md), [360ccc](/usc/21/360ccc.md), or [360ccc–1](/usc/21/360ccc–1.md) of this title from the requirements of [paragraph (1)](#f-1) when such requirements are not necessary for the protection of the public health.
  - (4) A [drug](/usc/21/321.md?p=g-1) which is subject to [paragraph (1)](#f-1) shall be deemed to be misbranded if at any time prior to dispensing its [label](/usc/21/321.md?p=k) fails to bear the statement “Caution: Federal law restricts this [drug](/usc/21/321.md?p=g-1) to use by or on the order of a [licensed](/usc/21/360eee.md?p=9) veterinarian.”. A [drug](/usc/21/321.md?p=g-1) to which [paragraph (1)](#f-1) does not apply shall be deemed to be misbranded if at any time prior to dispensing its [label](/usc/21/321.md?p=k) bears the statement specified in the preceding sentence.
- (g) **Regulation of combination products—**
  - (1)
    - (A) The [Secretary](/usc/21/321.md?p=d) shall, in accordance with this subsection, assign a primary agency center to regulate [products](/usc/21/360eee.md?p=13) that constitute a combination of a [drug](/usc/21/321.md?p=g-1), [device](/usc/21/321.md?p=h-1), or biological [product](/usc/21/360eee.md?p=13).
    - (B) The [Secretary](/usc/21/321.md?p=d) shall conduct the premarket review of any combination [product](/usc/21/360eee.md?p=13) under a single application, whenever appropriate.
    - (C) For purposes of this subsection, the term “primary mode of action” means the single mode of action of a combination [product](/usc/21/360eee.md?p=13) expected to make the greatest contribution to the overall intended therapeutic effects of the combination [product](/usc/21/360eee.md?p=13).
    - (D) The [Secretary](/usc/21/321.md?p=d) shall determine the primary mode of action of the combination [product](/usc/21/360eee.md?p=13). If the [Secretary](/usc/21/321.md?p=d) determines that the primary mode of action is that of—
      - (i) a [drug](/usc/21/321.md?p=g-1) (other than a biological [product](/usc/21/360eee.md?p=13)), the agency center charged with premarket review of [drugs](/usc/21/321.md?p=g-1) shall have primary jurisdiction;
      - (ii) a [device](/usc/21/321.md?p=h-1), the agency center charged with premarket review of [devices](/usc/21/321.md?p=h-1) shall have primary jurisdiction; or
      - (iii) a biological [product](/usc/21/360eee.md?p=13), the agency center charged with premarket review of biological [products](/usc/21/360eee.md?p=13) shall have primary jurisdiction.
    - (E) In determining the primary mode of action of a combination [product](/usc/21/360eee.md?p=13), the [Secretary](/usc/21/321.md?p=d) shall not determine that the primary mode of action is that of a [drug](/usc/21/321.md?p=g-1) or biological [product](/usc/21/360eee.md?p=13) solely because the combination [product](/usc/21/360eee.md?p=13) has any chemical action within or on the human body.
    - (F) If a [sponsor](/usc/21/360fff.md?p=8) of a combination [product](/usc/21/360eee.md?p=13) disagrees with the determination under [subparagraph (D)](#g-1-D)—
      - (i) such [sponsor](/usc/21/360fff.md?p=8) may request, and the [Secretary](/usc/21/321.md?p=d) shall provide, a substantive rationale to such [sponsor](/usc/21/360fff.md?p=8) that references scientific evidence provided by the [sponsor](/usc/21/360fff.md?p=8) and any other scientific evidence relied upon by the [Secretary](/usc/21/321.md?p=d) to support such determination; and
      - (ii)
        - (I) the [sponsor](/usc/21/360fff.md?p=8) of the combination [product](/usc/21/360eee.md?p=13) may propose one or more studies (which may be nonclinical, clinical, or both) to establish the relevance, if any, of the chemical action in achieving the primary mode of action of such [product](/usc/21/360eee.md?p=13);
        - (II) if the [sponsor](/usc/21/360fff.md?p=8) proposes any such studies, the [Secretary](/usc/21/321.md?p=d) and the [sponsor](/usc/21/360fff.md?p=8) of such [product](/usc/21/360eee.md?p=13) shall collaborate and seek to reach agreement, within a reasonable time of such proposal, not to exceed 90 calendar days, on the design of such studies; and
        - (III) if an agreement is reached under [subclause (II)](#g-1-F-ii-II) and the [sponsor](/usc/21/360fff.md?p=8) conducts one or more of such studies, the [Secretary](/usc/21/321.md?p=d) shall consider the data resulting from any such study when reevaluating the determination of the primary mode of action of such [product](/usc/21/360eee.md?p=13), and unless and until such reevaluation has occurred and the [Secretary](/usc/21/321.md?p=d) issues a new determination, the determination of the [Secretary](/usc/21/321.md?p=d) under [subparagraph (D)](#g-1-D) shall remain in effect.
  - (2)
    - (A) [^1] (i) To establish clarity and certainty for the [sponsor](/usc/21/360fff.md?p=8), the [sponsor](/usc/21/360fff.md?p=8) of a combination [product](/usc/21/360eee.md?p=13) may request a meeting on such combination [product](/usc/21/360eee.md?p=13). If the [Secretary](/usc/21/321.md?p=d) concludes that a determination of the primary mode of action pursuant to [paragraph (1)(D)](#g-1-D) is necessary, the [sponsor](/usc/21/360fff.md?p=8) may request such meeting only after the [Secretary](/usc/21/321.md?p=d) makes such determination. If the [sponsor](/usc/21/360fff.md?p=8) submits a written meeting request, the [Secretary](/usc/21/321.md?p=d) shall, not later than 75 calendar days after receiving such request, meet with the [sponsor](/usc/21/360fff.md?p=8) of such combination [product](/usc/21/360eee.md?p=13).
- (ii) A meeting under clause (i) may—
  - (I) address the standards and requirements for market approval or clearance of the combination [product](/usc/21/360eee.md?p=13);
  - (II) address other issues relevant to such combination [product](/usc/21/360eee.md?p=13), such as requirements related to postmarket modification of such combination [product](/usc/21/360eee.md?p=13) and good manufacturing practices applicable to such combination [product](/usc/21/360eee.md?p=13); and
  - (III) identify elements under subclauses [(I)](#ii-I) and [(II)](#ii-II) that may be more appropriate for discussion and agreement with the [Secretary](/usc/21/321.md?p=d) at a later date given that scientific or other information is not available, or agreement is otherwise not feasible regarding such elements, at the time a request for such meeting is made.
- (iii) Any agreement under this subparagraph shall be in writing and made part of the administrative record by the [Secretary](/usc/21/321.md?p=d).
  - (iv) Any such agreement shall remain in effect, except—
    - (I) upon the written agreement of the [Secretary](/usc/21/321.md?p=d) and the [sponsor](/usc/21/360fff.md?p=8) or applicant; or
    - (II) pursuant to a decision by the director of the reviewing division of the primary agency center, or a [person](/usc/21/321.md?p=e) more senior than such director, in consultation with consulting centers and the Office, as appropriate, that an issue essential to determining whether the standard for market clearance or other applicable standard under this chapter or the Public Health Service Act [[42 U.S.C. 201](/usc/42/201.md) et seq.] applicable to the combination [product](/usc/21/360eee.md?p=13) has been identified since the agreement was reached, or that deviating from the agreement is otherwise justifiable based on scientific evidence, for public health reasons.
  - (3) For purposes of conducting the premarket review of a combination [product](/usc/21/360eee.md?p=13) that contains an approved constituent part described in [paragraph (4)](#iii-4), the [Secretary](/usc/21/321.md?p=d) may require that the [sponsor](/usc/21/360fff.md?p=8) of such combination [product](/usc/21/360eee.md?p=13) submit to the [Secretary](/usc/21/321.md?p=d) only data or information that the [Secretary](/usc/21/321.md?p=d) determines is necessary to meet the standard for clearance or approval, as applicable, under this chapter or the Public Health Service Act, including any incremental risks and benefits posed by such combination [product](/usc/21/360eee.md?p=13), using a risk-based approach and taking into account any prior finding of safety and effectiveness or substantial equivalence for the approved constituent part relied upon by the applicant in accordance with [paragraph (5)](#iii-5).
  - (4) For purposes of [paragraph (3)](#iii-3), an approved constituent part is—
    - (A) a [drug](/usc/21/321.md?p=g-1) constituent part of a combination [product](/usc/21/360eee.md?p=13) being reviewed in a single application or request under section [360e](/usc/21/360e.md), [360(k)](/usc/21/360.md?p=k), or [360c(f)(2)](/usc/21/360c.md?p=f-2) of this title (submitted in accordance with [paragraph (5)](#iii-5)), that is an approved [drug](/usc/21/321.md?p=g-1), provided such application or request complies with [paragraph (5)](#iii-5);
    - (B) a [device](/usc/21/321.md?p=h-1) constituent part approved under [section 360e of this title](/usc/21/360e.md) that is referenced by the [sponsor](/usc/21/360fff.md?p=8) and that is available for use by the [Secretary](/usc/21/321.md?p=d) under [section 360j(h)(4) of this title](/usc/21/360j.md?p=h-4); or
    - (C) any constituent part that was previously approved, cleared, or classified under section [355](/usc/21/355.md), [360(k)](/usc/21/360.md?p=k), [360c(f)(2)](/usc/21/360c.md?p=f-2), or [360e](/usc/21/360e.md) of this title for which the [sponsor](/usc/21/360fff.md?p=8) has a right of reference or any constituent part that is a [nonprescription](/usc/21/360fff.md?p=5) [drug](/usc/21/321.md?p=g-1), as defined in [section 379aa(a)(2) of this title](/usc/21/379aa.md?p=a-2).
  - (5)
    - (A) If an application is submitted under section [360e](/usc/21/360e.md) or [360(k)](/usc/21/360.md?p=k) of this title or a request is submitted under [section 360c(f)(2) of this title](/usc/21/360c.md?p=f-2), consistent with any determination made under paragraph (1)(D), for a combination [product](/usc/21/360eee.md?p=13) containing as a constituent part an approved [drug](/usc/21/321.md?p=g-1)—
      - (i) the application or request shall include the certification or statement described in [section 355(b)(2) of this title](/usc/21/355.md?p=b-2); and
      - (ii) the applicant or requester shall provide notice as described in [section 355(b)(3) of this title](/usc/21/355.md?p=b-3).
    - (B) For purposes of this paragraph and [paragraph (4)](#iii-4), the term “approved [drug](/usc/21/321.md?p=g-1)” means an active ingredient—
      - (i) that was in an application previously approved under [section 355(c) of this title](/usc/21/355.md?p=c);
      - (ii) where such application is relied upon by the applicant submitting the application or request described in [subparagraph (A)](#iii-5-A);
      - (iii) for which full reports of investigations that have been made to show whether such [drug](/usc/21/321.md?p=g-1) is [safe](/usc/21/321.md?p=u) for use and whether such [drug](/usc/21/321.md?p=g-1) is effective in use were not conducted by or for the applicant submitting the application or request described in [subparagraph (A)](#iii-5-A); and
      - (iv) for which the applicant submitting the application or request described in [subparagraph (A)](#iii-5-A) has not obtained a right of reference or use from the [person](/usc/21/321.md?p=e) by or for whom the investigations described in [clause (iii)](#iii-5-B-iii) were conducted.
    - (C) The following provisions shall apply with respect to an application or request described in [subparagraph (A)](#iii-5-A) to the same extent and in the same manner as if such application or request were an application described in [section 355(b)(2) of this title](/usc/21/355.md?p=b-2) that referenced the approved [drug](/usc/21/321.md?p=g-1):
      - (i) Subparagraphs (A), (B), (C), and (D) of [section 355(c)(3) of this title](/usc/21/355.md?p=c-3).
      - (ii) Clauses (ii), (iii), and (iv) of [section 355(c)(3)(E) of this title](/usc/21/355.md?p=c-3-E).
      - (iii) Subsections (b) and (c) of [section 355a of this title](/usc/21/355a.md).
      - (iv) [Section 355f(a) of this title](/usc/21/355f.md?p=a).
      - (v) [Section 360cc(a) of this title](/usc/21/360cc.md?p=a).
    - (D) Notwithstanding any other provision of this subsection, an application or request for classification for a combination [product](/usc/21/360eee.md?p=13) described in [subparagraph (A)](#iii-5-A) shall be considered an application submitted under [section 355(b)(2) of this title](/usc/21/355.md?p=b-2) for purposes of [section 271(e)(2)(A) of title 35](/usc/35/271.md?p=e-2-A).
  - (6) Nothing in this subsection shall be construed as prohibiting a [sponsor](/usc/21/360fff.md?p=8) from submitting separate applications for the constituent parts of a combination [product](/usc/21/360eee.md?p=13), unless the [Secretary](/usc/21/321.md?p=d) determines that a single application is necessary.
  - (7) Nothing in this subsection shall prevent the [Secretary](/usc/21/321.md?p=d) from using any agency resources of the [Food](/usc/21/321.md?p=f) and [Drug](/usc/21/321.md?p=g-1) Administration necessary to ensure adequate review of the safety, effectiveness, or substantial equivalence of an article.
  - (8)
    - (A) Not later than 60 days after October 26, 2002, the [Secretary](/usc/21/321.md?p=d) shall establish within the Office of the [Commissioner](/usc/21/321.md?p=ee) of [Food](/usc/21/321.md?p=f) and [Drugs](/usc/21/321.md?p=g-1) an office to ensure the prompt assignment of combination [products](/usc/21/360eee.md?p=13) to agency centers, the timely and effective premarket review of such [products](/usc/21/360eee.md?p=13), and consistent and appropriate postmarket regulation of like [products](/usc/21/360eee.md?p=13) subject to the same statutory requirements to the extent permitted by law. Additionally, the office shall, in determining whether a [product](/usc/21/360eee.md?p=13) is to be designated a combination [product](/usc/21/360eee.md?p=13), consult with the component within the Office of the [Commissioner](/usc/21/321.md?p=ee) of [Food](/usc/21/321.md?p=f) and [Drugs](/usc/21/321.md?p=g-1) that is responsible for such determinations. Such office (referred to in this paragraph as the “Office”) shall have appropriate scientific and medical expertise, and shall be headed by a director.
    - (B) In carrying out this subsection, the Office shall, for each combination [product](/usc/21/360eee.md?p=13), promptly assign an agency center with primary jurisdiction in accordance with paragraph (1) for the premarket review of such [product](/usc/21/360eee.md?p=13).
    - (C)
      - (i) In carrying out this subsection, the Office shall help to ensure timely and effective premarket review that involves more than one agency center by coordinating such reviews, overseeing the timeliness of such reviews, and overseeing the alignment of feedback regarding such reviews.
      - (ii) In order to ensure the timeliness and alignment of the premarket review of a combination [product](/usc/21/360eee.md?p=13), the agency center with primary jurisdiction for the [product](/usc/21/360eee.md?p=13), and the consulting agency center, shall be responsible to the Office with respect to the timeliness and alignment of the premarket review.
- (iii) The Office shall ensure that, with respect to a combination [product](/usc/21/360eee.md?p=13), a designated [person](/usc/21/321.md?p=e) or [persons](/usc/21/321.md?p=e) in the primary agency center is the primary point or points of contact for the [sponsor](/usc/21/360fff.md?p=8) of such combination [product](/usc/21/360eee.md?p=13). The Office shall also coordinate communications to and from any consulting center involved in such premarket review, if requested by such primary agency center or any such consulting center. Agency communications and commitments, to the extent consistent with other provisions of law and the requirements of all affected agency centers, from the primary agency center shall be considered as communication from the [Secretary](/usc/21/321.md?p=d) on behalf of all agency centers involved in the review.
  - (iv) The Office shall, with respect to the premarket review of a combination [product](/usc/21/360eee.md?p=13)—
    - (I) ensure that any meeting between the [Secretary](/usc/21/321.md?p=d) and the [sponsor](/usc/21/360fff.md?p=8) of such [product](/usc/21/360eee.md?p=13) is attended by each agency center involved in the review, as appropriate;
    - (II) ensure that each consulting agency center has completed its premarket review and provided the results of such review to the primary agency center in a timely manner; and
    - (III) ensure that each consulting center follows the guidance described in [clause (vi)](#iii-vi) and advises, as appropriate, on other relevant regulations, guidances, and policies.
  - (v) In seeking agency action with respect to a combination [product](/usc/21/360eee.md?p=13), the [sponsor](/usc/21/360fff.md?p=8) of such [product](/usc/21/360eee.md?p=13)—
    - (I) shall identify the [product](/usc/21/360eee.md?p=13) as a combination [product](/usc/21/360eee.md?p=13); and
    - (II) may request in writing the participation of representatives of the Office in meetings related to such combination [product](/usc/21/360eee.md?p=13), or to have the Office otherwise engage on such regulatory matters concerning the combination [product](/usc/21/360eee.md?p=13).
  - (vi) Not later than 4 years after December 13, 2016, and after a public comment period of not less than 60 calendar days, the [Secretary](/usc/21/321.md?p=d) shall issue a final guidance that describes—
    - (I) the structured process for managing pre-submission interactions with [sponsors](/usc/21/360fff.md?p=8) developing combination [products](/usc/21/360eee.md?p=13);
    - (II) the best practices for ensuring that the feedback in such pre-submission interactions represents the Agency’s best advice based on the information provided during such pre-submission interactions;[^2]
    - (III) the information that is required to be submitted with a meeting request under paragraph (2), how such meetings relate to other types of meetings in the [Food](/usc/21/321.md?p=f) and [Drug](/usc/21/321.md?p=g-1) Administration, and the form and content of any agreement reached through a meeting under such paragraph (2);[^3]
  - (D) In carrying out this subsection, the Office shall ensure the consistency and appropriateness of postmarket regulation of like [products](/usc/21/360eee.md?p=13) subject to the same statutory requirements to the extent permitted by law.
  - (E)
    - (i) Any dispute regarding the timeliness of the premarket review of a combination [product](/usc/21/360eee.md?p=13) may be presented to the Office for resolution, unless the dispute is clearly premature.
    - (ii) During the review process, any dispute regarding the substance of the premarket review may be presented to the [Commissioner](/usc/21/321.md?p=ee) of [Food](/usc/21/321.md?p=f) and [Drugs](/usc/21/321.md?p=g-1) after first being considered by the agency center with primary jurisdiction of the premarket review, under the scientific dispute resolution procedures for such center. The [Commissioner](/usc/21/321.md?p=ee) of [Food](/usc/21/321.md?p=f) and [Drugs](/usc/21/321.md?p=g-1) shall consult with the Director of the Office in resolving the substantive dispute.
  - (F) The [Secretary](/usc/21/321.md?p=d), acting through the Office, shall review each agreement, guidance, or practice of the [Secretary](/usc/21/321.md?p=d) that is specific to the assignment of combination [products](/usc/21/360eee.md?p=13) to agency centers and shall determine whether the agreement, guidance, or practice is consistent with the requirements of this subsection. In carrying out such review, the [Secretary](/usc/21/321.md?p=d) shall consult with stakeholders and the directors of the agency centers. After such consultation, the [Secretary](/usc/21/321.md?p=d) shall determine whether to continue in effect, modify, revise, or eliminate such agreement, guidance, or practice, and shall publish in the Federal Register a notice of the availability of such modified or revised agreement, guidance or practice. Nothing in this paragraph shall be construed as preventing the [Secretary](/usc/21/321.md?p=d) from following each agreement, guidance, or practice until continued, modified, revised, or eliminated.
  - (G) Not later than one year after October 26, 2002 (except with respect to [clause (iv)](#iii-G-iv), beginning not later than one year after December 13, 2016), and annually thereafter, the [Secretary](/usc/21/321.md?p=d) shall report to the appropriate committees of Congress on the activities and impact of the Office. The report shall include provisions—
    - (i) describing the numbers and types of combination [products](/usc/21/360eee.md?p=13) under review and the timeliness in days of such assignments, reviews, and dispute resolutions;
    - (ii) identifying the number of premarket reviews of such [products](/usc/21/360eee.md?p=13) that involved a consulting agency center;
    - (iii) describing improvements in the consistency of postmarket regulation of combination [products](/usc/21/360eee.md?p=13); and
    - (iv) identifying the percentage of combination [products](/usc/21/360eee.md?p=13) for which a dispute resolution, with respect to premarket review, was requested by the combination [product](/usc/21/360eee.md?p=13)’s [sponsor](/usc/21/360fff.md?p=8).
  - (H) Nothing in this paragraph shall be construed to limit the regulatory authority of any agency center.
  - (9) As used in this subsection:
    - (A) The term “agency center” means a center or alternative organizational component of the [Food](/usc/21/321.md?p=f) and [Drug](/usc/21/321.md?p=g-1) Administration.
    - (B) The term “biological [product](/usc/21/360eee.md?p=13)” has the meaning given the term in section 351(i) of the Public Health Service Act ([42 U.S.C. 262(i)](/usc/42/262.md?p=i)).
    - (C) The term “market clearance” includes—
      - (i) approval of an application under section 355, 357,[^4] 360e, or [360j(g)](/usc/21/360j.md?p=g) of this title;
      - (ii) a finding of substantial equivalence under this part;
      - (iii) approval of a biologics license application under [subsection (a)](/usc/21/351.md?p=a) of section 351 of the Public Health Service Act ([42 U.S.C. 262](/usc/42/262.md)); and
      - (iv) de novo classification under [section 360c(a)(1) of this title](/usc/21/360c.md?p=a-1).
    - (D) The terms “premarket review” and “reviews” include all activities of the [Food](/usc/21/321.md?p=f) and [Drug](/usc/21/321.md?p=g-1) Administration conducted prior to approval or clearance of an application, notification, or request for classification submitted under section [355](/usc/21/355.md), [360(k)](/usc/21/360.md?p=k), [360c(f)(2)](/usc/21/360c.md?p=f-2), [360e](/usc/21/360e.md), or [360j](/usc/21/360j.md) of this title or under section 351 of the Public Health Service Act [[42 U.S.C. 262](/usc/42/262.md)], including with respect to investigational use of the [product](/usc/21/360eee.md?p=13).
- (h) **Regulation of certain products as drugs—**
  - (1) Any contrast agent, radioactive [drug](/usc/21/321.md?p=g-1), or OTC monograph [drug](/usc/21/321.md?p=g-1) shall be deemed to be a [drug](/usc/21/321.md?p=g-1) under [section 321(g) of this title](/usc/21/321.md?p=g) and not a [device](/usc/21/321.md?p=h-1) under [section 321(h) of this title](/usc/21/321.md?p=h).
  - (2) For purposes of this subsection:
    - (A) The term “contrast agent” means an article that is intended for use in conjunction with a medical imaging [device](/usc/21/321.md?p=h-1), and—
      - (i) is a diagnostic radiopharmaceutical, as defined in sections 315.2 and 601.31 of title 21, Code of Federal Regulations (or any successor regulations); or
      - (ii) is a diagnostic agent that improves the visualization of structure or function within the body by increasing the relative difference in signal intensity within the target tissue, structure, or fluid.
    - (B) The term “radioactive [drug](/usc/21/321.md?p=g-1)” has the meaning given such term in section 310.3(n) of title 21, Code of Federal Regulations (or any successor regulations), except that such term does not include—
      - (i) an implant or article similar to an implant;
      - (ii) an article that applies radiation from outside of the body; or
      - (iii) the radiation source of an article described in clause [(i)](#h-2-B-i) or [(ii)](#h-2-B-ii).
    - (C) The term “OTC monograph [drug](/usc/21/321.md?p=g-1)” has the meaning given such term in [section 379j–71 of this title](/usc/21/379j–71.md).
  - (3) Nothing in this subsection shall be construed as allowing for the classification of a [product](/usc/21/360eee.md?p=13) as a [drug](/usc/21/321.md?p=g-1) (as defined in [section 321(g) of this title](/usc/21/321.md?p=g)) if such [product](/usc/21/360eee.md?p=13)—
    - (A) is not described in [paragraph (1)](#h-1); and
    - (B) meets the definition of a [device](/usc/21/321.md?p=h-1) under [section 321(h) of this title](/usc/21/321.md?p=h),

    unless another provision of this chapter otherwise indicates a different classification.

  - (4) The [Secretary](/usc/21/321.md?p=d) shall waive the application fee under sections [379h](/usc/21/379h.md) and [379j–42](/usc/21/379j–42.md) of this title for applications for [drugs](/usc/21/321.md?p=g-1) that are—
    - (A) on September 30, 2022, legally marketed as [devices](/usc/21/321.md?p=h-1); and
    - (B) deemed [drugs](/usc/21/321.md?p=g-1) pursuant to [paragraph (1)](#h-1)[^5]

## Footnotes

[^1]: So in original. No subpar. (B) has been enacted.
[^2]: So in original. The word “and” probably should appear.
[^3]: So in original. The semicolon probably should be a period.
[^4]: See References in Text note below.
[^5]: So in original. Probably should be followed by a period.

## Source credit

(June 25, 1938, ch. 675, § 503, 52 Stat. 1051; Oct. 26, 1951, ch. 578, § 1, 65 Stat. 648; Pub. L. 87–781, title I, § 104(e)(2), Oct. 10, 1962, 76 Stat. 785; Pub. L. 91–601, § 6(e), formerly § 7(e), Dec. 30, 1970, 84 Stat. 1673, renumbered Pub. L. 97–35, title XII, § 1205(c), Aug. 13, 1981, 95 Stat. 716; Pub. L. 100–293, §§ 4–6, Apr. 22, 1988, 102 Stat. 96–98; Pub. L. 100–670, title I, § 105, Nov. 16, 1988, 102 Stat. 3983; Pub. L. 101–629, § 16(a), Nov. 28, 1990, 104 Stat. 4526; Pub. L. 102–108, § 2(d), Aug. 17, 1991, 105 Stat. 550; Pub. L. 102–300, § 6(d), June 16, 1992, 106 Stat. 240; Pub. L. 102–353, §§ 2(a)–(c), 4, Aug. 26, 1992, 106 Stat. 941, 942; Pub. L. 104–250, § 5(a), Oct. 9, 1996, 110 Stat. 3155; Pub. L. 105–115, title I, §§ 123(e), 126(a), (c)(1), (2), Nov. 21, 1997, 111 Stat. 2324, 2327, 2328; Pub. L. 107–250, title II, § 204, Oct. 26, 2002, 116 Stat. 1611; Pub. L. 108–282, title I, § 102(b)(5)(F), Aug. 2, 2004, 118 Stat. 903; Pub. L. 113–54, title II, § 204(a)(1)–(4), (b), Nov. 27, 2013, 127 Stat. 630–635; Pub. L. 114–255, div. A, title III, § 3038(a), Dec. 13, 2016, 130 Stat. 1105; Pub. L. 117–328, div. FF, title III, § 3621, Dec. 29, 2022, 136 Stat. 5877.)

## Notes

### Editorial Notes

### References in Text

The Comprehensive Drug Abuse Prevention and Control Act of 1970, referred to in subsec. (e)(4)(M)(ii), is Pub. L. 91–513, Oct. 27, 1970, 84 Stat. 1236, which is classified principally to chapter 13 (§ 801 et seq.) of this title. For complete classification of this Act to the Code, see Short Title note set out under section 801 of this title and Tables.

The Public Health Service Act, referred to in subsec. (g)(2)(A)(iv)(II), (3), is act July 1, 1944, ch. 373, 58 Stat. 682, which is classified generally to chapter 6A (§ 201 et seq.) of Title 42, The Public Health and Welfare. For complete classification of this Act to the Code, see Short Title note set out under section 201 of Title 42 and Tables.

Section 357 of this title, referred to in subsec. (g)(9)(C)(i), was repealed by Pub. L. 105–115, title I, § 125(b)(1), Nov. 21, 1997, 111 Stat. 2325.

### Codification

In subsec. (b)(5), “sections 4721, 6001, and 6151 of title 26” and “section 4761 of title 26” substituted for “section 3220 of the Internal Revenue Code (26 U.S.C. 3220)” and “section 3238(b) of the Internal Revenue Code (26 U.S.C. 3238(b))”, respectively, on authority of section 7852(b) of Title 26, Internal Revenue Code.

### Amendments

2022—Subsec. (h). Pub. L. 117–328 added subsec. (h).

2016—Subsec. (g)(1). Pub. L. 114–255, § 3038(a)(4), added par. (1) and struck out former par. (1) which read as follows: “The Secretary shall in accordance with this subsection assign an agency center to regulate products that constitute a combination of a drug, device, or biological product. The Secretary shall determine the primary mode of action of the combination product. If the Secretary determines that the primary mode of action is that of—

“(A) a drug (other than a biological product), the agency center charged with premarket review of drugs shall have primary jurisdiction,

“(B) a device, the agency center charged with premarket review of devices shall have primary jurisdiction, or

“(C) a biological product, the agency center charged with premarket review of biological products shall have primary jurisdiction.”

Subsec. (g)(2). Pub. L. 114–255, § 3038(a)(4), added par. (2). Former par. (2) redesignated (7).

Subsec. (g)(3). Pub. L. 114–255, § 3038(a)(1), (4), added par. (3) and struck out former par. (3) which read as follows: “The Secretary shall promulgate regulations to implement market clearance procedures in accordance with paragraphs (1) and (2) not later than 1 year after November 28, 1990.”

Subsec. (g)(4) to (6). Pub. L. 114–255, § 3038(a)(4), added pars. (4) to (6). Former pars. (4) and (5) redesignated (8) and (9), respectively.

Subsec. (g)(7). Pub. L. 114–255, § 3038(a)(2), redesignated par. (2) as (7).

Subsec. (g)(8). Pub. L. 114–255, § 3038(a)(3), redesignated par. (4) as (8).

Subsec. (g)(8)(C)(i). Pub. L. 114–255, § 3038(a)(5)(A)(i), amended cl. (i) generally. Prior to amendment, cl. (i) read as follows: “In carrying out this subsection, the Office shall ensure timely and effective premarket reviews by overseeing the timeliness of and coordinating reviews involving more than one agency center.”

Subsec. (g)(8)(C)(ii). Pub. L. 114–255, § 3038(a)(5)(A)(ii), inserted “and alignment” after “the timeliness” in two places.

Subsec. (g)(8)(C)(iii) to (vi). Pub. L. 114–255, § 3038(a)(5)(A)(iii), added cls. (iii) to (vi).

Subsec. (g)(8)(G). Pub. L. 114–255, § 3038(a)(5)(B)(i), inserted “(except with respect to clause (iv), beginning not later than one year after December 13, 2016)” after “October 26, 2002” in introductory provisions.

Subsec. (g)(8)(G)(iv). Pub. L. 114–255, § 3038(a)(5)(B)(ii)–(iv), added cl. (iv).

Subsec. (g)(9). Pub. L. 114–255, § 3038(a)(3), redesignated par. (5) as (9).

Subsec. (g)(9)(C). Pub. L. 114–255, § 3038(a)(6)(A), substituted semicolon for comma at end of cl. (i), semicolon for “, and” at end of cl. (ii), and “; and” for period at end of cl. (iii), and added cl. (iv).

Subsec. (g)(9)(D). Pub. L. 114–255, § 3038(a)(6)(B), added subpar. (D).

2013—Subsec. (d)(4). Pub. L. 113–54, § 204(b), added par. (4).

Subsec. (e). Pub. L. 113–54, § 204(a)(1)–(4), added pars. (1) to (6) and struck out former pars. (1) to (3). Prior to amendment, pars. (1) to (3) set out certain disclosure and licensing requirements for wholesale distributors and defined “authorized distributors of record” and “wholesale distribution”.

2004—Subsec. (f)(1)(A)(ii). Pub. L. 108–282, § 102(b)(5)(F)(i), substituted “360b of this title, a conditionally-approved application under section 360ccc of this title, or an index listing under section 360ccc–1 of this title” for “360b of this title”.

Subsec. (f)(3). Pub. L. 108–282, § 102(b)(5)(F)(ii), substituted “section 360b, 360ccc, or 360ccc–1” for “section 360b”.

2002—Subsec. (g)(1). Pub. L. 107–250, § 204(1)(A), substituted “shall in accordance with this subsection assign an agency center” for “shall designate a component of the Food and Drug Administration” in first sentence of introductory provisions.

Subsec. (g)(1)(A) to (C). Pub. L. 107–250, § 204(1)(B), substituted “the agency center charged” for “the persons charged”.

Subsec. (g)(4). Pub. L. 107–250, § 204(3), added par. (4). Former par. (4) redesignated (5).

Subsec. (g)(5). Pub. L. 107–250, § 204(2), (4), redesignated par. (4) as (5), added subpar. (A), and redesignated former subpars. (A) and (B) as (B) and (C), respectively.

1997—Subsec. (b)(1)(A) to (C). Pub. L. 105–115, § 126(c)(1), redesignated subpars. (B) and (C) as (A) and (B), respectively, and struck out former subpar. (A), which read as follows: “is a habit-forming drug to which section 352(d) of this title applies; or”.

Subsec. (b)(3). Pub. L. 105–115, § 126(c)(2), struck out reference to section 352(d) of this title before “355”.

Subsec. (b)(4). Pub. L. 105–115, § 126(a), amended par. (4) generally. Prior to amendment, par. (4) read as follows: “A drug which is subject to paragraph (1) of this subsection shall be deemed to be misbranded if at any time prior to dispensing its label fails to bear the statement ‘Caution: Federal law prohibits dispensing without prescription’. A drug to which paragraph (1) of this subsection does not apply shall be deemed to be misbranded if at any time prior to dispensing its label bears the caution statement quoted in the preceding sentence.”

Subsec. (g)(4)(A). Pub. L. 105–115, § 123(e)(1), substituted “section 351(i)” for “section 351(a)” and “262(i)” for “262(a)”.

Subsec. (g)(4)(B)(iii). Pub. L. 105–115, § 123(e)(2), substituted “biologics license application under subsection (a)” for “product or establishment license under subsection (a) or (d)”.

1996—Subsec. (f)(1)(A). Pub. L. 104–250 inserted “, other than a veterinary feed directive drug intended for use in animal feed or an animal feed bearing or containing a veterinary feed directive drug,” after “other than man” in introductory provisions.

1992—Subsec. (d)(1). Pub. L. 102–353, § 4(1), amended par. (1) generally. Prior to amendment, par. (1) read as follows: “Except as provided in paragraphs (2) and (3), no representative of a drug manufacturer or distributor may distribute any drug sample.”

Subsec. (d)(2). Pub. L. 102–353, § 4(2), substituted “authorized distributor of record” for “distributor” wherever appearing.

Subsec. (d)(3). Pub. L. 102–353, § 4(2), substituted “authorized distributor of record” for “distributor” and “authorized distributors of record” for “distributors” wherever appearing.

Subsec. (e)(1). Pub. L. 102–353, § 4(3), amended par. (1) generally. Prior to amendment, par. (1) read as follows: “Each person who is engaged in the wholesale distribution of drugs subject to subsection (b) of this section and who is not an authorized distributor of record of such drugs shall provide to each wholesale distributor of such drugs a statement identifying each sale of the drug (including the date of the sale) before the sale to such wholesale distributor. Each manufacturer shall maintain at its corporate offices a current list of such authorized distributors.”

Subsec. (e)(2)(A). Pub. L. 102–353, § 2(a), (d), temporarily inserted “or has registered with the Secretary in accordance with paragraph (3)”. See Termination Date of 1992 Amendment note below.

Subsec. (e)(3). Pub. L. 102–353, § 2(b), (d), temporarily added par. (3). Former par. (3) redesignated (4). See Termination Date of 1992 Amendment note below.

Subsec. (e)(4). Pub. L. 102–353, § 4(4), inserted “and subsection (d) of this section” after “For the purposes of this subsection”.

Pub. L. 102–353, § 2(b), (d), temporarily redesignated par. (3) as (4). See Termination Date of 1992 Amendment note below.

Subsec. (f)(1)(B). Pub. L. 102–353, § 2(c), which directed the substitution of “an order” for “and order”, could not be executed because “and order” did not appear in subpar. (B).

Subsec. (g)(3). Pub. L. 102–300 substituted “clearance” for “approval”.

1991—Subsec. (c). Pub. L. 102–108, § 2(d)(3), redesignated subsec. (c), relating to veterinary prescription drugs, as (f). Former subsec. (f) redesignated (g).

Subsec. (c)(2), (3)(B)(v). Pub. L. 102–108, § 2(d)(1), made technical amendment to reference to subsection (b) of this section involving corresponding provision of original act.

Subsec. (d)(3)(E). Pub. L. 102–108, § 2(d)(2), made technical amendment to reference to subsection (c)(1) of this section involving corresponding provision of original act.

Subsec. (f). Pub. L. 102–108, § 2(d)(4), redesignated subsec. (f), relating to regulation of combination products, as (g).

Pub. L. 102–108, § 2(d)(3), redesignated subsec. (c), relating to veterinary prescription drugs, as (f).

Subsec. (g). Pub. L. 102–108, § 2(d)(4), redesignated subsec. (f), relating to regulation of combination products, as (g).

1990—Pub. L. 101–629, § 16(a)(1), substituted “Exemptions and consideration for certain drugs, devices, and biological products” for “Exemptions in case of drugs and devices” in section catchline.

Subsec. (f). Pub. L. 101–629, § 16(a)(2), added subsec. (f).

1988—Subsec. (c). Pub. L. 100–670 added subsec. (c) relating to veterinary prescription drugs.

Pub. L. 100–293, § 4, added subsec. (c) relating to sales restrictions.

Subsec. (d). Pub. L. 100–293, § 5, added subsec. (d).

Subsec. (e). Pub. L. 100–293, § 6, added subsec. (e).

1970—Subsec. (b)(2). Pub. L. 91–601 included exemption from packaging requirements of subsec. (p) of section 352 of this title.

1962—Subsec. (b)(1)(C). Pub. L. 87–781 substituted “approved” for “effective”.

1951—Subsec. (b). Act Oct. 26, 1951, amended subsec. (b) generally to protect the public from abuses in the sale of potent prescription drugs, and to relieve retail pharmacists and the public from unnecessary restrictions on the dispensation of drugs that are safe to use without supervision of a doctor.

### Statutory Notes and Related Subsidiaries

### Effective Date of 2013 Amendment

Pub. L. 113–54, title II, § 204(c), Nov. 27, 2013, 127 Stat. 636, provided that: “The amendments made by subsections (a) and (b) [enacting section 360eee–2 of this title and amending this section] shall take effect on January 1, 2015.”

### Effective Date of 1997 Amendment

Amendment by Pub. L. 105–115 effective 90 days after Nov. 21, 1997, except as otherwise provided, see section 501 of Pub. L. 105–115, set out as a note under section 321 of this title.

### Termination Date of 1992 Amendment

Pub. L. 102–353, § 2(d), Aug. 26, 1992, 106 Stat. 941, provided that: “Effective September 14, 1994, the amendments made by subsections (a) and (b) [amending this section] shall no longer be in effect.”

### Effective Date of 1988 Amendment

Pub. L. 100–293, § 8, Apr. 22, 1988, 102 Stat. 100, provided that: General Rule.—Except as provided in subsection (b), this Act and the amendments made by this Act [amending this section and sections 331, 333, and 381 of this title and enacting provisions set out as notes under this section and section 301 of this title] shall take effect upon the expiration of 90 days after the date of the enactment of this Act [Apr. 22, 1988].Exception.— Section 503(d) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 353(d)] (as added by section 5 of this Act) shall take effect upon the expiration of 180 days after the date of the enactment of this Act [Apr. 22, 1988]. The Secretary of Health and Human Services shall by regulation issue the guidelines required by section 503(e)(2)(B) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 353(e)(2)(B)] (as added by section 6 of this Act) not later than 180 days after the date of the enactment of this Act. Section 503(e)(2)(A) of such Act shall take effect upon the expiration of 2 years after the date such regulations are promulgated and take effect.”

### Effective Date of 1970 Amendment

Amendment by Pub. L. 91–601 effective Dec. 30, 1970, and regulations establishing special packaging standards effective no sooner than 180 days or later than one year from date regulations are final, or an earlier date published in Federal Register, see section 8 of Pub. L. 91–601, set out as an Effective Date note under section 1471 of Title 15, Commerce and Trade.

### Effective Date of 1962 Amendment

Amendment by Pub. L. 87–781 effective Oct. 10, 1962, see section 107 of Pub. L. 87–781, set out as a note under section 321 of this title.

### Effective Date of 1951 Amendment

Amendment by act Oct. 26, 1951, effective six months after Oct. 26, 1951, see section 3 of act Oct. 26, 1951, set out as a note under section 333 of this title.

### Effective Medication Guides

Pub. L. 104–180, title VI, § 601, Aug. 6, 1996, 110 Stat. 1593, provided that: In General.—Not later than 30 days after the date of enactment of this Act [Aug. 6, 1996], the Secretary of the Department of Health and Human Services shall request that national organizations representing health care professionals, consumer organizations, voluntary health agencies, the pharmaceutical industry, drug wholesalers, patient drug information database companies, and other relevant parties collaborate to develop a long-range comprehensive action plan to achieve goals consistent with the goals of the proposed rule of the Food and Drug Administration on ‘Prescription Drug Product Labeling: Medication Guide Requirements’ (60 Fed. Reg. 44182; relating to the provision of oral and written prescription information to consumers). Goals.—Goals consistent with the proposed rule described in subsection (a) are the distribution of useful written information to 75 percent of individuals receiving new precriptions [sic] by the year 2000 and to 95 percent by the year 2006. Plan.—The plan described in subsection (a) shall— identify the plan goals; assess the effectiveness of the current private-sector approaches used to provide oral and written prescription information to consumers; develop guidelines for providing effective oral and written prescription information consistent with the findings of any such assessment; contain elements necessary to ensure the transmittal of useful information to the consuming public, including being scientifically accurate, non-promotional in tone and content, sufficiently specific and comprehensive as to adequately inform consumers about the use of the product, and in an understandable, legible format that is readily comprehensible and not confusing to consumers expected to use the product.[;] develop a mechanism to assess periodically the quality of the oral and written prescription information and the frequency with which the information is provided to consumers; and provide for compliance with relevant State board regulations. Limitation on the Authority of the Secretary.—The Secretary of the Department of Health and Human Services shall have no authority to implement the proposed rule described in subsection (a), or to develop any similar regulation, policy statement, or other guideline specifying a uniform content or format for written information voluntarily provided to consumers about prescription drugs if, (1) not later than 120 days after the date of enactment of this Act [Aug. 6, 1996], the national organizations described in subsection (a) develop and submit to the Secretary for Health and Human Services a comprehensive, long-range action plan (as described in subsection (a)) which shall be acceptable to the Secretary of Health and Human Services; (2) the aforementioned plan is submitted to the Secretary of Health and Human Services for review and acceptance: Provided, That the Secretary shall give due consideration to the submitted plan and that any such acceptance shall not be arbitrarily withheld; and (3) the implementation of (a) a plan accepted by the Secretary commences within 30 days of the Secretary’s acceptance of such plan, or (b) the plan submitted to the Secretary commences within 60 days of the submission of such plan if the Secretary fails to take any action on the plan within 30 days of the submission of the plan. The Secretary shall accept, reject or suggest modifications to the plan submitted within 30 days of its submission. The Secretary may confer with and assist private parties in the development of the plan described in subsections (a) and (b). Secretary Review.—Not later than January 1, 2001, the Secretary of the Department of Health and Human Services shall review the status of private-sector initiatives designed to achieve the goals of the plan described in subsection (a), and if such goals are not achieved, the limitation in subsection (d) shall not apply, and the Secretary shall seek public comment on other initiatives that may be carried out to meet such goals.”

### Congressional Findings

Pub. L. 100–293, § 2, Apr. 22, 1988, 102 Stat. 95, provided that: “The Congress finds the following: American consumers cannot purchase prescription drugs with the certainty that the products are safe and effective. The integrity of the distribution system for prescription drugs is insufficient to prevent the introduction and eventual retail sale of substandard, ineffective, or even counterfeit drugs. The existence and operation of a wholesale submarket, commonly known as the ‘diversion market’, prevents effective control over or even routine knowledge of the true sources of prescription drugs in a significant number of cases. Large amounts of drugs are being reimported to the United States as American goods returned. These imports are a health and safety risk to American consumers because they may have become subpotent or adulterated during foreign handling and shipping. The ready market for prescription drug reimports has been the catalyst for a continuing series of frauds against American manufacturers and has provided the cover for the importation of foreign counterfeit drugs. The existing system of providing drug samples to physicians through manufacturer’s representatives has been abused for decades and has resulted in the sale to consumers of misbranded, expired, and adulterated pharmaceuticals. The bulk resale of below wholesale priced prescription drugs by health care entities, for ultimate sale at retail, helps fuel the diversion market and is an unfair form of competition to wholesalers and retailers that must pay otherwise prevailing market prices. The effect of these several practices and conditions is to create an unacceptable risk that counterfeit, adulterated, misbranded, subpotent, or expired drugs will be sold to American consumers.”

### Executive Documents

### Transfer of Functions

For transfer of functions of Federal Security Administrator to Secretary of Health, Education, and Welfare [now Health and Human Services], and of Food and Drug Administration in the Department of Agriculture to Federal Security Agency, see notes set out under section 321 of this title.