---
kind: "section"
citation: "21 U.S.C. § 360"
title: "21"
title_heading: "Food and Drugs"
number: "360"
heading: "Registration of producers of drugs or devices"
release: "119-102"
date: "2026-07-12"
url: "https://uscodex.org/usc/21/360"
units:
  - "Chapter 9 — Federal Food, Drug, and Cosmetic Act"
  - "Subchapter V — Drugs and Devices"
  - "Part A — Drugs and Devices"
---

# §360. Registration of producers of drugs or devices

- (a) **Definitions—** As used in this section—
  - (1) the term “manufacture, preparation, propagation, compounding, or processing” shall include repackaging or otherwise changing the container, wrapper, or [labeling](/usc/21/321.md?p=m) of any [drug](/usc/21/321.md?p=g-1) [package](/usc/21/360eee.md?p=11-A) or [device](/usc/21/321.md?p=h-1) [package](/usc/21/360eee.md?p=11-A) in furtherance of the [distribution](/usc/21/360eee.md?p=5) of the [drug](/usc/21/321.md?p=g-1) or [device](/usc/21/321.md?p=h-1) from the original place of manufacture to the [person](/usc/21/321.md?p=e) who makes final delivery or sale to the ultimate consumer or user; and
  - (2) the term “name” shall include in the case of a partnership the name of each partner and, in the case of a corporation, the name of each corporate officer and director, and the [State](/usc/21/321.md?p=a-1) of incorporation.
- (b) **Annual registration—**
  - (1) During the period beginning on October 1 and ending on December 31 of each year, every [person](/usc/21/321.md?p=e) who owns or operates any establishment in any [State](/usc/21/321.md?p=a-1) engaged in the manufacture, preparation, propagation, compounding, or processing of a [drug](/usc/21/321.md?p=g-1) or [drugs](/usc/21/321.md?p=g-1) shall register with the [Secretary](/usc/21/321.md?p=d) the name of such [person](/usc/21/321.md?p=e), places of business of such [person](/usc/21/321.md?p=e), all such establishments, the unique facility identifier of each such establishment, and a point of contact e-mail address.
  - (2) During the period beginning on October 1 and ending on December 31 of each year, every [person](/usc/21/321.md?p=e) who owns or operates any establishment in any [State](/usc/21/321.md?p=a-1) engaged in the manufacture, preparation, propagation, compounding, or processing of a [device](/usc/21/321.md?p=h-1) or [devices](/usc/21/321.md?p=h-1) shall register with the [Secretary](/usc/21/321.md?p=d) his name, places of business, and all such establishments.
  - (3) The [Secretary](/usc/21/321.md?p=d) shall specify the unique facility identifier system that shall be used by registrants under [paragraph (1)](#b-1). The requirement to include a unique facility identifier in a registration under [paragraph (1)](#b-1) shall not apply until the date that the identifier system is specified by the [Secretary](/usc/21/321.md?p=d) under the preceding sentence.
- (c) **New producers—** Every [person](/usc/21/321.md?p=e) upon first engaging in the manufacture, preparation, propagation, compounding, or processing of a [drug](/usc/21/321.md?p=g-1) or [drugs](/usc/21/321.md?p=g-1) or a [device](/usc/21/321.md?p=h-1) or [devices](/usc/21/321.md?p=h-1) in any establishment which he owns or operates in any [State](/usc/21/321.md?p=a-1) shall immediately register with the [Secretary](/usc/21/321.md?p=d)—
  - (1) with respect to [drugs](/usc/21/321.md?p=g-1), the information described under [subsection (b)(1)](#b-1); and
  - (2) with respect to [devices](/usc/21/321.md?p=h-1), the information described under [subsection (b)(2)](#b-2)..[^1]
- (d) **Additional establishments—** Every [person](/usc/21/321.md?p=e) duly registered in accordance with the foregoing subsections of this section shall immediately register with the [Secretary](/usc/21/321.md?p=d) any additional establishment which he owns or operates in any [State](/usc/21/321.md?p=a-1) and in which he begins the manufacture, preparation, propagation, compounding, or processing of a [drug](/usc/21/321.md?p=g-1) or [drugs](/usc/21/321.md?p=g-1) or a [device](/usc/21/321.md?p=h-1) or [devices](/usc/21/321.md?p=h-1).
- (e) **Registration number; uniform system for identification of devices intended for human use—** The [Secretary](/usc/21/321.md?p=d) may assign a registration number to any [person](/usc/21/321.md?p=e) or any establishment registered in accordance with this section. The [Secretary](/usc/21/321.md?p=d) may also assign a listing number to each [drug](/usc/21/321.md?p=g-1) or class of [drugs](/usc/21/321.md?p=g-1) listed under [subsection (j)](#j). Any number assigned pursuant to the preceding sentence shall be the same as that assigned pursuant to the National Drug Code. The [Secretary](/usc/21/321.md?p=d) may by regulation prescribe a uniform system for the identification of [devices](/usc/21/321.md?p=h-1) intended for human use and may require that [persons](/usc/21/321.md?p=e) who are required to list such [devices](/usc/21/321.md?p=h-1) pursuant to [subsection (j)](#j) shall list such [devices](/usc/21/321.md?p=h-1) in accordance with such system.
- (f) **Availability of registrations for inspection—** The [Secretary](/usc/21/321.md?p=d) shall make available for inspection, to any [person](/usc/21/321.md?p=e) so requesting, any registration filed pursuant to this section; except that any list submitted pursuant to [paragraph (3)](#j-3) of subsection (j) and the information accompanying any list or notice filed under paragraph [(1)](#j-1) or [(2)](#j-2) of that subsection shall be exempt from such inspection unless the [Secretary](/usc/21/321.md?p=d) finds that such an exemption would be inconsistent with protection of the public health.
- (g) **Exclusions from application of section—** The foregoing subsections of this section shall not apply to—
  - (1) pharmacies which maintain establishments in conformance with any applicable local laws regulating the practice of pharmacy and medicine and which are regularly engaged in dispensing [prescription drugs](/usc/21/360eee.md?p=12) or [devices](/usc/21/321.md?p=h-1), upon prescriptions of practitioners [licensed](/usc/21/360eee.md?p=9) to administer such [drugs](/usc/21/321.md?p=g-1) or [devices](/usc/21/321.md?p=h-1) to patients under the care of such practitioners in the course of their professional practice, and which do not manufacture, prepare, propagate, compound, or process [drugs](/usc/21/321.md?p=g-1) or [devices](/usc/21/321.md?p=h-1) for sale other than in the regular course of their business of dispensing or selling [drugs](/usc/21/321.md?p=g-1) or [devices](/usc/21/321.md?p=h-1) at retail;
  - (2) practitioners [licensed](/usc/21/360eee.md?p=9) by law to prescribe or administer [drugs](/usc/21/321.md?p=g-1) or [devices](/usc/21/321.md?p=h-1) and who manufacture, prepare, propagate, compound, or process [drugs](/usc/21/321.md?p=g-1) or [devices](/usc/21/321.md?p=h-1) solely for use in the course of their professional practice;
  - (3) [persons](/usc/21/321.md?p=e) who manufacture, prepare, propagate, compound, or process [drugs](/usc/21/321.md?p=g-1) or [devices](/usc/21/321.md?p=h-1) solely for use in research, teaching, or chemical analysis and not for sale;
  - (4) any distributor who acts as a [wholesale distributor](/usc/21/360eee.md?p=29) of [devices](/usc/21/321.md?p=h-1), and who does not manufacture, repackage, process, or relabel a [device](/usc/21/321.md?p=h-1); or
  - (5) such other classes of [persons](/usc/21/321.md?p=e) as the [Secretary](/usc/21/321.md?p=d) may by regulation exempt from the application of this section upon a finding that registration by such classes of [persons](/usc/21/321.md?p=e) in accordance with this section is not necessary for the protection of the public health.

  In this subsection, the term “[wholesale distributor](/usc/21/360eee.md?p=29)” means any [person](/usc/21/321.md?p=e) (other than the [manufacturer](/usc/21/360hh.md?p=3) or the initial importer) who [distributes](/usc/21/360eee.md?p=5) a [device](/usc/21/321.md?p=h-1) from the original place of manufacture to the [person](/usc/21/321.md?p=e) who makes the final delivery or sale of the [device](/usc/21/321.md?p=h-1) to the ultimate consumer or user.

- (h) **Inspections—**
  - (1) **In general—** Every establishment that is required to be registered with the [Secretary](/usc/21/321.md?p=d) under this section shall be subject to inspection pursuant to [section 374 of this title](/usc/21/374.md).
  - (2) **Risk-based schedule for devices—**
    - (A) **In general—** The [Secretary](/usc/21/321.md?p=d), acting through one or more officers or employees duly designated by the [Secretary](/usc/21/321.md?p=d), shall inspect establishments described in [paragraph (1)](#h-1) that are engaged in the manufacture, propagation, compounding, or processing of a [device](/usc/21/321.md?p=h-1) or [devices](/usc/21/321.md?p=h-1) (referred to in this subsection as “[device](/usc/21/321.md?p=h-1) establishments”) in accordance with a risk-based schedule established by the [Secretary](/usc/21/321.md?p=d).
    - (B) **Factors and considerations—** In establishing the risk-based schedule under [subparagraph (A)](#h-2-A), the [Secretary](/usc/21/321.md?p=d) shall—
      - (i) apply, to the extent applicable for [device](/usc/21/321.md?p=h-1) establishments, the factors identified in [paragraph (4)](#h-4); and
      - (ii) consider the participation of the [device](/usc/21/321.md?p=h-1) establishment, as applicable, in international [device](/usc/21/321.md?p=h-1) audit programs in which the United States participates or the United States recognizes for purposes of inspecting [device](/usc/21/321.md?p=h-1) establishments.
  - (3) **Risk-based schedule for drugs—** The [Secretary](/usc/21/321.md?p=d), acting through one or more officers or employees duly designated by the [Secretary](/usc/21/321.md?p=d), shall inspect establishments described in [paragraph (1)](#h-1) that are engaged in the manufacture, preparation, propagation, compounding, or processing of a [drug](/usc/21/321.md?p=g-1) or [drugs](/usc/21/321.md?p=g-1) (referred to in this subsection as “[drug](/usc/21/321.md?p=g-1) establishments”) in accordance with a risk-based schedule established by the [Secretary](/usc/21/321.md?p=d).
  - (4) **Risk factors—** In establishing a risk-based schedule under paragraph [(2)](#h-2) or [(3)](#h-3), the [Secretary](/usc/21/321.md?p=d) shall inspect establishments according to the known safety risks of such establishments, which shall be based on the following factors:
    - (A) The compliance history of the establishment.
    - (B) The record, history, and nature of recalls linked to the establishment.
    - (C) The inherent risk of the [drug](/usc/21/321.md?p=g-1) or [device](/usc/21/321.md?p=h-1) manufactured, prepared, propagated, compounded, or processed at the establishment.
    - (D) The inspection frequency and history of the establishment, including whether the establishment has been inspected pursuant to [section 374 of this title](/usc/21/374.md) within the last 4 years.
    - (E) Whether the establishment has been inspected by a foreign government or an agency of a foreign government recognized under [section 384e of this title](/usc/21/384e.md).
    - (F) The compliance history of establishments in the country or region in which the establishment is located that are subject to regulation under this chapter, including the history of violations related to [products](/usc/21/360eee.md?p=13) exported from such country or region that are subject to such regulation.
    - (G) Any other criteria deemed necessary and appropriate by the [Secretary](/usc/21/321.md?p=d) for purposes of allocating inspection resources.
  - (5) **Effect of status—** In determining the risk associated with an establishment for purposes of establishing a risk-based schedule under [paragraph (3)](#h-3), the [Secretary](/usc/21/321.md?p=d) shall not consider whether the [drugs](/usc/21/321.md?p=g-1) manufactured, prepared, propagated, compounded, or processed by such establishment are [drugs](/usc/21/321.md?p=g-1) described in [section 353(b) of this title](/usc/21/353.md?p=b).
  - (6) **Annual report on inspections of establishments—** Not later than May 1 of each year, the [Secretary](/usc/21/321.md?p=d) shall make available on the Internet Web site of the [Food](/usc/21/321.md?p=f) and [Drug](/usc/21/321.md?p=g-1) Administration a report regarding—
    - (A)
      - (i) the number of domestic and foreign establishments registered pursuant to this section in the previous fiscal year;
      - (ii) the number of such registered establishments in each region of interest;
      - (iii) the number of such domestic establishments and the number of such foreign establishments, including the number of establishments in each region of interest, that the [Secretary](/usc/21/321.md?p=d) inspected in the previous fiscal year;
      - (iv) the number of inspections to support actions by the [Secretary](/usc/21/321.md?p=d) on applications under [section 355 of this title](/usc/21/355.md) or [section 262 of title 42](/usc/42/262.md), including the number of inspections to support actions by the [Secretary](/usc/21/321.md?p=d) on supplemental applications, including changes to manufacturing processes, the [Secretary](/usc/21/321.md?p=d) conducted in the previous fiscal year;
      - (v) the number of routine surveillance inspections the [Secretary](/usc/21/321.md?p=d) conducted in the previous fiscal year, including in each region of interest;
      - (vi) the number of for-cause inspections the [Secretary](/usc/21/321.md?p=d) conducted in the previous fiscal year, not including inspections described in [clause (iv)](#h-6-A-iv), including in each region of interest; and
      - (vii) the number of inspections the [Secretary](/usc/21/321.md?p=d) has recognized pursuant to an agreement entered into pursuant to [section 384e of this title](/usc/21/384e.md), or otherwise recognized, for each of the types of inspections described in clauses [(v)](#h-6-A-v) and [(vi)](#h-6-A-vi), including for inspections of establishments in each region of interest.[^2]
    - (B) with respect to establishments that manufacture, prepare, propagate, compound, or process an active ingredient of a [drug](/usc/21/321.md?p=g-1) or a finished [drug product](/usc/21/321.md?p=dd), the number of each such type of establishment;
    - (C) the percentage of the budget of the [Food](/usc/21/321.md?p=f) and [Drug](/usc/21/321.md?p=g-1) Administration used to fund the inspections described under [subparagraph (A)](#h-6-A); and
    - (D) the status of the efforts of the [Food](/usc/21/321.md?p=f) and [Drug](/usc/21/321.md?p=g-1) Administration to expand its recognition of inspections conducted or recognized by foreign regulatory authorities under [section 384e of this title](/usc/21/384e.md), including any obstacles to expanding the use of such recognition.
  - (7) **Region of interest—** For purposes of [paragraph (6)(A)](#h-6-A), the term “region of interest” means a foreign geographic region or country, including the People’s Republic of China, India, the European Union, the United Kingdom, and any other country or geographic region, as the [Secretary](/usc/21/321.md?p=d) determines appropriate.
- (i) **Registration of foreign establishments—**
  - (1) Every [person](/usc/21/321.md?p=e) who owns or operates any establishment within any foreign country engaged in the manufacture, preparation, propagation, compounding, or processing of a [drug](/usc/21/321.md?p=g-1) or [device](/usc/21/321.md?p=h-1) that is imported or offered for import into the United States shall, through electronic means in accordance with the criteria of the [Secretary](/usc/21/321.md?p=d)—
    - (A) upon first engaging in any such activity, immediately submit a registration to the [Secretary](/usc/21/321.md?p=d) that includes—
      - (i) with respect to [drugs](/usc/21/321.md?p=g-1), the name and place of business of such [person](/usc/21/321.md?p=e), all such establishments, the unique facility identifier of each such establishment, a point of contact e-mail address, the name of the United States agent of each such establishment, the name of each importer of such [drug](/usc/21/321.md?p=g-1) in the United States that is known to the establishment, and the name of each [person](/usc/21/321.md?p=e) who imports or offers for import such [drug](/usc/21/321.md?p=g-1) to the United States for purposes of importation; and
      - (ii) with respect to [devices](/usc/21/321.md?p=h-1), the name and place of business of the establishment, the name of the United States agent for the establishment, the name of each importer of such [device](/usc/21/321.md?p=h-1) in the United States that is known to the establishment, and the name of each [person](/usc/21/321.md?p=e) who imports or offers for import such [device](/usc/21/321.md?p=h-1) to the United States for purposes of importation; and
    - (B) each establishment subject to the requirements of [subparagraph (A)](#i-1-A) shall thereafter register with the [Secretary](/usc/21/321.md?p=d) during the period beginning on October 1 and ending on December 31 of each year.
  - (2) The establishment shall also provide the information required by [subsection (j)](#j).
  - (3) The [Secretary](/usc/21/321.md?p=d) is [authorized](/usc/21/360eee.md?p=2) to enter into cooperative arrangements with officials of foreign countries to ensure that adequate and effective means are available for purposes of determining, from time to time, whether [drugs](/usc/21/321.md?p=g-1) or [devices](/usc/21/321.md?p=h-1) manufactured, prepared, propagated, compounded, or processed by an establishment described in [paragraph (1)](#i-1), if imported or offered for import into the United States, shall be refused admission on any of the grounds set forth in [section 381(a) of this title](/usc/21/381.md?p=a).
  - (4) The [Secretary](/usc/21/321.md?p=d) shall specify the unique facility identifier system that shall be used by registrants under [paragraph (1)](#i-1) with respect to [drugs](/usc/21/321.md?p=g-1). The requirement to include a unique facility identifier in a registration under [paragraph (1)](#i-1) with respect to [drugs](/usc/21/321.md?p=g-1) shall not apply until the date that the identifier system is specified by the [Secretary](/usc/21/321.md?p=d) under the preceding sentence.
  - (5) The requirements of paragraphs [(1)](#i-1) and [(2)](#i-2) shall apply regardless of whether the [drug](/usc/21/321.md?p=g-1) or [device](/usc/21/321.md?p=h-1) undergoes further manufacture, preparation, propagation, compounding, or processing at a separate establishment outside the United States prior to being imported or offered for import into the United States.
- (j) **Filing of lists of drugs and devices manufactured, prepared, propagated and compounded by registrants; statements; accompanying disclosures—**
  - (1) Every [person](/usc/21/321.md?p=e) who registers with the [Secretary](/usc/21/321.md?p=d) under subsection [(b)](#b), [(c)](#c), [(d)](#d), or [(i)](#i) shall, at the time of registration under any such subsection, file with the [Secretary](/usc/21/321.md?p=d) a list of all [drugs](/usc/21/321.md?p=g-1) and a list of all [devices](/usc/21/321.md?p=h-1) and a brief statement of the basis for believing that each [device](/usc/21/321.md?p=h-1) included in the list is a [device](/usc/21/321.md?p=h-1) rather than a [drug](/usc/21/321.md?p=g-1) (with each [drug](/usc/21/321.md?p=g-1) and [device](/usc/21/321.md?p=h-1) in each list listed by its established name (as defined in [section 352(e) of this title](/usc/21/352.md?p=e)) and by any proprietary name) which are being manufactured, prepared, propagated, compounded, or processed by him for commercial [distribution](/usc/21/360eee.md?p=5) and which he has not included in any list of [drugs](/usc/21/321.md?p=g-1) or [devices](/usc/21/321.md?p=h-1) filed by him with the [Secretary](/usc/21/321.md?p=d) under this paragraph or [paragraph (2)](#j-2) before such time of registration. Such list shall be prepared in such form and manner as the [Secretary](/usc/21/321.md?p=d) may prescribe and shall be accompanied by—
    - (A) in the case of a [drug](/usc/21/321.md?p=g-1) contained in the applicable list and subject to section [355](/usc/21/355.md) or [360b](/usc/21/360b.md) of this title, or a [device](/usc/21/321.md?p=h-1) intended for human use contained in the applicable list with respect to which a performance standard has been established under [section 360d of this title](/usc/21/360d.md) or which is subject to [section 360e of this title](/usc/21/360e.md), a reference to the authority for the marketing of such [drug](/usc/21/321.md?p=g-1) or [device](/usc/21/321.md?p=h-1) and a copy of all [labeling](/usc/21/321.md?p=m) for such [drug](/usc/21/321.md?p=g-1) or [device](/usc/21/321.md?p=h-1);
    - (B) in the case of any other [drug](/usc/21/321.md?p=g-1) or [device](/usc/21/321.md?p=h-1) contained in an applicable list—
      - (i) which [drug](/usc/21/321.md?p=g-1) is subject to [section 353(b)(1) of this title](/usc/21/353.md?p=b-1), or which [device](/usc/21/321.md?p=h-1) is a restricted [device](/usc/21/321.md?p=h-1), a copy of all [labeling](/usc/21/321.md?p=m) for such [drug](/usc/21/321.md?p=g-1) or [device](/usc/21/321.md?p=h-1), a representative sampling of advertisements for such [drug](/usc/21/321.md?p=g-1) or [device](/usc/21/321.md?p=h-1), and, upon request made by the [Secretary](/usc/21/321.md?p=d) for good cause, a copy of all advertisements for a particular [drug product](/usc/21/321.md?p=dd) or [device](/usc/21/321.md?p=h-1), or
      - (ii) which [drug](/usc/21/321.md?p=g-1) is not subject to [section 353(b)(1) of this title](/usc/21/353.md?p=b-1) or which [device](/usc/21/321.md?p=h-1) is not a restricted [device](/usc/21/321.md?p=h-1), the [label](/usc/21/321.md?p=k) and [package](/usc/21/360eee.md?p=11-A) insert for such [drug](/usc/21/321.md?p=g-1) or [device](/usc/21/321.md?p=h-1) and a representative sampling of any other [labeling](/usc/21/321.md?p=m) for such [drug](/usc/21/321.md?p=g-1) or [device](/usc/21/321.md?p=h-1);
    - (C) in the case of any [drug](/usc/21/321.md?p=g-1) contained in an applicable list which is described in [subparagraph (B)](#j-1-B), a quantitative listing of its active ingredient or ingredients, except that with respect to a particular [drug product](/usc/21/321.md?p=dd) the [Secretary](/usc/21/321.md?p=d) may require the submission of a quantitative listing of all ingredients if he finds that such submission is necessary to carry out the purposes of this chapter;
    - (D) if the registrant filing a list has determined that a particular [drug product](/usc/21/321.md?p=dd) or [device](/usc/21/321.md?p=h-1) contained in such list is not subject to section [355](/usc/21/355.md) or [360b](/usc/21/360b.md) of this title, or the particular [device](/usc/21/321.md?p=h-1) contained in such list is not subject to a performance standard established under [section 360d of this title](/usc/21/360d.md) or to [section 360e of this title](/usc/21/360e.md) or is not a restricted [device](/usc/21/321.md?p=h-1) a brief statement of the basis upon which the registrant made such determination if the [Secretary](/usc/21/321.md?p=d) requests such a statement with respect to that particular [drug product](/usc/21/321.md?p=dd) or [device](/usc/21/321.md?p=h-1); and
    - (E) in the case of a [drug](/usc/21/321.md?p=g-1) contained in the applicable list, the name and place of business of each [manufacturer](/usc/21/360hh.md?p=3) of an excipient of the listed [drug](/usc/21/321.md?p=g-1) with which the [person](/usc/21/321.md?p=e) listing the [drug](/usc/21/321.md?p=g-1) conducts business, including all establishments used in the production of such excipient, the unique facility identifier of each such establishment, and a point of contact e-mail address for each such excipient [manufacturer](/usc/21/360hh.md?p=3).
  - (2) Each [person](/usc/21/321.md?p=e) who registers with the [Secretary](/usc/21/321.md?p=d) under this section shall report to the [Secretary](/usc/21/321.md?p=d), with regard to [drugs](/usc/21/321.md?p=g-1) once during the month of June of each year and once during the month of December of each year, and with regard to [devices](/usc/21/321.md?p=h-1) once each year during the period beginning on October 1 and ending on December 31, the following information:
    - (A) A list of each [drug](/usc/21/321.md?p=g-1) or [device](/usc/21/321.md?p=h-1) introduced by the registrant for commercial [distribution](/usc/21/360eee.md?p=5) which has not been included in any list previously filed by him with the [Secretary](/usc/21/321.md?p=d) under this subparagraph or paragraph (1) of this subsection. A list under this subparagraph shall list a [drug](/usc/21/321.md?p=g-1) or [device](/usc/21/321.md?p=h-1) by its established name (as defined in [section 352(e) of this title](/usc/21/352.md?p=e)), and by any proprietary name it may have and shall be accompanied by the other information required by [paragraph (1)](#j-1).
    - (B) If since the date the registrant last made a report under this paragraph (or if he has not made a report under this paragraph, since February 1, 1973) he has discontinued the manufacture, preparation, propagation, compounding, or processing for commercial [distribution](/usc/21/360eee.md?p=5) of a [drug](/usc/21/321.md?p=g-1) or [device](/usc/21/321.md?p=h-1) included in a list filed by him under [subparagraph (A)](#j-2-A) or [paragraph (1)](#j-1); notice of such discontinuance, the date of such discontinuance, and the identity (by established name (as defined in [section 352(e) of this title](/usc/21/352.md?p=e)) and by any proprietary name) of such [drug](/usc/21/321.md?p=g-1) or [device](/usc/21/321.md?p=h-1).
    - (C) If since the date the registrant reported pursuant to [subparagraph (B)](#j-2-B) a notice of discontinuance he has resumed the manufacture, preparation, propagation, compounding, or processing for commercial [distribution](/usc/21/360eee.md?p=5) of the [drug](/usc/21/321.md?p=g-1) or [device](/usc/21/321.md?p=h-1) with respect to which such notice of discontinuance was reported; notice of such resumption, the date of such resumption, the identity of such [drug](/usc/21/321.md?p=g-1) or [device](/usc/21/321.md?p=h-1) (each by established name (as defined in [section 352(e) of this title](/usc/21/352.md?p=e)) and by any proprietary name), and the other information required by [paragraph (1)](#j-1), unless the registrant has previously reported such resumption to the [Secretary](/usc/21/321.md?p=d) pursuant to this subparagraph.
    - (D) Any material change in any information previously submitted pursuant to this paragraph or [paragraph (1)](#j-1).
  - (3)
    - (A) Each [person](/usc/21/321.md?p=e) who registers with the [Secretary](/usc/21/321.md?p=d) under this section with regard to a [drug](/usc/21/321.md?p=g-1) shall report annually to the [Secretary](/usc/21/321.md?p=d) on the amount of each [drug](/usc/21/321.md?p=g-1) listed under [paragraph (1)](#j-1) that was manufactured, prepared, propagated, compounded, or processed by such [person](/usc/21/321.md?p=e) for commercial [distribution](/usc/21/360eee.md?p=5). Such information may be required to be submitted in an electronic format as determined by the [Secretary](/usc/21/321.md?p=d). The [Secretary](/usc/21/321.md?p=d) may require that information required to be reported under this paragraph be submitted at the time a public health emergency is declared by the [Secretary](/usc/21/321.md?p=d) under [section 247d of title 42](/usc/42/247d.md).
    - (B) By order of the [Secretary](/usc/21/321.md?p=d), certain biological [products](/usc/21/360eee.md?p=13) or categories of biological [products](/usc/21/360eee.md?p=13) regulated under [section 262 of title 42](/usc/42/262.md) may be exempt from some or all of the reporting requirements under [subparagraph (A)](#j-3-A), if the [Secretary](/usc/21/321.md?p=d) determines that applying such reporting requirements to such biological [products](/usc/21/360eee.md?p=13) or categories of biological [products](/usc/21/360eee.md?p=13) is not necessary to protect the public health.
  - (4) The [Secretary](/usc/21/321.md?p=d) may also require each registrant under this section to submit a list of each [drug product](/usc/21/321.md?p=dd) which (A) the registrant is manufacturing, preparing, propagating, compounding, or processing for commercial [distribution](/usc/21/360eee.md?p=5), and (B) contains a particular ingredient. The [Secretary](/usc/21/321.md?p=d) may not require the submission of such a list unless he has made a finding that the submission of such a list is necessary to carry out the purposes of this chapter.
  - (5) The [Secretary](/usc/21/321.md?p=d) shall require [persons](/usc/21/321.md?p=e) subject to this subsection to use, for purposes of this subsection, the unique facility identifier systems specified under subsections [(b)(3)](#b-3) and [(i)(4)](#i-4) with respect to [drugs](/usc/21/321.md?p=g-1). Such requirement shall not apply until the date that the identifier system under subsection [(b)(3)](#b-3) or [(i)(4)](#i-4), as applicable, is specified by the [Secretary](/usc/21/321.md?p=d).
- (k) **Report preceding introduction of devices into interstate commerce—** Each [person](/usc/21/321.md?p=e) who is required to register under this section and who proposes to begin the introduction or delivery for introduction into [interstate commerce](/usc/21/321.md?p=b) for commercial [distribution](/usc/21/360eee.md?p=5) of a [device](/usc/21/321.md?p=h-1) intended for human use shall, at least ninety days before making such introduction or delivery, report to the [Secretary](/usc/21/321.md?p=d) or [person](/usc/21/321.md?p=e) who is accredited under [section 360m(a) of this title](/usc/21/360m.md?p=a) (in such form and manner as the [Secretary](/usc/21/321.md?p=d) shall by regulation prescribe)—
  - (1) the class in which the [device](/usc/21/321.md?p=h-1) is classified under [section 360c of this title](/usc/21/360c.md) or if such [person](/usc/21/321.md?p=e) determines that the [device](/usc/21/321.md?p=h-1) is not classified under such section, a statement of that determination and the basis for such [person](/usc/21/321.md?p=e)’s determination that the [device](/usc/21/321.md?p=h-1) is or is not so classified, and
  - (2) action taken by such [person](/usc/21/321.md?p=e) to comply with requirements under section [360d](/usc/21/360d.md) or [360e](/usc/21/360e.md) of this title which are applicable to the [device](/usc/21/321.md?p=h-1).

  A notification submitted under this subsection that contains clinical trial data for an applicable [device](/usc/21/321.md?p=h-1) clinical trial (as defined in [section 282(j)(1) of title 42](/usc/42/282.md?p=j-1)) shall be accompanied by the certification required under [section 282(j)(5)(B)](/usc/42/282.md?p=j-5-B) of such title. Such certification shall not be considered an element of such notification.

- (l) **Exemption from reporting requirements—**
  - (1) A report under [subsection (k)](#k) is not required for a [device](/usc/21/321.md?p=h-1) intended for human use that is exempted from the requirements of this subsection under [subsection (m)](#m) or is within a type that has been classified into class I under [section 360c of this title](/usc/21/360c.md), or with respect to a change that is consistent with a predetermined change control plan cleared under [section 360e–4 of this title](/usc/21/360e–4.md). The exception established in the preceding sentence does not apply to any class I [device](/usc/21/321.md?p=h-1) that is intended for a use which is of substantial importance in preventing impairment of human health, or to any class I [device](/usc/21/321.md?p=h-1) that presents a potential unreasonable risk of illness or injury.
  - (2) Not later than 120 calendar days after December 13, 2016, and at least once every 5 years thereafter, as the [Secretary](/usc/21/321.md?p=d) determines appropriate, the [Secretary](/usc/21/321.md?p=d) shall identify, through publication in the Federal Register, any type of class I [device](/usc/21/321.md?p=h-1) that the [Secretary](/usc/21/321.md?p=d) determines no longer requires a report under [subsection (k)](#k) to provide reasonable assurance of safety and effectiveness. Upon such publication—
    - (A) each type of class I [device](/usc/21/321.md?p=h-1) so identified shall be exempt from the requirement for a report under [subsection (k)](#k); and
    - (B) the classification regulation applicable to each such type of [device](/usc/21/321.md?p=h-1) shall be deemed amended to incorporate such exemption.
- (m) **List of exempt class II devices; initial and final determinations by Secretary; publication in Federal Register—**
  - (1) The [Secretary](/usc/21/321.md?p=d) shall—
    - (A) not later than 90 days after December 13, 2016, and at least once every 5 years thereafter, as the [Secretary](/usc/21/321.md?p=d) determines appropriate—
      - (i) publish in the Federal Register a notice that contains a list of each type of class II [device](/usc/21/321.md?p=h-1) that the [Secretary](/usc/21/321.md?p=d) determines no longer requires a report under [subsection (k)](#k) to provide reasonable assurance of safety and effectiveness; and
      - (ii) provide for a period of not less than 60 calendar days for public comment beginning on the date of the publication of such notice; and
    - (B) not later than 210 calendar days after December 13, 2016, publish in the Federal Register a list representing the [Secretary](/usc/21/321.md?p=d)’s final determination with respect to the [devices](/usc/21/321.md?p=h-1) contained in the list published under [subparagraph (A)](#m-1-A).
  - (2) Beginning on the date that is 1 calendar day after the date of publication of the final list under [paragraph (1)(B)](#m-1-B), the [Secretary](/usc/21/321.md?p=d) may exempt a class II [device](/usc/21/321.md?p=h-1) from the requirement to submit a report under [subsection (k)](#k), upon the [Secretary](/usc/21/321.md?p=d)’s own initiative or a petition of an interested [person](/usc/21/321.md?p=e), if the [Secretary](/usc/21/321.md?p=d) determines that such report is not necessary to assure the safety and effectiveness of the [device](/usc/21/321.md?p=h-1). The [Secretary](/usc/21/321.md?p=d) shall publish in the Federal Register notice of the intent of the [Secretary](/usc/21/321.md?p=d) to exempt the [device](/usc/21/321.md?p=h-1), or of the petition, and provide a 60-calendar-day period for public comment. Within 120 days after the issuance of the notice in the Federal Register, the [Secretary](/usc/21/321.md?p=d) shall publish an order in the Federal Register that sets forth the final determination of the [Secretary](/usc/21/321.md?p=d) regarding the exemption of the [device](/usc/21/321.md?p=h-1) that was the subject of the notice. If the [Secretary](/usc/21/321.md?p=d) fails to respond to a petition within 180 days of receiving it, the petition shall be deemed to be granted.
  - (3) Upon the publication of the final list under [paragraph (1)(B)](#m-1-B)—
    - (A) each type of class II [device](/usc/21/321.md?p=h-1) so listed shall be exempt from the requirement for a report under [subsection (k)](#k); and
    - (B) the classification regulation applicable to each such type of [device](/usc/21/321.md?p=h-1) shall be deemed amended to incorporate such exemption.
- (n) **Review of report; time for determination by Secretary—**
  - (1) The [Secretary](/usc/21/321.md?p=d) shall review the report required in [subsection (k)](#k) and make a determination under [section 360c(f)(1) of this title](/usc/21/360c.md?p=f-1) not later than 90 days after receiving the report.
  - (2)
    - (A) Not later than 18 months after July 9, 2012, the [Secretary](/usc/21/321.md?p=d) shall submit to the Committee on Energy and [Commerce](/usc/21/360hh.md?p=4) of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate a report regarding when a premarket notification under [subsection (k)](#k) should be submitted for a modification or change to a legally marketed [device](/usc/21/321.md?p=h-1). The report shall include the [Secretary](/usc/21/321.md?p=d)’s interpretation of the following terms: “could significantly affect the safety or effectiveness of the [device](/usc/21/321.md?p=h-1)”, “a significant change or modification in design, material, chemical composition, energy source, or manufacturing process”, and “major change or modification in the intended use of the [device](/usc/21/321.md?p=h-1)”. The report also shall discuss possible processes for industry to use to determine whether a new submission under [subsection (k)](#k) is required and shall analyze how to leverage existing quality system requirements to reduce premarket burden, facilitate continual [device](/usc/21/321.md?p=h-1) improvement, and provide reasonable assurance of safety and effectiveness of modified [devices](/usc/21/321.md?p=h-1). In developing such report, the [Secretary](/usc/21/321.md?p=d) shall consider the input of interested stakeholders.
    - (B) The [Secretary](/usc/21/321.md?p=d) shall withdraw the [Food](/usc/21/321.md?p=f) and [Drug](/usc/21/321.md?p=g-1) Administration draft guidance entitled “Guidance for Industry and FDA Staff—510(k) [Device](/usc/21/321.md?p=h-1) Modifications: Deciding When to Submit a 510(k) for a Change to an Existing [Device](/usc/21/321.md?p=h-1)”, dated July 27, 2011, and shall not use this draft guidance as part of, or for the basis of, any premarket review or any compliance or enforcement decisions or actions. The [Secretary](/usc/21/321.md?p=d) shall not issue—
      - (i) any draft guidance or proposed regulation that addresses when to submit a premarket notification submission for changes and modifications made to a [manufacturer](/usc/21/360hh.md?p=3)’s previously cleared [device](/usc/21/321.md?p=h-1) before the receipt by the Committee on Energy and [Commerce](/usc/21/360hh.md?p=4) of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate of the report required in [subparagraph (A)](#n-2-A); and
      - (ii) any final guidance or regulation on that topic for one year after date of receipt of such report by the Committee on Energy and [Commerce](/usc/21/360hh.md?p=4) of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate.
    - (C) The [Food](/usc/21/321.md?p=f) and [Drug](/usc/21/321.md?p=g-1) Administration guidance entitled “Deciding When to Submit a 510(k) for a Change to an Existing [Device](/usc/21/321.md?p=h-1)”, dated January 10, 1997, shall be in effect until the subsequent issuance of guidance or promulgation, if appropriate, of a regulation described in [subparagraph (B)](#n-2-B), and the [Secretary](/usc/21/321.md?p=d) shall interpret such guidance in a manner that is consistent with the manner in which the [Secretary](/usc/21/321.md?p=d) has interpreted such guidance since 1997.
- (o) **Reprocessed single-use devices—**
  - (1) With respect to [reprocessed](/usc/21/321.md?p=ll-2-A) [single-use devices](/usc/21/321.md?p=ll-1) for which reports are required under [subsection (k)](#k):
    - (A) The [Secretary](/usc/21/321.md?p=d) shall identify such [devices](/usc/21/321.md?p=h-1) or types of [devices](/usc/21/321.md?p=h-1) for which reports under such subsection must, in order to ensure that the [device](/usc/21/321.md?p=h-1) is substantially equivalent to a predicate [device](/usc/21/321.md?p=h-1), include validation data, the types of which shall be specified by the [Secretary](/usc/21/321.md?p=d), regarding cleaning and sterilization, and functional performance demonstrating that the [single-use device](/usc/21/321.md?p=ll-1) will remain substantially equivalent to its predicate [device](/usc/21/321.md?p=h-1) after the maximum number of times the [device](/usc/21/321.md?p=h-1) is [reprocessed](/usc/21/321.md?p=ll-2-A) as intended by the [person](/usc/21/321.md?p=e) submitting the premarket notification. Within six months after October 26, 2002, the [Secretary](/usc/21/321.md?p=d) shall publish in the Federal Register a list of the types so identified, and shall revise the list as appropriate. Reports under [subsection (k)](#k) for [devices](/usc/21/321.md?p=h-1) or types of [devices](/usc/21/321.md?p=h-1) within a type included on the list are, upon publication of the list, required to include such validation data.
    - (B) In the case of each report under [subsection (k)](#k) that was submitted to the [Secretary](/usc/21/321.md?p=d) before the publication of the initial list under [subparagraph (A)](#o-1-A), or any revision thereof, and was for a [device](/usc/21/321.md?p=h-1) or type of [device](/usc/21/321.md?p=h-1) included on such list, the [person](/usc/21/321.md?p=e) who submitted the report under [subsection (k)](#k) shall submit validation data as described in [subparagraph (A)](#o-1-A) to the [Secretary](/usc/21/321.md?p=d) not later than nine months after the publication of the list. During such nine-month period, the [Secretary](/usc/21/321.md?p=d) may not take any action under this chapter against such [device](/usc/21/321.md?p=h-1) solely on the basis that the validation data for the [device](/usc/21/321.md?p=h-1) have not been submitted to the [Secretary](/usc/21/321.md?p=d). After the submission of the validation data to the [Secretary](/usc/21/321.md?p=d), the [Secretary](/usc/21/321.md?p=d) may not determine that the [device](/usc/21/321.md?p=h-1) is misbranded under [section 352(o)](/usc/21/352.md?p=o) of this title or adulterated under [section 351(f)(1)(B) of this title](/usc/21/351.md?p=f-1-B), or take action against the [device](/usc/21/321.md?p=h-1) under [section 331(p) of this title](/usc/21/331.md?p=p) for failure to provide any information required by [subsection (k)](#k) until (i) the review is terminated by withdrawal of the submission of the report under [subsection (k)](#k); (ii) the [Secretary](/usc/21/321.md?p=d) finds the data to be acceptable and issues a letter; or (iii) the [Secretary](/usc/21/321.md?p=d) determines that the [device](/usc/21/321.md?p=h-1) is not substantially equivalent to a predicate [device](/usc/21/321.md?p=h-1). Upon a determination that a [device](/usc/21/321.md?p=h-1) is not substantially equivalent to a predicate [device](/usc/21/321.md?p=h-1), or if such submission is withdrawn, the [device](/usc/21/321.md?p=h-1) can no longer be legally marketed.
    - (C) In the case of a report under [subsection (k)](#k) for a [device](/usc/21/321.md?p=h-1) identified under [subparagraph (A)](#o-1-A) that is of a type for which the [Secretary](/usc/21/321.md?p=d) has not previously received a report under such subsection, the [Secretary](/usc/21/321.md?p=d) may, in advance of revising the list under [subparagraph (A)](#o-1-A) to include such type, require that the report include the validation data specified in [subparagraph (A)](#o-1-A).
    - (D) [Section 352(o)](/usc/21/352.md?p=o) of this title applies with respect to the failure of a report under [subsection (k)](#k) to include validation data required under [subparagraph (A)](#o-1-A).
  - (2) With respect to critical or [semi-critical reprocessed single-use devices](/usc/21/321.md?p=mm-2) that, under subsection [(l)](#l) or [(m)](#m), are exempt from the requirement of submitting reports under [subsection (k)](#k):
    - (A) The [Secretary](/usc/21/321.md?p=d) shall identify such [devices](/usc/21/321.md?p=h-1) or types of [devices](/usc/21/321.md?p=h-1) for which such exemptions should be terminated in order to provide a reasonable assurance of the safety and effectiveness of the [devices](/usc/21/321.md?p=h-1). The [Secretary](/usc/21/321.md?p=d) shall publish in the Federal Register a list of the [devices](/usc/21/321.md?p=h-1) or types of [devices](/usc/21/321.md?p=h-1) so identified, and shall revise the list as appropriate. The exemption for each [device](/usc/21/321.md?p=h-1) or type included on the list is terminated upon the publication of the list. For each report under [subsection (k)](#k) submitted pursuant to this subparagraph the [Secretary](/usc/21/321.md?p=d) shall require the validation data described in [paragraph (1)(A)](#o-1-A).
    - (B) For each [device](/usc/21/321.md?p=h-1) or type of [device](/usc/21/321.md?p=h-1) included on the list under [subparagraph (A)](#o-2-A), a report under [subsection (k)](#k) shall be submitted to the [Secretary](/usc/21/321.md?p=d) not later than 15 months after the publication of the initial list, or a revision of the list, whichever terminates the exemption for the [device](/usc/21/321.md?p=h-1). During such 15-month period, the [Secretary](/usc/21/321.md?p=d) may not take any action under this chapter against such [device](/usc/21/321.md?p=h-1) solely on the basis that such report has not been submitted to the [Secretary](/usc/21/321.md?p=d). After the submission of the report to the [Secretary](/usc/21/321.md?p=d) the [Secretary](/usc/21/321.md?p=d) may not determine that the [device](/usc/21/321.md?p=h-1) is misbranded under [section 352(o)](/usc/21/352.md?p=o) of this title or adulterated under [section 351(f)(1)(B) of this title](/usc/21/351.md?p=f-1-B), or take action against the [device](/usc/21/321.md?p=h-1) under [section 331(p) of this title](/usc/21/331.md?p=p) for failure to provide any information required by [subsection (k)](#k) until (i) the review is terminated by withdrawal of the submission; (ii) the [Secretary](/usc/21/321.md?p=d) determines by order that the [device](/usc/21/321.md?p=h-1) is substantially equivalent to a predicate [device](/usc/21/321.md?p=h-1); or (iii) the [Secretary](/usc/21/321.md?p=d) determines by order that the [device](/usc/21/321.md?p=h-1) is not substantially equivalent to a predicate [device](/usc/21/321.md?p=h-1). Upon a determination that a [device](/usc/21/321.md?p=h-1) is not substantially equivalent to a predicate [device](/usc/21/321.md?p=h-1), the [device](/usc/21/321.md?p=h-1) can no longer be legally marketed.
    - (C) In the case of semi-critical [devices](/usc/21/321.md?p=h-1), the initial list under [subparagraph (A)](#o-2-A) shall be published not later than 18 months after the effective date of this subsection. In the case of critical [devices](/usc/21/321.md?p=h-1), the initial list under such subparagraph shall be published not later than six months after such effective date.
    - (D) [Section 352(o)](/usc/21/352.md?p=o) of this title applies with respect to the failure to submit a report under [subsection (k)](#k) that is required pursuant to [subparagraph (A)](#o-2-A), including a failure of the report to include validation data required in such subparagraph.
    - (E) The termination under [subparagraph (A)](#o-2-A) of an exemption under subsection [(l)](#l) or [(m)](#m) for a critical or [semi-critical reprocessed single-use device](/usc/21/321.md?p=mm-2) does not terminate the exemption under subsection [(l)](#l) or [(m)](#m) for the [original device](/usc/21/321.md?p=ll-3).
- (p) **Electronic registration and listing—**
  - (1) **In general—** Registrations and listings under this section (including the submission of updated information) shall be submitted to the [Secretary](/usc/21/321.md?p=d) by electronic means unless the [Secretary](/usc/21/321.md?p=d) grants a request for waiver of such requirement because use of electronic means is not reasonable for the [person](/usc/21/321.md?p=e) requesting such waiver.
  - (2) **Electronic database—** Not later than 2 years after the [Secretary](/usc/21/321.md?p=d) specifies a unique facility identifier system under subsections [(b)](#b) and [(i)](#i), the [Secretary](/usc/21/321.md?p=d) shall maintain an electronic database, which shall not be subject to inspection under [subsection (f)](#f), populated with the information submitted as described under [paragraph (1)](#p-1) that—
    - (A) enables personnel of the [Food](/usc/21/321.md?p=f) and [Drug](/usc/21/321.md?p=g-1) Administration to search the database by any field of information submitted in a registration described under [paragraph (1)](#p-1), or combination of such fields; and
    - (B) uses the unique facility identifier system to link with other relevant databases within the [Food](/usc/21/321.md?p=f) and [Drug](/usc/21/321.md?p=g-1) Administration, including the database for submission of information under [section 381(r) of this title](/usc/21/381.md?p=r).
  - (3) **Risk-based information and coordination—** The [Secretary](/usc/21/321.md?p=d) shall ensure the accuracy and coordination of relevant [Food](/usc/21/321.md?p=f) and [Drug](/usc/21/321.md?p=g-1) Administration databases in order to identify and inform risk-based inspections under [subsection (h)](#h).
- (q) **Reusable medical devices—**
  - (1) **In general—** Not later than 180 days after December 13, 2016, the [Secretary](/usc/21/321.md?p=d) shall identify and publish a list of reusable [device](/usc/21/321.md?p=h-1) types for which reports under [subsection (k)](#k) are required to include—
    - (A) instructions for use, which have been validated in a manner specified by the [Secretary](/usc/21/321.md?p=d); and
    - (B) validation data, the types of which shall be specified by the [Secretary](/usc/21/321.md?p=d);

    regarding cleaning, disinfection, and sterilization, and for which a substantial equivalence determination may be based.

  - (2) **Revision of list—** The [Secretary](/usc/21/321.md?p=d) shall revise the list under [paragraph (2)](#q-2),[^3] as the [Secretary](/usc/21/321.md?p=d) determines appropriate, with notice in the Federal Register.
  - (3) **Content of reports—** Reports under [subsection (k)](#k) that are submitted after the publication of the list described in [paragraph (1)](#q-1), for [devices](/usc/21/321.md?p=h-1) or types of [devices](/usc/21/321.md?p=h-1) included on such list, shall include such instructions for use and validation data.

## Footnotes

[^1]: So in original.
[^2]: So in original. The period probably should be a semicolon.
[^3]: So in original. Probably should be “paragraph (1),”.

## Source credit

(June 25, 1938, ch. 675, § 510, as added Pub. L. 87–781, title III, § 302, Oct. 10, 1962, 76 Stat. 794; amended Pub. L. 89–74, § 4, July 15, 1965, 79 Stat. 231; Pub. L. 91–513, title II, § 701(e), Oct. 27, 1970, 84 Stat. 1282; Pub. L. 92–387, §§ 3, 4(a)–(c), Aug. 16, 1972, 86 Stat. 560–562; Pub. L. 94–295, § 4(a), May 28, 1976, 90 Stat. 579; Pub. L. 105–115, title I, § 125(a)(2)(C), title II, §§ 206(a), 209(a), 213(b), title IV, § 417, Nov. 21, 1997, 111 Stat. 2325, 2338, 2341, 2347, 2379; Pub. L. 107–188, title III, § 321(a), June 12, 2002, 116 Stat. 675; Pub. L. 107–250, title II, §§ 201(e), 207, 211, title III, § 302(b), Oct. 26, 2002, 116 Stat. 1609, 1613, 1614, 1616; Pub. L. 108–214, § 2(c)(2), Apr. 1, 2004, 118 Stat. 576; Pub. L. 110–85, title II, §§ 222–224, title VIII, § 801(b)(3)(C), Sept. 27, 2007, 121 Stat. 853, 921; Pub. L. 112–144, title VI, § 604, title VII, §§ 701, 702(b)–705, July 9, 2012, 126 Stat. 1052, 1064–1066; Pub. L. 114–255, div. A, title III, §§ 3054, 3059(a), 3101(a)(2)(H), Dec. 13, 2016, 130 Stat. 1126, 1130, 1154; Pub. L. 115–52, title VII, § 701(a), title IX, § 901(e), Aug. 18, 2017, 131 Stat. 1054, 1076; Pub. L. 116–136, div. A, title III, § 3112(e), Mar. 27, 2020, 134 Stat. 363; Pub. L. 117–328, div. FF, title II, §§ 2511(a), 2515(a)(3), title III, §§ 3308(b)(1), 3613(a), 3616(c), Dec. 29, 2022, 136 Stat. 5803, 5806, 5836, 5872, 5875.)

## Notes

### Editorial Notes

### References in Text

The effective date of this subsection, referred to in subsec. (o)(2)(C), probably means the date of the enactment of Pub. L. 107–250, which enacted subsec. (o) of this section and was approved Oct. 26, 2002.

### Amendments

2022—Subsec. (h)(4)(F), (G). Pub. L. 117–328, § 3613(a), added subpar. (F) and redesignated former subpar. (F) as (G).

Subsec. (h)(6). Pub. L. 117–328, § 3616(c)(1)(A), substituted “Not” for “Beginning in 2014, not” in introductory provisions.

Subsec. (h)(6)(A). Pub. L. 117–328, § 3616(c)(1)(B), amended subpar. (A) generally. Prior to amendment, subpar. (A) read as follows:

“(A)(i) the number of domestic and foreign establishments registered pursuant to this section in the previous calendar year; and

“(ii) the number of such domestic establishments and the number of such foreign establishments that the Secretary inspected in the previous calendar year;”.

Subsec. (h)(6)(D). Pub. L. 117–328, § 3616(c)(1)(C)–(E), added subpar. (D).

Subsec. (h)(7). Pub. L. 117–328, § 3616(c)(2), added par. (7).

Subsec. (i)(5). Pub. L. 117–328, § 2511(a), added par. (5).

Subsec. (j)(3) to (5). Pub. L. 117–328, § 2515(a)(3), made technical amendment to directory language of Pub. L. 116–136, § 3112(e). See 2020 Amendment note below.

Subsec. (l)(1). Pub. L. 117–328, § 3308(b)(1), inserted “, or with respect to a change that is consistent with a predetermined change control plan cleared under section 360e–4 of this title” after “section 360c of this title”.

2020—Subsec. (j)(3) to (5). Pub. L. 116–136, § 3112(e), as amended by Pub. L. 117–328, § 2515(a)(3), added par. (3) and redesignated former pars. (3) and (4) as (4) and (5), respectively.

2017—Subsec. (h)(2). Pub. L. 115–52, § 701(a)(1), added par. (2) and struck out former par. (2). Prior to amendment, text read as follows: “Every establishment described in paragraph (1), in any State, that is engaged in the manufacture, propagation, compounding, or processing of a device or devices classified in class II or III shall be so inspected by one or more officers or employees duly designated by the Secretary, or by persons accredited to conduct inspections under section 374(g) of this title, at least once in the 2-year period beginning with the date of registration of such establishment pursuant to this section and at least once in every successive 2-year period thereafter.”

Subsec. (h)(4). Pub. L. 115–52, § 701(a)(2)(A), substituted “paragraph (2) or (3)” for “paragraph (3)” in introductory provisions.

Subsec. (h)(4)(C). Pub. L. 115–52, § 701(a)(2)(B), inserted “or device” after “drug”.

Subsec. (h)(6). Pub. L. 115–52, § 901(e), substituted “May 1” for “February 1” in introductory provisions.

2016—Subsec. (h)(4). Pub. L. 114–255, § 3101(a)(2)(H)(i), substituted “establishing a risk-based schedule” for “establishing the risk-based scheduled” in introductory provisions.

Subsec. (h)(6)(A). Pub. L. 114–255, § 3101(a)(2)(H)(ii)(I), substituted “calendar” for “fiscal” in cls. (i) and (ii).

Subsec. (h)(6)(B). Pub. L. 114–255, § 3101(a)(2)(H)(ii)(II), substituted “an active ingredient of a drug or a finished drug product” for “an active ingredient of a drug, a finished drug product, or an excipient of a drug”.

Subsec. (l). Pub. L. 114–255, § 3054(a), designated existing provisions as par. (1) and added par. (2).

Subsec. (m)(1). Pub. L. 114–255, § 3054(b)(1), added par. (1) and struck out former par. (1) which read as follows: “Not later than 60 days after November 21, 1997, the Secretary shall publish in the Federal Register a list of each type of class II device that does not require a report under subsection (k) to provide reasonable assurance of safety and effectiveness. Each type of class II device identified by the Secretary as not requiring the report shall be exempt from the requirement to provide a report under subsection (k) as of the date of the publication of the list in the Federal Register. The Secretary shall publish such list on the Internet site of the Food and Drug Administration. The list so published shall be updated not later than 30 days after each revision of the list by the Secretary.”

Subsec. (m)(2). Pub. L. 114–255, § 3054(b)(2)(B), substituted “60-calendar-day period” for “30-day period”.

Pub. L. 114–255, § 3054(b)(2)(A), which directed the substitution of “1 calendar day after the date of publication of the final list under paragraph (1)(B),” for “1 day after the date of publication of a list under this subsection,”, was executed by making the substitution for “1 day after the date of the publication of a list under this subsection,” to reflect the probable intent of Congress.

Subsec. (m)(3). Pub. L. 114–255, § 3054(b)(2)(C), added par. (3).

Subsec. (q). Pub. L. 114–255, § 3059(a), added subsec. (q).

2012—Subsec. (b)(1). Pub. L. 112–144, § 701(1)(A), which directed amendment of par. (1) by “striking ‘On or before’ and all that follows through the period at the end and inserting the following: ‘During the period beginning on October 1 and ending on December 31 of each year, every person who owns or operates any establishment in any State engaged in the manufacture, preparation, propagation, compounding, or processing of a drug or drugs shall register with the Secretary the name of such person, places of business of such person, all such establishments, the unique facility identifier of each such establishment, and a point of contact e-mail address.; and”, was executed as if an end quotation mark for the inserted material followed “address.”, to reflect the probable intent of Congress. Prior to amendment, stricken text read as follows: “On or before December 31 of each year every person who owns or operates any establishment in any State engaged in the manufacture, preparation, propagation, compounding, or processing of a drug or drugs shall register with the Secretary his name, places of business, and all such establishments.”

Subsec. (b)(3). Pub. L. 112–144, § 701(1)(B), added par. (3).

Subsec. (c). Pub. L. 112–144, § 701(2), substituted “with the Secretary—” and pars. (1) and (2) for “with the Secretary his name, place of business, and such establishment”.

Subsec. (h). Pub. L. 112–144, § 705, amended subsec. (h) generally. Prior to amendment, text read as follows: “Every establishment in any State registered with the Secretary pursuant to this section shall be subject to inspection pursuant to section 374 of this title and every such establishment engaged in the manufacture, propagation, compounding, or processing of a drug or drugs or of a device or devices classified in class II or III shall be so inspected by one or more officers or employees duly designated by the Secretary, or by persons accredited to conduct inspections under section 374(g) of this title, at least once in the two-year period beginning with the date of registration of such establishment pursuant to this section and at least once in every successive two-year period thereafter.”

Subsec. (i)(1). Pub. L. 112–144, § 702(b)(1)(A), amended introductory provisions generally. Prior to amendment, text read as follows: “Any establishment within any foreign country engaged in the manufacture, preparation, propagation, compounding, or processing of a drug or device that is imported or offered for import into the United States shall, through electronic means in accordance with the criteria of the Secretary—”.

Subsec. (i)(1)(A). Pub. L. 112–144, § 702(b)(1)(B), amended subpar. (A) generally. Prior to amendment, subpar. (A) read as follows: “upon first engaging in any such activity, immediately register with the Secretary the name and place of business of the establishment, the name of the United States agent for the establishment, the name of each importer of such drug or device in the United States that is known to the establishment, and the name of each person who imports or offers for import such drug or device to the United States for purposes of importation; and”.

Subsec. (i)(1)(B). Pub. L. 112–144, § 702(b)(1)(C), amended subpar. (B) generally. Prior to amendment, subpar. (B) read as follows: “each establishment subject to the requirements of subparagraph (A) shall thereafter—

“(i) with respect to drugs, register with the Secretary on or before December 31 of each year; and

“(ii) with respect to devices, register with the Secretary during the period beginning on October 1 and ending on December 31 of each year.”

Subsec. (i)(4). Pub. L. 112–144, § 702(b)(2), added par. (4).

Subsec. (j)(1)(E). Pub. L. 112–144, § 703(1), added subpar. (E).

Subsec. (j)(4). Pub. L. 112–144, § 703(2), added par. (4).

Subsec. (n). Pub. L. 112–144, § 604, designated existing provisions as par. (1) and added par. (2).

Subsec. (p). Pub. L. 112–144, § 704, inserted subsec. heading, designated existing provisions as par. (1) and inserted par. heading, and added pars. (2) and (3).

2007—Subsec. (b). Pub. L. 110–85, § 222(a), designated existing provisions as par. (1), struck out “or a device or devices” after “drug or drugs”, and added par. (2).

Subsec. (i)(1). Pub. L. 110–85, § 222(b), inserted text of par. (1) and struck out former text of par. (1) which related to registration requirement for foreign establishments engaged in the manufacture, preparation, propagation, compounding, or processing of a drug or device to be imported or offered for import into the United States.

Subsec. (j)(2). Pub. L. 110–85, § 223, in introductory provisions, substituted “Each person who registers with the Secretary under this section shall report to the Secretary, with regard to drugs once during the month of June of each year and once during the month of December of each year, and with regard to devices once each year during the period beginning on October 1 and ending on December 31, the following information:” for “Each person who registers with the Secretary under this section shall report to the Secretary once during the month of June of each year and once during the month of December of each year the following information:”.

Subsec. (k). Pub. L. 110–85, § 801(b)(3)(C), inserted concluding provisions.

Subsec. (p). Pub. L. 110–85, § 224, amended subsec. (p) generally. Prior to amendment, subsec. (p) read as follows: “Registrations under subsections (b), (c), (d), and (i) of this section (including the submission of updated information) shall be submitted to the Secretary by electronic means, upon a finding by the Secretary that the electronic receipt of such registrations is feasible, unless the Secretary grants a request for waiver of such requirement because use of electronic means is not reasonable for the person requesting such waiver.”

2004—Subsec. (o)(1)(B), (2)(B). Pub. L. 108–214, § 2(c)(2)(A), (B)(i), substituted “or adulterated” for “, adulterated”.

Subsec. (o)(2)(E). Pub. L. 108–214, § 2(c)(2)(B)(ii), substituted “semi-critical” for “semicritical”.

2002—Subsec. (h). Pub. L. 107–250, § 201(e), inserted “, or by persons accredited to conduct inspections under section 374(g) of this title,” after “duly designated by the Secretary”.

Subsec. (i)(1). Pub. L. 107–188, § 321(a)(1), substituted “On or before December 31 of each year, any establishment” for “Any establishment” and “shall, through electronic means in accordance with the criteria of the Secretary, register with the Secretary the name and place of business of the establishment, the name of the United States agent for the establishment, the name of each importer of such drug or device in the United States that is known to the establishment, and the name of each person who imports or offers for import such drug or device to the United States for purposes of importation” for “shall register with the Secretary the name and place of business of the establishment and the name of the United States agent for the establishment”.

Subsec. (j)(1). Pub. L. 107–188, § 321(a)(2), substituted “subsection (b), (c), (d), or (i)” for “subsection (b), (c), or (d)” in first sentence.

Subsec. (m)(1). Pub. L. 107–250, § 211, inserted at end “The Secretary shall publish such list on the Internet site of the Food and Drug Administration. The list so published shall be updated not later than 30 days after each revision of the list by the Secretary.”

Subsec. (o). Pub. L. 107–250, § 302(b), added subsec. (o).

Subsec. (p). Pub. L. 107–250, § 207, added subsec. (p).

1997—Subsec. (g). Pub. L. 105–115, § 213(b)(3), inserted at end “In this subsection, the term ‘wholesale distributor’ means any person (other than the manufacturer or the initial importer) who distributes a device from the original place of manufacture to the person who makes the final delivery or sale of the device to the ultimate consumer or user.”

Subsec. (g)(4), (5). Pub. L. 105–115, § 213(b)(1), (2), added par. (4) and redesignated former par. (4) as (5).

Subsec. (i). Pub. L. 105–115, § 417, amended subsec. (i) generally. Prior to amendment, subsec. (i) read as follows: “Any establishment within any foreign country engaged in the manufacture, preparation, propagation, compounding, or processing of a drug or drugs, or a device or devices, shall be permitted to register under this section pursuant to regulations promulgated by the Secretary. Such regulations shall require such establishment to provide the information required by subsection (j) of this section and shall require such establishment to provide the information required by subsection (j) of this section in the case of a device or devices and shall include provisions for registration of any such establishment upon condition that adequate and effective means are available, by arrangement with the government of such foreign country or otherwise, to enable the Secretary to determine from time to time whether drugs or devices manufactured, prepared, propagated, compounded, or processed in such establishment, if imported or offered for import into the United States, shall be refused admission on any of the grounds set forth in section 381(a) of this title.”

Subsec. (j)(1)(A), (D). Pub. L. 105–115, § 125(a)(2)(C), struck out “, 356, 357,” before “or 360b of this title”.

Subsec. (k). Pub. L. 105–115, § 206(a)(1), inserted “or person who is accredited under section 360m(a) of this title” after “report to the Secretary”.

Subsecs. (l), (m). Pub. L. 105–115, § 206(a)(2), added subsecs. (l) and (m).

Subsec. (n). Pub. L. 105–115, § 209(a), added subsec. (n).

1976—Subsec. (a)(1). Pub. L. 94–295, § 4(a)(2), substituted “drug package or device package” for “drug package”, “distribution of the drug or device” for “distribution of the drug”, and “ultimate consumer or user” for “ultimate consumer”.

Subsecs. (b) to (d). Pub. L. 94–295, § 4(a)(3), inserted “or a device or devices” after “drug or drugs”.

Subsec. (e). Pub. L. 94–295, § 4(a)(4), authorized the Secretary to prescribe by regulation a uniform system for the identification of devices intended for human use and authorized him, in addition, to require that persons who are required to list devices pursuant to subsec. (j) also list such devices in accordance with the system.

Subsec. (g)(1) to (3). Pub. L. 94–295, § 4(a)(5), substituted “drugs or devices” for “drugs”.

Subsec. (h). Pub. L. 94–295, § 4(a)(6), inserted reference to establishments engaged in the manufacture, propagation, compounding, or processing of a drug or drugs or of a device or devices classified in class II or III.

Subsec. (i). Pub. L. 94–295, § 4(a)(7), inserted reference to devices and inserted requirement that regulations require establishments to provide the information required by subsection (j) of this section in the case of a device or devices.

Subsec. (j)(1). Pub. L. 94–295, § 4(a)(8)(A), in introductory provisions substituted “a list of all drugs and a list of all devices and a brief statement of the basis for believing that each device included in the list is a device rather than a drug (with each drug and device in each list listed by its established name” for “a list of all drugs (by established name” and “drugs or devices filed” for “drugs filed”.

Subsec. (j)(1)(A). Pub. L. 94–295, § 4(a)(8)(B), substituted “the applicable list” for “such list”, inserted “or a device intended for human use contained in the applicable list with respect to which a performance standard has been established under section 360d of this title or which is subject to section 360e of this title,” after “360b of this title,”, and substituted “such drug or device” for “such drug” wherever appearing.

Subsec. (j)(1)(B). Pub. L. 94–295, § 4(a)(8)(C), in introductory provisions substituted “drug or device contained in an applicable list” for “drug contained in such list”.

Subsec. (j)(1)(B)(i). Pub. L. 94–295, § 4(a)(8)(D), substituted “which drug is subject to section 353(b)(1) of this title, or which device is a restricted device, a copy of all labeling for such drug or device, a representative sampling of advertisements for such drug or device, and, upon request made by the Secretary for good cause, a copy of all advertisements for a particular drug product or device, or” for “which is subject to section 353(b)(1) of this title, a copy of all labeling for such drug, a representative sampling of advertisements for such drug, and, upon request made by the Secretary for good cause, a copy of all advertisements for a particular drug product, or”.

Subsec. (j)(1)(B)(ii). Pub. L. 94–295, § 4(a)(8)(E), substituted “which drug is not subject to section 353(b)(1) of this title or which device is not a restricted device, the label and package insert for such drug or device and a representative sampling of any other labeling for such drug or device” for “which is not subject to section 353(b)(1) of this title, the label and package insert for such drug and a representative sampling of any other labeling for such drug”.

Subsec. (j)(1)(C). Pub. L. 94–295, § 4(a)(8)(F), substituted “an applicable list” for “such list”.

Subsec. (j)(1)(D). Pub. L. 94–295, § 4(a)(8)(G), substituted “a list” for “the list”, inserted “or the particular device contained in such list is not subject to a performance standard established under section 360d of this title or to section 360e of this title or is not a restricted device” after “or 360b of this title,”, and substituted “particular drug product or device” for “particular drug product” wherever appearing.

Subsec. (j)(2). Pub. L. 94–295, § 4(a)(8)(H), substituted “drug or device” for “drug” in subpars. (A), (B), and (C), and substituted “(each by established name” for “(by established name” in subpar. (C).

Subsec. (k). Pub. L. 94–295, § 4(a)(9), added subsec. (k).

1972—Subsec. (e). Pub. L. 92–387, § 4(a), inserted provision that the Secretary may assign a listing number to each drug or class of drugs listed under subsec. (j).

Subsec. (f). Pub. L. 92–387, § 4(b), inserted exception that the list submitted under subsec. (j)(3) and information submitted under subsec. (j)(1), (2) shall be exempt from inspection unless the Secretary determines otherwise.

Subsec. (i). Pub. L. 92–387, § 4(c), inserted provision that the regulations shall require such establishment to provide the information required by subsec. (j).

Subsec. (j). Pub. L. 92–387, § 3, added subsec. (j).

1970—Subsec. (a). Pub. L. 91–513 struck out provisions defining the wholesaling, jobbing, or distributing of depressant or stimulant drugs.

Subsec. (b). Pub. L. 91–513 struck out provisions covering establishments engaged in the wholesaling, jobbing, or distributing of depressant or stimulant drugs and the inclusion of the fact of such activity in the annual registration.

Subsec. (c). Pub. L. 91–513 struck out provisions covering new registrations of persons first engaging in the wholesaling, jobbing, or distributing of depressant or stimulant drugs and the inclusion of the fact of such activity in the registration.

Subsec. (d). Pub. L. 91–513 struck out number designation “(1)” preceding first sentence, struck out portion of such redesignated provisions covering the wholesaling, jobbing, or distributing of depressant or stimulant drugs, and struck out par. (2) covering the filing of supplemental registration whenever a person not previously engaged or involved with depressant or stimulant drugs goes into the manufacturing, preparation, or processing thereof.

1965—Pub. L. 89–74, § 4(e), included certain wholesalers in section catchline.

Subsec. (a)(2), (3). Pub. L. 89–74, § 4(a), added par. (2) and redesignated former par. (2) as (3).

Subsecs. (b), (c). Pub. L. 89–74, § 4(b), (c), inserted “or in the wholesaling, jobbing, or distributing of any depressant or stimulant drug” after “drug or drugs” and inserted requirement that establishment indicate activity in depressant or stimulant drugs at time of registration.

Subsec. (d). Pub. L. 89–74 § 4(d), designated existing provisions as par. (1), inserted “or the wholesaling, jobbing, or distributing of any depressant or stimulant drug” and the requirement that the additional establishment indicate activity in depressant or stimulant drugs at time of registration, and added par. (2).

### Statutory Notes and Related Subsidiaries

### Effective Date of 2020 Amendment

Amendment by Pub. L. 116–136 effective 180 days after Mar. 27, 2020, see section 3112(g) of Pub. L. 116–136, set out as a note under section 356c of this title.

### Effective Date of 2002 Amendment

Amendment by Pub. L. 107–188 effective upon the expiration of the 180-day period beginning June 12, 2002, see section 321(c) of Pub. L. 107–188, set out as a note under section 331 of this title.

### Effective Date of 1997 Amendment

Amendment by sections 206(a), 209(a), 213(b), and 417 of 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.

### Effective Date of 1972 Amendment

Pub. L. 92–387, § 5, Aug. 16, 1972, 86 Stat. 562, provided that: “The amendments made by this Act [amending this section and sections 331 and 335 of this title and enacting provisions set out below] shall take effect on the first day of the sixth month beginning after the date of enactment of this Act [Aug. 16, 1972].”

### Effective Date of 1970 Amendment

Amendment by Pub. L. 91–513 effective on first day of seventh calendar month that begins after Oct. 26, 1970, see section 704 of Pub. L. 91–513, set out as an Effective Date note under section 801 of this title.

### Effective Date of 1965 Amendment

Amendment by Pub. L. 89–74 effective Feb. 1, 1966, subject to registration with Secretary of names, places of business, establishments, and other prescribed information prior to Feb. 1, 1966, see section 11 of Pub. L. 89–74, set out as a note under section 321 of this title.

### Updating Regulations

Pub. L. 117–328, div. FF, title II, § 2511(b), Dec. 29, 2022, 136 Stat. 5804, provided that: “Not later than 2 years after the date of enactment of this Act [Dec. 29, 2022], the Secretary of Health and Human Services shall update regulations, as appropriate, to implement the amendment made by subsection (a) [amending this section].”

### Savings Provision

Amendment by Pub. L. 91–513 not to affect or abate any prosecutions for any violation of law or any civil seizures or forfeitures and injunctive proceedings commenced prior to the effective date of such amendment, and all administrative proceedings pending before the Bureau of Narcotics and Dangerous Drugs [now the Drug Enforcement Administration] on Oct. 27, 1970, to be continued and brought to final determination in accord with laws and regulations in effect prior to Oct. 27, 1970, see section 702 of Pub. L. 91–513, set out as a note under section 321 of this title.

### Device Modifications

Pub. L. 114–255, div. A, title III, § 3059(b), Dec. 13, 2016, 130 Stat. 1130, provided that: “The Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall issue final guidance regarding when a premarket notification under section 510(k) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360(k)) is required to be submitted for a modification or change to a legally marketed device. Such final guidance shall be issued not later than 1 year after the date on which the comment period closes for the draft guidance on such subject.”

### Declaration of Policy of Drug Listing Act of 1972

Pub. L. 92–387, § 2, Aug. 16, 1972, 86 Stat. 559, provided that: “The Federal Government which is responsible for regulating drugs has no ready means of determining what drugs are actually being manufactured or packed by establishments registered under the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.] except by periodic inspection of such registered establishments. Knowledge of which particular drugs are being manufactured or packed by each registered establishment would substantially assist in the enforcement of Federal laws requiring that such drugs be pure, safe, effective, and properly labeled. Information on the discontinuance of a particular drug could serve to alleviate the burden of reviewing and implementing enforcement actions against drugs which, although commercially discontinued, remain active for regulatory purposes. Information on the type and number of different drugs being manufactured or packed by drug establishments could permit more effective and timely regulation by the agencies of the Federal Government responsible for regulating drugs, including identification of which drugs in interstate commerce are subject to section 505 or 507 [21 U.S.C. 355, 357], or to other provisions of the Federal Food, Drug, and Cosmetic Act.”

### Congressional Declaration of Need for Registration and Inspection of Drug Establishments

Pub. L. 87–781, title III, § 301, Oct. 10, 1962, 76 Stat. 793, provided that: “The Congress hereby finds and declares that in order to make regulation of interstate commerce in drugs effective, it is necessary to provide for registration and inspection of all establishments in which drugs are manufactured, prepared, propagated, compounded, or processed; that the products of all such establishments are likely to enter the channels of interstate commerce and directly affect such commerce; and that the regulation of interstate commerce in drugs without provision for registration and inspection of establishments that may be engaged only in intrastate commerce in such drugs would discriminate against and depress interstate commerce in such drugs, and adversely burden, obstruct, and affect such interstate commerce.”

### Registration of Certain Persons Owning or Operating Drug Establishments Prior to Oct. 10, 1962

Pub. L. 87–781, title III, § 303, Oct. 10, 1962, 76 Stat. 795, provided that any person who, on the day immediately preceding Oct. 10, 1962, owned or operated an establishment which manufactured or processed drugs, registered before the first day of the seventh month following October, 1962, would be deemed to be registered in accordance with subsec. (b) of this section for the calendar year 1962 and if registered within this period and effected in 1963, be deemed in compliance for that calendar year.

### Executive Documents

### Ex. Ord. No. 14293. Regulatory Relief To Promote Domestic Production of Critical Medicines

Ex. Ord. No. 14293, May 5, 2025, 90 F.R. 19615, provided:

By the authority vested in me as President by the Constitution and the laws of the United States of America, it is hereby ordered:

Section 1. Purpose. During my first term, my Administration took unprecedented action to improve the well-being of the American people by restoring capacity for domestic production of critical pharmaceutical products. Notably, in Executive Order 13944 of August 6, 2020 (Combating Public Health Emergencies and Strengthening National Security By Ensuring Essential Medicines, Medical Countermeasures, and Critical Inputs Are Made In The United States) [42 U.S.C. 247d–6b note], I directed each executive department and agency involved in the procurement of Essential Medicines, Medical Countermeasures, and Critical Inputs to take a variety of actions to increase their domestic procurement of Essential Medicines, Medical Countermeasures, and Critical Inputs, as defined in section 7 of that order, and to identify vulnerabilities in our Nation’s supply chains for these products. Unfortunately, the prior administration did too little to advance these goals. Critical barriers and information gaps persist in establishing a domestic, resilient, and affordable pharmaceutical supply chain for American patients.

One key area of concern is the length of time it takes to build pharmaceutical manufacturing facilities in the United States today. New construction must navigate myriad Federal, State, and local requirements ranging from building standards and zoning restrictions to environmental protocols that together diminish the certainty needed to generate investment for large manufacturing projects. For pharmaceutical manufacturing, these barriers are heightened by unannounced inspections of domestic manufacturers by the Food and Drug Administration (FDA), which are more frequent than such inspections at international facilities. Industry estimates suggest that building new manufacturing capacity for pharmaceuticals and critical inputs may take as long as 5 to 10 years, which is unacceptable from a national security standpoint. Even expanding existing capacity or modifying existing production lines to produce new or different products requires extensive permitting and regulatory approval, making it more difficult to repurpose existing underutilized pharmaceutical manufacturing capacity available domestically.

It is in the best interest of the Nation to eliminate regulatory barriers to the domestic production of the medicines Americans need. My Administration will work to make the United States the most competitive nation in the world for the manufacture of safe and effective pharmaceutical products.

Sec. 2. Policy. It is the policy of the United States that the regulation of manufacturing pharmaceutical products and inputs be streamlined to facilitate the restoration of a robust domestic pharmaceutical manufacturing base.

Sec. 3. Streamlining Review of Domestic Pharmaceutical Manufacturing by the Food and Drug Administration. Within 180 days of the date of this order [May 5, 2025], the Secretary of Health and Human Services, through the Commissioner of Food and Drugs (FDA Commissioner), shall review existing regulations and guidance that pertain to the development of domestic pharmaceutical manufacturing and shall take steps to eliminate any duplicative or unnecessary requirements in such regulations and guidance; maximize the timeliness and predictability of agency review; and streamline and accelerate the development of domestic pharmaceutical manufacturing. The FDA Commissioner’s review shall encompass all regulations and guidance that apply to the inspection and approval of new and expanded manufacturing capacity, emerging technologies that enable the manufacturing of pharmaceutical products, active pharmaceutical ingredients, key starting materials, and associated raw materials in the United States. The FDA Commissioner shall:

(a) evaluate the current risk-based approach to prior approval of licensure inspections, including when such inspections are necessary, and seek to improve upon this approach to ensure all required inspections are prompt, efficient, and limited to what is necessary to ensure compliance with the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.] and other Federal law;

(b) identify and undertake measures necessary to expand, as practicable, existing programs that provide early technical advice before a facility is operational

;(c) identify and undertake measures necessary to improve enforcement of data reporting under section 510(j)(3) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360(j)(3)), including consideration of publicly displaying the list of facilities, including foreign facilities, that are not in compliance;

(d) provide clearer guidance regarding the requirements or recommendations for site changes, including moving production from a foreign to domestic facility, and validation of new or updated components necessary in manufacturing; and

(e) review and, as appropriate, seek to update any other relevant compliance policies, guidance documents, and regulations.

Sec. 4. Enhancing Inspection of Foreign Manufacturing Facilities. Within 90 days of the date of this order, the FDA Commissioner shall develop and advance improvements to the risk-based inspection regime that ensures routine reviews of overseas manufacturing facilities involved in the supply of United States medicines, which shall be funded by increased fees on foreign manufacturing facilities to the extent consistent with applicable law. Additionally, the FDA Commissioner shall publicly disclose the annual number of inspections that the FDA conducts on such foreign facilities, with specific detail by country and by manufacturer.

Sec. 5. Streamlining Review of Domestic Pharmaceutical Manufacturing by the Environmental Protection Agency. Within 180 days of the date of this order, the Administrator of the Environmental Protection Agency (EPA) shall take action to update regulations and guidance that apply to the inspection and approval of new and expanded manufacturing capacity of pharmaceutical products, active pharmaceutical ingredients, key starting materials, and associated raw materials in the United States to eliminate any duplicative or unnecessary requirements and maximize the timeliness and predictability of agency review.

Sec. 6. Centralized Coordination of Environmental Permits to Expand Domestic Pharmaceutical Manufacturing Capacity. For purposes of 42 U.S.C. 4336a [section 107 of the National Environmental Policy Act of 1969], the EPA shall be the lead agency for the permitting of pharmaceutical manufacturing facilities that require preparation of an Environmental Impact Statement pursuant to the National Environmental Policy Act of 1969, 42 U.S.C. 4321 et seq., unless that role is assumed by another agency. The lead agency shall designate a single point of contact within the agency to coordinate with permit applicants. The Office of Management and Budget shall coordinate with the lead agency and with other relevant agencies and the Federal Permitting Improvement Steering Committee, as needed, to expedite the review and approval of relevant permits.

Sec. 7. Streamlining Review of Domestic Pharmaceutical Manufacturing by the United States Army Corps of Engineers. Within 180 days of the date of this order, the Secretary of the Army, acting through the Assistant Secretary of the Army for Civil Works, shall review the nationwide permits issued under section 404 of the Clean Water Act of 1972 [probably means section 404 of the Federal Water Pollution Control Act] (33 U.S.C. 1344) and section 10 of the Rivers and Harbors Appropriation Act of 1899 (33 U.S.C. 403) to determine whether an activity-specific nationwide permit is needed to facilitate the efficient permitting of pharmaceutical manufacturing facilities.

Sec. 8. General Provisions. (a) Nothing in this order shall be construed to impair or otherwise affect:

(i) the authority granted by law to an executive department or agency, or the head thereof; or

(ii) the functions of the Director of the Office of Management and Budget relating to budgetary, administrative, or legislative proposals.

(b) This order shall be implemented consistent with applicable law and subject to the availability of appropriations.

(c) This order is not intended to, and does not, create any right or benefit, substantive or procedural, enforceable at law or in equity by any party against the United States, its departments, agencies, or entities, its officers, employees, or agents, or any other person.

(d) The Department of Health and Human Services shall provide funding for publication of this order in the Federal Register.