---
kind: "section"
citation: "21 U.S.C. § 360ccc–1"
title: "21"
title_heading: "Food and Drugs"
number: "360ccc–1"
heading: "Index of legally marketed unapproved new animal drugs for minor species"
release: "119-102"
date: "2026-07-12"
url: "https://uscodex.org/usc/21/360ccc-1"
units:
  - "Chapter 9 — Federal Food, Drug, and Cosmetic Act"
  - "Subchapter V — Drugs and Devices"
  - "Part F — New Animal Drugs for Minor Use and Minor Species"
---

# §360ccc–1. Index of legally marketed unapproved new animal drugs for minor species

- (a) **Establishment and content—**
  - (1) The [Secretary](/usc/21/321.md?p=d) shall establish an index limited to—
    - (A) [new animal drugs](/usc/21/321.md?p=v) intended for use in a [minor species](/usc/21/321.md?p=oo) for which there is a reasonable certainty that the animal or edible [products](/usc/21/360eee.md?p=13) from the animal will not be consumed by humans or [food](/usc/21/321.md?p=f)-producing animals; and
    - (B) [new animal drugs](/usc/21/321.md?p=v) intended for use only in a hatchery, tank, pond, or other similar contained man-made structure in an early, non-[food](/usc/21/321.md?p=f) life stage of a [food](/usc/21/321.md?p=f)-producing [minor species](/usc/21/321.md?p=oo), where safety for humans is demonstrated in accordance with the standard of [section 360b(d) of this title](/usc/21/360b.md?p=d) (including, for an antimicrobial [new animal drug](/usc/21/321.md?p=v), with respect to antimicrobial resistance).
  - (2) The index shall not include a [new animal drug](/usc/21/321.md?p=v) that is contained in or a [product](/usc/21/360eee.md?p=13) of a transgenic animal.
- (b) **Conferences—** Any [person](/usc/21/321.md?p=e) intending to file a request under this section shall be entitled to one or more conferences to discuss the requirements for indexing a [new animal drug](/usc/21/321.md?p=v).
- (c) **Request for determination of eligibility for inclusion in index—**
  - (1) Any [person](/usc/21/321.md?p=e) may submit a request to the [Secretary](/usc/21/321.md?p=d) for a determination whether a [new animal drug](/usc/21/321.md?p=v) may be eligible for inclusion in the index. Such a request shall include—
    - (A) information regarding the need for the [new animal drug](/usc/21/321.md?p=v), the species for which the [new animal drug](/usc/21/321.md?p=v) is intended, the proposed intended use and conditions of use, and anticipated annual [distribution](/usc/21/360eee.md?p=5);
    - (B) information to support the conclusion that the proposed use meets the conditions of subparagraph [(A)](#a-1-A) or [(B)](#a-1-B) of subsection (a)(1) of this section;
    - (C) information regarding the components and composition of the [new animal drug](/usc/21/321.md?p=v);
    - (D) a description of the methods used in, and the facilities and controls used for, the manufacture, processing, and packing of such [new animal drug](/usc/21/321.md?p=v);
    - (E) an environmental assessment that meets the requirements of the National Environmental Policy Act of 1969 [[42 U.S.C. 4321](/usc/42/4321.md) et seq.], as amended, and as defined in 21 CFR Part 25, as it appears on August 2, 2004, and amended thereafter or information to support a categorical exclusion from the requirement to prepare an environmental assessment;
    - (F) information sufficient to support the conclusion that the proposed use of the [new animal drug](/usc/21/321.md?p=v) is [safe](/usc/21/321.md?p=u) under [section 360b(d) of this title](/usc/21/360b.md?p=d) with respect to individuals exposed to the [new animal drug](/usc/21/321.md?p=v) through its manufacture or use; and
    - (G) such other information as the [Secretary](/usc/21/321.md?p=d) may deem necessary to make this eligibility determination.
  - (2) Within 90 days after the submission of a request for a determination of eligibility for indexing based on [subsection (a)(1)(A)](#a-1-A) of this section, or 180 days for a request submitted based on [subsection (a)(1)(B)](#a-1-B) of this section, the [Secretary](/usc/21/321.md?p=d) shall grant or deny the request, and notify the [person](/usc/21/321.md?p=e) who requested such determination of the [Secretary](/usc/21/321.md?p=d)’s decision. The [Secretary](/usc/21/321.md?p=d) shall grant the request if the [Secretary](/usc/21/321.md?p=d) finds that—
    - (A) the same [drug](/usc/21/321.md?p=g-1) in the same dosage form for the same intended use is not approved or conditionally approved;
    - (B) the proposed use of the [drug](/usc/21/321.md?p=g-1) meets the conditions of subparagraph [(A)](#a-1-A) or [(B)](#a-1-B) of subsection (a)(1), as appropriate;
    - (C) the [person](/usc/21/321.md?p=e) requesting the determination has established appropriate specifications for the manufacture and control of the [new animal drug](/usc/21/321.md?p=v) and has demonstrated an understanding of the requirements of current good manufacturing practices;
    - (D) the [new animal drug](/usc/21/321.md?p=v) will not significantly affect the human environment; and
    - (E) the [new animal drug](/usc/21/321.md?p=v) is [safe](/usc/21/321.md?p=u) with respect to individuals exposed to the [new animal drug](/usc/21/321.md?p=v) through its manufacture or use.

    If the [Secretary](/usc/21/321.md?p=d) denies the request, the [Secretary](/usc/21/321.md?p=d) shall thereafter provide due notice and an opportunity for an informal conference. A decision of the [Secretary](/usc/21/321.md?p=d) to deny an eligibility request following an informal conference shall constitute final agency action subject to judicial review.

- (d) **Request for addition to index—**
  - (1) With respect to a [new animal drug](/usc/21/321.md?p=v) for which the [Secretary](/usc/21/321.md?p=d) has made a determination of eligibility under [subsection (c)](#c), the [person](/usc/21/321.md?p=e) who made such a request may ask that the [Secretary](/usc/21/321.md?p=d) add the [new animal drug](/usc/21/321.md?p=v) to the index established under [subsection (a)](#a). The request for addition to the index shall include—
    - (A) a copy of the [Secretary](/usc/21/321.md?p=d)’s determination of eligibility issued under [subsection (c)](#c);
    - (B) a written report that meets the requirements in [subsection (d)(2)](#d-2) of this section;
    - (C) a proposed index entry;
    - (D) facsimile [labeling](/usc/21/321.md?p=m);
    - (E) anticipated annual [distribution](/usc/21/360eee.md?p=5) of the [new animal drug](/usc/21/321.md?p=v);
    - (F) a written commitment to manufacture the [new animal drug](/usc/21/321.md?p=v) and [animal feeds](/usc/21/321.md?p=w) bearing or containing such [new animal drug](/usc/21/321.md?p=v) according to current good manufacturing practices;
    - (G) a written commitment to [label](/usc/21/321.md?p=k), [distribute](/usc/21/360eee.md?p=5), and promote the [new animal drug](/usc/21/321.md?p=v) only in accordance with the index entry;
    - (H) upon specific request of the [Secretary](/usc/21/321.md?p=d), information submitted to the expert panel described in [paragraph (3)](#d-3); and
    - (I) any additional requirements that the [Secretary](/usc/21/321.md?p=d) may prescribe by general regulation or specific order.
  - (2) The report required in [paragraph (1)](#d-1) shall—
    - (A) be authored by a qualified expert panel;
    - (B) include an evaluation of all available target animal safety and effectiveness information, including anecdotal information;
    - (C) [state](/usc/21/321.md?p=a-1) the expert panel’s opinion regarding whether the benefits of using the [new animal drug](/usc/21/321.md?p=v) for the proposed use in a [minor species](/usc/21/321.md?p=oo) outweigh its risks to the target animal, taking into account the harm being caused by the absence of an approved or conditionally approved [new animal drug](/usc/21/321.md?p=v) for the [minor species](/usc/21/321.md?p=oo) in question;
    - (D) include information from which [labeling](/usc/21/321.md?p=m) can be written; and
    - (E) include a recommendation regarding whether the [new animal drug](/usc/21/321.md?p=v) should be limited to use under the professional supervision of a [licensed](/usc/21/360eee.md?p=9) veterinarian.
  - (3) A qualified expert panel, as used in this section, is a panel that—
    - (A) is composed of experts qualified by scientific training and experience to evaluate the target animal safety and effectiveness of the [new animal drug](/usc/21/321.md?p=v) under consideration;
    - (B) operates external to FDA; and
    - (C) is not subject to chapter 10 of title 5.

    The [Secretary](/usc/21/321.md?p=d) shall define the criteria for selection of a qualified expert panel and the procedures for the operation of the panel by regulation.

  - (4) Within 180 days after the receipt of a request for listing a [new animal drug](/usc/21/321.md?p=v) in the index, the [Secretary](/usc/21/321.md?p=d) shall grant or deny the request. The [Secretary](/usc/21/321.md?p=d) shall grant the request if the request for indexing continues to meet the eligibility criteria in [subsection (a)](#a) and the [Secretary](/usc/21/321.md?p=d) finds, on the basis of the report of the qualified expert panel and other information available to the [Secretary](/usc/21/321.md?p=d), that the benefits of using the [new animal drug](/usc/21/321.md?p=v) for the proposed use in a [minor species](/usc/21/321.md?p=oo) outweigh its risks to the target animal, taking into account the harm caused by the absence of an approved or conditionally-approved [new animal drug](/usc/21/321.md?p=v) for the [minor species](/usc/21/321.md?p=oo) in question. If the [Secretary](/usc/21/321.md?p=d) denies the request, the [Secretary](/usc/21/321.md?p=d) shall thereafter provide due notice and the opportunity for an informal conference. The decision of the [Secretary](/usc/21/321.md?p=d) following an informal conference shall constitute final agency action subject to judicial review.
- (e) **Index contents; publication—**
  - (1) The index established under [subsection (a)](#a) shall include the following information for each listed [drug](/usc/21/321.md?p=g-1)—
    - (A) the name and address of the [person](/usc/21/321.md?p=e) who holds the index listing;
    - (B) the name of the [drug](/usc/21/321.md?p=g-1) and the intended use and conditions of use for which it is being indexed;
    - (C) [product](/usc/21/360eee.md?p=13) [labeling](/usc/21/321.md?p=m); and
    - (D) conditions and any limitations that the [Secretary](/usc/21/321.md?p=d) deems necessary regarding use of the [drug](/usc/21/321.md?p=g-1).
  - (2) The [Secretary](/usc/21/321.md?p=d) shall publish the index, and revise it periodically.
  - (3) The [Secretary](/usc/21/321.md?p=d) may establish by regulation a process for reporting changes in the conditions of manufacturing or [labeling](/usc/21/321.md?p=m) of indexed [products](/usc/21/360eee.md?p=13).
- (f) **Removal from index; suspended listing—**
  - (1) If the [Secretary](/usc/21/321.md?p=d) finds, after due notice to the [person](/usc/21/321.md?p=e) who requested the index listing and an opportunity for an informal conference, that—
    - (A) the expert panel failed to meet the requirements as set forth by the [Secretary](/usc/21/321.md?p=d) by regulation;
    - (B) on the basis of new information before the [Secretary](/usc/21/321.md?p=d), evaluated together with the evidence available to the [Secretary](/usc/21/321.md?p=d) when the [new animal drug](/usc/21/321.md?p=v) was listed in the index, the benefits of using the [new animal drug](/usc/21/321.md?p=v) for the indexed use do not outweigh its risks to the target animal;
    - (C) the conditions of [subsection (c)(2)](#c-2) of this section are no longer satisfied;
    - (D) the manufacture of the [new animal drug](/usc/21/321.md?p=v) is not in accordance with current good manufacturing practices;
    - (E) the [labeling](/usc/21/321.md?p=m), [distribution](/usc/21/360eee.md?p=5), or promotion of the [new animal drug](/usc/21/321.md?p=v) is not in accordance with the index entry;
    - (F) the conditions and limitations of use associated with the index listing have not been followed; or
    - (G) the request for indexing contains any untrue statement of material fact,

    the [Secretary](/usc/21/321.md?p=d) shall remove the [new animal drug](/usc/21/321.md?p=v) from the index. The decision of the [Secretary](/usc/21/321.md?p=d) following an informal conference shall constitute final agency action subject to judicial review.

  - (2) If the [Secretary](/usc/21/321.md?p=d) finds that there is a reasonable probability that the use of the [drug](/usc/21/321.md?p=g-1) would present a risk to the health of humans or other animals, the [Secretary](/usc/21/321.md?p=d) may—
    - (A) suspend the listing of such [drug](/usc/21/321.md?p=g-1) immediately;
    - (B) give the [person](/usc/21/321.md?p=e) listed in the index prompt notice of the [Secretary](/usc/21/321.md?p=d)’s action; and
    - (C) afford that [person](/usc/21/321.md?p=e) the opportunity for an informal conference.

    The decision of the [Secretary](/usc/21/321.md?p=d) following an informal conference shall constitute final agency action subject to judicial review.

- (g) **Regulations concerning exemptions for investigational use—** For purposes of indexing [new animal drugs](/usc/21/321.md?p=v) under this section, to the extent consistent with the public health, the [Secretary](/usc/21/321.md?p=d) shall promulgate regulations for exempting from the operation of [section 360b of this title](/usc/21/360b.md) [minor species](/usc/21/321.md?p=oo) [new animal drugs](/usc/21/321.md?p=v) and [animal feeds](/usc/21/321.md?p=w) bearing or containing [new animal drugs](/usc/21/321.md?p=v) intended solely for investigational use by experts qualified by scientific training and experience to investigate the safety and effectiveness of [minor species](/usc/21/321.md?p=oo) animal [drugs](/usc/21/321.md?p=g-1). Such regulations may, at the discretion of the [Secretary](/usc/21/321.md?p=d), among other conditions relating to the protection of the public health, provide for conditioning such exemption upon the establishment and maintenance of such records, and the making of such reports to the [Secretary](/usc/21/321.md?p=d), by the [manufacturer](/usc/21/360hh.md?p=3) or the [sponsor](/usc/21/360fff.md?p=8) of the investigation of such article, of data (including but not limited to analytical reports by investigators) obtained as a result of such investigational use of such article, as the [Secretary](/usc/21/321.md?p=d) finds will enable the [Secretary](/usc/21/321.md?p=d) to evaluate the safety and effectiveness of such article in the event of the filing of a request for an index listing pursuant to this section.
- (h) **Labeling contents—** The [labeling](/usc/21/321.md?p=m) of a [new animal drug](/usc/21/321.md?p=v) that is the subject of an index listing shall [state](/usc/21/321.md?p=a-1), prominently and conspicuously—
  - (1) “LEGAL STATUS—In order to be legally marketed, a [new animal drug](/usc/21/321.md?p=v) intended for a [minor species](/usc/21/321.md?p=oo) must be Approved, Conditionally Approved, or Indexed by the [Food](/usc/21/321.md?p=f) and [Drug](/usc/21/321.md?p=g-1) Administration. THIS [PRODUCT](/usc/21/360eee.md?p=13) IS INDEXED—MIF #” (followed by the applicable [minor species](/usc/21/321.md?p=oo) index file number and a period) “Extra-[label](/usc/21/321.md?p=k) use is prohibited.”;
  - (2) except in the case of [new animal drugs](/usc/21/321.md?p=v) indexed for use in an early life stage of a [food](/usc/21/321.md?p=f)-producing animal, “This [product](/usc/21/360eee.md?p=13) is not to be used in animals intended for use as [food](/usc/21/321.md?p=f) for humans or [food](/usc/21/321.md?p=f)-producing animals.”; and
  - (3) such other information as may be prescribed by the [Secretary](/usc/21/321.md?p=d) in the index listing.
- (i) **Records and reports—**
  - (1) In the case of any [new animal drug](/usc/21/321.md?p=v) for which an index listing pursuant to [subsection (a)](#a) is in effect, the [person](/usc/21/321.md?p=e) who has an index listing shall establish and maintain such records, and make such reports to the [Secretary](/usc/21/321.md?p=d), of data relating to experience, and other data or information, received or otherwise obtained by such [person](/usc/21/321.md?p=e) with respect to such [drug](/usc/21/321.md?p=g-1), or with respect to [animal feeds](/usc/21/321.md?p=w) bearing or containing such [drug](/usc/21/321.md?p=g-1), as the [Secretary](/usc/21/321.md?p=d) may by general regulation, or by order with respect to such listing, prescribe on the basis of a finding that such records and reports are necessary in order to enable the [Secretary](/usc/21/321.md?p=d) to determine, or facilitate a determination, whether there is or may be ground for invoking [subsection (f)](#f). Such regulation or order shall provide, where the [Secretary](/usc/21/321.md?p=d) deems it to be appropriate, for the examination, upon request, by the [persons](/usc/21/321.md?p=e) to whom such regulation or order is applicable, of similar information received or otherwise obtained by the [Secretary](/usc/21/321.md?p=d).
  - (2) Every [person](/usc/21/321.md?p=e) required under this subsection to maintain records, and every [person](/usc/21/321.md?p=e) in charge or custody thereof, shall, upon request of an officer or employee designated by the [Secretary](/usc/21/321.md?p=d), permit such officer or employee at all reasonable times to have access to and copy and [verify](/usc/21/360eee.md?p=28) such records.
- (j) **Public disclosure of safety and effectiveness data—**
  - (1) Safety and effectiveness data and information which has been submitted in support of a request for a [new animal drug](/usc/21/321.md?p=v) to be indexed under this section and which has not been previously disclosed to the public shall be made available to the public, upon request, unless extraordinary circumstances are shown—
    - (A) if no work is being or will be undertaken to have the [drug](/usc/21/321.md?p=g-1) indexed in accordance with the request,
    - (B) if the [Secretary](/usc/21/321.md?p=d) has determined that such [drug](/usc/21/321.md?p=g-1) cannot be indexed and all legal appeals have been exhausted,
    - (C) if the indexing of such [drug](/usc/21/321.md?p=g-1) is terminated and all legal appeals have been exhausted, or
    - (D) if the [Secretary](/usc/21/321.md?p=d) has determined that such [drug](/usc/21/321.md?p=g-1) is not a [new animal drug](/usc/21/321.md?p=v).
  - (2) Any request for data and information pursuant to [paragraph (1)](#j-1) shall include a verified statement by the [person](/usc/21/321.md?p=e) making the request that any data or information received under such paragraph shall not be disclosed by such [person](/usc/21/321.md?p=e) to any other [person](/usc/21/321.md?p=e)—
    - (A) for the purpose of, or as part of a plan, scheme, or [device](/usc/21/321.md?p=h-1) for, obtaining the right to make, use, or market, or making, using, or marketing, outside the United States, the [drug](/usc/21/321.md?p=g-1) identified in the request for indexing; and
    - (B) without obtaining from any [person](/usc/21/321.md?p=e) to whom the data and information are disclosed an identical verified statement, a copy of which is to be provided by such [person](/usc/21/321.md?p=e) to the [Secretary](/usc/21/321.md?p=d), which meets the requirements of this paragraph.
- (k) **Date of determination in the case of recommended controls under the CSA—** In the case of a request under [subsection (d)](#d) to add a [drug](/usc/21/321.md?p=g-1) to the index under [subsection (a)](#a) with respect to a [drug](/usc/21/321.md?p=g-1) for which the [Secretary](/usc/21/321.md?p=d) provides notice to the [person](/usc/21/321.md?p=e) filing the request that the [Secretary](/usc/21/321.md?p=d) intends to issue a scientific and medical evaluation and recommend controls under the Controlled Substances Act [[21 U.S.C. 801](/usc/21/801.md) et seq.], a determination to grant the request to add such [drug](/usc/21/321.md?p=g-1) to the index shall not take effect until the interim final rule controlling the [drug](/usc/21/321.md?p=g-1) is issued in accordance with section 201(j) of the Controlled Substances Act [[21 U.S.C. 811(j)](/usc/21/811.md?p=j)].

## Source credit

(June 25, 1938, ch. 675, § 572, as added Pub. L. 108–282, title I, § 102(b)(4), Aug. 2, 2004, 118 Stat. 896; amended Pub. L. 114–89, § 2(a)(3)(C), Nov. 25, 2015, 129 Stat. 699; Pub. L. 115–234, title III, § 302, Aug. 14, 2018, 132 Stat. 2436; Pub. L. 117–286, § 4(a)(158), Dec. 27, 2022, 136 Stat. 4323.)

## Notes

### Editorial Notes

### References in Text

The National Environmental Policy Act of 1969, referred to in subsec. (c)(1)(E), is Pub. L. 91–190, Jan. 1, 1970, 83 Stat. 852, which is classified generally to chapter 55 (§ 4321 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 4321 of Title 42 and Tables.

The Controlled Substances Act, referred to in subsec. (k), is title II of Pub. L. 91–513, Oct. 27, 1970, 84 Stat. 1242, which is classified principally to subchapter I (§ 801 et seq.) of chapter 13 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.

### Amendments

2022—Subsec. (d)(3)(C). Pub. L. 117–286 substituted “chapter 10 of title 5.” for “the Federal Advisory Committee Act.”

2018—Subsec. (h)(1). Pub. L. 115–234, § 302(1), amended par. (1) generally. Prior to amendment, par. (1) read as follows: “ ‘Not approved by fda.—Legally marketed as an FDA indexed product. Extra-label use is prohibited.’;”.

Subsec. (h)(2). Pub. L. 115–234, § 302(2), substituted “or food-producing animals” for “or other animals”.

2015—Subsec. (k). Pub. L. 114–89 added subsec. (k).

### Statutory Notes and Related Subsidiaries

### Effective Date of 2018 Amendment

Pub. L. 115–234, title III, § 302, Aug. 14, 2018, 132 Stat. 2436, provided that the amendment made by section 302 is effective Oct. 1, 2018.