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

# §353a. Pharmacy compounding

- (a) **In general—** Sections [351(a)(2)(B)](/usc/21/351.md), [352(f)(1)](/usc/21/352.md), and [355](/usc/21/355.md) of this title shall not apply to a [drug product](/usc/21/321.md?p=dd) if the [drug product](/usc/21/321.md?p=dd) is compounded for an identified individual patient based on the receipt of a valid prescription order or a notation, approved by the prescribing practitioner, on the prescription order that a compounded [product](/usc/21/360eee.md?p=13) is necessary for the identified patient, if the [drug product](/usc/21/321.md?p=dd) meets the requirements of this section, and if the compounding—
  - (1) is by—
    - (A) a [licensed](/usc/21/360eee.md?p=9) pharmacist in a [State](/usc/21/321.md?p=a-1) [licensed](/usc/21/360eee.md?p=9) pharmacy or a Federal facility, or
    - (B) a [licensed](/usc/21/360eee.md?p=9) physician,

    on the prescription order for such individual patient made by a [licensed](/usc/21/360eee.md?p=9) physician or other [licensed](/usc/21/360eee.md?p=9) practitioner [authorized](/usc/21/360eee.md?p=2) by [State](/usc/21/321.md?p=a-1) law to prescribe [drugs](/usc/21/321.md?p=g-1); or

  - (2)
    - (A) is by a [licensed](/usc/21/360eee.md?p=9) pharmacist or [licensed](/usc/21/360eee.md?p=9) physician in limited quantities before the receipt of a valid prescription order for such individual patient; and
    - (B) is based on a history of the [licensed](/usc/21/360eee.md?p=9) pharmacist or [licensed](/usc/21/360eee.md?p=9) physician receiving valid prescription orders for the compounding of the [drug product](/usc/21/321.md?p=dd), which orders have been generated solely within an established relationship between—
      - (i) the [licensed](/usc/21/360eee.md?p=9) pharmacist or [licensed](/usc/21/360eee.md?p=9) physician; and
      - (ii)
        - (I) such individual patient for whom the prescription order will be provided; or
        - (II) the physician or other [licensed](/usc/21/360eee.md?p=9) practitioner who will write such prescription order.
- (b) **Compounded drug—**
  - (1) **Licensed pharmacist and licensed physician—** A [drug product](/usc/21/321.md?p=dd) may be compounded under [subsection (a)](#a) if the [licensed](/usc/21/360eee.md?p=9) pharmacist or [licensed](/usc/21/360eee.md?p=9) physician—
    - (A) compounds the [drug product](/usc/21/321.md?p=dd) using bulk [drug](/usc/21/321.md?p=g-1) substances, as defined in regulations of the [Secretary](/usc/21/321.md?p=d) published at section 207.3(a)(4) of title 21 of the Code of Federal Regulations—
      - (i) that—
        - (I) comply with the standards of an applicable United States Pharmacopoeia or National Formulary monograph, if a monograph exists, and the United States Pharmacopoeia chapter on pharmacy compounding;
        - (II) if such a monograph does not exist, are [drug](/usc/21/321.md?p=g-1) substances that are components of [drugs](/usc/21/321.md?p=g-1) approved by the [Secretary](/usc/21/321.md?p=d); or
        - (III) if such a monograph does not exist and the [drug](/usc/21/321.md?p=g-1) substance is not a component of a [drug](/usc/21/321.md?p=g-1) approved by the [Secretary](/usc/21/321.md?p=d), that appear on a list developed by the [Secretary](/usc/21/321.md?p=d) through regulations issued by the [Secretary](/usc/21/321.md?p=d) under [subsection (c)](#c);
      - (ii) that are manufactured by an establishment that is registered under [section 360 of this title](/usc/21/360.md) (including a foreign establishment that is registered under [section 360(i) of this title](/usc/21/360.md?p=i)); and
      - (iii) that are accompanied by valid certificates of analysis for each bulk [drug](/usc/21/321.md?p=g-1) substance;
    - (B) compounds the [drug product](/usc/21/321.md?p=dd) using ingredients (other than bulk [drug](/usc/21/321.md?p=g-1) substances) that comply with the standards of an applicable United States Pharmacopoeia or National Formulary monograph, if a monograph exists, and the United States Pharmacopoeia chapter on pharmacy compounding;
    - (C) does not compound a [drug product](/usc/21/321.md?p=dd) that appears on a list published by the [Secretary](/usc/21/321.md?p=d) in the Federal Register of [drug products](/usc/21/321.md?p=dd) that have been withdrawn or removed from the market because such [drug products](/usc/21/321.md?p=dd) or components of such [drug products](/usc/21/321.md?p=dd) have been found to be unsafe or not effective; and
    - (D) does not compound regularly or in inordinate amounts (as defined by the [Secretary](/usc/21/321.md?p=d)) any [drug products](/usc/21/321.md?p=dd) that are essentially copies of a commercially available [drug product](/usc/21/321.md?p=dd).
  - (2) **Definition—** For purposes of [paragraph (1)(D)](#b-1-D), the term “essentially a copy of a commercially available [drug product](/usc/21/321.md?p=dd)” does not include a [drug product](/usc/21/321.md?p=dd) in which there is a change, made for an identified individual patient, which produces for that patient a significant difference, as determined by the prescribing practitioner, between the compounded [drug](/usc/21/321.md?p=g-1) and the comparable commercially available [drug product](/usc/21/321.md?p=dd).
  - (3) **Drug product—** A [drug product](/usc/21/321.md?p=dd) may be compounded under [subsection (a)](#a) only if—
    - (A) such [drug product](/usc/21/321.md?p=dd) is not a [drug product](/usc/21/321.md?p=dd) identified by the [Secretary](/usc/21/321.md?p=d) by regulation as a [drug product](/usc/21/321.md?p=dd) that presents demonstrable difficulties for compounding that reasonably demonstrate an adverse effect on the safety or effectiveness of that [drug product](/usc/21/321.md?p=dd); and
    - (B) such [drug product](/usc/21/321.md?p=dd) is compounded in a [State](/usc/21/321.md?p=a-1)—
      - (i) that has entered into a memorandum of understanding with the [Secretary](/usc/21/321.md?p=d) which addresses the [distribution](/usc/21/360eee.md?p=5) of inordinate amounts of compounded [drug products](/usc/21/321.md?p=dd) interstate and provides for appropriate investigation by a [State](/usc/21/321.md?p=a-1) agency of complaints relating to compounded [drug products](/usc/21/321.md?p=dd) distributed outside such [State](/usc/21/321.md?p=a-1); or
      - (ii) that has not entered into the memorandum of understanding described in [clause (i)](#b-3-B-i) and the [licensed](/usc/21/360eee.md?p=9) pharmacist, [licensed](/usc/21/360eee.md?p=9) pharmacy, or [licensed](/usc/21/360eee.md?p=9) physician [distributes](/usc/21/360eee.md?p=5) (or causes to be distributed) compounded [drug products](/usc/21/321.md?p=dd) out of the [State](/usc/21/321.md?p=a-1) in which they are compounded in quantities that do not exceed 5 percent of the total prescription orders dispensed or distributed by such pharmacy or physician.

    The [Secretary](/usc/21/321.md?p=d) shall, in consultation with the National Association of Boards of Pharmacy, develop a standard memorandum of understanding for use by the [States](/usc/21/321.md?p=a-1) in complying with [subparagraph (B)(i)](#b-3-B-i).

- (c) **Regulations—**
  - (1) **In general—** The [Secretary](/usc/21/321.md?p=d) shall issue regulations to implement this section. Before issuing regulations to implement subsections [(b)(1)(A)(i)(III)](#b-1-A-i-III), [(b)(1)(C)](#b-1-C), or [(b)(3)(A)](#b-3-A), the [Secretary](/usc/21/321.md?p=d) shall convene and consult an [advisory committee](/usc/21/360fff.md?p=1) on compounding unless the [Secretary](/usc/21/321.md?p=d) determines that the issuance of such regulations before consultation is necessary to protect the public health. The [advisory committee](/usc/21/360fff.md?p=1) shall include representatives from the National Association of Boards of Pharmacy, the United States Pharmacopoeia, pharmacy, physician, and consumer organizations, and other experts selected by the [Secretary](/usc/21/321.md?p=d).
  - (2) **Limiting compounding—** The [Secretary](/usc/21/321.md?p=d), in consultation with the United States Pharmacopoeia Convention, Incorporated, shall promulgate regulations identifying [drug](/usc/21/321.md?p=g-1) substances that may be used in compounding under [subsection (b)(1)(A)(i)(III)](#b-1-A-i-III) for which a monograph does not exist or which are not components of [drug products](/usc/21/321.md?p=dd) approved by the [Secretary](/usc/21/321.md?p=d). The [Secretary](/usc/21/321.md?p=d) shall include in the regulation the criteria for such substances, which shall include historical use, reports in peer reviewed medical literature, or other criteria the [Secretary](/usc/21/321.md?p=d) may identify.
- (d) **Application—** This section shall not apply to—
  - (1) [compounded positron emission tomography drugs](/usc/21/321.md?p=ii) as defined in [section 321(ii) of this title](/usc/21/321.md?p=ii); or
  - (2) radiopharmaceuticals.
- (e) **“Compounding” defined—** As used in this section, the term “compounding” does not include mixing, reconstituting, or other such acts that are performed in accordance with directions contained in approved [labeling](/usc/21/321.md?p=m) provided by the [product](/usc/21/360eee.md?p=13)’s [manufacturer](/usc/21/360hh.md?p=3) and other [manufacturer](/usc/21/360hh.md?p=3) directions consistent with that [labeling](/usc/21/321.md?p=m).

## Source credit

(June 25, 1938, ch. 675, § 503A, as added Pub. L. 105–115, title I, § 127(a), Nov. 21, 1997, 111 Stat. 2328; amended Pub. L. 113–54, title I, § 106(a), Nov. 27, 2013, 127 Stat. 598.)

## Notes

### Editorial Notes

### Amendments

2013—Subsec. (a). Pub. L. 113–54, § 106(a)(1), struck out “unsolicited” before “receipt of a valid prescription” in introductory provisions.

Subsec. (b)(1)(A)(i)(III). Pub. L. 113–54, § 106(a)(4), substituted “subsection (c)” for “subsection (d)”.

Subsecs. (c) to (f). Pub. L. 113–54, § 106(a)(2), (3), redesignated subsecs. (d) to (f) as (c) to (e), respectively, and struck out former subsec. (c). Prior to amendment, subsec. (c) read as follows: “A drug may be compounded under subsection (a) of this section only if the pharmacy, licensed pharmacist, or licensed physician does not advertise or promote the compounding of any particular drug, class of drug, or type of drug. The pharmacy, licensed pharmacist, or licensed physician may advertise and promote the compounding service provided by the licensed pharmacist or licensed physician.”

### Statutory Notes and Related Subsidiaries

### Effective Date

Pub. L. 105–115, title I, § 127(b), Nov. 21, 1997, 111 Stat. 2330, provided that: “Section 503A of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 353a], added by subsection (a), shall take effect upon the expiration of the 1-year period beginning on the date of the enactment of this Act [Nov. 21, 1997].”