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

# §353b. Outsourcing facilities

- (a) **In general—** Sections [352(f)(1)](/usc/21/352.md), [355](/usc/21/355.md), and [360eee–1](/usc/21/360eee–1.md) of this title shall not apply to a [drug](/usc/21/321.md?p=g-1) compounded by or under the direct supervision of a [licensed](/usc/21/360eee.md?p=9) pharmacist in a facility that elects to register as an outsourcing facility if each of the following conditions is met:
  - (1) **Registration and reporting—** The [drug](/usc/21/321.md?p=g-1) is compounded in an outsourcing facility that is in compliance with the requirements of [subsection (b)](#b).
  - (2) **Bulk drug substances—** The [drug](/usc/21/321.md?p=g-1) is compounded in an outsourcing facility that does not compound using bulk [drug](/usc/21/321.md?p=g-1) substances (as defined in section 207.3(a)(4) of title 21, Code of Federal Regulations (or any successor regulation)), unless—
    - (A)
      - (i) the bulk [drug](/usc/21/321.md?p=g-1) substance appears on a list established by the [Secretary](/usc/21/321.md?p=d) identifying bulk [drug](/usc/21/321.md?p=g-1) substances for which there is a clinical need, by—
        - (I) publishing a notice in the Federal Register proposing bulk [drug](/usc/21/321.md?p=g-1) substances to be included on the list, including the rationale for such proposal;
        - (II) providing a period of not less than 60 calendar days for comment on the notice; and
        - (III) publishing a notice in the Federal Register designating bulk [drug](/usc/21/321.md?p=g-1) substances for inclusion on the list; or
      - (ii) the [drug](/usc/21/321.md?p=g-1) compounded from such bulk [drug](/usc/21/321.md?p=g-1) substance appears on the [drug](/usc/21/321.md?p=g-1) shortage list in effect under [section 356e of this title](/usc/21/356e.md) at the time of compounding, [distribution](/usc/21/360eee.md?p=5), and dispensing;
    - (B) if an applicable monograph exists under the United States Pharmacopeia, the National Formulary, or another compendium or pharmacopeia recognized by the [Secretary](/usc/21/321.md?p=d) for purposes of this paragraph, the bulk [drug](/usc/21/321.md?p=g-1) substances each comply with the monograph;
    - (C) the bulk [drug](/usc/21/321.md?p=g-1) substances are each 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
    - (D) the bulk [drug](/usc/21/321.md?p=g-1) substances are each accompanied by a valid certificate of analysis.
  - (3) **Ingredients (other than bulk drug substances)—** If any ingredients (other than bulk [drug](/usc/21/321.md?p=g-1) substances) are used in compounding the [drug](/usc/21/321.md?p=g-1), such ingredients comply with the standards of the applicable United States Pharmacopeia or National Formulary monograph, if such monograph exists, or of another compendium or pharmacopeia recognized by the [Secretary](/usc/21/321.md?p=d) for purposes of this paragraph if any.
  - (4) **Drugs withdrawn or removed because unsafe or not effective—** The [drug](/usc/21/321.md?p=g-1) does not appear on a list published by the [Secretary](/usc/21/321.md?p=d) of [drugs](/usc/21/321.md?p=g-1) that have been withdrawn or removed from the market because such [drugs](/usc/21/321.md?p=g-1) or components of such [drugs](/usc/21/321.md?p=g-1) have been found to be unsafe or not effective.
  - (5) **Essentially a copy of an approved drug—** The [drug](/usc/21/321.md?p=g-1) is not essentially a copy of one or more approved [drugs](/usc/21/321.md?p=g-1).
  - (6) **Drugs presenting demonstrable difficulties for compounding—** The [drug](/usc/21/321.md?p=g-1)—
    - (A) is not identified (directly or as part of a category of [drugs](/usc/21/321.md?p=g-1)) on a list published by the [Secretary](/usc/21/321.md?p=d), through the process described in [subsection (c)](#c), of [drugs](/usc/21/321.md?p=g-1) or categories of [drugs](/usc/21/321.md?p=g-1) that present demonstrable difficulties for compounding that are reasonably likely to lead to an adverse effect on the safety or effectiveness of the [drug](/usc/21/321.md?p=g-1) or category of [drugs](/usc/21/321.md?p=g-1), taking into account the risks and benefits to patients; or
    - (B) is compounded in accordance with all applicable conditions identified on the list described in [subparagraph (A)](#a-6-A) as conditions that are necessary to prevent the [drug](/usc/21/321.md?p=g-1) or category of [drugs](/usc/21/321.md?p=g-1) from presenting the demonstrable difficulties described in [subparagraph (A)](#a-6-A).
  - (7) **Elements to assure safe use—** In the case of a [drug](/usc/21/321.md?p=g-1) that is compounded from a [drug](/usc/21/321.md?p=g-1) that is the subject of a risk evaluation and mitigation strategy approved with elements to assure [safe](/usc/21/321.md?p=u) use pursuant to [section 355–1 of this title](/usc/21/355–1.md), or from a bulk [drug](/usc/21/321.md?p=g-1) substance that is a component of such [drug](/usc/21/321.md?p=g-1), the outsourcing facility demonstrates to the [Secretary](/usc/21/321.md?p=d) prior to beginning compounding that such facility will utilize controls comparable to the controls applicable under the relevant risk evaluation and mitigation strategy.
  - (8) **Prohibition on wholesaling—** The [drug](/usc/21/321.md?p=g-1) will not be sold or transferred by an entity other than the outsourcing facility that compounded such [drug](/usc/21/321.md?p=g-1). This paragraph does not prohibit administration of a [drug](/usc/21/321.md?p=g-1) in a health care setting or dispensing a [drug](/usc/21/321.md?p=g-1) pursuant to a prescription executed in accordance with [section 353(b)(1) of this title](/usc/21/353.md?p=b-1).
  - (9) **Fees—** The [drug](/usc/21/321.md?p=g-1) is compounded in an outsourcing facility that has paid all fees owed by such facility pursuant to [section 379j–62 of this title](/usc/21/379j–62.md).
  - (10) **Labeling of drugs—**
    - (A) **Label—** The [label](/usc/21/321.md?p=k) of the [drug](/usc/21/321.md?p=g-1) includes—
      - (i) the statement “This is a compounded [drug](/usc/21/321.md?p=g-1).” or a reasonable comparable alternative statement (as specified by the [Secretary](/usc/21/321.md?p=d)) that prominently identifies the [drug](/usc/21/321.md?p=g-1) as a compounded [drug](/usc/21/321.md?p=g-1);
      - (ii) the name, address, and phone number of the applicable outsourcing facility; and
      - (iii) with respect to the [drug](/usc/21/321.md?p=g-1)—
        - (I) the lot or batch number;
        - (II) the established name of the [drug](/usc/21/321.md?p=g-1);
        - (III) the dosage form and strength;
        - (IV) the statement of quantity or volume, as appropriate;
        - (V) the date that the [drug](/usc/21/321.md?p=g-1) was compounded;
        - (VI) the expiration date;
        - (VII) storage and handling instructions;
        - (VIII) the National Drug Code number, if available;
        - (IX) the statement “Not for resale”, and, if the [drug](/usc/21/321.md?p=g-1) is dispensed or distributed other than pursuant to a prescription for an individual identified patient, the statement “Office Use Only”; and
        - (X) subject to [subparagraph (B)(i)](#a-10-B-i), a list of active and inactive ingredients, identified by established name and the quantity or proportion of each ingredient.
    - (B) **Container—** The container from which the individual units of the [drug](/usc/21/321.md?p=g-1) are removed for dispensing or for administration (such as a plastic bag containing individual [product](/usc/21/360eee.md?p=13) syringes) shall include—
      - (i) the information described under [subparagraph (A)(iii)(X)](#a-10-A-iii-X), if there is not space on the [label](/usc/21/321.md?p=k) for such information;
      - (ii) the following information to facilitate adverse event reporting: www.fda.gov/medwatch and 1–800–FDA–1088 (or any successor Internet Web site or phone number); and
      - (iii) directions for use, including, as appropriate, dosage and administration.
    - (C) **Additional information—** The [label](/usc/21/321.md?p=k) and [labeling](/usc/21/321.md?p=m) of the [drug](/usc/21/321.md?p=g-1) shall include any other information as determined necessary and specified in regulations promulgated by the [Secretary](/usc/21/321.md?p=d).
  - (11) **Outsourcing facility requirement—** The [drug](/usc/21/321.md?p=g-1) is compounded in an outsourcing facility in which the compounding of [drugs](/usc/21/321.md?p=g-1) occurs only in accordance with this section.
- (b) **Registration of outsourcing facilities and reporting of drugs—**
  - (1) **Registration of outsourcing facilities—**
    - (A) **Annual registration—** Upon electing and in order to become an outsourcing facility, and during the period beginning on October 1 and ending on December 31 of each year thereafter, a facility—
      - (i) shall register with the [Secretary](/usc/21/321.md?p=d) its name, place of business, and unique facility identifier (which shall conform to the requirements for the unique facility identifier established under [section 360 of this title](/usc/21/360.md)), and a point of contact email address; and
      - (ii) shall indicate whether the outsourcing facility intends to compound a [drug](/usc/21/321.md?p=g-1) that appears on the list in effect under [section 356e of this title](/usc/21/356e.md) during the subsequent calendar year.
    - (B) **Availability of registration for inspection; list—**
      - (i) **Registrations—** 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 paragraph.
      - (ii) **List—** The [Secretary](/usc/21/321.md?p=d) shall make available on the public Internet Web site of the [Food](/usc/21/321.md?p=f) and [Drug](/usc/21/321.md?p=g-1) Administration a list of the name of each facility registered under this subsection as an outsourcing facility, the [State](/usc/21/321.md?p=a-1) in which each such facility is located, whether the facility compounds from bulk [drug](/usc/21/321.md?p=g-1) substances, and whether any such compounding from bulk [drug](/usc/21/321.md?p=g-1) substances is for sterile or nonsterile [drugs](/usc/21/321.md?p=g-1).
  - (2) **Drug reporting by outsourcing facilities—**
    - (A) **In general—** Upon initially registering as an outsourcing facility, once during the month of June of each year, and once during the month of December of each year, each outsourcing facility that registers with the [Secretary](/usc/21/321.md?p=d) under [paragraph (1)](#b-1) shall submit to the [Secretary](/usc/21/321.md?p=d) a report—
      - (i) identifying the [drugs](/usc/21/321.md?p=g-1) compounded by such outsourcing facility during the previous 6-month period; and
      - (ii) with respect to each [drug](/usc/21/321.md?p=g-1) identified under [clause (i)](#b-2-A-i), providing the active ingredient, the source of such active ingredient, the National Drug Code number of the source [drug](/usc/21/321.md?p=g-1) or bulk active ingredient, if available, the strength of the active ingredient per unit, the dosage form and route of administration, the [package](/usc/21/360eee.md?p=11-A) description, the number of individual units produced, and the National Drug Code number of the final [product](/usc/21/360eee.md?p=13), if assigned.
    - (B) **Form—** Each report under [subparagraph (A)](#b-2-A) shall be prepared in such form and manner as the [Secretary](/usc/21/321.md?p=d) may prescribe by regulation or guidance.
    - (C) **Confidentiality—** Reports submitted under this paragraph shall be exempt from inspection under [paragraph (1)(B)(i)](#b-1-B-i), unless the [Secretary](/usc/21/321.md?p=d) finds that such an exemption would be inconsistent with the protection of the public health.
  - (3) **Electronic registration and reporting—** Registrations and [drug](/usc/21/321.md?p=g-1) reporting under this subsection (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 waiver.
  - (4) **Risk-based inspection frequency—**
    - (A) **In general—** Outsourcing facilities—
      - (i) shall be subject to inspection pursuant to [section 374 of this title](/usc/21/374.md); and
      - (ii) shall not be eligible for the exemption under [section 374(a)(2)(A) of this title](/usc/21/374.md?p=a-2-A).
    - (B) **Risk-based schedule—** 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 outsourcing facilities in accordance with a risk-based schedule established by the [Secretary](/usc/21/321.md?p=d).
    - (C) **Risk factors—** In establishing the risk-based schedule, the [Secretary](/usc/21/321.md?p=d) shall inspect outsourcing facilities according to the known safety risks of such outsourcing facilities, which shall be based on the following factors:
      - (i) The compliance history of the outsourcing facility.
      - (ii) The record, history, and nature of recalls linked to the outsourcing facility.
      - (iii) The inherent risk of the [drugs](/usc/21/321.md?p=g-1) compounded at the outsourcing facility.
      - (iv) The inspection frequency and history of the outsourcing facility, including whether the outsourcing facility has been inspected pursuant to [section 374 of this title](/usc/21/374.md) within the last 4 years.
      - (v) Whether the outsourcing facility has registered under this paragraph as an entity that intends to compound a [drug](/usc/21/321.md?p=g-1) that appears on the list in effect under [section 356e of this title](/usc/21/356e.md).
      - (vi) Any other criteria deemed necessary and appropriate by the [Secretary](/usc/21/321.md?p=d) for purposes of allocating inspection resources.
  - (5) **Adverse event reporting—** Outsourcing facilities shall submit adverse event reports to the [Secretary](/usc/21/321.md?p=d) in accordance with the content and format requirements established through guidance or regulation under section 310.305 of title 21, Code of Federal Regulations (or any successor regulations).
- (c) **Regulations—**
  - (1) **In general—** The [Secretary](/usc/21/321.md?p=d) shall implement the list described in [subsection (a)(6)](#a-6) through regulations.
  - (2) **Advisory committee on compounding—** Before issuing regulations to implement [subsection (a)(6)](#a-6), the [Secretary](/usc/21/321.md?p=d) shall convene and consult an [advisory committee](/usc/21/360fff.md?p=1) on compounding. The [advisory committee](/usc/21/360fff.md?p=1) shall include representatives from the National Association of Boards of Pharmacy, the United States Pharmacopeia, pharmacists with current experience and expertise in compounding, physicians with background and knowledge in compounding, and patient and public health advocacy organizations.
  - (3) **Interim list—**
    - (A) **In general—** Before the effective date of the regulations finalized to implement [subsection (a)(6)](#a-6), the [Secretary](/usc/21/321.md?p=d) may designate [drugs](/usc/21/321.md?p=g-1), categories of [drugs](/usc/21/321.md?p=g-1), or conditions as described such[^1] subsection by—
      - (i) publishing a notice of such substances, [drugs](/usc/21/321.md?p=g-1), categories of [drugs](/usc/21/321.md?p=g-1), or conditions proposed for designation, including the rationale for such designation, in the Federal Register;
      - (ii) providing a period of not less than 60 calendar days for comment on the notice; and
      - (iii) publishing a notice in the Federal Register designating such [drugs](/usc/21/321.md?p=g-1), categories of [drugs](/usc/21/321.md?p=g-1), or conditions.
    - (B) **Sunset of notice—** Any notice provided under [subparagraph (A)](#c-3-A) shall not be effective after the earlier of—
      - (i) the date that is 5 years after November 27, 2013; or
      - (ii) the effective date of the final regulations issued to implement [subsection (a)(6)](#a-6).
  - (4) **Updates—** The [Secretary](/usc/21/321.md?p=d) shall review, and update as necessary, the regulations containing the lists of [drugs](/usc/21/321.md?p=g-1), categories of [drugs](/usc/21/321.md?p=g-1), or conditions described in [subsection (a)(6)](#a-6) regularly, but not less than once every 4 years. Nothing in the previous sentence prohibits submissions to the [Secretary](/usc/21/321.md?p=d), before or during any 4-year period described in such sentence, requesting updates to such lists.
- (d) **2 Definitions—** In this section:
  - (1) The term “compounding” includes the combining, admixing, mixing, diluting, pooling, reconstituting, or otherwise altering of a [drug](/usc/21/321.md?p=g-1) or bulk [drug](/usc/21/321.md?p=g-1) substance to create a [drug](/usc/21/321.md?p=g-1).
  - (2) The term “essentially a copy of an approved [drug](/usc/21/321.md?p=g-1)” means—
    - (A) a [drug](/usc/21/321.md?p=g-1) that is identical or nearly identical to an approved [drug](/usc/21/321.md?p=g-1), or a marketed [drug](/usc/21/321.md?p=g-1) not subject to [section 353(b) of this title](/usc/21/353.md?p=b) and not subject to approval in an application submitted under [section 355 of this title](/usc/21/355.md), unless, in the case of an approved [drug](/usc/21/321.md?p=g-1), the [drug](/usc/21/321.md?p=g-1) appears on the [drug](/usc/21/321.md?p=g-1) shortage list in effect under [section 356e of this title](/usc/21/356e.md) at the time of compounding, [distribution](/usc/21/360eee.md?p=5), and dispensing; or
    - (B) a [drug](/usc/21/321.md?p=g-1), a component of which is a bulk [drug](/usc/21/321.md?p=g-1) substance that is a component of an approved [drug](/usc/21/321.md?p=g-1) or a marketed [drug](/usc/21/321.md?p=g-1) that is not subject to [section 353(b) of this title](/usc/21/353.md?p=b) and not subject to approval in an application submitted under [section 355 of this title](/usc/21/355.md), unless there is a change that produces for an individual patient a clinical difference, as determined by the prescribing practitioner, between the compounded [drug](/usc/21/321.md?p=g-1) and the comparable approved [drug](/usc/21/321.md?p=g-1).
  - (3) The term “approved [drug](/usc/21/321.md?p=g-1)” means a [drug](/usc/21/321.md?p=g-1) that is approved under [section 355 of this title](/usc/21/355.md) and does not appear on the list described in [subsection (a)(4)](#a-4) of [drugs](/usc/21/321.md?p=g-1) that have been withdrawn or removed from the market because such [drugs](/usc/21/321.md?p=g-1) or components of such [drugs](/usc/21/321.md?p=g-1) have been found to be unsafe or not effective.
  - (4)
    - (A) The term “outsourcing facility” means a facility at one geographic location or address that—
      - (i) is engaged in the compounding of sterile [drugs](/usc/21/321.md?p=g-1);
      - (ii) has elected to register as an outsourcing facility; and
      - (iii) complies with all of the requirements of this section.
    - (B) An outsourcing facility is not required to be a [licensed](/usc/21/360eee.md?p=9) pharmacy.
    - (C) An outsourcing facility may or may not obtain prescriptions for identified individual patients.
  - (5) The term “sterile [drug](/usc/21/321.md?p=g-1)” means a [drug](/usc/21/321.md?p=g-1) that is intended for parenteral administration, an ophthalmic or oral inhalation [drug](/usc/21/321.md?p=g-1) in aqueous format, or a [drug](/usc/21/321.md?p=g-1) that is required to be sterile under Federal or [State](/usc/21/321.md?p=a-1) law.
- (d) **2 Obligation to pay fees—** Payment of the fee under [section 379j–62 of this title](/usc/21/379j–62.md), as described in [subsection (a)(9)](#a-9), shall not relieve an outsourcing facility that is [licensed](/usc/21/360eee.md?p=9) as a pharmacy in any [State](/usc/21/321.md?p=a-1) that requires pharmacy licensing fees of its obligation to pay such [State](/usc/21/321.md?p=a-1) fees.

## Footnotes

[^1]: So in original.
[^2]: So in original. Two subsecs. (d) have been enacted.

## Source credit

(June 25, 1938, ch. 675, § 503B, as added Pub. L. 113–54, title I, § 102(a)(2), Nov. 27, 2013, 127 Stat. 588.)

## Notes

### Editorial Notes

### Prior Provisions

A prior section 503B of act June 25, 1938, ch. 675, was renumbered section 503C by Pub. L. 113–54, § 102(a)(1), Nov. 27, 2013, 127 Stat. 587, and transferred to section 353c of this title.