Pharmacy Compounding of Human Drug Products Under Section 503A of the Federal Food, Drug, and Cosmetic Act Guidance | Guideline Explorer

Description

This guidance announces FDA’s intention with regard to enforcement of section 503A of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 353a) to regulate entities that compound drugs, now that section 503A has been amended by Congress to remove the advertising and solicitation provisions that were held unconstitutional by the U.S. Supreme Court in 2002 (see section II below). Several parts of section 503A require rulemaking and consultation with a Pharmacy Compounding Advisory Committee to implement. This guidance explains how the provisions will be applied pending those consultations and rulemaking. This guidance also describes some of the possible enforcement actions FDA can bring against individuals or firms that compound drugs in violation of the FD&C Act.

Scope & Applicability

Product Classes

4

outsourcing facilities

Entities registered under section 503B of the FD&C Act

positron emission tomography (PET) drugs

Drugs excluded from section 503A application

radiopharmaceuticals

Radioactive sterile and non-sterile drugs; Drugs with short half-lives requiring administration soon after production.

Compounded Drug Product

Drugs produced by state-licensed pharmacies or physicians

Stakeholders

3

licensed pharmacist

Individual compounding human drug products

licensed physician

Typically submit individual patient expanded access requests; The individual responsible for treating the patient under expanded access.; Healthcare provider seeking information for patients; doctor or clinical staff whom the patient can contact

Firm

Entities developing animal food ingredients and participating in AFIC.

Regulatory Context

Attributes

1

5% Limit

Limit on interstate distribution for states without an MOU

Identified Hazards

Hazards

1

Public health risks

FDA prioritizes enforcement based on greatest public health risks

Related CFR Sections (3)

21CFR207.3§ 207.3 Bulk drug substance.
Bulk drug substance, as referenced in sections 503A(b)(1)(A) and 503B(a)(2) of the Federal Food, Drug, and Cosmetic Act, previously defined in § 207.3(a)(4) , means the same as “active pharmaceutical ingredient” as defined in § 207.1 .Read full regulation →
21CFR216.24§ 216.24 Drug products withdrawn or removed from the market for reasons of safety or effectiveness.
The following drug products were withdrawn or removed from the market because such drug products or components of such drug products have been found to be unsafe or not effective. The following drug products may not be compounded under the exemptions provided by section 503A(a) or section 503B(a) ofRead full regulation →
21CFR201.5§ 201.5 Drugs; adequate directions for use.
Adequate directions for use means directions under which the layman can use a drug safely and for the purposes for which it is intended. ( Section 201.128 defines “intended use.”) Directions for use may be inadequate because, among other reasons, of omission, in whole or in part, or incorrect specifRead full regulation →

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CGMP/Finished Pharmaceuticals/Adulterated
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2025-12-23
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3D Imaging Drug Design and Development LLC
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Seaway Pharma Inc.
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