Description
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled “Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act.” This guidance describes FDA’s interim policy concerning compounding by human drug product compounders that are not outsourcing facilities using bulk drug substances while FDA develops the list of bulk drug substances that can be used in compounding under the applicable section of the Federal Food, Drug, and Cosmetic Act (FD&C Act). This guidance finalizes the draft guidance of the same title issued in December 2023 and replaces the final guidance of the same title issued in January 2017.
Key Topics
Terms and concepts identified from this document
Scope & Applicability
Product Classes
2Products compounded by outsourcing facilities within scope
Drugs produced by state-licensed pharmacies or physicians
Stakeholders
6Individual compounding human drug products
Entity that originally produced the bulk drug substance
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
FDA must consult this committee before developing the bulks list
Entities compounding drug products under section 503A; Entity compounding drug products
Allowed value for reporter qualification
Regulatory Context
Regulatory Activities
5Approval process under section 505
Approval process under section 505
Approval process for drugs under the FD&C Act
Investigational New Drug submissions
NPRM for placement of substances on the 503A bulks list
Document Types
4Bulk drug substances must be accompanied by a valid COA
certificates of analysis provided for specific lots
Public communication describing safety risks for Category 2 substances
Approved Drug Products With Therapeutic Equivalence Evaluations
Attributes
4Substances nominated that raise significant safety risks
Substances nominated without adequate support
Category of nominated bulk drug substances
Substances nominated with sufficient information under evaluation
Technical Details
Substances
3Raw materials used in compounding human drug products
Substance intended for incorporation into a finished drug product
Ingredients used in compounding drug products; Component used in compounding drug products
Processes
1The act of creating a drug product from bulk drug substances
Identified Hazards
Hazards
2FDA identifies risks relating to the use of certain bulk drug substances
Criteria for excluding a substance from Category 1
Standards & References
External Standards
6Official compendium for device recognition
Official compendium for drug and device recognition
Official drug substance monograph for compounding eligibility; Applicable quality standard for substances
National Formulary monograph for drug substances; National Formulary quality standard
United States Pharmacopeia standards for compendial drug substances; confirming conformance to the application-approved specification and USP
National Formulary monograph compliance
Related CFR Sections (4)
- 21CFR216.23§ 216.23 Bulk drug substances that can be used to compound drug products in accordance with section 503A of the Federal Food, Drug, and Cosmetic Act.
(a) The following bulk drug substances can be used in compounding under section 503A(b)(1)(A)(i)(III) of the Federal Food, Drug, and Cosmetic Act.Read full regulation →
- 21CFR207.1§ 207.1 What definitions and interpretations of terms apply to this part?
The definitions and interpretations of terms in sections 201 and 510 of the Federal Food, Drug, and Cosmetic Act apply to the terms used in this part, if not otherwise defined in this section. The following definitions apply to this part:Read full regulation →
- 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 →
Enforcement Impact
Deficiencies cited in Warning Letters referencing the same regulations
Related Warning Letters (1)
See Also (8)
- Compliance Policy for Certain Compounding of Oral Oxitriptan (5-HTP) Drug Products for Patients With Tetrahydrobiopterin (BH4) Deficiency Immediately in Effect Guidance for Industry (Status: Final)
- Submission of Quality Metrics Data Guidance for Industry (Status: Draft)
- Compounded Drug Products That Are Essentially Copies of Approved Drug Products Under Section 503B of the Federal Food, Drug, and Cosmetic Act Guidance for Industry (Status: Final)
- Compounded Drug Products That Are Essentially Copies of a Commercially Available Drug Product Under Section 503A of the Federal Food, Drug, and Cosmetic Act Guidance for Industry (Status: Final)
- Evaluation of Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the Federal Food, Drug, and Cosmetic Act (Status: Final)
- Drug Master Files Guidance for Industry (Status: Draft)
- Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products: Guidance for Industry (Status: Final)
- Risk Management Plans to Mitigate the Potential for Drug Shortages (Status: Draft)