Description
To qualify for exemptions under section 503A of the Federal Food, Drug, and Cosmetic Act (FD&CAct), a drug product must be compounded by a licensed pharmacist or physician who does not compoundregularly or in inordinate amounts any drug products that are essentially copies of a commerciallyavailable drug product, among other conditions. This guidance sets forth FDA’s policies regardingthis provision of section 503A, including the terms commercially available, essentially a copy of acommercially available drug product, and regularly or in inordinate amounts.
Scope & Applicability
Product Classes
5Human drug products produced by pharmacies or outsourcing facilities
FDA-approved drugs available in the market; Marketed drug products that compounded drugs cannot essentially copy; The reference marketed drug used for comparison
Regulated by CDER and CBER
Drugs produced by pharmacies that must meet 503A conditions
Over-the-counter medications evaluated under the drug monograph process
Stakeholders
5Individual compounding human drug products
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
Determines significant difference for the patient; Determines if a change produces a significant difference for a patient
Facilities registered under section 503B that compound human drug products; entities that compound drugs under section 503B; Entities that compound drug products under section 503B
medical professional requesting HCT/P for urgent need; requesting HCT/P based on urgent medical need
Regulatory Context
Attributes
3Amount of active ingredient present in each dosage
Recommended retention period for compounding records
proposed product must be bioequivalent to the RLD
Identified Hazards
Hazards
2Conditions whereby a drug may have been contaminated with filth
Contamination of raw materials or finished products
Related CFR Sections (2)
- 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 →
See Also (8)
- 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)
- 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)
- CVM GFI #256 - Compounding Animal Drugs from Bulk Drug Substances (Status: Final)
- CVM GFI #253 Current Good Manufacturing Practice for Animal Cells, Tissues, and Cell- and Tissue-Based Products (Status: Final)