Description
For a drug product compounded by an outsourcing facility to qualify for the exemptions undersection 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act), it must not be“essentially a copy of one or more approved drug products,” and must meet the other conditionsin section 503B. This guidance sets forth FDA’s policies concerning the essentially a copyprovision of section 503B.
Scope & Applicability
Product Classes
10Human drug products produced by pharmacies or outsourcing facilities
Over-the-counter drugs used in the evaluation of essentially a copy
Drug products approved by FDA used for comparison against compounded versions
Conventionally manufactured drugs with approved applications
Requires analytical comparability per ICH Q5E
Drugs produced by pharmacies that must meet 503A conditions
Drug products approved under section 505 of the FD&C Act; FDA-approved products used for comparison
Drugs approved via the ANDA process
Non-prescription drug products subject to monographs
Drugs produced by an outsourcing facility
Stakeholders
6Facilities registered under section 503B that compound human drug products; entities that compound drugs under section 503B; Entities that compound drug products under section 503B
Participant involved in implementing and participating in the REMS
Individual 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
responsible for justifying omission of studies
Determines significant difference for the patient; Determines if a change produces a significant difference for a patient
Regulatory Context
Attributes
4The physical form of the drug product.
determined by the treating veterinarian to justify compounding a copy
Standard for comparing compounded drugs to approved drugs
Amount of active ingredient present in each dosage
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 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)
- 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)