Description
Questions have periodically arisen regarding how various testing and/or examination requirements under the CGMP regulations (21 CFR Parts 210 and 211) are to be applied to repackers of finished dosage form drugs. In particular, there have been questions regarding whether it is appropriate to apply various "component" requirements in the CGMPRs (such as those under Section 211.84 concerning identity testing and analysis or receipt of a report of analysis for purity, strength, and quality) to finished dosage form drugs which an establishment receives and repackages. It has also been questioned how the requirements under 211.165 are to be applied to repackers, insofar as the requirements for appropriate laboratory determination for identity and strength of each active ingredient prior to release are concerned.
Scope & Applicability
Product Classes
1products received and repackaged by the establishment
Stakeholders
1Entity that receives drug products for repacking.
Regulatory Context
Attributes
1Records of investigational products should include expiration dates if applicable.
Related CFR Sections (3)
- 21CFR210.3§ 210.3 Definitions.
(a) The definitions and interpretations contained in section 201 of the act shall be applicable to such terms when used in this part and in parts 211 , 225 , and 226 of this chapter .Read full regulation →
- 21CFR211.165§ 211.165 Testing and release for distribution.
(a) For each batch of drug product, there shall be appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient, prior to release. Where sterility and/or pyrogen testing are conducted on sRead full regulation →
- 21CFR211.84§ 211.84 Testing and approval or rejection of components, drug product containers, and closures.
(a) Each lot of components, drug product containers, and closures shall be withheld from use until the lot has been sampled, tested, or examined, as appropriate, and released for use by the quality control unit.Read full regulation →
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See Also (8)
- CPG Sec. 410.100 *Finished Dosage Form Drug Products in Bulk Containers - Applications of Current Good Manufacturing Practice Regulations* (Status: Final)
- Changes to an Approved NDA or ANDA: Guidance for Industry (Status: Final)
- CVM GFI #83 Chemistry, Manufacturing and Controls Changes to Approved NADA/ANADA (Status: Final)
- Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs): Guidance for Industry (Status: Final)
- Assessing User Fees Under the Over-the-Counter Monograph Drug User Fee Program (Status: Draft)
- CVM GFI #278 Human User Safety in New and Abbreviated New Animal Drug Applications (Status: Final)
- Reporting Amount of Listed Drugs and Biological Products Under Section 510(j)(3) of the FD&C Act (Status: Final)
- Sterile Drug Products Produced by Aseptic Processing — Current Good Manufacturing Practice: Guidance for Industry (Status: Final)