FDA Releases Final Rule and Guidance on CGMP for PET Drugs
On December 9, the U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research issued the final rule and guidance on current good manufacturing practice (CGMP) for positron emission tomography (PET) drugs. The effective date is December 12, 2011.
FDA made the following modifications to the final rule per public comments received on the proposed rule (September 20, 2005):
- Substituted the term quality assurance for quality control and revised the definition.
- Clarified that the CGMP requirements followed for the study of PET drugs under an investigational new drug application (IND) or under the review of a Radioactive Drug Research Committee (RDRC) (which reviews and approves the use of radioactive drugs for certain limited research purposes in accordance with 21 CFR 361.1) may be either the regulations in part 212 or the standards in Chapter 823, Radiopharmaceuticals for Positron Emission Tomography Compounding of the 32d ed. of the USP (2009) (USP 32).
- Simplified the requirement for identification of a sample received for laboratory testing.
- Provided more flexibility in method for determining that each batch of a PET drug product conforms to specifications before final release.
- Revised the circumstances under which conditional final release may be acceptable.
Final rule (Public Inspection Desk): http://www.federalregister.gov/OFRUpload/OFRData/2009-29285_PI.pdf
Guidance: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm070306.pdf
