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FDA Proposes PET CGMPs
On September 15, the US Food and Drug Administration (Rockville, MD) proposed current good manufacturing practices (CGMPs) rules to govern drugs for positron emission tomography (PET) and simultaneously issued a draft guidance, “PET Drug Products-Current Good Manufacturing Practice.”
PET drugs are imaging agents, usually injected, with radioactive tags. The radioisotopes are produced in cyclotrons close to the point of use, typically have short half-lives, and must be administered within hours or minutes. Because the window of utility is so short, many traditional CGMP testing and validation requirements may not be appropriate. As production moves from academic medical centers into the commercial sector, however, standards are necessary.
The proposed rule exempts PET drugs from certain general provisions of 21 CFR Parts 210 and 211, and establishes a new Part 212 to cover PET production requirements. (The proposed rule also accepts the United States Pharmacopeia General Chapter <823> on compounding PET radiopharmaceuticals as the CGMP standard for investigational and research PET drugs.)
The proposed rule and draft guidance continue a process that began with public meetings and preliminary guidance in 1999, and “preliminary draft proposed rule” in 2002.
The 90-day comment period runs through mid-December. For information see www.fda.gov/cder/regulatory/pet/default.htm.