The U.S. Pharmacopeial Convention (USP) has adopted new quality assurance standards for compounding, producing, and researching PET drugs.
The standards are in response to U.S. Food and Drug Administration (FDA) current good manufacturing practice (cGMP) regulations for PET drugs that will become effective on December 11.
The revised standard -- formerly known as "General Chapter 823 Radiopharmaceuticals for Positron Emission Tomography-Compounding" -- is published in the November edition of the U.S. Pharmacopeia National Formulary and can be found on the USP site (USP 35-NF 30).
USP is petitioning the FDA to update the reference to USP 35-NF 30 in the PET cGMP regulations.
Until the FDA reference is updated, PET drugs produced for investigational and research purposes still must comply with General Chapter 823 of USP 32-NF 27 (2009) or the U.S. Code of Federal Regulations Title 21, Part 212, to meet cGMP requirements.
Chapter 823 will become official on May 1, 2012, when it will be known as "Positron Emission Tomography Drugs for Compounding, Investigational, and Research Uses."
