The U.S. Pharmacopeial Convention (USP) of Rockville, MD, has proposed new quality assurance standards for the production and compounding of PET drugs.
The proposed revisions in General Chapter 823, "Radiopharmaceuticals for Positron Emission Tomography -- Compounding," are designed to reflect changes in the use and development of PET drugs since the standards' original publication in 1998.
In its communiqué, USP noted that since then, the use and supply of PET drugs have increased in routine diagnostic imaging. In addition, the use of PET radiopharmaceuticals to accelerate and reduce the cost of drug discovery efforts has expanded, as has the development of new PET agents for cardiology, oncology, and neurology.
Areas addressed in the proposed revisions include the following:
- Differences between the organization of Chapter 823 and the provisions of the U.S. Food and Drug Administration (FDA) final rule and guidance issued for PET drugs in 2009
- Defined frequency for certain quality control tests
- Timing of the completion of certain quality control tests relative to product release, given the short time frame in which a PET drug must be administered after production
USP will take feedback on the proposed changes until March 31, 2011.
Related Reading
FDA issues final cGMP rules for PET drugs, December 11, 2009
USP report blasts radiology medication errors, January 19, 2006
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