To further protect the safety of patients taking individually prepared medications, the U.S. Pharmacopeial Convention (USP) has developed new and revised quality guidelines for pharmacists who compound—or individually prepare—drugs.
As the use of compounded medicines has grown in recent years, the need for clear and rigorous standards to help ensure these preparations are of high quality and purity has become increasingly important. USP has long had such standards, but is now proposing updates and new content for General Chapter Quality Assurance in Pharmaceutical Compounding (1163). USP is seeking comments on these proposed revisions from compounding pharmacists and other interested parties.
All existing content in the Quality Assurance in Pharmaceutical Compounding General Chapter was reviewed and updated. Entirely new content includes sections on training; physical testing of dosage units; weight and volume assessment; cleaning and disinfecting; containers, packaging, repackaging and storage; and outsourcing. The procedures in this chapter apply to compounded medicines intended for both human and veterinary use.
The proposed General Chapter (1163) revision is available for public comment in the January–February Pharmacopeial Forum at www.usp.org/USPNF/pf/1163comments.html. Comments may be submitted through April 15, 2010.
Date: January 29, 2010
Source: The United States Pharmacopeial Convention (USP)