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Quality of compounded medicines supported by new standards

Rockville, Md., January 29, 2010 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 compoundor individually preparethese life-saving 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.

According to Shawn Becker, R.N., USP's director of healthcare quality standards, "If a medicine is not commercially available, the only way a patient can get it is for the doctor to prescribe an individually compounded preparation. This happens frequently, for example, with pediatric or geriatric medicines, with drugs that treat unusual conditions, or when a patient is allergic to dyes or other ingredients in the manufactured medicine. The safety, quality and benefit of these compounded medications depend on correct ingredients and calculations, precise measurements and good pharmaceutical judgment. The updated USP guidelines are a key step in helping to ensure that vulnerable patients get the best quality medicines."

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.


Contact: Laura Provan
US Pharmacopeia

Page: 1

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