News Briefs: FDA issues new guide on pharmacy compounding
In the June 7 Federal Register, the Food and Drug Administration (FDA) announced the availability of a compliance policy guide for FDA staff and industry regarding pharmacy compounding.
The FDA developed the policy guide after an April 29 U.S. Supreme Court decision invalidated the compounding provisions of the FDA Modernization Act of 1997. The agency determined that it needed to issue guidance to the compounding industry and FDA staff on what types of compounding might be subject to enforcement action under current law.
According to the compliance policy guide, here are a few of the pharmacy compounding actions that may put pharmacists on the wrong side of the FDA:
- compounding of drugs in anticipation of receiving prescriptions, except in very limited quantities in relation to the amounts of drugs compounded after receiving valid prescriptions;
- compounding drugs that were withdrawn or removed from the market for safety reasons;
- receiving, storing, or using drug substances without first obtaining written assurance from the supplier that each lot of the drug substance has been made in an FDA-registered facility;
- receiving, storing, or using drug components not guaranteed or otherwise determined to meet official compendia requirements;
- using commercial scale manufacturing or testing equipment for compounding drug products.
To read the report, go to the following web site: www.fda.gov/ora/compliance_ref/cpg/cpgdrg/cpg460-200.html.
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