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FDA Offers Guidelines For Drug Compounders

by Britt E. Erickson
July 7, 2014 | A version of this story appeared in Volume 92, Issue 27

FDA’s expectations for large-scale drug-compounding pharmacies that act as drug manufacturers are spelled out in draft guidelines released last week. They address Good Manufacturing Practices for sterile drug products and the general safety of compounded human drug products. FDA issued the guidelines as part of its effort to implement the Drug Quality & Security Act, a law enacted last year to prevent public health crises caused by contaminated prescription drugs. Momentum for the law grew after a deadly outbreak of fungal meningitis in 2012 was linked to contaminated steroid injections. The drug quality law encourages large-scale compounding pharmacies that distribute products across state lines to register with FDA as “outsourcing facilities,” but it does not require them to do so. FDA’s draft guidelines would apply to those outsourcing facilities. Traditional compounding pharmacies, which typically mix small batches of drugs for individual patients, would remain regulated at the state, but not federal, level. In addition, FDA proposed a rule on July 1 that would revise the list of drug products that cannot be compounded because they have been removed from the market because of safety or efficacy concerns.


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