In early November, FDA finalized its guidance regarding insanitary conditions at compounding facilities.* This guidance document “specifically addresses drugs (including biological products) produced by pharmacies, federal facilities, and outsourcing facilities that compound or repackage drugs, or that mix, dilute, or repackage biological products.” Although these are nonbinding recommendations, FDA expects guidance documents to be reviewed and incorporated into practices or the facility is expected to provide alternative practices that meet the intent of the guidance document.
FDA defines insanitary conditions as “conditions that could cause a drug to become contaminated with filth or rendered injurious to health. The drug itself need not actually be contaminated. A drug that is actually contaminated with any filthy, putrid, or decomposed substance is deemed to be adulterated under section 501(a)(1) of the FD&C Act (21 U.S.C. 351(a)(1)).”
This document describes examples of insanitary conditions that FDA has observed and is issuing this guidance to help compounding facilities and state regulatory agencies understand the types of conditions that could cause a drug product to become contaminated. These examples are intended to help compounding facilities identify, prevent, and remediate insanitary conditions.
Anyone who has worked in any level of pharmacy practice in the last decade is aware of the potentially devastating impact that contaminated compounded medications can wreak on patient outcomes. We encourage your pharmacy to incorporate these guidance measures into your quality and safety programs.
All the best,
R. Mitchell Halvorsen
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