The Pew Charitable Trusts offered comments on a revised draft guidance document issued by the U.S. Food and Drug Administration (FDA) in September 2018 regarding how the agency will define “insanitary conditions” when enforcing the federal law that prohibits compounding drugs in such settings.
The update gives helpful direction to compounders and regulators and provides clarity with detailed examples of insanitary conditions. Examples provided in the guidance include the presence of vermin, mold, and standing water in the production or adjacent areas; use of ingredients that are not pharmaceutical grade; construction occurring adjacent to production without measures to prevent contamination of the compounding area; and inadequate handling of hazardous or potent drugs (which can lead to cross-contamination). However, Pew expresses concern over FDA’s signaling that it generally will not enforce the guidance with physicians who compound drugs. The development of comprehensive guidance on insanitary conditions is critical to the safety of compounded drugs. The agency undermines this objective by using its discretion to exempt physician compounding from its enforcement of the guidance.