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Comments on the FDA’s Revised Draft Guidance on Insanitary Conditions at Compounding Facilities new

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Public Citizen, in general, supports the Food and Drug Administration’s (FDA’s) draft guidance for industry “Insanitary Conditions at Compounding Facilities (Revision 1).” The numerous detailed examples of insanitary conditions provided in the draft guidance should assist compounding facilities in identifying and remediating insanitary conditions. However, Public Citizen strongly objects to the FDA’s addition of a statement indicating that for physician compounding or repackaging of drug products, the agency does not intend to enforce legal requirements that prohibit the preparation, packing, and holding of drugs under insanitary conditions.

View our other work related to pharmacy compounding.