FDA issues new guidelines on drug compounding, packaging

The U.S. Food and Drug Administration released five new draft documents last week on compounding and repackaging to help commercial entities comply with important public health laws.

“The draft-guidance documents provide information to pharmacies, outsourcing facilities, health care entities and others about these FDA-proposed policies, which are critical to protecting the public health,” Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, said.

The documents include:

• Draft guidance for entities considering whether to register as outsourcing facilities under section 503B of the federal Food, Drug and Cosmetics Act
• Draft guidance for the repackaging certain human drug products by pharmacies and outsourcing facilities
• Draft guidance for mixing, diluting or repackaging biological products outside the scope of an approved biologics license application
• Draft guidance for adverse event reporting for outsourcing facilities under section 503B of the Food, Drug and Cosmetics Act
• Draft memorandum of understanding between a state and the U.S. Food and Drug Administration addressing certain distributions of compounded human drug products

These documents are the newest in a series of policy documents connected to FDA mistakes in drugs that were manufactured by state-licensed pharmacies, outsourcing facilities and federal facilities.