Guidance Sets Compliance Limits for Compounding Near Replicas of Approved Drugs

The FDA is laying out compliance parameters for outsourcing facilities that compound near replicas of approved drugs, urging them not to distribute such products to patients that could use an approved drug.

The draft document released last week contends that compounders should not produce near-duplicate drugs — which it defines as those having the same active ingredient, route of administration, dosage form and strength, and inactive ingredients as an approved drug — due to the potential health risks and the impact on the development of life-saving drugs.

Because federal regulations governing compounding facilities prohibit outsourcing facilities from producing near duplicates in most instances, it spotlights existing exemptions that outsourcers can use to remain compliant, such as changing the route of administration or removing an inactive ingredient. An exemption also exists for approved drugs that are in shortage.