FDA In Brief > FDA In Brief: FDA continues to advance oversight of drug compounding by finalizing a rule providing information on several bulk drug substances compounders not registered as outsourcing facilities can and cannot use

FDA In Brief > FDA In Brief: FDA continues to advance oversight of drug compounding by finalizing a rule providing information on several bulk drug substances compounders not registered as outsourcing facilities can and cannot use

FDA In Brief: FDA continues to advance oversight of drug compounding by finalizing a rule providing information on several bulk drug substances compounders not registered as outsourcing facilities can and cannot use

Today, the U.S. Food and Drug Administration issued a final rule under section 503A of the Federal Food Drug and Cosmetic Act, placing, for the first time, six bulk drug substances on the list of substances that compounders can use to compound drugs, known as the 503A bulks list. This rule also identifies four bulk drug substances that are not included on the 503A bulks list, and therefore cannot be used in compounding under section 503A. The rule establishes the criteria for evaluating nominated bulk drug substances for inclusion on the 503A bulks list. These criteria include the physical and chemical characterization of the substance, safety issues raised by use of the substance in compounded drug products, evidence of effectiveness or lack of effectiveness of a drug product compounded with the substance and historical use of ...