Interim Policy on Compounding Drugs Using Bulk Drug Substances

Interim Policy on Compounding Drugs Using Bulk Drug Substances

FDA issued a revised final guidance in January 2017, Guidance for Industry, Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic Act, which is in place while the FDA develops the 503B bulks list. The guidance describes conditions under which the agency does not intend to take action against outsourcing facilities that compound drug products from bulk drug substances that cannot otherwise be used in compounding under section 503B. FDA issued this guidance document to avoid unnecessary disruption to patient treatment while FDA evaluates the bulk drug substances nominated for use in compounding under section 503B of the FD&C Act. The guidance documents describe three categories of bulk drug substances nominated by the public for use in compounding. The categories are: Category 1 – These substances may be eligible for inclusion on the 503B bulks list, were nominated with sufficient information for FDA to evaluate them, and do not appear on any other list. FDA does not intend to take action against an outsourcing facility for compounding drugs using bulk drug substances identified in Category 1 provided that the conditions described in the guidance document are met. Category 2 – These are bulk drug substances that were nominated with sufficient supporting information for FDA to evaluate them, but FDA has identified significant safety risks relating to the use of these substances in compounding pending further evaluation. Drug products compounded using these substances are not eligible for the policy described for the substances in Category 1. FDA would consider taking action against an outsourcing facility for compounding drug products with this bulk drug substance under its general enforcement policies. See Safety Risks Associated with Certain Bulk Drug Substances Nominated for Use in Compounding for the substances and a summary of the identified safety risks. Category 3 – These substances may be eligible for inclusion on the 503B bulks list, but were nominated with insufficient supporting information for FDA to evaluate them. The substances are not eligible for the policy that applies to substances in Category 1. FDA would consider taking action against an outsourcing facility for compounding drug products with this bulk drug substance under its general enforcement policies. These bulk drug substances can be re-nominated with sufficient supporting information through Bulk Drug Substances That Can Be Used To Compound Drug Products in Accordance With Section 503B of the Federal Food, Drug, and Cosmetic Act; Establishment of a Public Docket. For additional information: Bulk Drug Substances Used in Compounding Under Section 503B of the FD&C Act

For more information, please visit FDA's Human Drug Compounding web site.