Compounding Guidance Finalized by FDA

With much activity still surrounding compounding pharmacies and outsourcing facilities, and with enforcement action still on the rise, today FDA issued two final Guidance documents that describe the types of bulk drug substances that can be used for compounding for section 503A (pharmacies) and 503B (outsourcing facilities) without FDA enforcement action.  This also obviously assumes that the facility is operating in accordance with the appropriate controls by state or federal agencies.

The Guidance on bulk substances for compounding under section 503A (here) and those that are permissible under section 503B (here) describe three categories of bulk products:

Category 1 – These substances may be eligible for inclusion on the list of bulk drug substances that can be used in compounding under section 503A or 503B, were nominated with sufficient information for FDA to evaluate them and do not appear to present a significant safety risk in compounding at this time. FDA does not intend to take action against a compounder for compounding drugs using bulk drug substances listed in Category 1 of either 503A or 503B, whichever is applicable, provided that the conditions described in the guidance documents and all other applicable requirements of the FD&C Act are met.

Category 2 – These are bulk drug substances that were nominated with sufficient supporting information for FDA to evaluate them, but raise significant safety concerns, and are not eligible for the policy that applies to substances in Category 1. These bulk drug substances cannot be used in compounding unless FDA publishes a final rule (section 503A (b)(1)(A)(i)(III)) or final Federal Register notice (section 503B(a)(2)(A)) authorizing the particular substance’s use in compounding. See Safety Risks Associated with Certain Bulk Drug Substances Nominated for Use in Compounding for a list of the substances and a summary of the identified safety risks.

Category 3 – These are bulk drug substances that were nominated for inclusion on the bulk drug substances lists without sufficient supporting information for FDA to evaluate them and are not eligible for the policy that applies to substances in Category 1. These bulk drug substances cannot be used in compounding, and FDA will not consider them for the bulk drug substances lists unless the substances are re-nominated with sufficient supporting information through the following dockets:

Other information specific to 503A and 503B can be gleaned from the two Guidance documents referenced above.  Also please see the FDA notice announcing the availability of these final Guidance documents describing the FDA’s interim policy here.