Update: FDA revises final guidances on interim policy for certain bulk drug substances used in compounding

[1/13/17] FDA today, in response to stakeholder feedback, issued revised versions of two final guidance documents regarding the use of bulk drug substances in compounding.

The agency clarified that the policies described in the guidances do not apply to inactive ingredients. Inactive ingredients are not included in the definition of a “bulk drug substance” and, therefore, can be used in compounding without appearing on the bulk drug substances lists developed under sections 503A or 503B of the Federal Food, Drug, and Cosmetic Act, if all applicable conditions are met.

The agency is also providing for regular updates to the categories of bulk drug substances described in the guidances. Previously, FDA stated that it would not evaluate new nominations for placement in one of the three categories until after it completed its review of substances already nominated with adequate supporting information.

The guidances now state that FDA will determine after submissions are received whether new nominations, including re-nominations of substances with additional supporting information, have sufficient information for FDA to review them. After making that determination, FDA will place nominated substances in the appropriate category on FDA’s website. FDA generally intends to update the categories with any new nominations the first business day of each month. This revised policy will further minimize unnecessary disruptions to patient treatment while FDA develops the lists of bulk drug substances for use in compounding.

FDA issues final guidances on interim policy for certain bulk drug substances used in compounding

[6/9/2016] FDA today issued two final guidance documents regarding the use of bulk drug substances in compounding under sections 503A or 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

These guidance documents explain FDA’s policy regarding the conditions under which the agency does not intend to take action against state-licensed pharmacies, federal facilities, and licensed physicians (under section 503A) or outsourcing facilities (under section 503B) that compound drug products from bulk drug substances that cannot otherwise be used in compounding under these sections.

FDA is issuing these guidance documents to avoid unnecessary disruption to patient treatment while FDA evaluates the bulk drug substances nominated for use in compounding under sections 503A or 503B of the FD&C Act. Additionally, these guidance documents clarify the process FDA is using to evaluate these substances.

The guidance documents describe three categories of bulk drug substances nominated by the public for use in compounding. The substances listed in each category may be found at:

The categories are:

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: