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

FDA on 1/13/17, 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.

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