FDA Withdraws Draft Guidance For Industry #230

8 November 2017 Reed Smith Client Alerts

Page d'accueil Perspectives FDA Withdraws Draft Guidance For Industry #230

The U.S. Food & Drug Administration (“FDA”) announced in an early morning press release on November 7, 2017, that it is withdrawing the draft Guidance for Industry #230, “Compounding Animal Drugs from Bulk Drug Substances.”¹ FDA confirmed that it does not intend to finalize the current draft guidance. Rather, it will issue a new draft guidance in early 2018 for public comment.

Auteurs: Rachael G. Pontikes Emily L. Hussey

The draft guidance was issued in May 2015 and proposed conditions under which FDA generally would not take action against the compounding of animal drugs from bulk drug substances. The draft guidance immediately received a flurry of comments from industry stakeholders contesting not only the authority of FDA to regulate the compounding of animal drugs, but also its position that federal law does not permit the compounding of animal drugs from bulk drug substances. Industry stakeholders also took issue with the specific parameters under which FDA proposed to regulate the compounding of animal drugs from bulk substances.

The industry comments appear to have had their intended effect, as FDA has chosen to withdraw the draft guidance in its entirety rather than revise it in its current form. Although FDA does not provide any specifics on the approach FDA intends to take with the new draft guidance, it does concede that it will consider issues that are specific to compounding of animal drugs, “including the significance of using compounding drugs as a treatment option in various veterinary settings and animal species.

Ultimately, FDA’s decision to withdraw the draft guidance is a bit of good news for industry stakeholders who have been waiting for FDA to make its next move on animal drug compounding. Despite FDA assurances, however, it remains to be seen whether and to what extent FDA will take industry stakeholders’ comments into account in forming the new draft guidance.

FDA Press Release, “FDA Announces Withdrawal of Draft Guidance for Industry #230 Regarding Animal Drug Compounding,” Nov. 7, 2017, fda.gov

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