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Pharmaceuticals / Regulatory Affairs

FDA, Endo Pause Bulk Compounding Lawsuit Pending FDA Guidance

Jan. 29, 2018

The FDA filed a joint motion with Endo to pause the company’s lawsuit accusing the agency of breaking the law with its decree authorizing bulk compounding of drugs.

In the lawsuit filed last October, two Endo subsidiaries alleged the FDA had treated provisions on bulk compounding in the 2013 Drug Quality and Security Act as non-binding guidance rather than federal law when it put in place an “interim” program at odds with the legislation because it requires less scrutiny by the agency.

On Jan.18, FDA Commissioner Scott Gottlieb released the agency’s compounding policy priorities for 2018, including a plan to release guidance in March on criteria for determining the substances outsourcing facilities may compound. Gottlieb said the agency intends to address concerns from industry about compounding from bulk drug substances.

In light of the agency’s announcement, both parties proposed the stay either until March 30, until the guidance’s early publication, or an announcement that the guidance will be published after March. The stay would also end if the plaintiffs notified the FDA that a company has begun compounding bulk vasopressin under the agency’s interim policy.

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