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Focus on Regulation

Tag Archives: compounding

New Guidance Makes Clear that FDA Is Focused on Insanitary Conditions at Pharmacy Compounders

Today, FDA published yet another draft guidance targeting drug compounders, entitled Insanitary Conditions at Compounding Facilities (the Draft Guidance). Notably, it makes clear to pharmacy compounders that although they may be exempt from FDA’s current Good Manufacturing Practice (cGMP) requirements, they are not exempt from FDA’s prohibition on insanitary conditions. And FDA, along with state

FDA Publishes Draft Guidances and Memorandum of Understanding on Drug Compounding and Repackaging

On February 13, 2015, FDA issued four draft guidance documents and a draft memorandum of understanding (MOU) regarding the compounding of drug and biological products and the regulation of outsourcing facilities under the Drug Quality and Security Act (DQSA), enacted in November 2013.

Three of the guidance documents clarify the circumstances under which an entity should register as an outsourcing facility and the circumstances under which FDA expects to exercise enforcement discretion as to entities that repackage human prescription drug products or mix, dilute, or repackage biological products. The last guidance addresses adverse event reporting requirements for outsourcing facilities. The agency also published a draft MOU that may be used between a state and FDA concerning responsibilities for oversight of compounding activities.

Update: Government Files Brief Seeking Dismissal of KV’s Lawsuit

To update our previous post on this subject, on July 20, 2012, the government filed its brief opposing KV’s request for injunctive relief and moved to dismiss the case.  In its brief, the government argues that  KV lacks standing to sue because, in June 2012—prior to KV filing suit—the agency posted on its website a statement and a

KV Sues FDA over its Interpretation and Application of Orphan Drug Exclusivity, Drug Compounding, Unapproved Drugs, and Import Provisions

K-V Pharmaceutical Company (“KV”) and its wholly-owned subsidiary, Ther-Rx Corporation (“Ther-Rx”) filed suit in the U.S. District Court for the District of Columbia on July 5, 2012 against the FDA seeking declaratory and injunctive relief to “restore” KV’s 7-year orphan drug exclusivity for MAKENA (hydroxyprogesterone caproate or 17P) Injection, 250 mg/mL.