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• FDA to exercise enforcement discretion on compounded FIP treatment

  This week, FDA announced that it does not intend to enforce new animal drug approval requirements for products compounded from GS-441524, under specific conditions. read more →

• Advocacy in ACTion

  APC’s Scott Brunner and Savannah Cunningham attended PCCA ACT Legislative Conference this week — as did APC Board Vice President Gina Besteman and many other APC members. read more →

• Get the scoop on the hottest topics in compounding

  EduCon’s first session is in less than two months, and you don’t want to miss it.  read more →

• South Carolina allows 503B sourcing

  Kudos to the Outsourcing Facilities Association for their work in shepherding through South Carolina HB 3592. Signed into law on Monday, it explicitly allows 503B sourcing. read more →

• A terrific tool to train the team

  Our 15-hour virtual course is a thorough, convenient, and affordable resource for learning the ethical, legal, and regulatory framework in which compounding is done. read more →

• We’re headed for Tampa! (Oh, and Boston, too)

  We’ll be in the Tampa/St. Pete area on June 12 for our next CompoundED UpDATE — part of a series of regional meetings made possible by a grant from PCCA. We’ll also be in Boston on June 18 for a compounder get-together. read more →

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December 1, 2023

APC files amicus in Novo case against Tennessee compounder

A U.S. District Court judge approved APC filing an amicus brief this week in Novo Nordisk’s lawsuit against Tennessee compounder (and APC PFM) DCA Pharmacy.  “This is great news,” said APC’s Scott Brunner. “It means the brief, which explains the essential role compounding pharmacies play in preparing copies of FDA-approved drugs when those drugs appear on the FDA drug shortage list, was accepted and will be considered by the court. The brief also clarifies for the court that pharmacy compounding is authorized in state and federal law and is not, as Novo asserts, ‘unauthorized drug manufacturing.’”    APC awaits responses from courts to its requests to submit the amicus brief in the three other Novo lawsuits against compounding pharmacies.  APC is represented by Boesen & Snow Law, Scottsdale, Arizona. The legal action is supported by APC’s Legal Action Fund, which is funded by contributions from APC members.