APC Advocacy

• MOCs to FDA: “We are troubled”

  Eight members of Congress wrote to FDA Center for Veterinary Medicine director Dr. Steven Solomon this week to express concern that CVM’s GFI 256 on animal compounding may result in delayed care for veterinary patients. read more →

• New Model Act incorporates APC-recommended compounding questionnaire

  Several changes to NABP’s new Model Act were recommended by APC, including a requirement that licensed compounding pharmacies provide to the state board of pharmacy basic information about their compounding operations. read more →

• 100 MOCs sign letter to TRICARE

  One hundred members of Congress signed a letter of concern sent last week to the Department of Defense in response to recent TRICARE changes that threaten beneficiaries’ access to community pharmacies, especially in rural areas. read more →

• Two proposed state regs changes to be aware of

  Kentucky and Arkansas have recently proposed regulations changes to be aware of. read more →

• The threat to compounded hormones just got real

  See inside for details, then take our survey and attend our stakeholder briefing on October 13. read more →

• October 6 stakeholder briefing on measuring patient outcomes

  The best tool you have for demonstrating the value of your therapies is your patients—what they say about the compounded medications you dispense to them. read more →

• FDA uses back door to restrict DTE compounding

  In a Sep 16 letter to NABP CEO Al Carter, FDA states that DTE products “can put patients at harm” and that “therapies containing DTE are biological products subject to licensure under Section 351(i) of the PHS Act.” read more →

• IMPORTANT STAKEHOLDER BRIEFING: Measuring Patient Outcomes

  If patient-reported outcomes can prove your value, why aren’t more of you collecting them? read more →

• URGENT: Deadline for joint Congressional letter on GFI 256 is September 30

  One result of last week’s Compounders on Capitol Hill visits has been the creation of a joint congressional letter to FDA’s Center for Veterinary Medicine raising concerns about the great ambiguity in GFI 256 on animal compounding read more →

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