Important Updates on Top Issues from APC
Recently, the Alliance for Pharmacy Compounding (APC, formerly IACP) held their Advocacy Town Hall, which you can watch in its entirety at the bottom of this post. APC leaders covered in depth a number of urgent, important issues for compounding pharmacies including:
- The FDA’s Guidance for Industry (GFI) on compounding for animal use
- The FDA’s Memorandum of Understanding (MOU) on interstate compounding distribution
- Clawbacks from ESI in based on patient-prescriber relationship
- Recent NASEM reports on compounded bHRT and pain cream
FDA’s GFI on compounding for animal use
Anthony Grzib of Wedgewood Pharmacy addressed the main questions and concerns compounders and veterinarians may have from the FDA’s GFI #256 “Compounding Animal Drugs from Bulk Drug Substances.”
The comment period for the GFI has been extended to October 15, 2020. APC will be submitting concerns as an organization and encourages pharmacists to submit comments as well as encourage the veterinarians and pet owners they work with to submit comments on the impact the GFI would have on patient access.
FDA’s MOU on interstate compounding distribution
APC’s David Pore spoke to the FDA’s MOU asking states to establish a tracking, reporting, and record-keeping framework for interstate distribution of compounded drugs. APC joined with NCPA, APhA, and NASPA to submit a letter to the Office of Management and Budget (OMB) saying the FDA has underestimated the administrative burden on state boards of pharmacy and asking for the OMB to send the MOU back to the FDA for more careful data collection.
Clawbacks from ESI in based on patient-prescriber relationship
David Miller of Keystone Pharmacy summarized the recent recoupment notice letters many compounders received regarding Tricare/CHAMPUS compounded prescriptions from 2015 regarding a DHA investigation into physician-patient relationships. Pharmacists are rightfully concerned about how scripts are being labeled as fraudulent and standards of proof for office visits and prescriber-patient relationships.
Since the APC call, ESI has suspended clawbacks. Learn more about the latest status >
Recent NASEM reports on HRT and pain creams
APC will be putting together task forces on both compounded bHRT and pain creams in response to FDA-funded reports from the National Academies of Sciences, Engineering, and Medicine (NASEM). Scott Brunner, APC Executive Director, outlined plans for the task forces made of pharmacist members of APC to pull together patient outcome data and identify research to make a compelling case for both common compounding treatments to the FDA as it slowly responds to NASEM’s conclusions.
Watch the full video call below for more information on all the topics above, along with a briefing on APC’s political action committee and a message from APC President Shawn Hodges of Innovation Compounding in Kennesaw, GA, on how APC is doing more than ever before to advocate for compounders.
APC ADVOCACY TOWN HALL, SUMMER 2020
We’re proud to stand with APC
It’s as important as ever to invest in protecting the compounding industry, and to come together to advocate for the essential service that compounding pharmacies provide. Letco is proud to be a “silver tier” corporate patron supporting APC’s efforts to protect and advance the compounding industry.
For more information on memberships for pharmacists, technicians, and students, visit www.a4pc.org/join
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