We’re advising FDA to assure clear understanding of compliance standards and enforcement on GFI 256, regarding veterinary compounding.
We’re pushing back against FDA’s recent back-door reclassification of DTE as a biologic.
We’ve released a series of member-only briefing documents to help you educate prescribers about compounding on topics such as “The Truth About Pharmacy Compounding” and “Compounding Peptides: It’s Complicated.”
We’re developing federal legislation that would:
• Eliminate the MOU and replace it with reporting by pharmacies that ship more than 50 percent of their production out of state
• Establish an adverse events reporting framework for 503A pharmacies
• Implement the “urgent-use compounding” provisions of HR 3662 from the previous Congress.
We’re developing a 15-hour virtual certificate program–The Ethical, Legal and Regulatory Foundations of Pharmacy Compounding–that will launch in Q2 2023. Priced at $495, the program will serve as entry-level training for compounding pharmacists and technicians.
With amoxicillin in shortage, our advocacy resulted in FDA issuing guidance creating a path by which 503A pharmacies can more easily compound beta lactams.
We’re developing a “decision points document” to assist state boards of pharmacy in implementing and enforcing USP <800> and <797>.
We’re still working to save compounded hormones—therapies that benefit millions of Americans–in the wake of implicit threats to restrict them. Contribute to our campaign at compounding.com.
We’ve launched a portal to help our members aggregate patient-reported outcomes to demonstrate that compounded medications are benefiting millions of patients–data that will be essential in making a case for cBHT if FDA moves to restrict it.
Via our Legal Action Fund, we filed two amicus briefs last year in court cases, one defending compounders’ right to compound methylcobalamin and another addressing ambiguity in FDA’s insanitary conditions guidance.
March 26–28: APC’s Owner Summit 2023; The Grand Hotel Golf Resort + Spa; Point Clear, AL
April 6: An APC webinar, Making the Case for Advanced Pharmacy Technicians.
April 20: An APC webinar, Compounding for Women’s Health Conditions.
May 25: An APC webinar, IV Nutrition. More details coming soon.
June 1: APC Fellows Program application deadline
June 6: An APC webinar, Compounding for Cosmetic Needs. More details coming soon.
June 29: An APC webinar, Trends in Veterinary Pharmacy: What Compounders Need to Know. More details coming soon.
September 19–20: APC’s Compounders on Capitol Hill 2023; Hilton National Mall; Washington, DC
FOLLOW US
