APC: ! What We’re Working On

! What We're Working On

We launched a 15-hour virtual CE programThe Ethical, Legal and Regulatory Foundations of Pharmacy Compounding–on August 1, 2023. Priced at $495, the program serves as entry-level training for compounding pharmacists and technicians.

We’re advocating for HR 167, legislation that would allow compounders temporarily to provide “urgent use” medications to hospitals and clinics when those drugs are in shortage. Read our recent op-ed in STAT.

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 event reporting framework for 503A pharmacies

We sent a memo to assist state boards of pharmacy in implementing and enforcing USP <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 ‘Compounding the Joy’ campaign.

We’re pushing back against FDA’s recent back-door reclassification of DTE as a biologic. 

We’re advising FDA to assure clear understanding of compliance standards and enforcement on GFI 256, regarding veterinary compounding. 

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.”

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’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.