We’re implementing the “urgent-use compounding” provisions of HR 167 from the 118th Congress. Read the recent op-ed published in Stat regarding the role of compounding in drug shortages.
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.
April 5-June 15: GFI 256 Compliance webinar (on-demand), sponsored by APC and PCCA.
Now available on-demand: The FDA Compounding Quality Center of Excellence is announcing the availability of two self-guided, online courses:
June 1: APC Fellows Program application deadline
June 1: APC and OutcomeMD Express Lunch & Learn for Existing Users
June 6: An APC webinar, Popular Compounds and Unique Ingredients for Cosmetic Compounding, 2pm – 3pm EDT
June 29: An APC webinar, Trends in Veterinary Pharmacy: What Compounders Need to Know, 2pm – 3pm EDT
August 17-18: Informa Connect’s Compounding Pharmacy Compliance, The Westin Copley Place, Boston, MA
September 11-13: FDA’s Compounding Quality Center of Excellence Annual Conference (free, virtual)
September 19-20: APC’s Compounders on Capitol Hill 2023; Hilton National Mall; Washington, DC
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