Shortage Drug Compounding and GLP-1s
For comprehensive APC statement, CLICK HERE.
For semaglutide primer for reporters, CLICK HERE.

 

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 working with compounders licensed in California, to illuminate how the rules proposed by the California Board of Pharmacy go above and beyond the national standards set by USP.

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 working with FDA to assure continued clear understanding of compliance standards and enforcement on GFI 256.  

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’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.

Upcoming Events

Available on-demand: The FDA Compounding Quality Center of Excellence provides these self-guided, online courses:

2024

March 14: OutcomeMD Lunch & Learn program for existing users

March 21: An APC webinar, Demystifying the DSCSA for Compounders

March 21: APhA Sterile Compounding Recertification Course

March 31: APC Fellows Program applications due

April 4-6: APC’s Pharmacy Compounding Owner Summit, La Jolla, CA

April 11: An APC webinar, Vet GFI 256 One Year Later — Where Are We? 

April 12-14: Personalized Medicine Certification Course 1: Endocrinology in Scottsdale, Ariz.

May 9: An APC webinar, Soft Skills for Hard Jobs (registration link available soon)

May 9: OutcomeMD Lunch & Learn program for existing users and those interested in learning more

May 14-15: PCCA ACT Legislative Conference, Washington, DC

September 17-18: Compounders on Capitol Hill (CCH) in Washington D.C.

November 15-17: Personalized Medicine Certification Course 1: Endocrinology in St. Pete Beach, Fla.

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