Telling your story, one reporter at a time

The photo inset below on the left was taken last Friday morning at Preston’s Pharmacy (a PFM, I might add) in Arlington, Virginia. It’s not a pharmacist or technician in the photo. It’s a healthcare reporter. read more →
There’s a lot you can learn from errors

Patient safety is job one in any pharmacy, but especially in compounding pharmacies. So on those rare occasions when errors occur — in your pharmacy or someone else’s — you want to be able to learn from them. read more →
What does FD&C Act really say about USP compliance?

In response to inquiries from state boards of pharmacy regarding the enforceability of revised USP Chapters <795>, <797>, and <800>, a recent memo aims to clarify references in the Food, Drug & Cosmetic Act. read more →
Letter seeks clarity on semaglutide compounding in California

Last week, we sent a letter to the California Board of Pharmacy requesting clarification of its position on compounding semaglutide. read more →
There’s a committee for that

APC is recruiting committee members for 2024. read more →
Welcome to our new PFMs!

The number of APC Pharmacy-Facility Members continues to grow. read more →
FAQs and other new-chapter resources from USP

APC leaders met this week with USP staff for a touch-base. One outcome of that meeting is the need to spread the word about several USP compounding resources. read more →
Court publishes dismissal in Novo case against Brooksville

In a ruling published this week, the U.S. District Court for the Middle District of Florida, Tampa Division, granted a motion to dismiss in the case of Novo Nordisk, Inc. v. Brooksville Pharmaceuticals. read more →
Bad journalism, ketamine studies, and scammers

I don’t have a clever theme to unite the three things I want to share this week, so I’ll just dive in... read more →

Shortage Drug Compounding and Semaglutide
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 program–The 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 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.