APC Resources

Racehorses, compounding and confusion

In recent weeks there’s been a persistent rumor that the governing body for horse-racing has banned compounded drugs because they are not FDA approved. But that’s not the case. read more →
Coming soon: Compounding certificate program for your new hires

Later this spring, we’ll be debuting a new 15-hour certificate program, “The Ethical, Legal, and Regulatory Framework of Pharmacy Compounding.” read more →
California BOP compounding proposals out of sync with national standards

The California Board of Pharmacy’s Enforcement and Compounding Committee met yesterday to discuss proposed regulations related to sterile compounding. read more →
March policy video: Here’s what’s happening

Check out the latest public policy update video from APC Director of Public Policy Savannah Cunningham, PharmD. read more →
GFI 256 enforcement starts April 1. Is your pharmacy ready? Our 3/22 webinar can help…

In advance of the April 1, 2023, enforcement date for the new animal compounding guidance from FDA, APC and PCCA are partnering to offer a CE webinar aimed at helping you bring your animal compounding operations into compliance. read more →
CVM issues Letter to Industry on GFI 256 phase-in

In response to a request from APC and NCPA, FDA’s Center for Veterinary Medicine last week issued a Letter to Industry explaining the phased-in approach to enforcement the agency plans to take on GFI 256. read more →
Explain yourself to prescribers

The Prescriber Briefs developed by APC and the Pharmacy Compounding Foundation are excellent resources for educating prescribers about pharmacy compounding—including laws, guidance, and standards you must adhere to. read more →
Extended: APC Fellows application date (now June 1)

Since the program’s inception, 112 pharmacists have been nominated to this elite group. Thirteen new members were inducted during last year's Compounders on Capitol Hill. read more →
OPEN TO ALL COMPOUNDERS: GFI 256 compliance webinar

In advance of the Apr 1, 2023, enforcement date for the new animal compounding guidance from FDA, APC and PCCA are partnering to offer a CE webinar aimed at helping you bring your animal compounding operations into compliance. read more →

More APC News

The Alliance for Pharmacy Compounding is
the voice for pharmacy compounding.

What we're working on

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.