Alliance for Pharmacy Compounding

Alliance for Pharmacy Compounding We're the voice for pharmacy compounding and the advocate for thousands of pharmacy compounding profe

APC isn't the only one asking FDA to rethink its DTE classification. A new citizen petition filed August 27 adds signifi...
09/04/2026

APC isn't the only one asking FDA to rethink its DTE classification. A new citizen petition filed August 27 adds significant legal and scientific weight to the effort, arguing that thyroglobulin, the protein FDA relies on to classify DTE as a biologic, isn't actually the active pharmaceutical ingredient. That distinction belongs to T3 and T4, and the petition argues FDA's own guidance and relevant case law back that up. It complements APC's petition filed in January and strengthens the overall case for keeping patient access intact.

https://hubs.la/Q04wMJ300

Pop in your headphones, the August episode of Essential is out.The latest episode brings in Kristen Jones, PharmD, of Ph...
09/04/2026

Pop in your headphones, the August episode of Essential is out.

The latest episode brings in Kristen Jones, PharmD, of Pharmacists Mutual to talk candidly about how insurance companies view compounding, and where members may be more exposed than they realize. Also covered: DTE updates, peptide news, and a California bill that has finally run its course. Tune in on Spotify or wherever you listen to podcasts.

Podbean: https://hubs.la/Q04wDj4C0

Spotify: https://hubs.la/Q04wDXqZ0

Apple: https://hubs.la/Q04wD7jF0

Meet our new state regulatory affairs director. Sarah Derr, PharmD, MPS, joined the APC staff this week. She is former M...
09/03/2026

Meet our new state regulatory affairs director. Sarah Derr, PharmD, MPS, joined the APC staff this week. She is former Minnesota Pharmacists Association executive director and CEO.

Sarah's background also includes work with the Iowa Healthcare Collaborative and Iowa Pharmacy Association, where she partnered with boards of pharmacy, legislators and regulators on complex policy issues. She's eager to get to know members and dig into the state policy and regulatory issues that matter most to pharmacy compounding.

Did you miss day one? Day two? Well, third time is a charm. The final night of EduCon is tonight, and it’s the only day ...
09/03/2026

Did you miss day one? Day two? Well, third time is a charm.

The final night of EduCon is tonight, and it’s the only day left offering live CE credit. Dr. Peter Marta opens the night with a session on testosterone replacement optimization. Leila Turner follows with the second session of the night on HRT in the age of the removal of the black box warning.

Even if you missed the first 4 sessions, your one registration covers the whole thing, on demand sessions included, so there’s no reason to not register.

Register at https://bit.ly/3TgwgUd.

FDA issued a safety communication following adverse events associated with compounded IV glutathione made with dietary s...
09/02/2026

FDA issued a safety communication following adverse events associated with compounded IV glutathione made with dietary supplement-grade glutathione. FDA reports that some patients required hospitalization and that two pharmacies have recalled affected preparations.

The takeaway for compounders is simple: verify that every API and excipient is appropriate for its intended route of administration. Carefully review labels, COAs, supplier qualifications, and the source and quality of materials before using them in compounded preparations.

Read FDA’s safety communication: https://hubs.la/Q04vLGk90

09/01/2026

FDA updated its GLP-1 webpage today, but don’t mistake an updated webpage for a new rule.

The 28-day timeframe for an opened multiple-dose vial is not new, not specific to compounded drugs, and not specific to GLP-1s.

New webpage language. Same standard: The 28-day discard timeframe for multiple-dose vials has been part of USP standards for nearly two decades.

Read more at: https://bit.ly/4h5mr4x

FDA’s recent glutathione safety communication is a good reminder: When purchasing APIs and excipients, don’t stop at the...
09/01/2026

FDA’s recent glutathione safety communication is a good reminder: When purchasing APIs and excipients, don’t stop at the assay or grade on the COA. It’s the compounder’s responsibility to verify that each ingredient is appropriate for the intended route of administration. Check the labeling, source, supplier qualifications, specifications, and COA before that ingredient makes its way into a preparation.

FDA has named Clint Narver as the permanent director of the Office of Compounding Quality and Compliance. APC welcomes M...
08/31/2026

FDA has named Clint Narver as the permanent director of the Office of Compounding Quality and Compliance. APC welcomes Mr. Narver to the role and looks forward to working with him.

Mr. Narver returns to FDA after most recently serving as a partner at the law firm McGuireWoods, where he advised clients on FDA regulatory and compliance matters, including issues related to compounding. He previously served at FDA as an Associate Chief Counsel and later as an Assistant Director in the Department of Justice's Consumer Protection Branch.

Edisa Gozun, PharmD, will serve as deputy director. Gozun is a pharmacist and longtime FDA official who has worked on federal compounding policy since the early implementation of the Drug Quality and Security Act. Her previous roles at FDA include Branch Chief for Compounding and Pharmacy Practices, acting director of a compounding division and, most recently, director of OCQC's Division of Compounding II. We welcome and look forward to working with them in their new roles.

Nobody went into compounding dreaming of walking Senate office hallways in uncomfortable shoes. And yet, here we are. Co...
08/31/2026

Nobody went into compounding dreaming of walking Senate office hallways in uncomfortable shoes. And yet, here we are. Compounders on Capitol Hill runs September 14 – 16 at the Ritz-Carlton Pentagon City, and if you want your Hill visits guaranteed, you need to sign up by EOD tomorrow.

We say “guaranteed” because after that date, we’re at the mercy of scheduling, staff availability, and whatever else is happening on the Hill that week. You can still register for CCH and ask for a Hill visit after September 1 — we just can’t promise it’ll happen.

Register today: https://hubs.la/Q04vLJDT0

This FDA meeting has your name on it. Compounding testosterone for menopausal patients? Mark September 17 on your calend...
08/28/2026

This FDA meeting has your name on it. Compounding testosterone for menopausal patients? Mark September 17 on your calendar for FDA’s public workshop examining the evidence, and the gaps, in testosterone therapy for menopausal women. The hybrid event runs 9:00am - 4:30pm ET, in person at FDA’s White Oak campus in Silver Spring, http://Md., or virtually. FDA is also opening a public docket (FDA-2026-N-5479) for 60 days, with comments due by October 19.

Register: https://hubs.la/Q04vLQK70

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