In a draft report and plan for guidance documents released by FDA earlier this year, the agency indicated that it intends to issue guidance documents without a public notice and comment period.
Let’s say you’re APC. You get a call from a producer at a major news network saying that their celebrity medical doctor is doing a story on GLP-1 drugs and wants to include compounded GLP-1s in the piece.
The deadline to apply for 2024 induction is March 31, so review the information on the APC Fellows webpage and start your application now. The induction will take place at APC’s Compounders on Capitol Hill event in September.
There are a half-dozen “big deals” that APC will announce in the next three weeks, every one of them focused one way or another on assuring patient access, pharmacy/facility compliance, and practice efficiency.
OMB concluded their review of FDA’s proposed rule on Drug Products That Present Demonstrable Difficulties for Compounding Under Sections 503A and 503B of the Federal Food Drug and Cosmetic Act and returned it with changes.
The U.S. Court of Appeals for the Fifth Circuit has accepted an amicus brief filed by APC in the case Zyla Life Sciences v. Wells Pharma.
This week, we updated our statement on rules governing compounding, what FDA guidance says about permissibility of compounding “essentially a copy” of an FDA-approved drug – and what those have to do with GLP-1s.
We’ve been busy this week on the state regulatory front, submitting comments on bills in Illinois and Maryland and sending our new statement on peptide compounding to all state boards of pharmacy. Here’s the lowdown.
Are you a pharmacist or technician committed to patient care through quality pharmacy compounding and the highest ethical and professional standards? If so, you should apply to be an APC Fellow.
Long-time APC booster Kalchem International has increased its support for APC to become a $25,000 Silver level Corporate Patron for this year. Hanszen Laporte law firm has also become a Bronze-level APC Corporate Patron this week.
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