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• CALL TO ACTION: Tell FDA to deny drugmakers’ request

  Drugmakers are urging FDA to prohibit compounded GLP-1s. FDA needs to hear from you and your patients NOW!   Two years into the GLP-1 injectable shortage, drugmakers Eli Lilly and Novo Nordisk have asked FDA to take emergency action to prohibit compounding of tirzepatide and semaglutide. Both companies sent letters to FDA asking that their API be added to the ‘demonstrably difficult to compound list.’ The fact is, millions of doses have been safely prepared and dispensed by compounding pharmacies across the U.S. during this shortage. GLP-1s are not particularly difficult for sterile compounding labs to prepare. APC is leading an effort to oppose the drugmakers’ request, and we need your help — whether your pharmacy compounds GLP-1 drugs or not.   What you can do NOW Tell your patients who take compounded GLP-1s to reach out to FDA. We’ve made it easy for them to do. Direct them to compounding.com/tellFDA where they’ll find a letter pre-drafted. All they have to do is add their name and address and hit send. We need hundreds of thousands of patients to flood FDA with these letters of concern. To make it easy for you to inform patients about the effort, we’ve prepared this bag-stuffer that you can download, customize, and share with patients.   Write to FDA yourself. If you are the owner or manager of a compounding pharmacy that compounds GLP-1 drugs in any dosage form, we have prepared this letter for you to adapt, put on your letterhead, and send to FDA. You can either submit it electronically or hard-mail it. Instructions for both options are in the instructions at the top of the letter. The point is, FDA needs to hear from you and your patients about this. We believe it’s the only way to derail this effort by drugmakers to place GLP-1 drugs off limits for compounding. And just remember: If they’re successful in prohibiting GLP-1s, they’ll try this move again with other compounded therapies — maybe even compounded hormones. Take action today. Patient access to compounded drugs is at stake.   →

• APC to FDA: Just say no to Lilly

  This week APC's lawyers sent a formal comment to the FDA about Eli Lilly’s request that tirzepatide be added to the Demonstrably Difficult to Compound list. read more →

• California BOP sends proposed compounding regs to comment period

  The California State Board of Pharmacy decided to move the modified proposed sterile compounding regulations forward to a 30-day comment period. read more →

• Checking in on the post-Chevron fallout

  What’s happened in the world of federal regulation since the end of Chevron? read more →

• Hi, Noom!

  Welcome to our newest Bronze-level Corporate Patron, Noom! read more →

• PFMs can get 2.5% credit card processing

  A new benefit for APC’s Pharmacy/Facility Members: They may be able to cut their credit card processing fees to just 2.5% – 2.8%. read more →

• Phoenix compounders, rise!

  The latest of APC’s new regional meetings — CompoundED UpDATE — is coming to the Phoenix area December 5. read more →

• APC election results: directors and bylaws

  See the results of APC's elections, including four new directors and several changes to our bylaws. read more →

More News

The recent withdrawal of Makena by the FDA has created complications for pharmacy compounders, particularly regarding the use of hydroxyprogesterone.

While hydroxyprogesterone has a USP monograph and is not on the list of drugs withdrawn for safety or efficacy at this time, it seems likely that it will be added to the list due to the reason for Makena’s removal from the market.

The FDA’s FAQs on the substance are correct from a strict reading of the law, but the issue lies in how compounding as a whole will be viewed if pharmacies continue to make a drug that the FDA panel has said doesn’t work and ultimately led to the removal of a similar drug from the market.

At present, it is unclear whether the FDA plans to officially put hydroxyprogesterone on the list of drugs withdrawn for safety or efficacy, and even if they did, it may not materially change the current situation.

Ongoing, it is essential that compounding pharmacies closely monitor any changes in the FDA’s list of drugs withdrawn for safety or efficacy and adjust their practices accordingly to ensure that they are providing the best possible care for their patients.