Big Buttons

• FDA doubles down: Tirzepatide is off shortage

  ...but that doesn't mean the issue is completely settled. read more →

• A couple of state updates

  Good news from Alabama, but a problem in Massachusetts read more →

• Defending GLP-1 compounding

  The latest letters APC's been sending to oppose efforts to restrict compounding read more →

• Thumbs-up for FDA crackdown

  APC was thrilled when the FDA announced it was taking action against illegal online businesses claiming to sell “research-grade” compounds. read more →

• A PANS/PANDAS explainer

  For your patients: Information about a couple of underdiagnosed pediatric mental health conditions read more →

• What, a year?

  In the final board chair column of the year, here are our top 7 accomplishments in 2024. read more →

• “Simply not a rational approach to regulating an industry”

  This week APC offered its final (and pointed) suggestions to the California Board of Pharmacy on their proposed significant – and we would say unjustified – changes to their compounding regulations. read more →

• Get a cease and desist letter from Verrica?

  APC has heard reports from several pharmacies that have received them — here's what to know. 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While hydroxyprogesterone has a USP monograph and is not on the list of drugs withdrawn for safety or efficacy at this time, it seems likely that it will be added to the list due to the reason for Makena’s removal from the market.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At present, it is unclear whether the FDA plans to officially put hydroxyprogesterone on the list of drugs withdrawn for safety or efficacy, and even if they did, it may not materially change the current situation.

Ongoing, it is essential that compounding pharmacies closely monitor any changes in the FDA’s list of drugs withdrawn for safety or efficacy and adjust their practices accordingly to ensure that they are providing the best possible care for their patients.