April 14, 2023
Makena withdrawal creates confusion for compounders
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While hydroxyprogesterone has a USP monograph and is not on the list of drugs withdrawn for safety or efficacy at this time, it seems likely that it will be added to the list due to the reason for Makena’s removal from the market.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At present, it is unclear whether the FDA plans to officially put hydroxyprogesterone on the list of drugs withdrawn for safety or efficacy, and even if they did, it may not materially change the current situation.
Ongoing, it is essential that compounding pharmacies closely monitor any changes in the FDA’s list of drugs withdrawn for safety or efficacy and adjust their practices accordingly to ensure that they are providing the best possible care for their patients.