FDA to query compounding pharmacies amid safety concerns
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The Food and Drug Administration plans to survey compounding pharmacies that make specialized copies of prescription drugs amid ongoing concerns over quality and safety problems at the facilities, according to a notice the agency released Wednesday.
Why it matters: Compounded drugs by nature aren't FDA-approved. They've proliferated over the past two years, largely due to demand for copycat GLP-1 drugs for weight loss, many of which are sold online. Hormone-based therapies and pain medicines also are frequently compounded.
- The FDA allowed compounded versions of GLP-1s while drugs like Wegovy and Ozempic were in shortage but plans to halt the practice by May 22.
State of play: Health and Human Services Secretary Robert F. Kennedy Jr. is moving forward with a survey of challenges and opportunities for 250 outsourcing facilities that was first proposed last year by the Biden administration.
- While the facilities are supposed to provide large batches of compounded drugs to hospitals, clinics and other health providers, the "FDA continues to find concerning quality and safety problems during inspections of outsourcing facilities," per the notice.
- Questions will cover financial considerations that inform business decisions, compounders' quality control and their interactions with FDA regulators.
- The results will help the FDA make decisions on training for and other engagement with the facilities, the notice says.
- "Although compounded drugs can serve an important medical need for certain patients when an approved drug is not medically appropriate, compounded drugs also present a risk to patients," the notice says.
Zoom in: Compounded drugs are mixed or altered to either tailor a drug to a specific patient's needs, or to boost production of branded drugs that are in shortage.
- Wednesday's notice doesn't mention compounded GLP-1 drugs, which have been priced at a fraction of the brand-name products.
- FDA set the May 22 deadline for outsourcing facilities to stop producing compounded GLP-1s after the agency declared earlier this year that the brand-name drugs are no longer in shortage.
- GLP-1 manufacturers Novo Nordisk and Eli Lilly have moved to sell branded drugs through online pharmacies that have made their names selling compounded products. The drugmakers are going to court to stop compounders from making copycats.
