Zepbound and Wegovy, the new weight-loss drugs made by Eli Lilly & Co. and Novo Nordisk A/S, are all the rage. They are also in short supply in the US. Because of that, a special class of businesses called "compounding pharmacies" are allowed to make copies, often selling them for prices that are substantially cheaper than name brands, which can cost more than $1,000 a month. But compounded drugs don't have to go through the rigorous Food and Drug Administration approval process that's supposed to guarantee that the medicines are safe and that they work. That's leading to all sorts of problems, my colleague Madison Muller and I reported earlier this week. Pharmacy boards in Arizona and Louisiana have disciplined pharmacies for improper practices, and other states are investigating issues. Podcast: Big Take: The FDA Loophole Fueling Ozempic Knockoffs Even so, business is booming. Bankers estimate that the compounded weight-loss drug industry could become a $1-billion-a-year market. Hundreds of thousands of Americans are taking the knockoffs. Maybe you're one of them. So how can you make sure you're getting the drugs from a good compounding pharmacy? I hopped on the phone with Robert MacArthur, pharmacy director at the Rockefeller University Hospital in New York, and a board-certified sterile compounding pharmacist, to get some answers. Here's what he recommends, including questions you can ask to verify the quality of the drugs. First, there are two types of compounding pharmacies: 503As, and 503Bs. The latter are required to meet higher standards and have more federal oversight, so they're a better source, MacArthur says. Both patients as well as health care providers can ask for more information about what tests the pharmacy did on the drugs. Tests should include potency (how strong the drug is), sterility (whether or not it's contaminated) and stability (how long it will last). Patients could ask prescribers what test were done, and clinicians should be able to get the test results from the pharmacy, MacArthur says. "If the medical professional cannot answer that question appropriately, with the information the patient's asking for, then they shouldn't be prescribing the product or they shouldn't be ordering the product from that supplier," he says. Finally, patients can look up the pharmacies to see if they've gotten in trouble with the FDA here. MacArthur says patients can look at the compounder's response to see how it addressed issues, and check whether it is getting dinged for the same violation over and over. State agencies also generally list disciplinary actions on their websites. "The quality compounding pharmacies are real places with real people that do real science, and they make quality products," MacArthur says. "They're not like elves in a hollow tree making cookies somewhere." — Ike Swetlitz |
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