The Food and Drug Administration is warning consumers not to use any drugs made by a compounding pharmacy in California after regulators realized the pharmacy was making drugs that need to be sterile—particularly injectable drugs—without using sterile ingredients or any sterilization steps.

The products made by the pharmacy, Fullerton Wellness LLC, in Ontario, California, include semaglutide, which is intended to mimic brand-name weight-loss and diabetes drugs Wegovy and Ozempic. Fullerton also made tirzepatide, which is intended to mimic weight-loss and diabetes drugs Zepbound and Mounjaro.

The FDA became aware of the problem after a patient submitted a complaint to the regulator that a vial of semaglutide from Fullerton Wellness had an unidentified "black particulate" floating in it. Semaglutide, like tirzepatide, is injected under the skin and is intended to be sterile.

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Amid ongoing legal battles over coveted GLP-1 therapies, a drug vendor in Washington state is accused of running an outlandish scheme to sell do-it-yourself kits to make illicit knockoff versions of weight-loss and diabetes drugs, Zepbound and Mounjaro.

For the alleged scheme, vendor Pivotal Peptides has customers buy a set of ingredients they have to mix together to create their own injectable versions of the drugs. Customers don't need a prescription or even a medical consultation to order the kit, even though the brand-name drugs are prescription-only. That may not be surprising, though, since the dubious white powder customers receive is stated to be "a research chemical for lab research and veterinary purposes only." Once purchased, the kit's instructions recommend users disinfect their home work surface before beginning and stress the importance of using the sterile water included in the kit to dissolve the powder to the desired concentration. The instructions then explain how to inject oneself with the homemade mixture using a 30-gauge syringe.

That's all according to a lawsuit filed Monday by pharmaceutical giant Eli Lilly, maker of tirzepatide-based Zepbound and Mounjaro, which are sold as ready-to-use medicines in single-dose pens or vials. The lawsuit against Pivotal Peptides is one of three that Lilly filed this week, all accusing questionable drugmakers of unlawfully selling knockoff versions of its tirzepatide drugs that have not been tested or approved. But the one against Pivotal Peptides stands out for the scheme the owners allegedly used to sell their knockoff version.

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Facing a lawsuit, the Food and Drug Administration has decided to reconsider its decision to take popular weight-loss and diabetes drugs off of the national shortage list, which will allow compounding pharmacies to continue selling cheaper copycat versions—at least for now.

A trade organization representing compounding pharmacies sued the agency last week over its October 2 announcement that there was no longer a shortage of tirzepatide drugs, branded as Mounjaro for diabetes and Zepbound for weight loss. The products, members of the extremely popular and effective class of GLP-1 drugs, had been on the shortage list since December 2022.

Being on the list meant that compounding pharmacies were legally allowed to make "essentially copies" of the products; the only time these pharmacies—also called outsourcing facilities—can make imitation versions of approved drugs, such as tirzepatide, is when the products appear on the shortage list. So, with the FDA's announcement, compounders were immediately barred from making any more of the lucrative drugs and had 60 days to fulfill existing orders.

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Enlarge / An Eli Lilly & Co. Zepbound injection pen arranged in the Brooklyn borough of New York, US, on Thursday, March 28, 2024. (credit: Getty | helby Knowles)

Pharmaceutical giant Eli Lilly earned praise this week with an announcement that it is now selling starter dosages of its popular weight-loss drug tirzepatide (Zepbound) at a price significantly lower than before. But the cheers were short-lived as critics quickly noticed that Lilly also quietly raised the price on current versions of the drug—a move that was notably missing from the company's press release this week.

In the past, Lilly sold Zepbound only in injectable pens with a list price of $1,060 for a month's supply. Several dosages are available—2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg, or 15 mg—and patients progressively increase their dosage until they reach a maintenance dosage. The recommended maintenance dosages are 5 mg, 10 mg, or 15 mg. The higher the dose, the more the weight loss. For instance, people using the 15 mg doses lost an average of 21 percent of their weight over 17 months in a clinical trial, while those on 5 mg doses only lost an average of 15 percent of their weight.

On Tuesday, Lilly announced that it will now sell Zepbound in vials, too. And a month's supply of vials with the 2.5 mg doses will cost $399, while a month's supply of 5 mg doses is priced at $549—a welcome drop from the $1,060 price tag. These prices are for a self-pay option, meaning that patients with a valid, on-label prescription can buy them directly from Lilly if they have no insurance or have insurance that does not cover the drug.

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