The process of reducing GLP-1 Compounded Medicines has begun

The end of the tirzepatide shortage caused a difficult time for many patients taking the combined form of the drug. As WIRED recently reported, many of these patients are concerned that they will not be able to purchase or obtain brand name versions of their medications. Although Eli Lilly recently introduced a new, cheaper version of Mounjaro and Zepbound (which comes in a vial instead of an injection pen), the price per month, which ranges from $400 to $550 depending on dosage, is still it is much higher than most of the existing composite containers.

Some entrepreneurs say that even people willing—and able—to switch to brand-name products may run into problems finding the medicine right away. At a meeting held on October 9 by the Alliance for Pharmacy Compounding, four entrepreneurs said they are still having trouble filling prescriptions for name-brand tirzepatide. “If there is a shortage from the FDA, I expect to be able to get that product,” Scott Welch, co-owner of Preston’s Pharmacy in Virginia, said during the “roundtable”, explaining that he he could not buy a name-brand. Mounjaro or Zepbound from his dealer after the shortage is over.

The GLP-1 compounding industry has begun to face the challenge of staying in business. Shortly after the shortage ended, a trade group called the Outsourcing Facilities Association filed a lawsuit in federal court in Texas against the FDA, claiming that tirzepatide was still in short supply and that the decision to end the shortage which by law is “suddenly depriving patients of access to treatment. much-needed treatment and deliberately raising drug prices.”

Some telehealth companies that sell combined tirzepatide have developed versions of the drug with other ingredients, including glycine, niacinamide and other B vitamins. Since these products are not direct copies of Eli Lilly’s offerings, other manufacturers I tried to argue that they are still allowed to produce versions with additional functional tools. Lilly does not consider this acceptable. Forbes says: “Since Lilly’s FDA-approved drugs are available, there is no basis for producing large quantities or mass-marketing tirzepatide, either alone or in combination with other compounds.” “Some organizations are trying to create a new, unregulated way to produce illegal drugs in large quantities and evade the law by making mixed products mixed with other ingredients. That’s not how our system works—there’s no way to mass market illegal drugs to the American people.”

Meanwhile, while Novo Nordisk’s GLP-1 drugs are still in short supply, the company recently pushed back against compounded semaglutide by publishing a peer-reviewed article in the journal Pharmaceutical Research examining clinical trials of the samples. 26 of combined semaglutide. The study found that the samples were of “significantly lower quality than specified” and contained impurities such as minerals and chemical residues. “The strength of many of the samples tested was significantly lower than what the product labels indicated and some of these products contained ingredients banned by the FDA,” says Novo Nordisk spokesperson Jamie Bennett .

With increasing evidence that GLP-1s such as tirzepatide are effective treatments for other diseases beyond obesity and diabetes – including addiction and Parkinson’s disease – demand is only expected to increase. It remains to be seen if the pharmaceutical companies will be able to keep up with the demand or if the drugs will return to the shortage and the compounders will be able to return to the market.