Why pharmacists don’t know how many patients they were compounding and why they turn to black market sites to compound their products – a frustration for the pharmaceutical industry

Welch says when his customers can’t get either brand-name or compounded products from him, he fears they will turn to what he called black market websites, which might have counterfeit products that could be harmful. That is the biggest worry for me.

As small businesses, neither of them has a lawyer on staff. One chose to continue compounding after the FDA paused enforcement of its regulations as it reexamines the shortage. The other chose to compound on its own and instead of opting for an outsourcing facility to do so, they decided to use a compounder.

“When companies file this type of actions, it will make the agency reticent in future circumstances,” she says. This creates a dynamic in which pharmaceutical and compounders companies can threaten to tie them up for a while.

Government agencies don’t want to be bogged down by other processes that keep them from doing their jobs. Agencies can’t afford lawsuits and they are expensive.

While the battle over diabetes and weight-loss drugs is unprecedented, the drug companies aren’t exactly using a new playbook, says Feldman, the law professor at the University of California.

While the FDA looks at a number of factors before deciding whether to take something off the list, including the drugmaker’s ability to fulfill backorders, Lee Rosebush, who chairs the trade group, says the agency didn’t do enough. The agency didn’t ask his group or members how many patients they were compounding the drugs for.

“The comment period for the proposed rule closed on June 18, 2024,” an FDA spokesperson wrote in an email to NPR. The agency is looking at comments for consideration of the final rule.

With Ozempic and Wegovy, the key ingredient in semaglutide, was added to an FDA list of drugs deemed too difficult to compound safely. In August, Eli Lilly took a similar action.

To understand why compounding pharmacists can make copies of semaglutide (the key ingredient in Ozempic and Wegovy) and tirzepatide (the key ingredient in Mounjaro and Zepbound), you have to understand the shortage rule.

“Our current manufacturing investment of over $20 billion in the past four years is the most significant in our history, and will allow us to continue increasing capacity to safely bring these medicines to people who need them,” Eli Lilly spokesperson Courtney Kasinger wrote in an email.

Eli Lilly can’t make Zep bound and Mounjaro anymore: a case study of the FDA’s lawsuit against compounding pharmacies

A few days after the suit was filed, the agency said it would re-evaluate its decision, allowing compounders to continue preparing tirzepatide in the meantime.

That would be a basic question if you hadn’t even asked how big the market is. As a result, he argues, it’s hard to know if Eli Lilly can supply the drugs for all the patients using name brand drugs and the ones who had been using compounded versions and would need to switch.

Currently two of the drugs— Zepbound for obesity and Mounjaro for Type 2 diabetes — can’t legally be compounded, but the FDA said it will turn a blind eye to the practice for now while it evaluates whether it was right to end the shortage earlier this fall. Patients and compounders are stuck in a tricky legal situation.

Over the summer, Eli Lilly, declared that Zepbound and Mounjaro were “available,” implying that they were not in short supply anymore. They were removed from the official drug shortage list by the FDA.

The FDA says that compounding pharmacies can’t make more than four copies of the same drug at a time. And bulk compounders, called outsourcing facilities, can’t fill orders starting 60 days after a shortage ends.

She couldn’t. At the time, she could only order one box per day. She could only take care of 30 patients per month because of that.

The FDA was sued by the outsourcing facilities association, questioning whether it was appropriate to remove the drug from the shortage list.

Custom drugs are prepared for people who need them. If a patient can’t swallow pills, they’ll make a liquid version of the brand name pill.

Source: Drugmakers and pharmacists battle over who gets to make obesity drugs

Ordering GLP-1 Drugs for Obesity: Why Do So Many People Want Their Next Injectment? The Case of Ozempic

As the battle over who gets what share of the multi-billion dollar obesity drug market continues, some patients are left wondering how they’re going to get their next injections — and from whom.

Drugmakers have had difficulty keeping up with the high demand of Ozempic and other diabetes and weight loss drugs. compounding pharmacy made their own versions of the drugs for more than two years.

Since they debuted, injectable GLP-1 drugs like Ozempic have been in high demand. The cardiovascular benefits of the medications are just one of the reasons why they have expanded their appeal. For people who don’t like needles, these medications are not a good option, because they require a weekly shot.

“As a pharmacist, I can appreciate the excitement in the rise in oral semaglutide, since it is an easier route than injectables,” says Melinda Lee, a pharmacist who runs the pharmaceutical packaging company Parcel Health as well as a GLP-1 drug availability database. It is easy to ship and store oral versions since they do not need to be refrigerated. Lee isn’t sold on the enthusiasm, but she understands it. While taking a drug by mouth might be more appealing than a needle, when it comes to GLP-1s, the evidence that they’re as effective just isn’t there yet, she says.

These drugs are low in price and are usually shipped overnight after a prospective patient fills out a quick online questionnaire. A month’s supply of semaglutide lozenges with vitamin B6 added from the telehealth startup Strut, for example, costs $149 without insurance, versus Wegovy’s $1,000-plus price tag.