By FDA law, compounding pharmacies are not allowed to compound and medications that is available as a commercially sold product. One exception is when a commercially produced product is in short supply or on back order. With these new GLP-1 medications, the very exact GLP-1 raw medication powder is NOT AVAILABLE to compounding pharmacies. Apparently these compounding pharmacies are using a drug that is MAYBE similar to the GLP-1 meds on the market from the pharmas, but none have been thru clinical trials nor approved by the FDA to be safe and effective in humans. I have also read some reports of some very serious – even FATAL – reports from pts using these meds.

Lilly has started selling their Zepbound direct to pts thru their exclusive mail order pharmacy in Columbus Ohio and if you get the 2.5mg or 5 mg in a VIAL. The 2.5 mg is abt $400 and the 5 mg is abt $535 for four shots.  https://investor.lilly.com/news-releases/news-release-details/lilly-releases-zepboundr-tirzepatide-single-dose-vials-expanding 

While this prices is about HALF of the auto-inject pens from Lilly but still a little more than the compounding pharmacies, but at least you know that you are getting the real FDA approved product.

FDA Targets GLP-1 Providers with Warning Letters

On December 17, the U.S. Food and Drug Administration (FDA) issued Warning Letters to five companies offering various GLP-1 products, including Semaglutide, Tirzepatide, Retatrutide, Cagrilintide, Mazdutide, Survodutide, and Sermorelin. Based on FDA’s review of therapeutic claims made on websites and social media platforms, the FDA determined that these products are unapproved new drugs. The FDA stated in their Warning Letters that these products have been introduced or delivered for introduction into interstate commerce in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a) and 331(d).

 

Online Sellers of Compounded GLP-1s Often Don’t Mention Risks

https://www.medpagetoday.com/endocrinology/obesity/113838

40.5% noted efficacy claims not listed on the labels of their originator products

Many online sellers of compounded GLP-1 receptor agonists may be misleading customers, a cross-sectional study suggested.

Out of 79 websites that sold a compounded GLP-1 agent, 11 (13.9%) failed to mention the medications were compounded versions and seven (8.9%) wrongfully referred to them as generics, Alissa Chen, MD, MPH, of Yale University School of Medicine in New Haven, Connecticut, and colleagues detailed in a research letter in JAMA Health Forum

Half of the websites (49.4%) failed to mention risks including adverse effects, warnings and precautions, and contraindications, and 40.5% advertised an efficacy claim not in the authorized label of the FDA-approved branded GLP-1 agent.

A total of 34 websites (43%) stated the compounded medications weren’t FDA approved, while 29 (36.7%) stated or implied they were.

“Compounded medications contain the same active ingredients as in branded medications but may contain different inactive ingredients and are not FDA approved,” Chen’s group pointed out. “U.S. federal law requires advertising of all prescriptions, including compounded medications, to be ‘truthful, non-misleading, and accurate’; however, the extent to which compounded medication advertising meets this mandate is unclear.”

An estimated 11% of GLP-1 users obtain their prescription through an online provider or website, so it is important online sellers use non-misleading advertising, they added.

But compound pharmacies and their products “fall into a regulatory gray zone,” noted accompanying viewpoint authors T. Joseph Mattingly II, PharmD, MBA, PhD, of the University of Utah College of Pharmacy in Salt Lake City, and Rena Conti, PhD, of Boston University.

“Since compounded products are copies of originator products, the pharmacy references the FDA-approved label attesting to safety and efficacy, but unlike the originator, the pharmacy does not technically attest to their manufacturing according to Current Good Manufacturing Practice,” they explained. “Moreover, unlike originator products, the 2002 Thompson v. Western States Medical Center Supreme Court decision ruled that advertising prohibitions on compound pharmacies and their products are a violation of the First Amendment.”

Although their advertising may not necessarily be illegal, they do appear to violate Congress’s intent to support patient access to safe and effective drugs, added Mattingly and Conti.

In an editor’s note Julie Donohue, PhD, of the University of Pittsburgh, said it’s “unclear” if FDA regulations intended to apply to advertising by manufacturers should also apply to compound pharmacies.

While compounders won’t be able to make copies of GLP-1 agents as shortages start to resolve, resolving the shortage “will not prevent questionable marketing practices of online pharmacies and others, nor will it resolve the illegal trade of counterfeit or adulterated products,” Mattingly and Conti said.

In order to better protect consumers, they recommended more advertising requirements for compounders, “aggressive” prosecution of counterfeiters, and an independent task force to determine when to add or remove a drug from the drug shortages list.

Chen and co-authors initially reviewed 98 websites that sold GLP-1 agents from July through September 2024. Of these, 79 websites sold compounded semaglutide (Ozempic, Wegovy, Rybelsus), tirzepatide (Mounjaro, Zepbound), or liraglutide (Victoza, Saxenda), or a prescription for such. All websites sold compounded semaglutide, 72.2% sold compounded tirzepatide, and 3.8% sold compounded liraglutide.

A total of 52 websites (65.8%) featured a mark of certification, 50 of which displayed LegitScript certification. Two websites didn’t provide prescriptions for compounded GLP-1 drugs and required a prior prescription.

All but one website required clinician involvement to obtain the medication and 63.3% required a completion of a questionnaire reviewed by a clinician. Five websites required an in-person visit, eight required lab work, and 31 required a telehealth visit.

Including discounts, the median first month’s price for the compounded medication was $231 for semaglutide, $330 for tirzepatide, and $248 for liraglutide.

The researchers pointed out that because they reviewed all information reported on websites, including on subpages and linked blogs, there’s a good chance they overestimated the amount of information that typical consumers review.

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