Why Is the FDA Cracking Down on Compounded GLP-1 Medications?

This week, the Food and Drug Administration (FDA) again issued warnings to telehealth organizations for their promotion of glucagon-like peptide 1 (GLP-1) medications. The warning letters were sent to 30 telehealth companies that market compounded versions of the popular weight-loss medications. The FDA is cracking down on false and misleading claims made by telehealth organizations, such as Hims & Hers, about their compounded GLP-1 medications.

Misleading Marketing and False Claims

Many of the recent warning letters were issued to companies whose websites listed GLP-1 products that promoted having “the same active ingredient as Ozempic and Wegovy.” Under the Federal Food, Drug, and Cosmetic Act, a compounding pharmacy cannot regularly manufacture or compound excessive amounts of drugs that are essentially copies of existing medications.

The FDA takes misleading marketing seriously and has sent thousands of letters about promotional materials. Advertisements for prescription medications must be truthful and accurate, including those from compounding pharmacies. The FDA may require manufacturers or distributors to correct misleading claims. Hims & Hers removed its version of Wegovy after an FDA notice.

Safety concerns with Compounded GLP-1 Medications

The FDA has seen a surge in reported adverse events, which are undesirable side effects, injuries, or complications. Injectable GLP-1 medications require refrigeration, and exposure to improper temperatures can compromise their quality. The FDA has received consumer complaints about medications that were not properly packed with ice or that arrived warm.

Some other examples of GLP-1 adverse events from compounded pharmacies include:

• A product labeled as containing tirzepatide that did not actually have the compounded ingredient

• Hospitalizations from people taking the incorrect dose

• The compounded medication contains more of the active ingredient than it should

• Doses increased more quickly than recommended

When a patient receives incorrect doses or the dose is increased too quickly, they may experience nausea, vomiting, abdominal pain, constipation, or diarrhea.

How the GLP-1 Drug Shortage Led to Compounding

The original intent of a compounding pharmacy was for a doctor or pharmacist to combine, mix, or alter ingredients of a drug to create a medication that meets the specific needs of a patient. Often, this type of pharmacy is used when a patient has sensitivities or allergies to certain ingredients or cannot use the medication in its original form, such as when a patient cannot swallow a pill.

The FDA allows compounding pharmacies to fill the gap during drug shortages. During drug shortages, the same level of federal restrictions may not apply to the compounding pharmacies. Most often, this means compounding pharmacies can essentially create copies of the approved drugs. However, the FDA does not review the compounded copies for quality, safety, or effectiveness before they are marketed to consumers.

The GLP-1 shortage officially began in March 2022 when the FDA added semaglutide to the shortage list. Semaglutide is the active ingredient in Wegovy and Ozempic. Tirzepatide, the active ingredient in Mounjaro and Zepbound, was added to the list later that same year.

The GLP-1 shortages were caused by a sudden, overwhelming demand for the medications' weight loss benefits. The shortages lasted about three years, ending when most of the drugs were removed from the FDA list in February 2025.

How to Stay Safe When Buying GLP-1 Medications Online

The FDA has seized counterfeit GLP-1 drugs, which may contain too much, too little, or none of the active ingredient. Watch for warning signs that your online pharmacy is unsafe:

• No prescription is required

• The medications you receive look different than what you get from a local pharmacy, are in a foreign language, or have no expiration date

• They offer too-good-to-be-true discounts

• You’re charged for products you did not order

• The website doesn’t have written protections of your personal or financial information

There are legitimate compounding pharmacies selling GLP-1 medications. Signs that an online pharmacy is safe:

• A prescription from a healthcare provider is required

• The pharmacy has a physical address located in the United States

• There is a licensed pharmacist on staff who you can speak to if you have questions

• The pharmacy is licensed with the state board of pharmacy

GLP-1 medications are likely to remain popular for the near future. They are highly effective for weight loss and other health issues. Given the high price tag of over $1,000 a month, it’s easy to see why the compounded versions remain popular.

Consumers wanting to use compounding or telehealth pharmacies to get affordable versions of GLP-1 medications can still do so, but buyer beware. Do your due diligence and research the pharmacy or telehealth company before purchasing any products.