What is happening with glucagon-like peptide 1 (GLP-1) medications?

The FDA declared the end of shortages for semaglutide (Ozempic, Wegovy) and tirzepatide (Mounjaro, Zepbound), leading to the restriction of compounded versions of GLP-1 drugs. This is primarily due to concerns about the safety and quality of compounded GLP-1 drugs, citing reports of adverse events, potential dosing errors and the use of unapproved ingredients.

Tirzepatide: On March 5, 2025, a U.S. District Court judge denied a motion for a preliminary injunction that would have allowed certain compounding pharmacies to continue producing compounded versions of tirzepatide. As a result of the court ruling, this marks the end of the Food and Drug Administration’s (FDA) enforcement discretion as follows:

• Small-scale compounders (i.e., 503A facilities), licensed by individual states and physician compounding, must stop producing compounded tirzepatide immediately.
• Larger-scale federally licensed compounders (503B outsourcing facilities) have until March 19, 2025, to wind down their production and distribution of compounded tirzepatide.

Semaglutide: The FDA will not enforce violations tied to compounding semaglutide products during these periods: 

• Small-scale compounders (i.e., 503A facilities), licensed by individual states and physician compounding, until April 22, 2025, or the district court’s decision on the preliminary injunction in OFA v. FDA (4:25-cv-00174, N.D. Tex.), whichever is later. 

• Larger-scale federally licensed compounders (503B outsourcing facilities), until May 22, 2025, or the district court’s decision on the preliminary injunction in OFA v. FDA (4:25-cv-00174), whichever is later.

For a timeline and critical insights into the evolving regulatory landscape surrounding tirzepatide and semaglutide, we share dates and articles from our partner legal firm, ByrdAdatto:

• 08/19/24: Tirzepatide and Semaglutide Still on the Drug Shortage List, But for How Long?
• 10/02/24: Tirzepatide No Longer on FDA’s Drug Shortage List
• 12/20/24: FDA Removes Semaglutide from Drug Shortage List
• 02/18/25: FDA states pharmacies must discontinue compounding, distributing and dispensing tirzepatide
• 02/24/25: FDA Confirms End of Tirzepatide Drug Shortage
• 03/05/25: U.S. District Court ruling prevents compounding tirzepatide (while lawsuit was ongoing)
• 03/19/25: Suppliers must cease Tirzepatide distribution
• 04/22/25: Pharmacies must cease selling compounded semaglutide
• 05/22/25: Facilities that supply compounded semaglutide injections must cease distributing

Why was there a shortage of glucagon-like peptide-1 (GLP-1) medication in the first place?

This was largely caused by a surge in demand, partly fueled by off-label prescriptions for weight loss, exceeding the manufacturers' ability to meet demand. The manufacturers, Novo Nordisk (Ozempic, Wegovy) and Eli Lilly (Mounjaro, Zepbound), struggled to keep up with the rapidly increasing demand, leading to shortages.

Why is the spotlight now on compounding pharmacies?

Some compounding pharmacies began creating their own versions of GLP-1 medications, which was initially approved due to shortages and limited availability of the FDA-approved versions. The FDA is now moving to restrict this practice, citing safety concerns and potential for substandard quality.

Why is compounding an FDA-approved drug a big deal?

“Compounding” is the process of combining, mixing or altering ingredients in approved drugs to typically make medications for individual patients. Under the Federal Food, Drug, and Cosmetic Act, compounding pharmacies can't generally create drugs that are essentially “copies" of commercially available drugs, unless the drug is on the FDA's shortage list.

Generally speaking, what compounding is allowed?

Per FDA regulations enacted under the Drug Quality and Security Act (DQSA), compounding can be done in two settings: pharmacies (503A compounding) and outsourcing facilities (503B compounding).

Section 503A permits compounding of drug products “as customized therapies for identified individual patients whose medical needs cannot be met by commercially available drug products.”

503B compounding, on the other hand, is performed at “outsourcing facilities,” which are subject to stricter FDA oversight, including cGMP requirements, a requirement to register with FDA, periodic FDA inspections and an obligation to submit adverse event reports and other product-specific information to FDA. Unlike 503A, 503B permits the production of compounded medicines in bulk without individual prescriptions.

Nevertheless, 503B, like 503A, does not permit compounding of “essentially copies” of commercially available, FDA-approved products.

If I want to continue offering my patients GLP-1 wellness care, can I prescribe to a pharmacy?

Yes, you can.

What about the cost?

When prescribed to a pharmacy, the cost of medication to your patient is subject to the agreed-upon rates that pharmacy holds with your patient’s insurance carrier. This may vary depending on the dispensing pharmacy. Lots of patients can look this up on their insurance carrier’s portal or use websites like GoodRx. The costs involved with off-label prescribing may be subject to higher variance.

Self-pay is also an option. Eli Lilly has announced the launch of 7.5 mg and 10 mg Zepbound (tirzepatide) single-dose vials, available for $499 with the new Zepbound Self Pay Journey Program. Lilly also reduced the price of the 2.5 mg and 5 mg vials. These offerings are available exclusively through LillyDirect Self Pay Pharmacy Solutions, allowing patients to access savings outside of insurance.

What about ease of coverage?

This will depend on your patient’s clinical diagnosis and the coverage provided by their insurance carrier. As with all insurance plans, some medications are considered out of network or require prior authorization, which can be time-consuming.

Can providers continue dispensing GLP-1 medications if a patient doesn’t have a clinical diagnosis of diabetes or obesity?

The patient’s diagnosis must justify the prescription, which is consistent with current standards, and providers must adhere to their state’s laws regarding prescribing and in-office dispensing. As with other medications, prescribers may prescribe these medications for off-label purposes, provided it aligns with the accepted standard of care and falls within their scope of practice.

What if my patient is more “weight or wellness bothered” and does not have a true clinical indication for management with GLP-1 medication?

See above. There is also variance with medical scope per the drugs approval. As an example, Zepbound (tirzepatide), is approved by the FDA for chronic weight management in adults with obesity (BMI of 30 kg/m2 or greater) or overweight (BMI of 27 kg/m2 or greater) with at least one weight-related condition, which can include conditions other than type 2 diabetes. This would be at the dispensing provider’s discretion and scope of practice.

Does the cessation of the shortage exception apply only to injectable GLP-1 medications, or does it include oral versions as well?

The shortage that allowed for compounding exceptions applied specifically to injectable GLP-1 medications. Oral versions were not in shortage, so they did not qualify for the compounding exception under those circumstances.

Can compounders add ingredients like B12 to GLP-1 formulations to reduce nausea and still comply with regulations?

Compounding an essential copy of an FDA-approved drug is generally not permitted under standard 503A compounding rules. Compounding a drug not in shortage would need to meet one of the FDA’s exceptions. These exceptions must meet specific criteria as outlined in FDA guidance. You should speak with an attorney to discuss the scope and requirements of these limited exceptions.

What if I prescribe a year’s worth of medication to my patient? 

Prescribers are required to follow their state’s accepted standard of care. Over-prescribing or failing to provide appropriate oversight and management of a patient’s condition could fall below this standard and may result in regulatory or professional consequences.

AmSpa will be closely following legislation to keep you informed with any developments that could impact your aesthetic practice’s service offerings. For the latest updates, visit our resource page: Medical Weight Loss in a Med Spa Practice.