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February 21, 2025 - The landscape of GLP-1 medication availability is undergoing significant changes, with the U.S. Food and Drug Administration (FDA) announcing the resolution of shortages for key drugs like semaglutide (Wegovy and Ozempic) and tirzepatide (Zepbound and Mounjaro). These decisions have major implications for compounding pharmacies and patient access to these popular weight-loss and diabetes medications. Patients who rely on affordable medication from reputable compounding pharmacies may now be required to purchase the brand named GLP-1 medications at a considerably higher cost which may make them unaffordable to many of the same people who rely on them

Semaglutide Shortage Resolved, Compounding Restrictions Imminent:

The FDA has officially determined that the shortage of semaglutide injection products, including Wegovy and Ozempic, is resolved. This decision follows confirmation from Novo Nordisk, the manufacturer, that their production capacity can meet current and projected national demand. While localized supply disruptions may occur as products move through the supply chain, the overall national shortage is considered over. Compounding pharmacies and organizations are determined to fight this ruling in the courts as the belief is that between diabetic patients and those who are reliant on them for weight loss, that the large manufacturers of the drugs will not be able to keep up with the demand despite their reassurances

This resolution triggers restrictions on compounding pharmacies that have been producing versions of these drugs during the shortage. To ensure a smooth transition for patients, the FDA has provided a grace period:

• 503A Pharmacies (State-Licensed): Compounding, distribution, and dispensing of semaglutide injection products that are essentially copies of FDA-approved products is allowed for 60 calendar days from February 21, 2025, until April 22, 2025.
• 503B Outsourcing Facilities: Compounding, distribution, and dispensing of semaglutide injection products is allowed for 90 calendar days from February 21, 2025, until May 22, 2025.

Tirzepatide Shortage Also Addressed:

Similarly, the FDA has also declared the tirzepatide shortage resolved, following a re-evaluation of its previous determinations. This decision, mirroring the semaglutide action, activates similar grace periods for compounding pharmacies. Much like Wegovy and Ozempic, commercial grade Mounjaro (Tirzepatide) has been a huge breakthrough for weight loss and patients have had tremendous results while taking the subcutaneous injections. Unfortunately the grace period is about to end and many compounding pharmacies will no longer me manufacteuring these drugs which will spike the demand and costs for certain.

• 503A Pharmacies: Compounding, distributing or dispensing tirzepatide injections within 60 calendar days from December 19th 2024, until February 18, 2025.
• 503B Outsourcing Facilities: compounding, distributing or dispensing tirzepatide injections within 90 calendar days from December 19th 2024, until March 19, 2025.

It is important to note, that despite these grace periods, the FDA retains the authority to take action against compounders for violations of other statutory or regulatory requirements, particularly regarding substandard quality or unsafe products.

Impact on Compounding Pharmacies and Market Dynamics:

The FDA's decisions have significant market repercussions. Companies like Hims & Hers Health, which have heavily promoted compounded versions of GLP-1 medications, have seen substantial stock declines. The ability to produce and sell these compounded versions, which are often cheaper than brand-name drugs, is now significantly curtailed.

The Alliance for Pharmacy Compounding has raised concerns about the transition for patients currently relying on compounded medications, emphasizing the need for a smooth shift to FDA-approved alternatives.

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Ongoing Monitoring of GLP-1 Availability:

The FDA continues to actively monitor the availability of other GLP-1 medications, including dulaglutide and liraglutide, which remain in shortage. The agency stresses that while manufacturers may report "available" status for certain products, this does not constitute an official FDA determination that the shortage is resolved.

Key Considerations:

• FDA Enforcement: The FDA emphasizes the legal restrictions on compounding copies of FDA-approved drugs, particularly when shortages are resolved.
• Patient Transition: Patients currently using compounded GLP-1 medications should consult with their healthcare providers to discuss transitioning to FDA-approved alternatives.
• Supply Chain Stability: While national shortages are resolved, localized supply disruptions may still occur.
• Safety and Quality: FDA-approved drugs undergo rigorous review for safety, effectiveness, and quality, whereas compounded drugs do not receive the same level of oversight but still receive quality control measures as do the pharmacies that manufacture them.

Where to Find Updates:

For the most current information on GLP-1 medication availability and drug shortages, please refer to the FDA’s Drug Shortages Database.

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