News Report · Endocrinology

FDA Proposes Exclusion of Semaglutide and Tirzepatide from 503B Bulks List: Impact on Compounding Access

June 12, 2026

Clinical Perspective

Prescribers of semaglutide and tirzepatide should be aware of the FDA's proposal, which may limit access to compounded versions of these medications. The data supports that FDA-approved GLP-1 therapies are sufficient for patient needs. How will this impact patients who rely on compounded alternatives for their treatment?

Dr. Amit Desai · Endocrinology

The FDA proposed to exclude semaglutide, tirzepatide, and liraglutide from the 503B bulks list, determining no clinical need for outsourcing facilities to compound these drugs from bulk substances ^[1].

Clinical Context

Semaglutide and tirzepatide are GLP-1 receptor agonists used for managing type 2 diabetes and obesity. These medications have gained popularity due to their efficacy in weight management and glycemic control. Historically, compounding pharmacies have provided alternatives for patients when these medications are not available through traditional channels. However, the recent FDA proposal raises concerns about patient access to compounded versions of these drugs, especially in light of ongoing supply issues and the demand for effective obesity treatments.

Key Findings

The FDA's proposal to exclude semaglutide, tirzepatide, and liraglutide from the 503B bulks list indicates that outsourcing facilities cannot lawfully compound these drugs unless there is a clear clinical need ^[1].
The determination is based on the FDA's evaluation, which found insufficient evidence to support the need for compounding these GLP-1 medications from bulk substances ^[1].
This decision comes as the national supply of GLP-1 medications stabilizes, following previous shortages that impacted patient access ^[2].
The FDA is inviting public comments on this proposal until June 29, 2026, before making a final determination ^[1].
The agency has emphasized that compounded drugs should only be used when FDA-approved options are unavailable or inadequate for specific patient needs ^[2].
Concerns regarding the quality and safety of compounded GLP-1 drugs have been raised, particularly with reports of improper storage and labeling issues ^[8].

Safety & Tolerability

Hyperglycemia reported with semaglutide — monitor blood glucose levels during treatment ^[1].
Gastrointestinal disturbances reported — exact frequency not available in public source summary ^[1].
Injection site reactions reported with tirzepatide ^[1].
Nausea and vomiting reported with GLP-1 receptor agonists — advise patients on potential side effects ^[1].
Risk of pancreatitis — monitor for abdominal pain and other symptoms ^[1].
Complete adverse event profile available in the full prescribing information for semaglutide and tirzepatide ^[1].

Study Design

The FDA's proposal is based on a review of nominations for including semaglutide, tirzepatide, and liraglutide on the 503B bulks list. The review process involved evaluating clinical needs and safety considerations associated with these drugs. The FDA's determination reflects its commitment to ensuring that compounded medications meet necessary safety and efficacy standards. Key limitations include the reliance on public input and the potential for ongoing supply chain issues that may affect patient access to FDA-approved drugs.

FAQ

What is semaglutide approved for?

Semaglutide is approved for managing type 2 diabetes and for weight management in adults with obesity. This approval is based on its efficacy in improving glycemic control and facilitating weight loss.

How does semaglutide work?

Semaglutide works as a GLP-1 receptor agonist, which stimulates insulin secretion in response to elevated blood glucose levels, inhibits glucagon release, and slows gastric emptying, leading to reduced appetite and weight loss.

What is the recommended dose of semaglutide?

The recommended dose of semaglutide for diabetes management is 0.25 mg subcutaneously once weekly, which can be increased to 1 mg once weekly based on patient response. Clinicians should consult current prescribing information for full dosing guidance. Full dosing guidance is available in the prescribing information for semaglutide.

What are the most common side effects of semaglutide?

Common side effects of semaglutide include nausea, vomiting, diarrhea, and constipation. These side effects are generally mild and tend to decrease over time as the body adjusts to the medication.

How does tirzepatide compare to semaglutide?

Tirzepatide is another GLP-1 receptor agonist that has shown superior weight loss results compared to semaglutide in clinical trials, making it an alternative option for patients seeking weight management solutions.

Who qualifies for semaglutide treatment?

Semaglutide treatment is typically indicated for adults with a diagnosis of type 2 diabetes or obesity, particularly those who have not achieved adequate glycemic control or weight loss with lifestyle modifications alone.

FDA Proposes Exclusion of Semaglutide and Tirzepatide from 503B Bulks List: Impact on Compounding Access

FDA Proposes Exclusion of Semaglutide and Tirzepatide from 503B Bulks List: Impact on Compounding Access

Clinical Perspective

Clinical Context

Key Findings

Safety & Tolerability

Study Design

FAQ

References

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