Are Compounding Pharmacies Still Making Semaglutide?

Last reviewed: June 4, 2026

Last updated: June 4, 2026

Written by: Jay Hastings, CEO of PlexusDx

Jay Hastings is the CEO of PlexusDx, a precision health company focused on genetic testing, blood biomarker insights, and personalized wellness recommendations. He has more than 20 years of experience across healthcare innovation, genomics, laboratory operations, healthcare investing, and strategic finance.

Medically reviewed by: Jayden Lee, PharmD, EMBA

Jayden Lee, PharmD, EMBA, is the PlexusDx Medical Science Liaison with a PharmD and MBA specializing in pharmacogenomics and clinical product development, with a proven ability to bridge the gap between genomic research and practical patient outcomes. Dr. Lee has more than 10 years of professional experience in clinical pharmacy, academia, and research.

Yes, licensed compounding pharmacies still prepare semaglutide — but "making" is the wrong verb, and the legal basis is not the one that applied in 2024. Compounding is preparation against a prescription for an individual patient, not manufacturing of a finished product. The shortage-based allowance that made compounded semaglutide broadly available ended when FDA enforcement discretion closed on April 22 and May 22, 2025. What continues is patient-specific compounding, which the FDA frames as appropriate for a patient who cannot be treated with an FDA-approved medication.

Compounding Is Not Manufacturing

A manufacturer produces standardised finished products under FDA-registered facility oversight, with an approved application, reviewed labeling and post-marketing obligations. A compounding pharmacy prepares a medication for a named patient pursuant to a valid prescription.

Section 503A of the Federal Food, Drug, and Cosmetic Act governs traditional pharmacy compounding and exempts it from certain requirements, including FDA premarket approval. State boards of pharmacy are the primary regulator, with FDA involvement in defined circumstances. Section 503B covers outsourcing facilities, a separate category. PlexusDx works only with licensed 503A compounding pharmacies.

That exemption is why the FDA states plainly that compounded drugs are not FDA-approved and that it does not verify their safety, effectiveness or quality before they are marketed. The exemption is from premarket review, not from all oversight.

The Legal Basis Shifted in 2025

While semaglutide was on the FDA drug shortage list, federal law permitted compounders to prepare compounded versions of it subject to specified conditions. That was the mechanism behind the volume of compounded semaglutide on the market during 2023 and 2024.

Once the shortage resolved, the allowance closed. Enforcement discretion for compounded semaglutide ended April 22 and May 22, 2025 depending on the type of compounder, after the corresponding tirzepatide dates of February 18 and March 19, 2025.

The pathway that remains is older and narrower: compounding for a patient whose medical need cannot be met by an FDA-approved drug, determined by the prescriber for that individual and documented accordingly.

What Pharmacies May Not Do

They may not use semaglutide salt forms. The FDA states that semaglutide sodium and semaglutide acetate are different active ingredients from the one used in the approved drugs, that it does not have information on whether these salts share the same chemical and pharmacologic properties, and that it is not aware of any lawful basis for their use in compounding.

They may not compound with retatrutide or cagrilintide, which cannot be used in compounding under federal law. Neither is a component of an FDA-approved drug, and neither has been found safe and effective for any condition.

They may not dispense without a prescription. That requirement is what separates lawful compounding from the unapproved market the FDA has warned about — including products labeled "for research purposes" or "not for human consumption" sold to consumers with dosing instructions.

What Oversight Looks Like Now

State boards of pharmacy inspect and license, and United States Pharmacopeia standards for sterile compounding govern facility design, air quality, personnel technique, beyond-use dating and environmental monitoring.

The FDA has established an import alert covering GLP-1 active pharmaceutical ingredients with potential quality concerns. It functions as a green list, exempting API from manufacturers that appear compliant based on inspection or evaluation, and the agency states it does not create new limits on lawful compounding of GLP-1 drugs.

The agency has also acted against fraudulent products: compounded semaglutide and tirzepatide with false label information, including labels naming pharmacies that did not compound the product or that do not exist.

The Reported Safety Picture

As of May 31, 2026 the FDA reported 990 adverse event reports associated with compounded semaglutide and more than 730 associated with compounded tirzepatide. It notes that federal law does not require state-licensed pharmacies which are not outsourcing facilities to submit adverse event reports, so these are likely undercounts.

Many reported events appear consistent with those seen with the approved products. A distinct subset relates to dosing errors — incorrect measurement and self-administration by patients, miscalculation by clinicians, and prescribing beyond the doses in the approved label.

Cold chain problems are a third category. The agency has received complaints of compounded GLP-1 drugs arriving warm or with inadequate ice packs, and recommends not using any injectable GLP-1 drug that arrives warm or with insufficient refrigeration.

What This Means If You Are Currently Supplied

Ask your prescriber to explain the clinical basis documented for your prescription. That is a reasonable question and a legitimate part of your record.

Ask which pharmacy compounds it, confirm the licence with your state board, and confirm that the base form rather than a salt form is used. Ask what potency and sterility testing is performed.

And plan for continuity. Because this regulatory position has moved before, having a discussed alternative — an approved product through coverage, a manufacturer program, or a different agent — is worth arranging before an interruption rather than during one.

How Your Genetics Relate to GLP-1 Pathways

Not everyone responds to GLP-1 medications the same way. Genetic variants — including GIPR rs1800437, FTO rs9939609, and MC4R rs17782313 — relate to the biological pathways these medications act on. These are pathway-level associations only and do not predict how much weight you will lose or how you will respond to any specific medication. PlexusDx maps 14 pathways, 49 peptides, and 150+ genetic insights so you and your provider can see how your genes relate to these pathways. It does not recommend, prescribe, or determine which medication, dose, or peptide is right for you. The PlexusDx Precision Peptide Genetic Test ($298) gives you and your provider pathway-level genetic context to support a more personalized conversation. Genetics is a guide, not a guarantee.

Access Personalized GLP-1 Care Through PlexusDx

PlexusDx offers seven prescription GLP-1 protocols to all 50 states — no membership, no insurance required, async intake or live consult. The Semaglutide Injection is $189/mo month-to-month, or from $149/mo on the 6-month plan. Medications are dispensed from licensed 503A compounding pharmacies following strict quality and safety standards. Add a Precision Peptide Genetic Test for $298 to personalize your protocol from day one.

Frequently Asked Questions

Are compounding pharmacies still allowed to prepare semaglutide?

Yes, on a patient-specific basis. The broad shortage-based allowance ended when FDA enforcement discretion for compounded semaglutide closed on April 22 and May 22, 2025. What continues is compounding for a patient whose medical need cannot be met by an FDA-approved drug, as determined and documented by the prescriber and filled by a state-licensed pharmacy.

Is compounding the same as manufacturing?

No. Manufacturing produces standardised finished products under FDA-registered facility oversight with an approved application and reviewed labeling. Compounding prepares a medication for a named patient against a valid prescription, under section 503A, which exempts it from FDA premarket approval. That is why the FDA states compounded drugs are not FDA-approved and are not verified before marketing.

What ended in 2025 and why?

The allowance tied to the drug shortage listings. Federal law permits compounders to prepare versions of drugs on FDA's shortage list under specified conditions, and that basis fell away once supply recovered. Enforcement discretion ended February 18 and March 19, 2025 for tirzepatide and April 22 and May 22, 2025 for semaglutide, depending on the type of compounder.

Who regulates compounding pharmacies?

State boards of pharmacy are the primary regulator for section 503A compounders, licensing and inspecting them, with United States Pharmacopeia standards governing sterile compounding practice including facility design, air quality, personnel technique, beyond-use dating and environmental monitoring. The FDA retains involvement in defined circumstances and regulates 503B outsourcing facilities separately.

Can pharmacies compound with semaglutide salt forms?

No. The FDA states that semaglutide sodium and semaglutide acetate are different active ingredients from the one used in the approved drugs, that it does not have information on whether these salts share the same chemical and pharmacologic properties as the approved ingredient, and that it is not aware of any lawful basis for their use in compounding.

Medical and Editorial Standards

Medical review process: This article was reviewed for medical accuracy, scientific clarity, evidence alignment, and appropriate discussion of genetics, medications, supplements, biomarkers, and health-related claims.

Sources and evidence: PlexusDx educational content is developed using peer-reviewed research, clinical literature, reputable medical references, and, where applicable, public health or regulatory guidance.

Commercial transparency: PlexusDx offers genetic testing, blood biomarker testing, personalized supplement recommendations, and related precision wellness services. Product mentions are intended to help readers understand available options and should not be interpreted as medical advice.

Important disclaimer: PlexusDx educational content is for informational purposes only and should not be used as a substitute for professional medical advice, diagnosis, or treatment. Always consult a qualified healthcare provider before making decisions about medications, supplements, genetic testing, lab testing, or health-related care.