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.
For most people the answer is yes, but on a narrower legal basis than in 2024 — and it depends on your individual clinical situation rather than on general availability. When semaglutide was on the FDA drug shortage list, compounders could prepare versions of it under a specific statutory allowance. That allowance ended with the shortage: FDA enforcement discretion for compounded semaglutide closed on April 22 and May 22, 2025, following the tirzepatide dates of February 18 and March 19, 2025. What remains is compounding based on a documented individual clinical need, which is a real but different pathway.
What Changed and Why
The FDA states that compounders may prepare compounded versions of a drug on FDA's drug shortages list if the compounded drug meets certain conditions detailed in federal law. That was the basis on which compounded semaglutide and tirzepatide became widely available during the supply crunch.
Once the shortages resolved, that basis fell away. The tirzepatide enforcement discretion period ended February 18 and March 19, 2025 depending on the type of compounder; the semaglutide dates were April 22 and May 22, 2025.
What did not change is the older and more fundamental pathway. The FDA's own framing is that a drug may be compounded for a patient who cannot be treated with an FDA-approved medication, and that compounded drugs should only be used in patients whose medical needs cannot be met by an FDA-approved drug.
What Determines Whether You Personally Can Get One
The first requirement is a prescription from a licensed clinician who has evaluated you. There is no route to a compounded preparation that bypasses this, and the FDA lists the absence of clinician screening among its telehealth red flags.
The second is a clinical rationale that the prescriber documents. The examples the FDA gives are illustrative of the principle: a patient with an allergy to a dye who needs the medication made without it, or a patient who cannot swallow a tablet and needs a liquid form. The determination is made by the prescriber for that patient.
The third is a state-licensed pharmacy willing and able to compound it. Availability varies by state, by pharmacy, and by what a given pharmacy's sourcing and testing programme supports.
What Is Definitely Off the Table
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 lacks information on whether they share the same chemical and pharmacologic properties, and that it is not aware of any lawful basis for their use in compounding.
Retatrutide and cagrilintide, which cannot be used in compounding under federal law. They are not components of FDA-approved drugs and have not been found safe and effective for any condition. The FDA has issued warnings to telehealth companies, API distributors and outsourcing facilities about them.
And anything sold without a prescription — including products labeled "for research purposes" or "not for human consumption," which the agency has warned about specifically because they were sold to consumers for human use with dosing instructions.
What Could Change Again
Supply conditions can shift. If an approved product returns to the shortage list, the statutory allowance for compounding versions of shortage drugs becomes available again under the conditions federal law specifies.
Enforcement priorities also evolve. The FDA has established an import alert covering GLP-1 active pharmaceutical ingredients with potential quality concerns, structured as a green list that exempts compliant manufacturers, and has stated the alert does not create new limits on lawful compounding of GLP-1 drugs.
Patent and exclusivity timelines govern when approved generics could exist. Until one is approved, there is no generic semaglutide, and a compounded preparation is not a substitute for that — the FDA is explicit that compounded drugs and generic drugs are not the same.
Planning for Continuity
Because the regulatory basis for this category has moved before, it is worth having a plan that does not assume it will stay fixed. Ask your prescriber what the alternative is if your current route becomes unavailable.
That matters clinically, not just logistically. Randomised withdrawal trials across the GLP-1 class consistently show substantial weight regain after discontinuation, so an interruption produces the same outcome as stopping.
The approved products remain available through the normal prescription channel, and coverage, manufacturer programs and older generic anti-obesity agents are all legitimate parts of a contingency plan worth discussing before you need one.
What to Verify Before You Commit
Which pharmacy will compound and dispense, and whether it is licensed in your state. Whether the base form rather than a salt form is used. What potency and sterility testing is performed. Whether a licensed clinician will be reachable after delivery.
On arrival, check the packaging against the FDA's published warning signs: damaged packaging, missing instructions for use, label spelling errors, an incorrect pharmacy address, or medicine that looks different from what you received before.
Injectable GLP-1 drugs require refrigeration as stated in their package inserts. The FDA recommends not using any injectable GLP-1 drug that arrives warm or with insufficient refrigeration.
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
Can I still get compounded semaglutide?
In many cases yes, but on a narrower legal basis than during the shortage. The shortage-based allowance ended when FDA enforcement discretion for compounded semaglutide closed on April 22 and May 22, 2025. What remains is compounding based on a documented individual clinical need, which requires a prescriber's determination for you specifically and a willing state-licensed pharmacy.
What ended in 2025, exactly?
The enforcement discretion tied to the drug shortage listings. Federal law allows compounders to prepare versions of a drug on FDA's shortage list under certain conditions, and that basis fell away once the shortages resolved. The tirzepatide dates were February 18 and March 19, 2025; the semaglutide dates were April 22 and May 22, 2025, depending on the type of compounder.
What makes a compounded preparation appropriate now?
The FDA frames it as a drug compounded for a patient who cannot be treated with an FDA-approved medication, and states that compounded drugs should only be used in patients whose medical needs cannot be met by an FDA-approved drug. The determination is made by the prescriber for that individual patient and documented, then filled by a state-licensed pharmacy.
Could compounded semaglutide become widely available again?
It could, if supply conditions change. Federal law provides an allowance for compounding versions of drugs on the FDA shortage list under specified conditions, so a return to shortage status would reopen that pathway. Enforcement priorities also evolve. Nothing about the current position should be treated as permanent in either direction.
Will there ever be a generic semaglutide?
Generic approval depends on patent and exclusivity timelines and on a manufacturer filing an abbreviated application establishing therapeutic equivalence under section 505(j). No approved generic semaglutide exists today. A compounded preparation is not a generic — the FDA states explicitly that compounded drugs and generic drugs are not the same.
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.
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