GLP-1 TV · Patient story · views checked Oct 2026
How HIMS can keep compounding Semaglutide: 503a's and what they mean
Our summary
According to the video, the FDA has removed semaglutide from its shortage list. Some people take that to mean Hims & Hers can no longer compound it. The creator says that reading is wrong and uses the video to explain how much, and under what conditions, Hims could keep compounding. They say the shortage exception comes with a wind-down period, which they think is 90 or possibly 120 days.
One person's experience, in their words. Not medical advice.
Where semaglutide costs least today
The three cheapest partner programs for semaglutide, all in per month, checked weekly.
What else the video covers
The creator's main focus is the 503a exception, which they describe as a clinical necessity exception. They point to two FDA guidance documents, which they describe as non-binding and ambiguous, and encourage Hims investors to read them. The creator says a physician with an established patient relationship can have a compounded version made when there is a clinical reason, such as an allergy to an ingredient or a need for a specific dosage. They say Hims uses physicians for this and may argue that personalization based on factors like weight or blood test results makes its product clinically necessary. The creator guesses the company will announce this approach on its earnings call.
The creator expects pushback from Novo Nordisk, which they say called a Hims Super Bowl ad reckless and dangerous. They predict arguments that the exception was not meant for this scale, and they expect a lawsuit. They say new patients are harder, because Hims would need to show a clinical necessity, and they speculate that the acquisition of a New Jersey lab was meant to support that case. They also mention liraglutide and Hims' other product lines. They close by saying GLP-1 revenue will not vanish overnight but is unlikely to grow at its earlier pace. The creator labels all of this as speculation and says they are a Hims shareholder.
Our summary of what is said, in our words. Doses, results and prices are the speaker’s, not advice.
Takeaways
The main points, in the order they come up. Tap a time to play from there.
- 0:00 The creator says removal of semaglutide from the FDA shortage list does not by itself mean Hims can no longer compound it.
- 0:33 The creator explains that the shortage exception comes with a wind-down period, which they believe is 90 or possibly 120 days.
- 1:47 The creator describes the 503a exception as allowing compounding for clinically necessary cases through a physician with an established patient relationship.
- 4:09 The creator expects Novo Nordisk to push back, arguing that the exception is not meant for this scale and that compounding can be unsafe.
- 6:42 The creator says new patients are harder to serve after the next few months because Hims must show a clinically necessary condition.
- 9:13 The creator predicts a Novo Nordisk lawsuit and a gradual change in GLP-1 revenue rather than a sudden drop.
Key moments
From the creator's own chapters. Tap one to play from there.
What the video says
As stated in the video, not checked by us. Doses and results are the speaker’s, not advice.
- Medication
- semaglutide
- Who is speaking
- Patient
Questions this video answers
Can Hims still compound semaglutide after it left the FDA shortage list?
The creator says yes, at least for a while. They explain that the company can rely on the 503a clinical necessity exception, though they call the rules ambiguous and expect legal challenges.
What is the 503a exception for compounded drugs?
The creator describes it as a clinical necessity exception. A physician with an established patient relationship can have a compounded version made when there is a specific reason, such as an allergy, trouble swallowing pills, or a need for a particular dosage.
What might Novo Nordisk do about Hims compounding semaglutide?
The creator expects Novo Nordisk to file a lawsuit, possibly within the week. They say the company will likely argue that the exception is not meant for this scale and that personalization adds nothing beyond a copy of the drug.
Can new Hims customers still get compounded semaglutide?
The creator says new customers can for the next few months. After that, they say the company would have to show a clinically necessary condition for each person, which they think will be harder and more costly.
Videos on the same question
The closest videos in the library by what is said in them, not by title.
The FDA Just Shut Down 503B Compounded Semaglutide | DOWNSIZED LIVE!This is a live episode of the DOWNSIZED show hosted by Christopher and Lorraine Durham, who say they have lost over 150 pounds together on Zepbound.
Hims Stock Down -11% as GLP-1 Shortage Ends for Drug that Hims STILL DOESN'T SELL and NEVER SOLD!The creator of the Beat The Denominator channel says Hims stock fell 11% after the FDA moved tirzepatide off its drug shortage list, even though, according to the video, Hims does not sell tirzepatide and never has.
Novo Nordisk vs. Compounded Semaglutide: What It Means for YouIn this live news update, Christopher Durham of the DOWNSIZED channel says Novo Nordisk has asked the FDA to put compounded semaglutide on the demonstrable difficulties for compounding (DDC) list.
Giving myself the 1st Shot - Semaglutide compound from Henry Meds - day 1/wk 1In this video, the creator films her first semaglutide injection on June 10, 2023.
Read next
Our guides closest to what this video covers, with prices checked weekly.
- Semaglutide side effects, and what compounding does and does not change
Semaglutide's side effects are gastrointestinal: nausea, vomiting, diarrhoea and constipation, worst early and after each dose increase. Those belong to the molecule, so they are the same whether it came in a Novo Nordisk pen or a compounding pharmacy's vial. What compounding changes is everything around the molecule. A compounded drug is not FDA-approved, so the finished product has not been reviewed for safety, effectiveness or manufacturing quality, and the FDA has said the enforcement discretion that allowed 503A pharmacies to compound semaglutide has ended. It also usually arrives as a vial and a syringe rather than a pre-set pen, which moves dose measurement to you.
- 503A vs 503B pharmacies: who makes compounded semaglutide and tirzepatide, and how to check yours
A 503A pharmacy is a state-licensed pharmacy that compounds one prescription for one named patient, overseen mainly by its state board of pharmacy. A 503B outsourcing facility registers with FDA, follows the same manufacturing rules as drug factories (cGMP), is inspected by FDA and may make batches without a prescription. Since the shortages ended in 2025, both face tight limits on copying semaglutide and tirzepatide. FDA's records show 19 registered 503B facilities reported a compounded GLP-1 in the last two years.
- Is compounded semaglutide safe? What FDA actually says, and what it does not
Compounded semaglutide is the same molecule as Wegovy and Ozempic, made by a licensed pharmacy rather than Novo Nordisk, and it is lawful. What it is not is FDA-approved: in FDA's words, the agency "does not review compounded drugs for safety, effectiveness or quality before they are marketed". FDA's published concerns are specific, and none of them is that the molecule is different. They are dosing errors from self-measured vials, products shipped warm, fraudulent labels naming pharmacies that never made them, and doses above the approved label. Each is checkable before you buy, and this page shows how.
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