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Telehealth Growth Desk. Memo dated February 25, 2025.
Re: The semaglutide shortage ended four days ago. The first deadline is 56 days out and the second is 86.
If your clinic is built around compounded semaglutide, this is the memo to read twice. It covers what the FDA announced, what the dates mean, the options that are realistic, and a plan you can start on Monday. It is educational, not legal or medical advice. Your counsel and your licensed clinicians decide what applies to you.
What did the FDA announce on February 21, 2025?
- Feb 21, 2025FDA determines the shortage resolved
- Apr 22, 2025503A grace period ends
- May 22, 2025503B grace period ends
The FDA determined that the shortage of semaglutide injection was resolved, and it set enforcement grace periods for compounders. According to the FDA's GLP-1 compounding page, the periods run until April 22, 2025 for state-licensed pharmacies and physicians (503A) and May 22, 2025 for outsourcing facilities (503B).1 The dates are from the FDA's announcement. I am citing them as announced.
This is the second act, not the first
The FDA had already walked this path with tirzepatide. In October 2024 it declared that shortage resolved, a court remanded the decision for reevaluation, and on December 19, 2024 the FDA again determined it resolved, with 60 days for 503A compounders (until February 18, 2025) and 90 days for 503B facilities (until March 19, 2025).1 On February 11, 2025 the FDA clarified that those tirzepatide periods would run until the listed dates or a court decision on an injunction motion, whichever came later.1
What that tells you
Dates can move, and a court can move them. That does not mean you should plan on a delay. It means you should plan for the announced date and keep an eye on the news, not the other way around.
What do the dates actually mean?
They are not a ban on all compounding. They mark when the shortage exception ends.
503A and 503B in one minute
Under section 503A, compounding for an individual patient on a patient-specific prescription is exempt from FDA approval, current good manufacturing practice and adequate-directions labeling requirements. Section 503B covers a voluntary category called outsourcing facilities, which must follow current good manufacturing practice, are inspected by the FDA, and can distribute under a patient-specific prescription or an order not tied to an individual patient, such as office stock.3
Essentially a copy
The FDA generally considers a compounded drug essentially a copy of a commercially available drug if it has the same active ingredient in the same, similar or easily substitutable strength, and the commercial product can be given by the same route. A prescriber can document a significant difference for an identified patient to avoid that label.1
While a drug is on the shortage list, the rules around copies are more flexible. When the shortage is declared resolved, that flexibility ends after the grace period.1 That is the heart of this memo.
Compounded does not mean approved
Compounded drugs are not FDA-approved, and the FDA says it does not review their safety, effectiveness or quality before they are marketed.2 That is true of every compounded product.
What your pharmacy should tell you
Ask your compounding partner, in writing, three things. Which category are they: 503A or 503B? What is their plan for each product after the grace period? And what documentation will they require from your prescribers for any patient-specific preparation? A partner that cannot answer clearly is a partner you should worry about.
Who is affected, and how?
Almost every clinic that sells a compounded semaglutide product as its core offer.
- Clinics and brands built on compounded semaglutide. Your main product is the one with a deadline.
- Pharmacies and outsourcing facilities supplying them. They face the same dates under different categories. Ask your pharmacy how they plan to operate after the date, in writing.
- Patients mid-treatment. They are the most important people in this story. Their care plans are for their clinicians to decide.
- Marketing and sales teams. Every ad, page and script that names the product needs a review, starting with the limits I laid out in what clinics can and cannot claim.
What are the realistic options for a clinic?
There are four. You can combine them.
| Path | What it looks like, and the catch |
|---|---|
| Move to FDA-approved products | Clinicians prescribe approved brands where clinically appropriate. Costs and coverage change for patients, so pricing and the value story need work. |
| A narrow, documented patient-specific path | A prescriber documents a significant clinical difference for an identified patient. This is narrow, fact-specific and legally sensitive. It needs counsel, not a template. |
| Shift to a care program | The value is the clinical program, monitoring, nutrition, coaching and follow-up, not a single compounded vial. |
| Diversify the offer | Add other categories so one product decision does not decide the business. |
Option one: approved products
This is the cleanest path legally. The tradeoff is that the price patients see may be different, and the story you tell has to change from "affordable access to a drug" to "the best care around the drug." That is a harder sell, and a better business if you can deliver it.
Option two: the narrow path
Some clinicians will explore patient-specific compounding where there is a documented, individual clinical reason. I am not going to tell you where that line sits, because I am not a lawyer or a clinician. I will say that building your whole business on an exception is a bad plan. If you use it, use it carefully, with written advice from counsel.
How do you choose between them?
Ask five questions, in this order, with your counsel and clinical lead in the room.
- What can we legally and clinically offer after each date? Start with the rules, not with revenue.
- What do our patients actually value? Price, convenience, clinician access, results tracking? Ask them.
- What does each path do to our margin per patient? Do the math with real costs.
- Which path can we execute well in 86 days? A good plan you can run beats a perfect plan you cannot.
- What happens to our business if the rules change again? Prefer the path that survives another surprise.
Options three and four
A clinic that sells a program, not a product, survives product changes. That means the quality of intake, monitoring, support and results tracking becomes the thing patients are paying for.
Look at a well-known public example (I covered Hims earlier). Hims & Hers reported fourth quarter 2024 revenue of $481.1 million, up 95%, and full-year revenue of $1.48 billion, up 69%, on 2.2 million subscribers. Its CFO said revenue excluding the GLP-1 offering rose 43% to over $1.2 billion in 2024.4
$1.2B+
The point is not to copy that company. The point is that even the category's biggest player describes weight loss as an accelerant to a broader business.
An offer built on a regulatory exception has a shelf life. Build the part that lasts longer than the exception.
How do you protect patients during the transition?
By putting care first and communication early. This is clinical territory, so what follows is operational, not medical advice.
Let clinicians lead on each patient
Each patient's plan is a clinical decision for their prescriber. Your job is to make sure clinicians have the time, the information and the lead time to decide properly, and that nobody is rushed by a sales calendar.
Write down what you decided and why
Keep a simple record of each decision: the date, who made it, what information they had and what the plan is. If anyone asks later how you handled the transition, a clear paper trail is the best answer you can give.
Tell patients early and plainly
Patients should hear about changes from you, in your words, with enough notice to ask questions and make choices with their clinician. A surprise is the worst way to learn that a product is changing. Say what is changing, when, what their options are and how to reach someone.
What should change in your marketing?
Almost everything that names the product.
- Inventory every claim. Ads, landing pages, emails, scripts, social posts. List where the product name or promise appears.
- Retire anything that implies approval or equivalence to an approved drug. Compounded products are not FDA-approved.
- Rewrite the offer around the program. The care, the clinician access and the results tracking.
- Recalculate unit economics. New product costs, new price points and a different patient lifetime value change what you can pay to acquire a patient.
- Check platform policies and certifications for your category before changing creative or launching new offers.
- Set a freeze date. After it, no new ad or page goes live without a compliance review.
I run paid traffic for a living, so here is the blunt version (my clinic work lives on my telehealth page). An offer built on a regulatory exception has a shelf life, and your cost to acquire a patient has to be justified by what that patient is worth after the exception is gone.
What to say instead
Say what you actually deliver: a licensed clinician reviewing each patient, a plan built around the person, check-ins, and tracking over time. Describe the experience in plain words and avoid language that implies a drug is something it is not. The pitch moves from "get the drug cheaply" to "get care that helps you keep the result."
What is a 30-60-90 plan before the deadlines?
| Window | What gets done |
|---|---|
| Next 30 days | Inventory products and patients, brief clinicians, ask your pharmacy for its plan in writing, pick your path with counsel. |
| Days 31 to 60 | Rewrite the offer, pages and scripts. Draft patient communications. Rebuild unit economics. Brief the team. |
| Days 61 to 86 | Launch the new offer, stop retired claims, run patient communications and track what happens. |
Put a name next to every line of that plan. Plans without owners are wishes. Meet weekly for fifteen minutes, with one question on the table: what is blocking the next step? If the answer is a decision from counsel or a clinical lead, escalate it that day. The calendar is the one thing in this memo nobody can negotiate, so every week you lose is a week you do not get back.
The bottom line
The shortage is over, and the exception that made the old model possible is on a clock. You can read that as a threat or as a deadline for building something sturdier.
Sell care, not a loophole. Do it on dates you chose, with clinicians in front, counsel at your side and patients told early. Then the next regulatory headline will be a news item, not an emergency.
This article is educational and is not legal advice. Talk to a qualified healthcare attorney about your situation.
Keep building.Ekai
Questions people ask
When did the FDA declare the semaglutide shortage over?
On February 21, 2025 the FDA determined that the shortage of semaglutide injection was resolved. It announced enforcement grace periods ending April 22, 2025 for state-licensed pharmacies and physicians (503A) and May 22, 2025 for outsourcing facilities (503B).
Can pharmacies still compound semaglutide after the shortage ends?
Once the grace periods end, compounders generally can no longer rely on the shortage to make products that are essentially copies of the commercially available drug. FDA says a 503A compounder may still compound where a prescriber documents a significant difference for an identified patient. Talk to counsel before relying on that.
What does essentially a copy mean?
FDA generally considers a compounded drug essentially a copy if it has the same active ingredient as a commercially available product, in the same, similar or easily substitutable strength, and the commercial product can be given by the same route of administration.
How should a telehealth clinic prepare for the end of compounded semaglutide?
List what you sell, confirm your clinicians' plan for each patient, decide which program you will offer going forward, update your marketing claims, and set dates for each step ahead of the April 22 and May 22 deadlines. Dates could move if courts intervene, so build for the announced deadlines.
Sources
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