GLP-1 compliance in 2026: what changed for telehealth brands

GLP-1 telehealth changed sharply in 2025, and the effects are still working through the industry in 2026. If you run a weight loss or GLP-1 telehealth program, the rules you launched under may not be the rules you operate under today. Knowing what changed, and what is still changing, decides whether the program survives.

This post is a practical summary for telehealth operators, drawn from published FDA actions, DEA guidance, and industry developments. It is not a legal opinion, so take questions about your own program to a healthcare attorney.

The big shifts in 2025

FDA shortage resolutions

The FDA resolved the tirzepatide (Mounjaro/Zepbound) shortage in December 2024 and the semaglutide (Ozempic/Wegovy) shortage in February 2025. Everything else followed from those two decisions, because they ended the legal basis most compounding pharmacies were using to produce GLP-1 medications.

Compounding restrictions

After the shortage resolutions, the FDA set deadlines for compounders to stop producing semaglutide and tirzepatide.

• 503A pharmacies (individual prescriptions) had to stop routine compounding of tirzepatide by February 18, 2025, and of semaglutide by April 22, 2025.
• 503B outsourcing facilities (larger batches) had to stop by March 19, 2025, for tirzepatide and by May 22, 2025, for semaglutide.
• 503A pharmacies can still compound semaglutide or tirzepatide when the prescriber documents a change that makes a significant clinical difference for a specific patient. Without that, the product counts as a copy of the approved drug, and the FDA has said it won't act against a pharmacy that fills four or fewer prescriptions of a copy in a calendar month.
• 503B outsourcing facilities can't compound them from bulk drug substance, because neither drug is on the FDA's 503B bulks list or its drug shortage list.

In February 2026, the FDA said it intends to restrict GLP-1 active pharmaceutical ingredients meant for unapproved compounded drugs, and that companies can't market a compounded GLP-1 as a generic, as the same as an approved drug, or as having the same active ingredient.

FDA warning letters

In September 2025, the FDA began sending warning letters to telehealth companies over their marketing of compounded GLP-1 medications. In March 2026 it announced 30 more, and it was still sending them in June 2026. The letters cite false or misleading claims about compounded semaglutide and tirzepatide, and they made it plain that enforcement is happening now. The FDA's page for telehealth companies on promoting compounded drugs lists the claims it objects to, including calling a compounded drug a generic or the same as an approved drug, saying it comes from an FDA-approved pharmacy, and implying the telehealth company is the compounder.

The SAFE Drugs Act

On December 9, 2025, Reps. Yakym and Carson introduced the SAFE Drugs Act (H.R. 6509). As introduced, it would require large-scale 503B outsourcing facilities, meaning those that compound any drug product more than 100 times a year, to be inspected before they first compound a drug and reinspected at least every two years. In the Senate, the HELP Committee reported its version (S. 3794) on July 27, 2026. That version drops the 503B inspection rules. Instead, 503A compounders that ship drugs out of state would report serious adverse events, those that ship more than 5 percent of their compounded drugs out of state would file annual reports, and every 503A compounded drug would carry a label saying it isn't FDA-approved. Neither version has become law, but the bill shows Congress is still paying attention to compounding.

What this means for telehealth operators

If you were using compounded GLP-1s

The business model built on compounded semaglutide or tirzepatide as a cheaper alternative to brand-name medications is effectively over for the vast majority of use cases. Operators who built programs around compounded GLP-1s have four places to go.

• Move to brand-name medications. Novo Nordisk's Wegovy and Eli Lilly's Zepbound are off FDA's shortage list. Cost per patient is higher, and the path is fully compliant.
• Pursue a manufacturer DTC partnership. Novo Nordisk partnered with Hims & Hers in April 2025 to sell Wegovy direct-to-consumer online, then terminated the partnership in June 2025 after Hims kept offering compounded semaglutide. Novo sued Hims in February 2026, then on March 9, 2026, dropped the suit and signed a new deal under which Hims offers Wegovy (pill and injection) and Ozempic at Novo's self-pay prices and stops advertising compounded GLP-1s. Similar arrangements may emerge for other brands.
• Offer alternative treatments, such as non-GLP-1 weight loss programs, lifestyle-based approaches or medication classes that don't face the same compounding restrictions.
• Broaden the service mix with TRT, HRT, longevity and wellness services so the business doesn't depend on a single drug class.

If you're using brand-name GLP-1s

If your program already uses brand-name semaglutide or tirzepatide through legitimate pharmacy channels, the changes work in your favor. The compounding crackdown removed a wave of lower-cost competitors, and the market that remains suits operators who invested in compliant infrastructure from the start.

Your compliance obligations stay the same: proper e-prescribing through licensed providers, fulfillment through licensed pharmacies, LegitScript certification for advertising, and HIPAA-compliant data handling throughout.

DEA telehealth prescribing rules in 2026

The DEA telehealth prescribing flexibilities are a separate question from GLP-1 compounding, and they are still moving. The COVID-era emergency flexibilities have been extended through December 31, 2026.

• Prescribing Schedule II-V controlled substances by audio-video telehealth without an in-person evaluation remains permitted through the end of 2026.
• Audio-only telehealth is permitted for opioid use disorder treatment.
• DEA sent a final telemedicine special registration rule to the White House for review in August 2026, and it hasn't been published yet.
• The Ryan Haight Act's in-person examination requirement is suspended for these categories through the extension period.

State-level compliance considerations

Federal changes get the headlines, but state telehealth regulations matter as much and vary widely.

• The Interstate Medical Licensure Compact (IMLC) covers more than 40 states plus DC and Guam, and imlcc.com keeps the current list. It makes multi-state licensing easier, though it doesn't make it automatic.
• States such as New York, California, Florida, and Texas have their own telehealth practice requirements, which may be stricter than federal rules.
• Some states require specific informed consent disclosures for telehealth visits.
• Prescription drug monitoring program (PDMP) requirements vary by state and are increasingly enforced.

Building compliance into your infrastructure

The operators best placed for the next round of changes built these five things into their infrastructure from the start.

• A patient experience kept separate from fulfillment, so you can swap your pharmacy without rebuilding what patients see.
• A website built to LegitScript's requirements from day one, so you aren't retrofitting it after an application denial.
• A flexible checkout where you can change plan offerings, pricing, and intake flows quickly when regulations change what you can offer.
• Room to change provider networks, so you aren't locked into one that adapts more slowly than you need.
• Audit-ready data practices: HIPAA-compliant systems with proper logging, encryption and access controls from day one.

Where GLP-1 compliance goes from here

2026 is a compliance turning point for GLP-1 telehealth, and the easy money from compounded medications is gone. The operators who do well will have legitimate pharmacy relationships, proper LegitScript certification, a diversified service mix, and infrastructure flexible enough to adapt as the rules keep changing.

The market is still very large. The obesity-specific GLP-1 segment is projected to hit $40+ billion in North America by 2035 (Precedence Research), and compliant operators are the ones in position to capture it. The crackdown is clearing out competitors who cut corners, which ultimately helps operators who invested in doing things properly.