For two years, compounded semaglutide and tirzepatide were the loudest business story in the peptide-adjacent world, and the whole thing rested on one regulatory condition: the drugs were in shortage. That condition ended, on dates FDA has published, and the aftermath explains a great deal about the enforcement letters, platform policies and content risks this library covers. Here is the timeline from the primary record.
The mechanism: shortage was the permission
Compounding copies of an approved drug is ordinarily restricted, but when a drug appears on FDA's shortage list, 503A pharmacies and 503B outsourcing facilities may prepare versions to cover the gap. The GLP-1 compounding boom was that allowance operating at national scale. It was always conditional, and the condition was always going to resolve.
The dates that ended it
FDA determined the tirzepatide shortage resolved on October 2, 2024, and the semaglutide shortage resolved in early 2025. Its statement, FDA clarifies policies for compounders as national GLP-1 supply begins to stabilize, laid out wind-down periods rather than a cliff: enforcement discretion for 503A pharmacies has ended, and for 503B outsourcing facilities it ran until March 19, 2025 for tirzepatide and May 22, 2025 for semaglutide. Neither drug appears on the shortage list today.
FDA then moved to close the other door. In a press announcement, the agency proposed excluding semaglutide, tirzepatide and liraglutide from the 503B bulks list, the mechanism that could otherwise have supported continued outsourcing-facility production. A proposal is not a final rule, but the direction is unambiguous.
Where the demand went
Demand of that size does not evaporate when its legal supply channel narrows; it migrates. Part of it went back to the approved products. Part of it went somewhere the enforcement record documents: online sellers offering semaglutide, retatrutide, cagrilintide, tirzepatide and mazdutide as research chemicals. On December 10, 2024, in the middle of this wind-down, FDA issued warning letters to a group of those sellers, charging the products as unapproved new drugs and stating that research-only labeling did not change what the websites showed the products were for. Our research-use article covers those letters in full.
The sequence matters more than any single event: shortage resolved, wind-down dated, bulks-list door proposed shut, enforcement letters to the gray market, all within months. That is not a scattered set of actions. It is an agency working a category end to end, and it is the environment every peptide-adjacent business now markets in.
What it means for marketing in this category
- Status claims need dates. A page describing what compounders may do that was accurate in 2024 is wrong now, and the difference is citable to the day. Undated regulatory content in this category is a liability with a publish button.
- Platform exposure follows enforcement. Google's ads policy reaches products subject to any government or regulatory action or warning, so the letters tightened the paid-channel exclusion for the whole category, not just their recipients.
- The trust vacuum is the opportunity. A category full of confidently wrong, undated content is exactly where precise, sourced, current pages win both rankings and AI citations, which is the strategy this library exists to demonstrate.
The usual boundary applies: this is a marketing firm reading the public record, not legal or regulatory advice, and a business with compounding questions needs counsel. What the record teaches marketers is simple and uncomfortable: in this category the rules move faster than most content calendars, and the sites that win are the ones whose pages carry dates and survive being checked against the documents they cite.
Frequently asked questions
Is compounded semaglutide or tirzepatide still allowed?
The shortage-based allowance ended on published dates. FDA declared the tirzepatide shortage resolved on October 2, 2024 and semaglutide resolved in 2025; enforcement discretion for 503A pharmacies has ended and for 503B facilities ran until March 19, 2025 for tirzepatide and May 22, 2025 for semaglutide. Narrow lawful compounding grounds unrelated to shortage remain a matter for regulatory counsel, not a marketing page.
What did FDA propose about the 503B bulks list?
In a published press announcement FDA proposed excluding semaglutide, tirzepatide and liraglutide from the 503B bulks list, the mechanism that could otherwise support outsourcing-facility compounding of those drugs. A proposal is not a final rule, but it signals the agency's direction clearly.
How do the December 2024 warning letters connect to the GLP-1 wind-down?
They landed mid-sequence. As the lawful compounding channel narrowed, FDA sent letters on December 10, 2024 to online sellers offering GLP-1 substances as research chemicals, charging unapproved new drugs and rejecting research-only labeling where site evidence showed otherwise. The wind-down and the letters are one enforcement picture.
Why does this matter for a peptide company's content?
Because every status claim in this category now has a date attached in the public record, and content that is undated or stale is checkably wrong. Precise, dated, sourced pages are simultaneously the compliance-safe option and the content that ranks and gets cited by AI systems in a category full of confident errors.
