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Compounded semaglutide and tirzepatide

Compounded semaglutide and tirzepatide are mixed by pharmacies, not sold as FDA-approved finished products. FDA does not check each batch for safety, strength or quality before sale. The drugs became widely available while both injections were on FDA’s shortage list. FDA ended the tirzepatide shortage on December 19, 2024 and the semaglutide shortage on February 21, 2025. Neither semaglutide nor tirzepatide is on FDA’s shortage list today, checked 14 August 2026.

Source: 14 FDA and Federal Register documents, all read 2026-08-12

What matters first

FDA approval
Compounded batches are not approved
Tirzepatide shortage ended
December 19, 2024
Semaglutide shortage ended
February 21, 2025
Federal pathways
Sections 503A and 503B

Below: what compounded means in law, the two kinds of pharmacy that can do it, a dated timeline of every FDA document, and where each drug stands now. We name and link no pharmacy, outsourcing facility or telehealth service anywhere on this site.

What compounded means, and what it does not mean

Compounding means making a drug for a patient outside the approved-product system. Federal law allows it under sections 503A and 503B. In limited cases, those sections excuse a drug from premarket approval, standard manufacturing rules, and full directions on the label.

Excused is not the same as passed. FDA says it plainly: compounded drugs are not FDA-approved, and the agency does not check them for safety, effectiveness or quality before they are sold. Everything else on this page follows from that.

The two sections, side by side

The section decides who inspects the preparer and which standards apply. It also decides whether a named prescription must come first.

DimensionSection 503A — pharmacy or physicianSection 503B — outsourcing facilityStatutory hook
Who may compoundA pharmacist in a state-licensed pharmacy or federal facility, or a physician.A pharmacist, or someone under a pharmacist’s direct supervision, in a registered outsourcing facility. The facility need not be a pharmacy.503A(a); 503B(a), 503B(d)(4)(B)
Registration with FDANot a condition of section 503A.Required. The facility must register with FDA and meet the reporting conditions.503B(a)(1), 503B(b)
Manufacturing standardExempt from current good manufacturing practice requirements when the section 503A conditions are met.Subject to current good manufacturing practice. The section 503B exemption list does not include that requirement.503A(a); 503B(a)
Prescription requirementMust be based on a valid prescription for an identified individual patient, though limited quantities may be prepared in anticipation of one.May supply without a patient-specific prescription — for example, as office stock ordered by a hospital.503A(a); 503B(d)(4)(C)
Routine oversightPrimarily state boards of pharmacy, day to day. FDA conducts surveillance and for-cause inspections.Primarily FDA, which inspects on a risk-based schedule.FDA compounding questions and answers
Adverse-event reporting to FDANot a condition of section 503A.Required, in the content and format FDA specifies.503B(b)(5)
Product labelingNot specified as a condition of section 503A.The label must carry specified information, including the statement “This is a compounded drug”.503B(a)(10)
Interstate distributionLimited — 5 percent of total prescription orders, or more where the state has a memorandum of understanding with FDA.Not restricted by section 503B.503A(b)(3)(B)
Copies of approved drugsMay not compound regularly or in inordinate amounts a product that is essentially a copy of a commercially available drug.May not compound a product that is essentially a copy of one or more approved drugs.503A(b)(1)(D), 503A(b)(2); 503B(a)(5), 503B(d)(2)
Bulk substancesThe substance must meet a USP or NF monograph, or be a component of an approved drug, or appear on the 503A bulks list.The substance must appear on the 503B bulks list, or the drug compounded from it must be on the shortage list at the time.503A(b)(1)(A); 503B(a)(2)

Where each molecule stands

The two drugs went the same way a few months apart. Each has its own page with the detail and the side-effect reports.

MoleculeApproved brandsShortage resolved503A window ended503B window endedSide-effect reports
TirzepatideMounjaro, Zepbound2024-12-192025-03-052025-03-19more than 730
SemaglutideOzempic, Wegovy, Rybelsus2025-02-212025-04-242025-05-22990

Side-effect reports are FDA’s published counts as of May 31, 2026. Pharmacies compounding under section 503A do not have to report them at all, so the real numbers are higher by an unknown amount.

Where each molecule stands on the shortage list today

The dates above are the FDA orders that ended each shortage. This is the list itself, read on 14 August 2026.

Semaglutide

Not in shortage

Semaglutide is not on FDA’s shortage list, checked 14 August 2026.

The database holds 3 discontinuation notices for Semaglutide Tablet, updated 4 June 2026.

A manufacturer has told FDA it is stopping this product. A discontinuation is not a shortage.

Tirzepatide

Not in shortage

Tirzepatide is not on FDA’s shortage list, checked 14 August 2026.

FDA’s shortage database holds no tirzepatide record at all.

Status comes from FDA’s drug shortage database on the date shown. The list changes daily. FDA drug shortage database · openFDA 2026-08-14

The shortage list itself, every record and both downloads →

When the list changes

This status can change without notice

Shortage listing is the switch. While a drug sits on that list, compounding a copy of it is allowed; when FDA takes it off, the window starts closing on a deadline.

FDA’s list moves daily and we re-read it against the status published here. Give an address and you get a note when a molecule on this page goes on or comes off, with the FDA record linked.

We mail a confirmation link and store nothing against your address until you open it. Sourcing updates only — what changed in the data, never what to take. One click unsubscribes, from any message. What the updates cover.

4Read the complete legal recordWhy shortage status controlled the window, the dated history, limits, and related records

Why the shortage list was the whole story

Both sections ban compounding something that is essentially a copy of a drug you can already buy. Semaglutide and tirzepatide are drugs you can already buy, so a compounded version is about as close to a copy as it gets.

A shortage listing switched that ban off. FDA then treated the drug as unavailable, so the copy rule stopped applying. Large outsourcing facilities could also work from bulk powder. Both routes depended on the shortage. They narrowed again when it ended.

The timeline

Newest first. Every entry links the primary document it came from and the date that document was retrieved.

  1. Rulemakingboth

    The comment period is extended to July 30, 2026

    A second notice at 91 FR 38719 pushed the comment deadline on the May 1 notice out to July 30, 2026. A proposal is not a final decision. When we last checked the docket, no final notice had been published.

    Source: Federal Register, 91 FR 38719 (2026-06-26), document 2026-12937, Docket No. FDA-2018-N-3240 — Extension of Comment Period · retrieved 2026-08-12

  2. Safety communicationboth

    FDA publishes its current side-effect counts and its position on salt forms

    As of May 31, 2026, FDA has 990 side-effect reports for compounded semaglutide and more than 730 for compounded tirzepatide. Both counts are floors. Pharmacies working under section 503A never have to report. FDA says “it is likely that adverse events from compounded versions of these drugs are underreported”. The same page says salt forms such as semaglutide sodium and semaglutide acetate “are different active ingredients than are used in the approved drugs”.

    Source: FDA’s Concerns with Unapproved GLP-1 Drugs Used for Weight Loss (content current as of 06/15/2026) · retrieved 2026-08-12

  3. Rulemakingboth

    The proposal is published in the Federal Register and opened for comment

    The proposal appeared at 91 FR 23431 under Docket FDA-2018-N-3240. It covers semaglutide, tirzepatide and liraglutide. Comments were first due June 30, 2026.

    Source: Federal Register, 91 FR 23431 (2026-05-01), document 2026-08552, Docket No. FDA-2018-N-3240 — List of Bulk Drug Substances for Which There Is a Clinical Need Under Section 503B · retrieved 2026-08-12

  4. Rulemakingboth

    FDA proposes to exclude both drugs from the 503B bulks list

    FDA proposed leaving semaglutide, tirzepatide and liraglutide off the 503B bulks list. The agency said it found no clinical need for large outsourcing facilities to make them from bulk powder.

    Source: FDA Proposes to Exclude Semaglutide, Tirzepatide, and Liraglutide on 503B Bulks List (news release, April 30, 2026) · retrieved 2026-08-12

  5. Enforcement window setboth

    FDA restates where the two drugs stand and how it reads “essentially a copy”

    FDA says neither drug was on the shortage list or the 503B bulks list. Adding an ingredient such as vitamin B12 may still make a product a copy. The update also explains a narrow rule for four or fewer prescriptions a month.

    Source: FDA clarifies policies for compounders as national GLP-1 supply begins to stabilize (content current as of 04/01/2026) · retrieved 2026-08-12

  6. Window closedsemaglutide

    The semaglutide injunction is denied and the section 503A window ends

    The district court denied the preliminary injunction motion in Outsourcing Facilities Association v. FDA, 4:25-cv-00174 (N.D. Tex.). The section 503A period of enforcement discretion ended, and the section 503B period ran to May 22, 2025.

    Source: FDA clarifies policies for compounders as national GLP-1 supply begins to stabilize (content current as of 04/01/2026) · retrieved 2026-08-12

  7. Window closedtirzepatide

    The tirzepatide injunction is denied and the section 503A window ends

    The district court denied the plaintiffs’ preliminary injunction motion. FDA had made its deadlines conditional on that ruling. So the section 503A period ended, and the section 503B period ran to March 19, 2025 as scheduled.

    Source: FDA clarifies policies for compounders as national GLP-1 supply begins to stabilize (content current as of 04/01/2026) · retrieved 2026-08-12

  8. Shortage resolvedsemaglutide

    FDA determines the semaglutide shortage resolved and sets the same two-step runway

    The declaratory order states that the semaglutide injection product shortage is resolved. It sets the same structure as before. Pharmacists and physicians under section 503A get 60 calendar days, until April 22, 2025. Outsourcing facilities under section 503B get 90, until May 22, 2025.

    Source: Declaratory Order: Resolution of Shortages of Semaglutide Injection Products (Ozempic and Wegovy), February 21, 2025 · retrieved 2026-08-12

  9. Shortage resolvedtirzepatide

    A new declaratory order re-determines the tirzepatide shortage resolved and sets two deadlines

    The order “revokes and replaces FDA’s October 2, 2024 decision on the same subject”. It also gives compounders a fixed runway. Pharmacists and physicians under section 503A get 60 calendar days, until February 18, 2025. Outsourcing facilities under section 503B get 90, until March 19, 2025.

    Source: Declaratory Order: Resolution of Shortages of Tirzepatide Injection Products (Mounjaro and Zepbound), December 19, 2024 · retrieved 2026-08-12

  10. Enforcement window settirzepatide

    FDA states an interim position for the reevaluation period

    In a letter, FDA said it did not intend to act against the plaintiffs during the reevaluation, or for two weeks after its decision. It also intended “to treat compounders consistently at this time”, which extended the same forbearance beyond the parties to the case.

    Source: FDA letter on the compounding of tirzepatide during the reevaluation period, October 17, 2024 · retrieved 2026-08-12

  11. Litigationtirzepatide

    The removal is challenged and remanded to FDA for reevaluation

    FDA was sued on October 7, 2024. Four days later, a court sent the decision back to the agency for another review. The shortage question reopened.

    Source: FDA letter on the compounding of tirzepatide during the reevaluation period, October 17, 2024 · retrieved 2026-08-12

  12. Shortage resolvedtirzepatide

    FDA first determines the tirzepatide shortage resolved

    FDA announced it had determined the shortage of tirzepatide injection was resolved, and removed the products from the shortage list. In FDA’s words, the drug “has been in shortage since 2022 due to increased demand”.

    Source: FDA clarifies policies for compounders as national GLP-1 supply begins to stabilize (content current as of 04/01/2026) · retrieved 2026-08-12

  13. Added to shortage listtirzepatide

    Tirzepatide injection is added to FDA’s drug shortage list

    FDA says tirzepatide injection entered the shortage list on December 15, 2022. That listing opened the main window for compounded copies.

    Source: Declaratory Order: Resolution of Shortages of Tirzepatide Injection Products (Mounjaro and Zepbound), December 19, 2024 · retrieved 2026-08-12

  14. Added to shortage listsemaglutide

    Semaglutide injection is on the shortage list for both approved brands

    FDA says Wegovy entered the shortage list in March 2022 and Ozempic in August 2022. The order gives months, not exact days.

    Source: Declaratory Order: Resolution of Shortages of Semaglutide Injection Products (Ozempic and Wegovy), February 21, 2025 · retrieved 2026-08-12

What remains uncertain

  • This is a summary of public regulatory records for education. It is not legal advice, and it does not describe any individual product, pharmacy or arrangement.
  • Enforcement discretion is not permission. FDA’s statements say what the agency did not intend to act on, during a stated window, on stated conditions. They never made a compounded copy an approved drug.
  • The 503B bulks proposal is a proposal. As of the date this page was checked, the docket carried the May 2026 notice and the June 2026 comment extension, and no final determination.
  • Side-effect counts are floors, not totals. Pharmacies compounding under section 503A do not have to report side effects to FDA. The published counts understate what has occurred.
  • State law is not covered here. Boards of pharmacy carry the day-to-day oversight of section 503A compounding, and their requirements differ by state.

Questions people actually ask

Is compounded semaglutide the same as Ozempic or Wegovy?

No. FDA has checked the approved products for safety, effectiveness and quality. It has not checked a compounded one. FDA tells patients to use a compounded drug only when an approved one cannot meet a medical need. Fill the prescription at a state-licensed pharmacy.

Did compounding of these drugs become unlawful?

Compounding itself is still lawful. The broad shortage-based windows ended in March 2025 for tirzepatide and May 2025 for semaglutide. The copy rule came back, along with the limit on working from bulk powder. Whether any particular preparation still qualifies is a question about that preparation, which depends on the prescription and pharmacy involved.

What is the 503B bulks list, and why does it matter here?

It is FDA’s list of bulk ingredients outsourcing facilities are allowed to compound from. With the shortage over, it is the main remaining route to bulk semaglutide or tirzepatide. FDA says neither is on it. On April 30, 2026, the agency proposed keeping both off. The proposal appears at 91 FR 23431.

Does adding vitamin B12 make a compounded product not a copy?

Not on its own. FDA addressed exactly that in April 2026. Semaglutide mixed with something like vitamin B12 can still count as essentially a copy. That applies if it is given the same way, at strengths within ten percent of the products already sold.

What is a salt form, and why does FDA object to it?

Some compounded products used semaglutide sodium or semaglutide acetate instead of the ingredient in the approved drugs. FDA says those are different active ingredients. It has no information on whether they behave the same way, and it knows of no lawful basis for using them in compounding.

Who inspects a compounding pharmacy?

A 503A pharmacy answers day to day to its state board of pharmacy, with FDA dropping in for surveillance or for-cause inspections. A 503B outsourcing facility answers mainly to FDA and is inspected on a risk-based schedule. It also has to meet a manufacturing standard that 503A pharmacies do not.

Are GLP-1 skin patches a form of compounding?

No — different subject entirely. The patches sold online are sold as supplements and contain plant ingredients, not a GLP-1 drug. The evidence is in the transdermal delivery record.

Questions readers ask

Is compounded semaglutide as good as Ozempic?

Nobody has tested one against the other, so there is no comparison to report. A compounded preparation runs no trials of its own — that is what separates it from an approved product.

Two other things differ. The strength in the vial was chosen by whoever mixed it, and it carries no FDA-reviewed label.

Can I still get my compounded semaglutide?

Both broad windows have closed. FDA ended the semaglutide shortage in February 2025. The 503A window closed in April and the 503B window in May.

One narrow lane survives: a 503A pharmacy preparing it for a named patient with a documented clinical need. That is a prescriber’s judgment, not a route anyone can shop for.

Is the FDA banning compounded semaglutide?

Not a ban, and the distinction matters. Compounding a copy of an approved drug is allowed while FDA lists a shortage, and stops being allowed when the shortage ends. The shortage ended.

FDA has also proposed leaving both drugs off the 503B bulks list. That is a proposed rule, not a ban already in force.

How long will it take me to lose 30 lbs on semaglutide?

No trial published a time to a pound target, and none of them studied a compounded preparation at all.

The published result belongs to the approved products: an average of 13.7% of body weight over 72 weeks in the head-to-head trial.

Sources

  1. FDA clarifies policies for compounders as national GLP-1 supply begins to stabilize (content current as of 04/01/2026) · U.S. Food and Drug Administration · retrieved 2026-08-12
  2. FDA’s Concerns with Unapproved GLP-1 Drugs Used for Weight Loss (content current as of 06/15/2026) · U.S. Food and Drug Administration · retrieved 2026-08-12
  3. Declaratory Order: Resolution of Shortages of Tirzepatide Injection Products (Mounjaro and Zepbound), December 19, 2024 · U.S. Food and Drug Administration · retrieved 2026-08-12
  4. Declaratory Order: Resolution of Shortages of Semaglutide Injection Products (Ozempic and Wegovy), February 21, 2025 · U.S. Food and Drug Administration · retrieved 2026-08-12
  5. FDA letter on the compounding of tirzepatide during the reevaluation period, October 17, 2024 · Office of Compounding Quality and Compliance, CDER · retrieved 2026-08-12
  6. FD&C Act Provisions that Apply to Human Drug Compounding · U.S. Food and Drug Administration · retrieved 2026-08-12
  7. Human Drug Compounding Laws · U.S. Food and Drug Administration · retrieved 2026-08-12
  8. Compounding and the FDA: Questions and Answers · U.S. Food and Drug Administration · retrieved 2026-08-12
  9. Compounding when Drugs are on FDA’s Drug Shortages List · U.S. Food and Drug Administration · retrieved 2026-08-12
  10. 503B Bulk Drug Substances List · U.S. Food and Drug Administration · retrieved 2026-08-12
  11. FDA alerts health care providers, compounders and patients of dosing errors associated with compounded injectable semaglutide products · U.S. Food and Drug Administration · retrieved 2026-08-12
  12. FDA Proposes to Exclude Semaglutide, Tirzepatide, and Liraglutide on 503B Bulks List (news release, April 30, 2026) · U.S. Food and Drug Administration · retrieved 2026-08-12
  13. Federal Register, 91 FR 23431 (2026-05-01), document 2026-08552, Docket No. FDA-2018-N-3240 — List of Bulk Drug Substances for Which There Is a Clinical Need Under Section 503B · Office of the Federal Register · retrieved 2026-08-12
  14. Federal Register, 91 FR 38719 (2026-06-26), document 2026-12937, Docket No. FDA-2018-N-3240 — Extension of Comment Period · Office of the Federal Register · retrieved 2026-08-12
  15. 21 U.S.C. § 353a — Pharmacy compounding (FD&C Act section 503A) · United States Code, 2023 Edition — via GovInfo · retrieved 2026-08-12
  16. 21 U.S.C. § 353b — Outsourcing facilities (FD&C Act section 503B) · United States Code, 2023 Edition — via GovInfo · retrieved 2026-08-12
  17. Public Law 113-54, the Drug Quality and Security Act, November 27, 2013 (127 Stat. 587) · U.S. Government Publishing Office · retrieved 2026-08-12

How we checked these details

Medically reviewed by Jennifer Montecillo, MD · non-practicing medical reviewer

Reviewed 2026-08-12

Every entry comes from fda.gov, the Federal Register or the United States Code. We do not use trade press or seller summaries. This is a plain summary of public records for education: not legal advice, not a treatment recommendation, and it contains no dose. The wider rules are in the sourcing methodology and the editorial policy; corrections go to contact@healthspanledger.com.