Research

GLP-1 shortage resolution statistics 2026 in the US

FDA national shortages for semaglutide and tirzepatide are resolved. See 2026 US access, compounding, price, Medicare, safety, and maintenance facts.

2026-08-17 · 13 min read

Introduction

FDA national shortages for semaglutide and tirzepatide are resolved. See 2026 US access, compounding, price, Medicare, safety, and maintenance facts.

Eight facts to know

  1. December 19, 2024 - Tirzepatide shortage resolved
  2. February 21, 2025 - Semaglutide shortage resolved
  3. 2022 - Semaglutide shortage began
  4. 605 - Compounded semaglutide reports
  5. 545 - Compounded tirzepatide reports
  6. July 1, 2026 - Medicare Bridge launch
  7. $50 monthly - Medicare Bridge copay
  8. 13 states - Medicaid obesity coverage

What resolved shortages mean at the pharmacy

FDA's shortage finding measures national supply, not the inventory in one pharmacy near you. FDA says intermittent local disruptions can continue while products move through manufacturers, distributors, and pharmacies. A pharmacy message saying out of stock does not by itself show that the medicine has returned to a national shortage. When a refill is blocked, ask what is actually blocking it. Is the issue the product, a specific strength, a wholesaler delay, an insurance rejection, or a prior authorization? The answer can save time because those problems have different routes for resolution.

Shortage and access timeline
DateEventWhat it means
2022Semaglutide injections entered shortageApproved products became hard to obtain for many people.
December 19, 2024FDA resolved tirzepatide injection shortageRoutine compounded copies faced tighter federal limits.
February 21, 2025FDA resolved semaglutide injection shortageNational supply was judged able to meet demand.
April 22, 2025Many 503A semaglutide enforcement periods endedA former shortage alone no longer supported routine copies.
May 22, 2025503B semaglutide enforcement period endedOutsourcing facilities also faced restored limits.
July 1, 2026Medicare GLP-1 Bridge launchedSome eligible Part D members gained a $50 monthly route.

Source: Source: U.S. Food and Drug Administration, FDA clarifies policies for compounders as national GLP-1 supply begins to stabilize; Centers for Medicare & Medicaid Services, Medicare GLP-1 Bridge.

Timeline showing semaglutide shortage beginning in 2022, tirzepatide resolution in December 2024, semaglutide resolution in February 2025, and Medicare Bridge launch in July 2026.
FDA shortage resolution timelineNational shortage status changed before the 2026 Medicare access program began.Source: Sources listed in this guide.
Chart summary

The timeline separates the end of national shortages from the later Medicare access program.

Compounding after the shortage

A compounded GLP-1 product is not the same as an FDA-approved product. FDA does not pre-review compounded medicines for safety, effectiveness, or manufacturing quality. Federal compounding pathways can apply in defined circumstances, but FDA says compounders generally cannot regularly make products that are essentially copies of commercially available approved drugs. Being cheaper, sold in a vial, or shipped to a home does not on its own establish a medical need for a compounded copy. FDA says compounded drugs should generally be used when a patient's medical need cannot be met by an FDA-approved drug. Individual circumstances and state pharmacy rules can matter, so this is a useful discussion for a prescriber and pharmacist rather than a decision to make from advertising alone.

FDA has described reports of dosing errors, doses beyond approved labeling, warm deliveries, inadequate cold packs, fraudulent labels, and use of semaglutide salt forms such as semaglutide sodium or semaglutide acetate. FDA says it does not know of a lawful basis for using those salt forms in compounding. Products labeled for research use or not for human consumption should not be used as medicines. Through July 31, 2025, FDA had received 605 adverse-event reports associated with compounded semaglutide and 545 associated with compounded tirzepatide. Those reports are incomplete and cannot prove that the compounded product caused each event. They do show why concentration, dose measurement, shipping, and pharmacy identity matter.

Bar chart comparing FDA adverse-event report counts associated with compounded semaglutide and compounded tirzepatide.
Compounded GLP-1 adverse event reportsReport counts signal safety concerns but do not prove causation or reveal an individual risk rate.Source: Sources listed in this guide.
Chart summary

FDA report totals through July 31, 2025 are signals for caution, not proof that a compounded drug caused each event.

Cost and coverage in 2026

A listed cash price, insurance copay, and public-program benefit are different numbers. Lilly lists regular self-pay KwikPen prices for Zepbound from $299 to $699 per 28-day month, depending on strength. Taxes, fees, eligibility rules, and offer terms can change, so confirm the current terms before filling. Coverage remains uneven. KFF counted 13 state Medicaid fee-for-service programs covering GLP-1 medicines for obesity in January 2026. Even where coverage exists, prior authorization and other utilization rules are common. Employer plans and Medicaid managed-care plans may use different rules from a state fee-for-service policy.

Access and price figures
MeasureFigurePractical meaning
Medicare GLP-1 Bridge$50 per monthDefined copay for eligible participants, not universal Medicare coverage.
Zepbound KwikPen 2.5 mg$299 per 28 daysOfficial regular self-pay price before possible taxes and fees.
Zepbound KwikPen 5 mg$399 per 28 daysSelf-pay price, not an insurance copay.
Zepbound KwikPen 7.5 mg$499 per 28 daysSelf-pay price subject to program terms.
Zepbound KwikPen 10 mg, 12.5 mg, 15 mg$699 per 28 daysListed price does not compare clinical benefit by strength.
Medicaid obesity coverage13 states in January 2026Coverage remains limited and policy can change.

Source: Source: Eli Lilly, Zepbound Savings and Insurance Options; KFF, Medicaid Coverage of and Spending on GLP-1s; Centers for Medicare & Medicaid Services, Medicare GLP-1 Bridge.

Chart of Lilly listed regular Zepbound KwikPen self-pay prices by strength for a 28-day supply.
Zepbound self-pay prices by strengthThe official regular self-pay price rises from $299 at 2.5 mg to $699 at 10 mg and above.Source: Sources listed in this guide.
Chart summary

Listed regular self-pay prices for a 28-day KwikPen supply rise by strength, before possible taxes and fees.

The Medicare GLP-1 Bridge started July 1, 2026 and is scheduled to end December 31, 2027. CMS says eligible Medicare Part D members can receive certain GLP-1 medicines for weight management at a $50 monthly copay outside the usual Part D payment flow. It requires a qualifying prescription and prior authorization. It is not a general obesity-drug benefit for every person with Medicare. CMS says people already eligible for GLP-1 treatment through standard Part D coverage for type 2 diabetes, moderate-to-severe obstructive sleep apnea, or certain liver disease cannot use the Bridge simply because their plan does not list the medicine for another reason. Ask the plan or pharmacist whether the prescription should go through regular Part D or the Bridge.

What trials say about staying on treatment

Supply and payment interruptions matter because GLP-1 treatment often has a maintenance component. In STEP 1, adults with overweight or obesity taking once-weekly semaglutide 2.4 mg with lifestyle intervention lost an average 14.9% of starting weight at 68 weeks, compared with 2.4% with placebo. For someone starting at 220 pounds, 14.9% is about 33 pounds on average, not a guaranteed result. SURMOUNT-4 tested what happened after people had already used tirzepatide for 36 weeks. They lost an average 20.9% during that lead-in. Over the next 52 weeks, people who continued tirzepatide lost another 5.5% on average, while those switched to placebo regained 14.0% from the point of switching.

Maintenance and withdrawal trial results
Trial measureResultWhat it can mean
STEP 1 semaglutide at 68 weeks14.9% average weight lossAbout 33 pounds in a 220-pound starting-weight example.
STEP 1 placebo at 68 weeks2.4% average weight lossLifestyle support produced less average loss in this trial.
SURMOUNT-4 lead-in at 36 weeks20.9% average weight lossParticipants entered the withdrawal comparison after substantial loss.
SURMOUNT-4 continuing tirzepatide5.5% further loss over 52 weeksContinuing treatment maintained and increased the earlier average loss.
SURMOUNT-4 switching to placebo14.0% regain over 52 weeksRegain was common after stopping in this trial.
Maintained at least 80% of initial loss89.5% continuing vs 16.6% placeboContinuation was much more likely to preserve most prior loss.

Source: Source: New England Journal of Medicine, Once-Weekly Semaglutide in Adults with Overweight or Obesity; JAMA, SURMOUNT-4 tirzepatide maintenance and withdrawal trial.

Comparison of SURMOUNT-4 lead-in loss, further loss while continuing tirzepatide, regain after placebo switch, and maintenance of prior loss.
Tirzepatide continuation and withdrawalAfter initial loss, continued tirzepatide and withdrawal produced sharply different average results.Source: Sources listed in this guide.
Chart summary

After initial loss, participants who continued tirzepatide had a very different average maintenance result from those switched to placebo.

The trial does not mean everyone must remain on a GLP-1 medicine indefinitely. It does mean that stopping due to cost, access, side effects, or preference deserves a plan. A clinician can help weigh maintenance goals, monitoring, food routines, activity, and what to do if a refill interruption occurs. Approved products also have important safety warnings. The Zepbound label includes severe gastrointestinal reactions, dehydration-related kidney injury, gallbladder disease, pancreatitis, serious allergic reactions, and a boxed warning about thyroid C-cell tumors seen in rats. It says Zepbound should not be used by people with a personal or family history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia syndrome type 2. Labels are not individual treatment instructions.

A practical refill and coverage routine

Keep a short record of the exact medicine name, product form, strength, fill date, pharmacy, insurance decision, out-of-pocket amount, side effects, and refill date. That record is useful when a pharmacy changes, a prior authorization is submitted, a savings offer is checked, or a clinician needs to understand what happened. If a refill fails, contact the pharmacy first and ask whether the problem is stock, a particular strength, wholesaler supply, an insurance rejection, or authorization. Then call the plan number on the insurance card for the exact drug and ask about diagnosis criteria, quantity limits, prior authorization, and appeals. Do not change products, strength, or dose without direction from the prescriber.

Questions for a clinician or pharmacist

  • Is my prescription for an FDA-approved product and an approved use?
  • Is the barrier supply, coverage, prior authorization, or price?
  • Can the pharmacy identify whether another location has the prescribed product?
  • If I have Medicare, could I qualify for the Medicare GLP-1 Bridge?
  • If I am considering a compounded product, what medical need cannot be met by the FDA-approved option?
  • Which symptoms need a call to the prescriber, urgent care, or emergency care?
  • If treatment stops, what follow-up and maintenance plan fits my situation?

Methodology

  • Source priority was FDA shortage and safety materials, FDA-approved labels, CMS program guidance, official manufacturer pricing, peer-reviewed trial reports, ClinicalTrials.gov, and KFF policy research.
  • Facts and links were checked on August 17, 2026. FDA's Drug Shortages Database should be checked again before a refill or compounding decision because status can change.
  • Affiliate pages, telehealth marketing, online pharmacy advertising, social posts, peptide sellers, research-use vendors, generic price trackers, unverified directories, and unsupported launch claims were excluded or treated cautiously.
  • National shortage status cannot determine stock at one pharmacy, insurance eligibility, an individual's safe dose, suitability, switching plan, or the quality and legality of a particular compounded product.
  • Adverse-event reports are not proof of causation and do not provide a patient-level rate. Trial averages cannot predict one person's result.

Update history

  1. Updated source review.

Data notes

The figures use the dated values shown in the tables. Dollar amounts are official listed self-pay or program copay figures, not estimates of an individual's out-of-pocket cost. Trial percentages are group averages.

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Frequently asked questions

Are GLP-1 shortages over in the United States?

For injectable tirzepatide and semaglutide, FDA resolved the national shortages on December 19, 2024 and February 21, 2025, respectively. Local or strength-specific delays can still occur.

Does shortage resolved mean every pharmacy has my medicine?

No. FDA says local and intermittent disruptions can happen while products move through the supply chain. A refill failure can also be caused by insurance, prior authorization, or a wholesaler issue.

Can I get compounded semaglutide or tirzepatide because it costs less?

Cost alone does not establish a reason for a routine compounded copy under FDA's framework. FDA says compounded drugs should generally be used when medical needs cannot be met by an FDA-approved drug.

Are compounded GLP-1 medicines FDA-approved?

No. Compounded medicines do not receive FDA premarket review for safety, effectiveness, or manufacturing quality.

What concerns has FDA raised about compounded GLP-1s?

FDA has described dosing errors, high doses, warm shipments, inadequate cold packs, fraudulent labels, and semaglutide salt forms. FDA also received hundreds of related adverse-event reports, which do not prove causation.

What is the Medicare GLP-1 Bridge?

It is a CMS demonstration running from July 1, 2026 through December 31, 2027. Eligible Medicare Part D members can obtain certain GLP-1 medicines for weight management for a $50 monthly copay.

Does everyone with Medicare qualify for the $50 program?

No. Eligibility depends on plan type, clinical criteria, intended use, and standard Part D eligibility. A qualifying prescription and prior authorization are required.

How much does Zepbound cost without insurance in 2026?

Lilly lists regular self-pay KwikPen prices from $299 to $699 for a 28-day supply depending on strength. Terms, taxes, fees, and eligibility can affect what a person pays.

Will I regain weight if I stop a GLP-1 medicine?

In SURMOUNT-4, participants switched from tirzepatide to placebo regained an average 14.0% of body weight over 52 weeks after a 36-week lead-in. Individual outcomes vary, but maintenance planning matters.

Where can I check current shortage and coverage details?

Use FDA's Drug Shortages Database for national status. For coverage, call the number on the plan card and ask about the exact medicine, diagnosis criteria, prior authorization, quantity limits, and appeal process.

Sources and review

  1. FDA policies for compounders as GLP-1 supply begins to stabilize · U.S. Food and Drug Administration
  2. FDA's Concerns with Unapproved GLP-1 Drugs Used for Weight Loss · U.S. Food and Drug Administration
  3. Drug Shortages · U.S. Food and Drug Administration
  4. FDA Proposes to Exclude Semaglutide, Tirzepatide, and Liraglutide on 503B Bulks List · U.S. Food and Drug Administration
  5. Medicare GLP-1 Bridge · Centers for Medicare & Medicaid Services
  6. CMS Launches Medicare GLP-1 Bridge, Expanding Access to GLP-1 Medications · Centers for Medicare & Medicaid Services
  7. Information for Part D Plans · Centers for Medicare & Medicaid Services
  8. Medicaid Coverage of and Spending on GLP-1s · KFF
  9. Health Tracking Poll: Prescription Drug Costs, Views on Trump Administration Actions, and GLP-1 Use · KFF
  10. Zepbound Savings and Insurance Options · Eli Lilly
  11. Zepbound prescribing information · U.S. Food and Drug Administration
  12. Wegovy prescribing information · U.S. Food and Drug Administration
  13. STEP 1 semaglutide trial · ClinicalTrials.gov
  14. Once-Weekly Semaglutide in Adults with Overweight or Obesity · New England Journal of Medicine
  15. SURMOUNT-4 tirzepatide maintenance and withdrawal trial · JAMA
  16. FDA source · U.S. Food and Drug Administration

Review

Written by Lina Research Team, Source-reviewed GLP-1 research

Source-reviewed by Lina Research Team, Source review. Primary and near-primary sources were checked for dates, labels, pricing, coverage, safety, and trial figures before publication. Not clinically reviewed unless a clinical reviewer is named.

Source review completed 2026-08-17. Approval and availability sources are checked monthly.