Quick answer
An FDA-maintained list of drugs in short supply. Inclusion historically permitted compounding pharmacies to legally produce non-FDA-approved versions of those drugs; semaglutide and tirzepatide were both delisted in 2024-2025.
Full definition
The FDA Drug Shortage List identifies drug products that are in supply shortage, as defined under the Food and Drug Administration Safety and Innovation Act. Inclusion on the list provides certain regulatory flexibilities, including allowing 503A and 503B compounding pharmacies to compound copies of those drugs during the shortage period. Tirzepatide was removed from the shortage list in October 2024; semaglutide was removed in February 2025. Removal triggered phased deadlines for compounders to cease production, with 503B facilities subject to faster deadlines than 503A pharmacies.
Deep dive
FDA Drug Shortage List: complete reference
The FDA Drug Shortage List is a database maintained by the FDA Office of Drug Shortages tracking commercial pharmaceutical products with insufficient supply to meet US demand. Listing has significant regulatory implications: it creates a legal basis for state-licensed compounding pharmacies to prepare "essentially copy" versions of listed drugs under 503A and 503B exemptions, which is otherwise prohibited for commercially-available products. For GLP-1 medications, semaglutide was listed in 2022 and resolved February 2025; tirzepatide was listed in 2023 and resolved December 2024. The shortage listings enabled the dramatic 2023-2024 expansion of compounded GLP-1 production via telehealth platforms. Once FDA declares a shortage "resolved," the legal basis for ongoing mass compounding narrows substantially — though individual patient-specific compounding under 503A traditional indications (allergy to inactive ingredient, custom dose) remains legal. The FDA Drug Shortage Database is publicly searchable at accessdata.fda.gov; new listings/resolutions are announced via FDA email updates.
- In practice
- Wegovy was on the FDA shortage list 2022-2024. During that time, compounding pharmacies could legally make "essentially copy" semaglutide. After shortage resolved February 2025, that legal pathway largely closed.
- Clinical context
- FDA shortage status is the regulatory hinge для compounded GLP-1 legality. Check current status before relying on availability assumptions.
Medications
FDA Drug Shortage List is most directly relevant to the following GLP-1 medications:
Related terms
- Compounded Semaglutide — A non-FDA-approved version of semaglutide prepared by a licensed compounding pharmacy. Was permitted…
- Compounded Tirzepatide — A non-FDA-approved version of tirzepatide prepared by a compounding pharmacy. The FDA shortage was r…
- 503A Compounding Pharmacy — A state-licensed pharmacy that prepares patient-specific compounded medications based on a valid pre…
- 503B Outsourcing Facility — A federally registered pharmacy that produces compounded medications in bulk for healthcare faciliti…
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GLP1Zoom glossary is educational reference. Definitions are summary interpretations of clinical sources and not a substitute for prescribing-information detail. Full disclaimer.
References
Glucagon-Like Peptide-1 Receptor Agonists: Mechanisms и Clinical Use (Drucker, Cell Metabolism)(2018)
Tirzepatide GIP/GLP-1 Dual Agonism: Mechanism Review (Lancet Diabetes & Endocrinology)(2021)
GLP-1 Effects on Gastric Emptying: Pharmacology Review (American J Physiology)(2020)
Endocrine Society Clinical Practice Guideline: Pharmacological Management of Obesity(2015)
STEP-1 trial: Once-Weekly Semaglutide in Adults with Overweight or Obesity (Wilding et al., NEJM)(2021)
SURMOUNT-1 trial: Tirzepatide Once Weekly для Treatment of Obesity (Jastreboff et al., NEJM)(2022)
SUSTAIN-6 trial: Semaglutide and Cardiovascular Outcomes (Marso et al., NEJM)(2016)
SURPASS-2 trial: Tirzepatide vs Semaglutide в Type 2 Diabetes (Frias et al., NEJM)(2021)
LEADER trial: Liraglutide and Cardiovascular Outcomes в T2D (Marso et al., NEJM)(2016)