Peptide Rulebook

Semaglutide

Also known as: Ozempic, Rybelsus, Wegovy

Semaglutide is currently approved product — specific indication/route for fda-approved drug product.

Not legal or medical advice.

This page is for informational purposes only. Always verify the current official source or consult a qualified professional before making compliance, prescribing, purchasing, or clinical decisions. Read full disclaimer.

A GLP-1 receptor agonist approved in three FDA-approved products with different routes, indications, and strengths.

Current status

FDA-approved drug product: Approved product — specific indication/route; National drug shortage: Shortage resolved; 503A compounding of copies: Copy restrictions apply after shortage resolution

Status assertions by activity, jurisdiction, date, qualification, and sources
ActivityStatusAs ofJurisdictionQualificationSources
FDA-approved drug productApproved product — specific indication/routeJun 4, 2021United States federalOzempic injection approved 2017-12-05 (T2D); Rybelsus tablets approved 2019-09-20 (T2D); Wegovy injection approved 2021-06-04 (weight management).
National drug shortageShortage resolvedFeb 21, 2025United States federalFDA determined the semaglutide injection shortage was resolved on 2025-02-21. Oral Rybelsus was not in shortage.
503A compounding of copiesCopy restrictions apply after shortage resolutionFeb 21, 2025United States federalCompounded copies of Ozempic/Wegovy are generally restricted under 503A now that the shortage is resolved. FDA's transition enforcement discretion ended in April/May 2025.

What this means

  • ✓ FDA-approved drug product: Approved product — specific indication/route. Ozempic injection approved 2017-12-05 (T2D); Rybelsus tablets approved 2019-09-20 (T2D); Wegovy injection approved 2021-06-04 (weight management).
  • ✓ National drug shortage: Shortage resolved. FDA determined the semaglutide injection shortage was resolved on 2025-02-21. Oral Rybelsus was not in shortage.
  • ✓ 503A compounding of copies: Copy restrictions apply after shortage resolution. Compounded copies of Ozempic/Wegovy are generally restricted under 503A now that the shortage is resolved. FDA's transition enforcement discretion ended in April/May 2025.

What this does not mean

  • ✗ Status in one jurisdiction does not automatically apply elsewhere.
  • ✗ An approved active ingredient is not the same as an approved finished product.
  • ✗ “Research use” labeling does not make an unapproved drug lawful for human use.

Timeline

  1. FDA resolves semaglutide injection shortage

    final/effective

    Declaratory order finds shortage resolved and ends shortage-based compounding exceptions.

  2. FDA approves Wegovy

    final

    Semaglutide injection approved for chronic weight management.

  3. FDA approves Ozempic

    final

    Semaglutide injection approved for T2D.

Controlling sources

Last verified: 2025-03-01
Reviewer: External Regulatory Reviewer
Next review: 2025-06-01

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