The U.S. Food and Drug Administration (FDA) is issuing this message as a part of FDA’s continued outreach efforts to assist the import community. 

FDA Filing Accuracy: GLP-1 Drugs

The U.S. Food and Drug Administration (FDA) is issuing this message as a part of FDA’s continued outreach efforts to assist the import community. 

Glucagon-like peptide-1 (GLP-1) drugs, such as semaglutide (e.g. Ozempic, Wegovy, Rybelsus) and tirzepatide (e.g. Mounjaro and Zepbound) are a class of FDA regulated medications primarily used to treat type 2 diabetes and/or obesity.  FDA has provided information regarding  drug shortages for semaglutide and tirzepatide and has clarified compounding policies regarding unapproved GLP-1 drugs. Unapproved GLP-1 drugs remain a concern for the FDA. The agency has established a green list import alert (66-80) to help stop GLP-1 active pharmaceutical ingredients (APIs) that have potential quality concerns from entering the U.S. supply chain.

GLP-1 drugs (and all other FDA-regulated products) imported into the U.S. must comply with applicable requirements under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. Chapter 9) and Title 21 of the Code of Federal Regulations. Failure to comply with an applicable FDA legal requirement may subject the party making entry to various enforcement actions.

FDA has observed that some GLP-1 drug products are being misclassified as cosmetics, peptides, or inaccurate drug products, inappropriately disclaimed as non-FDA regulated products, or falsely declared “for research purposes” or “not for human consumption.” As a reminder, GLP-1 drug products fall within FDA’s regulatory scope and are subject to FDA review. Entry data transmitted to FDA through CBP’s Automated Commercial Environment (ACE) should be timely and accurate. Inaccurate data transmission of GLP-1 drugs may delay FDA’s ability to make admissibility decisions on compliant products or these products will be subject to enforcement actions.

Parties entering products regulated by FDA, whether a formal (e.g. type 01) or informal entry (e.g. type 11), are responsible under existing law for exercising reasonable care in making entry, including proper classification of FDA regulated products such as GLP-1 drugs. Meeting these obligations helps ensure that all applicable legal requirements are addressed.

FDA encourages parties making entry for FDA-regulated products to review transmitted data for accuracy and timeliness. The following resources are available to aid parties with ensuring that timely and accurate data is transmitted for GLP-1 products:

Resources and Tips for Entering GLP-1 Drugs

• Harmonized Tariff Schedule of the United States: S. International Trade Commission’s website
• ACE requirements for the electronic transmission of drugs to FDA are found in section 7 of the FDA Supplemental Guide
• The active ingredient should be identified using a valid drug product code in the FDA Product Code Builder. For example:

Active Ingredient in GLP-1	FDA Product Code
Semaglutide	61P[][]72
Tirzepatide	61P[][]74

• Importing Human Drugs
• Additional documentation may be needed to facilitate FDA clearance of GLP-1 drug shipments intended for certain uses:
  • Pharmacy Compounding (IUC 013): Certification of analysis (COA) and other laboratory data may be requested (21 U.S.C. § 353a and § 353b, 21 C.F.R. § 211.165).
    • Unapproved drugs or drugs under IND are NOT amenable for pharmacy compounding (21 U.S.C. § 355, 21 U.S.C. § 353a).
  • Research and development (R&D) for laboratory testing non-human use (IUC 017): An intended use statement may be required that includes the type of research and development to be conducted (21 C.F.R. § 312.2(b), 21 C.F.R. § 201.125, 21 U.S.C. § 331(a)). Further, such statement must affirm that the quantity is reasonable for the intended R&D use and that the manufactured product(s) will not be introduced into commercial distribution.

Contact Information

For general import operations and policy questions: Imports@fda.hhs.gov