Compounded GLP-1 and dual gip/GLP-1 receptor agonists: a statement from the American Diabetes Association
Open accessAbstract
The use of glucagon-like peptide 1 receptor agonist (GLP-1 RA) and dual glucose-dependent insulinotropic polypeptide (GIP) and GLP-1 RA (GIP/GLP-1 RA) classes has increased substantially over the past several years for treating type 2 diabetes and obesity. Increased demand for these pharmacotherapies has resulted in temporary product shortages for both GLP-1 RA and dual GIP/GLP-1 RA medications. These shortages, in part, have led to entities producing and marketing compounded formulations that bypass regulatory measures, raising safety, quality, and efficacy concerns. Even as shortages resolve, compounded GLP-1 RA and GIP/GLP-1 RA products continue to be heavily marketed to people with diabetes and obesity. The purpose of this statement by the American Diabetes Association is to guide health care professionals and people with diabetes and/or obesity in these circumstances of medication unavailability to promote optimal care and medication use safety.
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The American Diabetes Association and a variety of obesity advocacy organizations have warned against taking compounded GLP-1 drugs, citing the lack of regulatory oversight.
“The American Diabetes Association and a variety of obesity advocacy organizations, representing both clinicians and patients, have also warned against taking compounded GLP-1 drugs, citing the lack of regulatory oversight of both compounded formulations and prescribers of compounded products [29,30].”
From Affordable access to GLP-1 obesity medications: strategies to guide market action and policy solutions in the US (2025) · cites this paper as [30]
The ADA statement (Abstract; page not provided) recommends against non-FDA-approved compounded GLP-1 products and says they do not undergo FDA review for safety, quality, or effectiveness. It does not attribute its warning to a lack of regulatory oversight of prescribers; it also says compounding facilities are regulated under federal or state rules. This source supports the ADA portion of the sentence, not the separate claim about other advocacy organizations. (LLM, conf=0.86)
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- Authors
- Neumiller, J. J., Bajaj, M., Bannuru, R. R., McCoy, R. G., Pekas, E. J., Segal, A. R., & ElSayed, N. A.
- Affiliations
- Washington State University Spokane (US)
- Baylor College of Medicine (US)
- American Diabetes Association (US)
- University of Maryland, Baltimore (US)
- Massachusetts College of Pharmacy and Health Sciences (US)
- Corresponding author
- ElSayed, Nuha A.
- ORCID
- Venue
- Diabetes Care
- Publisher
- American Diabetes Association
- Published
- 2024-12-02
- Volume
- 48
- Issue
- 2
- Pages
- 177-181
- ISSN
- 0149-5992 (ISSN-L)
- 1935-5548
- OpenAlex
- W4404921087
- Cited by
- 49
- References
- 8
- Citations by year
- 2026: 25 · 2025: 23 · 2024: 1
- FWCI
- 16.47
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- Diabetes Care (publishedVersion)
- PubMed (publishedVersion)
- Funders
- American Diabetes Association
- Topics
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Treatment and Management
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Research
- Health Sciences › Medicine › Pharmacology › Pharmacology and Obesity Treatment
- Keywords
- GLP-1 receptor agonists, GIP/GLP-1 receptor agonist, compounded medications, drug shortages, type 2 diabetes, obesity, drug safety, off-label drug use
- MeSH terms
- Glucagon-Like Peptide-1 Receptor, Glucagon-Like Peptide-1 Receptor Agonists, Diabetes Mellitus, Type 2, Gastric Inhibitory Polypeptide, Humans, Hypoglycemic Agents, Obesity, Receptors, Gastrointestinal Hormone, United States, Glucagon-Like Peptide 1
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