Novo Nordisk Calls for FDA to Prohibit Compounding Pharmacies from Providing Semaglutide

Following the FDA removal of tirzepatide (Mounjaro; Zepbound; Eli Lilly) from the drug shortage list, Novo Nordisk called upon the FDA to prohibit compounding pharmacies to provide semaglutide (Ozempic; Wegovy) products, citing difficulties in recreating the molecule in compounding facilities.¹

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Previously, FDA officials voiced concerns over counterfeit semaglutide and adverse events (AEs) resulting from the off-label use of products with impurities, particularly from med spas, which are aesthetic medical centers combined with a day spa. In 2023, the FDA issued a letter to health care providers stating that there were over 350 cases of AEs associated with compounded semaglutide, with over 260 classified as serious in nature. The AEs have been reported due to dosing error, higher doses than approved by the FDA, and products containing salt forms of the product instead of the base forms. Furthermore, Novo Nordisk stated that some entities were selling compounded semaglutide in combination with BPC-157, which has been prohibited by the FDA due to safety risk.^2,3

Compounding medications must meet criteria to qualify for exemptions under sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act. Section 503A restricts the compounding of drugs that are essentially copies of those commercially available, and Section 503B restricts outsourcing facilities from making compounded drugs that are a copy of 1 or more FDA-approved drugs. However, the FDA has stated that compounded drugs can be used if the approved drug is on the FDA’s drug shortage list, which semaglutide is currently on. Up until October 21, 2024, tirzepatide was also listed as in shortage.^3,4

Novo Nordisk is calling for the FDA to prevent compounding pharmacies from creating the semaglutide compound, urging the agency to add semaglutide to the Demonstrable Difficulties for Compounding (DDC) Lists. The DDC Lists would prohibit compounding pharmacies from compounding semaglutide due to the potential safety risks, even if the drug remained in shortage.^1,5

The company states, “Semaglutide products belong on these lists due to the complexities associated with their formulations, delivery mechanisms, dosage forms, achievement of bioavailability, compounding processes, and physicochemical and analytical testing. We request that FDA convene and consult an advisory committee on compounding to discuss the addition of semaglutide products to both DDC Lists and promulgate regulations adding semaglutide products to the DDC Lists.”¹

The FDA reviews 6 criteria to determine whether a drug or product belongs on the DDC Lists: complex formulation, complex drug delivery mechanism, complex dosage form, bioavailability achievement complexity, compounding process complexity, and physiochemical or analytic testing complexity. Novo Nordisk has submitted data on each of the 6 criteria as well as a risk and benefit analysis.^1,5

According to the company, the risks include each of the 6 criteria and numerous safety risks, which include over 500 reports of AEs including 10 deaths, liver cirrhosis after using the compounded drug with nicotinamide adenine dinucleotide+, and immunogenicity issues caused by peptide-related impurities, including serious type I and III hypersensitivity reactions and cross-reactions that could neutralize semaglutide and increase the risk of worsening chronic conditions. Additionally, the company states that subpotent drugs could reduce or cause no efficacy in the treatment of chronic conditions and superpotent drugs could lead to an increase of serious adverse reactions.⁵

The company lists the benefits of compounded semaglutide including equivalency and clinical need. However, Novo Nordisk claims there is not sufficient and meaningful evidence for these benefits.⁵

According to the American Pharmacists Association, compounding pharmacies are essential to patients, especially for those who need specialized medication, those who cannot tolerate a specific medication, and those who need medications that are currently in shortage. Compounding pharmacies provide access to patients for their medication beyond what other types of pharmacies can offer. The FDA has oversight over the integrity and safety of the compounded drugs and the Drug Enforcement Administration oversees compounded controlled substances. Further, the US Pharmacopeia Convention issues standards for compounding medication.⁶

As for tirzepatide, another glucagon-like peptide-1 receptor agonist that is in demand, the Outsourcing Facilities Association sued the FDA over the sudden removal of the drug from the drug shortage list. Currently, the FDA will reevaluate the decision and does not intend to take action against the plaintiffs for the violation of the Federal Food, Drug, and Cosmetic Act, including the compounding of tirzepatide.⁷

REFERENCES

1. Docket No. FDA-2017-N-2562. Covington and Burling LLP. October 22, 2024. Accessed October 25, 2024. https://www.regulations.gov/document/FDA-2017-N-2562-0029

2. Gallagher A. Compounded, Counterfeit Semaglutide Poses Severe Risk to Patients. Pharmacy Times. May 2, 2024. Accessed October 25, 2024. https://www.pharmacytimes.com/view/compounded-counterfeit-semaglutide-poses-severe-risk-to-patients

3. Hofmann JL, Covion J. Clinicians, Pharmacists Should Work to Ensure Safety Compounded GLP-1 Medications. Pharmacy Times. October 23, 2024. Accessed October 25, 2024. https://www.pharmacytimes.com/view/clinicians-pharmacists-should-work-to-ensure-safety-compounded-glp-1-medications

4. Gallagher A. Outsourcing Facilities Association Sues FDA Over Sudden Removal of Tirzepatide From Drug Shortage List. Pharmacy Times. October 14, 2024. Accessed October 25, 2024. https://www.pharmacytimes.com/view/outsourcing-facilities-association-sues-fda-over-sudden-removal-of-tirzepatide-from-drug-shortage-list

5. Novo Nordisk. Nomination of Semaglutide Products to the Demonstrable Difficulties for Compounding Lists. October 22, 2024. Accessed October 25, 2024. https://www.regulations.gov/document/FDA-2017-N-2562-0029

6. Frequently Asked Questions About Pharmaceutical Compounding. American Pharmacists Association. 2024. Accessed October 25, 2025. https://www.pharmacist.com/Practice/Patient-Care-Services/Compounding/Compounding-FAQs

7. Gallagher A. FDA To Reevaluate Removal of Tirzepatide From Drug Shortage List. Pharmacy Times. October 23, 2024. Accessed October 25, 2024. https://www.pharmacytimes.com/view/fda-will-reevaluate-removal-of-tirzepatide-from-drug-shortage-list