Novo Nordisk, the manufacturer of Ozempic and Wegovy, has petitioned the Food and Drug Administration (FDA) to add semaglutide, the active ingredient in Wegovy and Ozempic, to the "Demonstrable Difficulties for Compounding" list, which would effectively ban compounding pharmacies from producing compounded versions of these medications.
Wegovy and Ozempic and other semaglutide medications, such as Rybelsus, are widely used for diabetes management and weight loss. As the drugs’ ability to reduce weight became better known, demand boomed, and Novo Nordisk struggled to ramp up its manufacturing fast enough. In early 2022, the FDA added semaglutide to its drug shortage database.
Many clinics turned to compounded versions of semaglutide during the shortage to maintain patient care.
When Are Compounded Drugs Allowed?
Section 503A of the Federal Food, Drug, and Cosmetic Act (FD&C Act) describes conditions that must be satisfied for drugs compounded by state-licensed pharmacies and state-licensed physicians to qualify for exemption from the three sections of the FD&C Act that cover:
- Current good manufacturing practice;
- Labeling of drugs with adequate directions for use; and
- The approval of drugs under new drug applications or abbreviated drug applications.
Section 503B of the FD&C Act describes conditions that must be satisfied for drugs compounded by an outsourcing facility to qualify for exemption from the sections of the FD&C Act that address:
- Labeling of drugs with adequate directions for use;
- Approval of drugs under new drug applications or abbreviated drug applications; and
- Drug supply chain security requirements.
The purpose of Sections 503A and 503B is to enable the compounding of customized therapies for individual patients whose medical needs cannot be met by commercially available drugs. For example, a patient who has an allergy to a certain dye may need medication to be made without it, or an elderly patient or a child who cannot swallow a tablet or capsule may need medicine in liquid dosage form.
However, Sections 503A and 503B generally prohibit the compounding of drug products that are essential copies of commercially available or approved drug products.
The FDA does not consider a drug product to be commercially available, however, if it has been discontinued and is no longer marketed, or if the drug appears on the FDA drug shortage list, such as Wegovy.
Pharmacies may compound FDA essential copies of drug products that are shortage-listed drugs, but this permission isn't guaranteed – certain drugs may still be restricted from compounding despite being in shortage.
How Does The FDA Decide Which Drugs Belong on Its Drug Shortage List?
The FDA maintains a drug shortage database based on several key criteria:
- When manufacturers report anticipated disruptions or discontinuances in drug production
- When the FDA becomes aware of significant supply issues through market surveillance
- When healthcare providers or patients report consistent difficulty obtaining medications
- When a drug's demand significantly exceeds available supply
On October 30, 2024, Novo Nordisk confirmed that all doses of Wegovy and Ozempic are now listed as available in the U.S., although the company cautioned people may still experience “variability” in filling their prescriptions.
The FDA has not yet removed the semaglutide drugs from its shortage list.
What Types Of Drugs Cannot Be Compounded?
Drugs that cannot be compounded include:
- Copycat drugs. Drugs that are “essentially copies” of commercially available or FDA-approved drugs, unless the drug appears on the FDA drug shortage list (see exception in next bullet).
- Drugs that present compounding difficulties. Drugs that the FDA has identified as presenting "demonstrable difficulties for compounding". Such drugs may not be compounded even if they appear on the FDA drug shortage list.
- Biological products. Federal law does not allow biologics to be compounded outside of an approved biologics license application. On March 23, 2020, biological products that were regulated under the FD&C were transitioned to regulation under the Public Health Services Act. As a result, the 503A and 503B exemptions for drug products no longer apply to biological products.
On October 22, 2024, Novo Nordisk submitted a nomination to the FDA, arguing that semaglutide products belong on the Demonstrable Difficulties for Compounding (DDC) list due to “the complexities associated with their formulations, delivery mechanisms, dosage forms, achievement of bioavailability, compounding processes, and physicochemical and analytical testing.”
The FDA has yet to make a final decision on whether to ban compounded versions of semaglutide. If added to the DDC list, physicians, compounding pharmacies, and outsourcing facilities would be prohibited from making semaglutide medicines, even in the face of shortages.
Immediate Impact on Weight-Loss Clinics and Semaglutide Prescribers
For now, the FDA has not removed semaglutide from its shortage list, nor assigned the drug to a DDC list. With pharmacies still struggling to stock up on the branded versions of popular weight-loss medications, the FDA may not move quickly to act.
However, these drugs may eventually become illegal to compound, and weight loss clinics and providers with semaglutide patients under their care should consider these steps to prepare for the inevitability:
- Review current patient prescriptions and identify patients using compounded versions of semaglutide.
- Prepare patients for the shift to brand-name drugs and advise them of the potential price difference. Compounded semaglutide drugs are generally considered significantly cheaper than brand-name options like Ozempic or Wegovy, as they bypass the high costs associated with brand-name manufacturing, distribution, and injection pens.
- Consider alternative treatment plans for patients who cannot afford treatment due to higher costs.
Stay Informed About FDA Updates
Compounded semaglutide has been pivotal in managing obesity and related conditions in the face of nationwide shortages. The eventual ban of a compounded version could significantly alter your patients’ ability to afford care and available treatment plans. Be ready to communicate the impact with your patients and discuss alternatives.
At Hendershot Cowart P.C., we are following developments on this issue and will continue to share updates as merited.
