By Amina Niasse
NEW YORK (Reuters) -Ohio is taking steps to more tightly regulate how some large drug-compounding pharmacies in the state operate, including those making weight-loss drug copies, by limiting the amount of medicine they keep on hand.
The move could have implications for online telehealth companies that rely on Ohio-based pharmacies producing copies in specialized doses, including one in the state owned by Hims and Hers.
Hims and other telehealth companies flourished over the last year when a shortage of Novo Nordisk’s Wegovy and Eli Lilly’s Zepbound allowed them to compound mass quantities, but are now selling what they call individualized doses. During the shortage, copies of Wegovy and Zepbound were estimated to have risen to millions of doses.
Novo and Lilly dispute that their production is legal.
The Ohio Board of Pharmacy said a new regulation will target the batches large pharmacies produce in anticipation of prescriptions, limiting them to 250 units of a drug at a time. It applies to those that make sterile injectable drugs, including the popular weight-loss drugs. Details of the regulation have not previously been reported.
“It’s meant to ensure [personalized compounding] is patient-specific and not creating mass production of these drugs, as a manufacturer typically would,” a spokesperson for the Ohio Board of Pharmacy said. For injectable weight-loss drugs, each unit represents a vial.
Novo and Eli Lilly, the latter of which filed a comment on the new regulation with Ohio urging it to adopt the batch size limit to ensure patient safety, have said that the compounding underway does not qualify as personalized. Novo has sued to stop some companies from doing so in certain situations.
RULE EXPECTED BY YEAR END
The Ohio rule, expected to be adopted by the end of 2025 with a one-year grace period for companies to comply, aligns the state with national standards meant to ensure safety and reduce the risk of infectious outbreaks, the spokesperson said.
According to a 2025 National Association of Boards of Pharmacy survey, at least 30 states require compounders to comply with the limit, which is based on guidance from industry group the United States Pharmacopeia. State pharmacy boards are tasked with regulating compounding pharmacies in conjunction with the Food and Drug Administration.
Hims has owned a pharmacy in Ohio since 2020 and last year in a press release said it planned to use that location to meet national demand for treatments. The company’s 2024 revenue was $1.48 billion, 19% of which was from weight-loss drugs.
“Hims & Hers has a long track record of working closely with regulators to adhere to robust safety standards, and we will continue to do so as requirements evolve,” a spokesperson for the company said in an e-mailed statement.
LILLY, NOVO PUSH BACK
A spokesperson for Novo said state boards should prohibit mass sales of weight-loss drug copies to protect patient safety.
Lilly in a comment to Reuters said it encouraged it and other regulators to take additional steps to stop mass compounding and raised potential safety and effectiveness issues, including the possibility of bacterial contamination or other impurities.
Industry group the Alliance for Pharmacy Compounding opposed the change in comments to the state, saying it would increase the risk of contaminated drugs.
“The more batches the pharmacy makes, the more times that compounding technician has to enter and leave the clean room,” a spokesperson for the alliance said, indicating that each new entry provided an opportunity for improper handwashing or clothing that is not sterile.
The spokesperson said the organization advocated for batch limitations that vary based on each facility’s operational capacity.
(Reporting by Amina Niasse; Editing by Caroline Humer and Mark Porter)
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