*

Ohio to limit drug-compounding pharmacies' batch sizes,

potentially affecting telehealth firm Hims & Hers

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New rule expected by year end targets mass production,

ensuring

patient-specific compounding

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Compounding pharmacy industry group warns Ohio rule may

increase

contamination risks

By Amina Niasse

NEW YORK, Sept 8 (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 ( LLY ) 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 ( LLY ), 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.