Ozempic shortage shines light on drug compounding

The national shortage of diabetes and weight loss medicines Ozempic and Wegovy has popularized pharmacy-mixed, off-brand alternatives, a lucrative market  based on the common practice of drug compounding, the production of medicines by pharmacies instead of pharmaceutical companies.

But while drug compounding is a cornerstone of Port Family Pharmacy, owner and pharmacist Michael Vineburg said he is shying away from offering compound medicines using Semaglutide, the active ingredient in Ozempic and Wegovy, because it’s a medical and legal “gray area.”

“I’d be making a lot of money if I did,” he said.

When it’s available, Ozempic can cost patients nearly $1,000 a month, an amount not usually covered by insurance, while a compounded variant can cost a fraction of that.

And there’s plenty of demand for the compound medicine, Vineburg said. The pharmaceutical companies that produce the name-brand drugs were only ready to supply less than half the actual demand they experienced.

Last year, the Federal Drug Administration placed Ozempic and Wegovy on its shortage list, which allows pharmacies to produce compound versions despite active patents. Drug ingredient manufacturers quickly began selling pharmacies Semaglutide for use in compounding.

While Vineburg said he doesn’t have a sterile lab required to compound injectable Semaglutide similar to Ozempic, he’s been contacted by several large pharmacies that offered to make it for him.

The issue, he said, is that the process the pharmaceutical companies use to produce the medicine is proprietary, so pharmacies are left guessing at the method.

There have also been issues with some manufacturers producing salt forms of Semaglutide that have poor efficacy and can cause side effects, Vineburg said.

He said he offers drug compounding for patients who have unique needs, such as an allergy to commercial drug ingredients, and for pets, including compounding medicine into dog treats.

Recently, Vineburg said, a cancer patient needed a 40 milliliter dose of a medicine and was prescribed two 20 milliliter tablets, which was the only commercially available dose. That prescription would have likely cost the patient about $1,000.

But because he was able to compound a 40 milliliter non-commercially tablet, it only cost the patient about $40, Vineburg said.

Kyle Beyer, owner of North Shore Pharmacy and Compounding Center in Cedarburg, said he partners with a large-scale compounding pharmacy with decades of experience to provide patients compound Semaglutide when the name-brand medicines are unavailable.

He said he provides the compound medicine only because his patients are unable to fill their Ozempic and Wegovy prescriptions, not to profit off the shortage.

“You’ll find these banner ads online from pharmacies that are actively marketing Semaglutide, and that was never the intent of this FDA authorization. It’s really just to solve a shortage,” he said. “They’re doing a ton of direct-to-consumer advertising, and we are not.

“The second the FDA announces this drug is not on shortage, all of those fly-by-night companies will disappear.”

Beyer said drug compounding, which has it origins in the early days of modern medicine, is experiencing a resurgence in popularity.

“We’ve seen an increase in interest and growth,” he said. “For a segment of the population that is trying to find a solution that manufactured medicine doesn’t solve, compounding is the next step.”

He said some patients have celiac disease and can’t process the gluten binders in some medications. Others need much higher or lower doses than are commercially available.

“We are able to make the medication in the dosage you need without the extra ingredients,” he said, noting compounded drugs often have shorter shelf lives than commercially available drugs.

There are a lot of misunderstandings about what can and can’t be done with compounding, Beyer said. For instance, pharmacies cannot make a compound drug from a regular prescription, but rather require a specific prescription from a doctor.

North Shore Pharmacy in Cedarburg, formerly Ye Olde Pharmacy, produces compound medication for its store in Shorewood, Beyer said.

“Our Cedarburg store’s been there for 30 years with a compounding lab, so we have a lot of knowledge and expertise on what works and what doesn’t. It’s a very unique skill set,” he said. “Our whole thing is keeping it simple and keeping it local.”

For Vineburg, compounding is the backbone of independent pharmacies like his.

“If I were to only do traditional prescriptions, we wouldn’t be around,” he said. “If you’re going to be an independent pharmacy, you have to do everything.”

Compound medicine is usually not covered by insurance, which makes providing the medicine a largely free-market endeavor, he said.

“We try to stay competitive,” he said.