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The copycat drugs are made by compounding pharmacies allowed by the FDA to make off-label versions of pharmaceutical products that are in short supply, says Kelly Ann Barnes, Northeastern professor of pharmacy law.
With summer around the corner, telehealth outlets and medical spas are going into hyperdrive advertising the sale of semaglutide, the active ingredient in popular weight-loss drugs Ozempic and Wegovy.
Recent shortages of the brand-name drugs have opened the door to copycat versions that, while legal, also raise some concerns for consumers, says Kelly Ann Barnes, Northeastern professor of pharmacy law.
The copycat drugs are made by specialized pharmacies known as compounding pharmacies, which are allowed by the U.S. Food and Drug Administration to make off-label versions of pharmaceutical products that are in short supply, she says.
But recently the FDA has warned that some compounding pharmacies are producing counterfeit or improperly formulated versions of semaglutide, Barnes says. She urges consumers to exercise caution when shopping around for weight-loss drugs.
Compounding is the process of combining two or more drugs to create a medication, according to the FDA.
The process is often used to tailor a medication to the needs of an individual patient, such as to create a liquid version of a pill for an individual who has trouble swallowing, Barnes says.
Compounding pharmacies also are allowed to copy formulations of commercially available drugs if the latter are in short supply, as is the case with Wegovy and the diabetes drug Ozempic, she says.
Popular demand for the brand-name drugs for weight loss has outstripped supply from parent company Novo Nordisk and placed them on the FDA’s backorder list, Barnes says.
The supply shortage opened the door for compounding pharmacies to mix their own semaglutide formulations, resulting in an explosion of sale offerings from online telehealth outlets and medical spas.
Some customers are mistakenly under the impression that injectable compounded semaglutide is a generic version of Ozempic, Barnes says.
“A compounded product is never a generic (drug). Generic products are approved by the FDA” in a similar manner to brand-name drugs, although the process is streamlined, Barnes says.
The FDA neither approves compounded drugs nor does it evaluate them for safety and efficacy, she says.
The day-to-day responsibility for monitoring compounding pharmacies to make sure they follow best pharmacy and sterile compounding practices generally falls to state boards of pharmacy, Barnes says.
She says Massachusetts regulations and oversight of pharmacies located within Massachusetts are particularly stringent, tightening after improper practices at the New England Compounding Center led to a nationwide fungal meningitis outbreak that sickened 793 patients and killed 64 people in 2012.
The FDA says it has received adverse event reports after patients used compounded semaglutide and advised that patients not use a “compounded drug if an approved drug is available.”
The federal agency also says it has received reports that some compounders may be using salt forms of semaglutide that are different from the active ingredients used in the approved drugs.
It says it’s not aware of “whether the semaglutide salts have the same safety and efficacy profile as semaglutide.”
“You’re not getting the exact same thing,” Barnes says.
She says that’s a concern, especially since many people are ordering the drugs online without a physical, lab tests or follow-up appointments.
WCVB reporter Brittany Johnson, who interviewed Barnes for a Boston Channel 5 report on compounded semaglutide that aired May 20, says when she ordered the weight-loss drugs online in the course of her reporting, she was promised a telehealth visit.
Instead Johnson got approval via video messages from board-certified physicians and received the compounded products within days.
“In a true telehealth visit, you’re communicating person to person,” Barnes says.
It’s easy to order semaglutide online, with many telehealth sites offering Memorial Day or summer specials.
But before ordering, customers should ask which compounding pharmacy is being used and check to make sure it is licensed in the state it is operating in, Barnes says.
She says it’s also a good idea to see if the pharmacy is accredited by the national Pharmacy Compounding Accreditation Board or similar accreditation organization because accredited pharmacies are inspected to ensure high standards.
“You have to do your homework,” Barnes says.