Copycat versions of popular drugs like Ozempic and Mounjaro have continued to proliferate in a postshortage era, with some experts saying “regulatory neglect” is allowing for potentially dangerous, unapproved drugs to reach consumers.

When the Food and Drug Administration (FDA) adds a drug to its official shortage list, compounding pharmacies can sell their own versions of that drug so patients can continue to access medications.

This was the case when weight loss drugs like tirzepatide and semaglutide went into shortage due to high demand. Online companies like Hims & Hers and Ro entered the GLP-1 market with compounded versions of Wegovy and Zepbound.

These medications contain the same active pharmaceutical ingredient as the branded version but are formulated slightly differently, such as altering a medication for a patient who can’t swallow pills. Due to the often highly individualized nature of compounded drugs, they are not FDA-approved.

But although the FDA has since removed these drugs from its shortage list, stakeholders say compounded drugs continue to be sold, and lawmakers in Congress have begun raising concerns with federal regulators.

There are two types of compounding pharmacies, 503A and 503B. 503A compounding pharmacies fulfill personalized, patient-specific prescriptions. 503B compounding pharmacies can do the same while also fulfilling bulk orders for clients like hospitals.

Prior to the end of the shortage, telehealth companies primarily relied on 503B compounders, but according to those in the drug space, online sellers are turning to 503A compounders to keep the lucrative business going.

Novo Nordisk, the manufacturer of semaglutide, partnered with Hims & Hers to sell a low-cost version of its branded product Wegovy after the........

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