The FDA established deadlines for compounding pharmacies to stop producing specific drugs after a shortage, with smaller pharmacies having until April 22. Despite this, some continue offering modified versions of drugs like tirzepatide. Experts suggest these pharmacies believe adjustments in formulation could give them a legal edge over patent infringement. However, the legality of these practices is questionable, as the argument is that these products aren't truly tailored to individual patients, raising concerns about safety and personalization in compounded medicines.
"There are some ways that compounders tailor a medication to the patient, such as by adding another ingredient that might help with a side effect or an additional concern or diagnosis," says Annie Lambert, a pharmacist and clinical program manager.
"It's a minority," says Jayne Hornung, chief clinical officer at MMIT, commenting on the compounding pharmacies continuing to sell tirzepatide despite regulations.
Hornung says that companies continuing to sell tirzepatide are hoping the vitamin additives and other tweaks will allow them to argue they aren't selling straightforward copies of Lilly's patented drugs.
Mass-producing compounded versions of existing drugs with additives was not widespread until recently, according to Nicole Snow, a pharmacist.
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