
"The U.S. Food and Drug Administration recently announced plans to crack down on the active pharmaceutical ingredients used in glucagonlike peptide 1 (GLP-1) drugs produced at compounding pharmacies, which make customized medications when FDA-approved drugs are unavailable. The agency's move has unleashed a host of questions about the safety and effectiveness of compounded drugs. What exactly does the FDA's notice crack down on?"
"In recent years, thousands of retailerssome legitimate and some illegalhave emerged to offer compounded versions of GLP-1 weight-loss drugs, which are typically taken in weekly injections, at extremely low prices, often without requiring a prescription. High demand for these drugs has meant that there has been a lot of money to be made, says Joshua King, a medical toxicologist at the University of Maryland, suggesting the financial opportunity triggered this burst of compounding pharmacies."
The FDA plans to crack down on active pharmaceutical ingredients used by compounding pharmacies to produce GLP-1 weight-loss drugs. Compounding pharmacies create customized medications when FDA-approved products are unavailable. Thousands of retailers, some legitimate and some illegal, have offered low-cost compounded GLP-1 versions, often without prescriptions, driven by high consumer demand and profit opportunities. The crackdown aims to remove questionable active ingredients from the market but could also hinder legitimate compounders. The FDA notice specifically named a major provider, and subsequent actions included a canceled product launch and a patent-related lawsuit from a branded drug developer.
Read at www.scientificamerican.com
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