Compounding Pharmacies Slowly Begin Registering with FDA — Physician’s First Watch
Compounding Pharmacies Slowly Begin Registering with FDA
By Amy Orciari Herman
Fourteen compounding pharmacies have registered with the FDA since the option became available in November 2013. These compounders represent just a fraction of the estimated 7500 pharmacies in the U.S. that provide advanced compounding services.
Pharmacies that register with the FDA will be known as "outsourcing facilities." They have to pay a fee, comply with good manufacturing standards, undergo routine inspections by the agency, and report adverse events linked to their products, according to a Reuters report.
FDA commissioner Margaret Hamburg sent letters to hundreds of hospitals last week urging them to purchase compounding medicines from only registered pharmacies.