A better registration system would find misbranded drugs

摘要

This ruling could encourage Congress to craft new legislation to clarify FDA authority to regulate high-volume compounding as part of next year's user fee renewal campaign. Such a move would be supported by patient groups such as the Allergy and Asthma Network Moth-ers of Asthmatics and the Consumer Health Alliance for Safe Medication (CHASM), which have pressed for tighter controls on compounding by Congress and FDA In a petition filed with FDA in March 2005, CHASM (which acknowledges support from pharmaceutical manufacturers) requested that all compounded drug products carry labels stating that they are not regulated by FDA and have not been tested for safety, efficacy, or sterility.