Hamburg still wants authority over compounding pharmacies

FDA Commissioner Margaret Hamburg said FDA must have new authorities to regulate pharmacy compounding and called for legislation to establish minimum federal standards for firms that compound sterile drug products. Hamburg said the legislation should give FDA "clear authority" to proactively inspect compounding pharmacies to determine the scope and nature of their operations. She said the agency is working with states to inspect state-licensed pharmacies, but said agency inspectors "are being delayed in their work or denied full access to records" at some facilities. The comments came in a (see BioCentury Extra, March 18). ...