FDA Drug Diversion Act

Proposed rule for state regulation of drug wholesalers is expected to be available within the next two weeks, FDA said. The guideline proposes minimum standards for storage and handling, record keeping, and licensing. States will use the guidelines as a basis for developing their own regulations. Wholesalers must be licensed by the state two years after FDA publishes the final rule, the agency said. In addition, a guidance letter to industry on implementation of the act is expected to be available the week of Aug. 1 ("The Pink Sheet" July 25, T&G-1).