Committee sends bill on compounding, drug tracing to full Senate

The U.S. Senate Health, Education, Labor and Pensions (HELP) committee agreed by voice vote on Wednesday to send to the full Senate a bill that would streamline drug tracking and make compounding manufacturers subject to stricter regulation by FDA. The committee voted to incorporate the previously separate Drug Supply Chain Security Act into the Pharmaceutical Compounding Quality and Accountability Act. The joint bill, S. 959, would create an electronic, unit-level system for tracking and tracing pharmaceutical products to be phased in over 10 years. The bill also would define compounding manufacturers as entities that make sterile products without or in advance of a prescription and sell those products across state lines. It would enable FDA to specify drugs that cannot be compounded, including biologics and drugs with complex formulations. A vote by the full Senate on the combined bill has not yet been scheduled (see BioCentury Extra, May 15). ...