A bipartisan group of senators introduced into the U.S. Senate on Wednesday a bill that would streamline drug supply chain tracking, while a separate bipartisan group of senators introduced a bill that would make compounding manufacturers subject to stricter regulation by FDA. Sharing many of the same requirements as a drug tracing bill making its way through the U.S. House of Representatives, the Drug Supply Chain Security Act would create an electronic, national system for tracking and tracing pharmaceutical products. The Senate bill calls for unit-level tracing to be phased-in over 10 years, while the House bill did not (see above). Manufacturers would be required to put systems in place allowing them to track and trace their products, and all parties in the supply chain would not be allowed to accept drugs if all transaction information and the history of the product are not provided.
The second bill, S. 959, defines compounding manufacturers as entities that make sterile products without or in advance of a prescription and sell those products across state lines, as well as entities that repackage preservative-free sterile drug products or pool sterile products. Under the bill -- which is in line with a discussion draft|http://www.help.senate.gov/imo/media/KER13169.pdf]] released last month by the Senate Health, Education, Labor and Pensions (HELP) committee -- FDA also would be able to specify drugs that cannot be compounded, including biologics and drugs with complex formulations. The bill prohibits compounding of marketed, FDA-approved drugs except in cases of a dose shortage (see BioCentury Extra, April 26)
The Senate HELP committee is scheduled to consider both bills on May 22.
Quoted from here