FDA to hold off on enforcing some parts of major supply chain law until 2024

The FDA on Fri­day pub­lished fi­nal guid­ance ex­plain­ing how it will not en­force some pro­vi­sions of a ma­jor sup­ply chain law un­til next year, rather than this No­vem­ber, af­ter stake­hold­ers asked for more time to ful­ly com­ply.

The Drug Sup­ply Chain Se­cu­ri­ty Act (DSC­SA), which passed in 2013, re­quires com­pa­nies to elec­tron­i­cal­ly trace drugs through­out the sup­ply chain in an ef­fort to com­bat coun­ter­feit prod­ucts. The leg­is­la­tion set a dead­line of Nov. 27 to im­ple­ment sev­er­al ma­jor pro­vi­sions, but FDA said in the guid­ance Fri­day that it is ex­tend­ing that dead­line by one year, to Nov. 27, 2024.

Unlock this article instantly by becoming a free subscriber.

You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.