Bio­phar­ma sup­ply chain se­cu­ri­ty: FDA guid­ance spells out new ex­pec­ta­tions

The FDA on Thurs­day un­loaded a suite of two new guid­ance doc­u­ments and two fi­nal doc­u­ments to bet­ter pro­tect the bio­phar­ma sup­ply chain, ex­plain­ing how com­pa­nies will need to track and trace drugs down to the pack­age lev­el by late 2023, and how they need to ID sus­pect drugs.

Since 2013, the Drug Sup­ply Chain Se­cu­ri­ty Act (DSC­SA) has out­lined the drug dis­tri­b­u­tion se­cu­ri­ty re­quire­ments that the FDA is putting in place to build an elec­tron­ic, in­ter­op­er­a­ble sys­tem by No­vem­ber 27, 2023, which will ul­ti­mate­ly iden­ti­fy and trace cer­tain pre­scrip­tion drugs all the way down to the pack­age lev­el as they are dis­trib­uted with­in the US.

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