FDA Issues Draft Guidance for Identification and Notification of Suspect Products

As discussed in our April 11, 2014 Alert, the Drug Supply Chain Security Act (DSCSA) was enacted “to build an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed within the United States.” Recently, the U.S. Food and Drug Administration (FDA) has issued a draft Guidance for Industry for implementing the DSCSA with respect to identification of suspect products and notification thereof.

Starting January 1, 2015, trading partners and manufacturers are required to “notify FDA and immediate trading partners (that they have reason to believe may have received [or possess] the illegitimate product) not later than 24 hours after making the determination.”

Click here to read the full Alert, written by Duane Morris partner Rick Ball and associate Carolyn Alenci.