Draft Guideline on Product Identifier Requirements Under the Drug Supply Chain Security Act



The Drug Supply Chain Security Act (DSCSA) (Title II of Public Law 113-54) was signed into  law on November 27, 2013. Section 202 of the DSCSA added section 582 to the FD&C Act.  This section established product tracing, product identifier, and verification requirements for  manufacturers, repackagers, wholesale distributors, and dispensers to facilitate the tracing of a  product through the pharmaceutical distribution supply chain.  Failure to comply with the  requirements of section 582 is a prohibited act under section 301(t) of the FD&C Act (21 U.S.C.  331(t)). 

An important requirement of the product tracing scheme outlined in the DSCSA is the product  identifier.  Section 582 requires that each package and homogenous case of product in the pharmaceutical distribution supply chain bear a product identifier in both a human-readable form and on a machine-readable data carrier.  The product identifier includes the product’s  standardized numerical identifier,lot number, and expiration date.  Manufacturers are required  to begin affixing or imprinting a product identifier to each package and homogenous case of a  product intended to be introduced in a transaction into commerce no later than November 27,  2017.  Repackagers are required to do the same no later than November 27, 2018.
For more details download the draft guideline from below link...
https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-drugs-gen/documents/document/ucm565272.pdf
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