FDA Set to 'Grandfather' Pre-Compliance Date Drug Packages From Some Supply Chain Law Requirements
The Food and Drug Administration intends to exempt pharmaceutical manufacturers and repackagers from certain product identifier requirements for drugs packaged before those provisions of the Drug Supply Chain Security Act come into effect in November 2018, FDA said in a…
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recently issued draft guidance. Section 582 of the 2014 law says manufacturers and repackagers must start affixing or imprinting a product identifier to each package and homogeneous case of pharmaceuticals, including imports, by Nov. 27, 2017, for manufacturers, and Nov. 27, 2018, for repackagers. FDA recently said it intends to give manufacturers an additional year, until November 2018, to comply (see 1706300031). Now, the agency says it will “grandfather” packages or cases of drug products that are already in the pharmaceutical supply chain on that compliance date as exempt from certain requirements, including some product identifier verification activities, “where there is documentation it was packaged by a manufacturer before Nov. 27, 2018.”