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FDA Set to 'Grandfather' Pre-Compliance Date Drug Packages From Some Supply Chain Law Requirements
November 30, 2017 |FDA

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those provisions of the Drug Supply Chain Security Act come into effect in November 2018, FDA said in a recently issued draft guidance.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.”

FDA West Coast Import Division Issues Instructions on Importer Communications
November 29, 2017 |FDA

The Food and Drug Administration’s Division of West Coast Imports recently issued a document detailing its policies concerning communications with the office. The document, provided by the Columbia River Customs Brokers and Forwarders Association, specifies that uploading documents and checking status should be done via FDA’s Import Trade Auxiliary Communications System. It includes directions on communicating with FDA’s West Coast Import Division during agency investigations, entry reviews and compliance reviews, as well as requesting FDA authorization for canceling an entry with CBP.