FDA issued a June 30 draft guidance document saying, “FDA does not intend to take action against manufacturers who do not affix or imprint a product identifier to each package and homogenous case of products intended to be introduced in a transaction into commerce before November 26, 2018. This represents a one year delay in enforcement of the requirement for manufacturers to affix or imprint product identifiers. For the products that manufacturers introduce in a transaction into commerce before November 26, 2018, without a product identifier, FDA also does not intend to take action against manufacturers who do not use a product identifier to verify such product at the package level.”
Called the “Product Identifier Requirements Under the Drug Supply Chain Security Act—Compliance Policy, Guidance for Industry,” FDA’s guidance is open for comments and suggestions submitted within 60 days of publication in the Federal Register.
The announcement offers relief to companies struggling to meet the DSCSA’s Nov. 27, 2017 enforcement deadline, but the one-year delay “will have important consequences for the industry,” said RxTrace’s Dirk Rodgers in a July 3, 2017 column on the subject.
Serialization and track-and-trace software supplier Adents made the following comments pertaining to the postponement news: “Though the law itself remains unchanged (a formal amendment would require an act of Congress), news recently broke that penalization for the law’s key facets – most crucially, the necessity of printing a unique product identification code on all Rx units of sale and homogenous cases distributed domestically – will be put off until November 2018. Leading up to the announcement, however, an alarmingly high number of pharmaceutical manufacturers and CMOs did not have serialization solutions in place sufficient to meet the initial November 2017 deadline.”
“With the postponement, companies who have not yet completed the serialization process stand to gain the most,” said Christophe Devins, Adents’ CEO.
Jean-Pierre Allard, Chief Technology Officer—Traceability with Optel Group added, “This law enforcement waiver will allow all pharmaceutical companies in the U.S. to become compliant with the opportunity to install custom serialization systems that do not compromise line efficiency. OPTEL has been involved in the FDA’s public hearings since November 2016. We stood in front of the FDA commissioner to explain the reality of all solution providers: November 2017 compliance represented an unprecedented challenge that was technically unachievable.”