What Does The Deferment In The DSCSA Deadline Enforcement Mean For Your Organization?

By Yves Massicotte, President, Ropack Pharma Solutions

When the US Food and Drug Administration (FDA) announced on June 30 its intention to postpone taking action against pharmaceutical companies and CMOs who do not meet the DSCSA mandated deadline of November 2017, a collective sigh of relief spread through the pharmaceutical manufacturing industry. The one-year delay should not, however, be interpreted as a “free pass.” On the contrary, the FDA directive is firm: prescription drug manufacturers are required to meet the November 27, 2017 deadline for affixing or imprinting product identifiers to each package and homogenous case of products “intended to be introduced in a transaction into commerce,” even though the FDA postpones enforcement until November 28, 2018.