In a recently released FDA final guidance, entitled “Enhanced Drug Distribution Security Requirements Under Section 582(g)(1) of the Federal Food, Drug, and Cosmetic Act—Compliance Policies,” the FDA announced a one-year delay on the deadline for manufacturers and their trading partners to comply with the Drug Supply Chain Security Act’s final enhanced drug distribution security requirements, as described in the same document. Previously, the deadline was November 27 of this year.
The delay specifically addresses the requirements for system-wide electronic interoperable systems to be put in place to track products throughout the supply chain. It also applies to the processing of saleable returns. The same FDA guidance describes the compliance policies the FDA will employ regarding the enforcement of requirements for interoperable, electronic, package-level product tracing and provides information to help supply chain partners in their efforts to comply with the requirements for tracing at the package level.
The FDA also recently issued a guidance called “Waivers, Exceptions, and Exemptions from the Requirements of Section 582 of the Federal Food, Drug, and Cosmetic Act,” which describes the process a trading partner or other stakeholder should use to request a waiver, exception, or exemption from the requirements of the Federal Food, Drug, and Cosmetic Act, as well as the factors the FDA will consider when it evaluates one of these requests from an authorized trading partner or other stakeholder. Additionally, this guidance describes the process the FDA intends to follow once every two years to review and make determinations on renewing a previously approved waiver, exception, or exemption, where applicable.
Requests for waivers, exceptions, and exemptions should be submitted through the FDA’s CDER NextGen Portal page.