As the final enforcement deadline for the Drug Supply Chain Security Act gets ever closer, companies across the pharmaceutical supply chain are either putting the finishing touches on their DSCSA compliance implementation, scrambling to make quick progress, or watching (increasingly) nervously to see when they really need to get started.
As if more evidence was needed that this last group should really consider becoming one of the first two, the FDA announced a limited round of exemptions that really just point to how specific and targeted such exemptions will be. Put simply: the DSCSA plan is in place for the pharma industry, and the changes from here on out will be small.
In May, the FDA issued new DSCSA exemptions for manufacturers, wholesale distributors, dispensers, and repackagers, regarding certain Covid-19 products "introduced by a manufacturer or repackager in a transaction into interstate commerce before November 27, 2024."
These affect section 582 product tracing, product identifier, and package-level verification requirements; all other measures of DSCSA must still apply, and the exemptions don't extend to transactions of any other products (e.g. your business isn't exempt from DSCSA overall just because you handle these products).
Though the exemptions apply to package-level verification with the product identifier, the FDA notes that pharma businesses must still conduct prompt investigations into potentially illegitimate products in coordination with their trading partners, and to follow DSCSA's procedures for notification, disposal, and reporting upon determining that a product is illegitimate. As well, if a company has reason to believe a product is illegitimate after receiving a trading partner's verification request, it must say so upon responding.
The FDA also advises that trading partners continue to comply with full DSCSA requirements in their handling of covered Covid-19 products as long as doing so doesn't hurt "timely distribution" of them.
With this release, the FDA sought to avoid any possible supply chain disruptions "that could harm the [...] recovery" from the Covid-19 pandemic, even as the federal public health emergency was brought to a close on May 11. Its scope is narrow, and the language ensures that the exemption can't be extrapolated to other products or facets of business.
As such, there's no reason to look for signals that the U.S. will slow its timeline for enforcing DSCSA compliance throughout the industry.
If you haven't begun, or are only making slow progress — get in touch today! We're here to help.
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