As posted in the Federal Register on Sept. 24, and in a guidance docket on FDA’s site, FDA is allowing a one-year delay, to November 2020, in the salable-returns requirements of the Drug Supply Chain Security Act (DSCSA). FDA’s notice cites minimizing “possible disruptions in the distribution of prescription drugs in the United States” as a the reason; as with postponements of earlier milestones in DSCSA compliance, FDA faces the reality that full, timely enforcement of DSCSA could affect patient access to needed medicines.
The so-called “salable returns” requirements of DSCSA (Sec. 582(c)(4)(D), to be specific) mandate that wholesaler distributors verify the authenticity of drugs that have been returned to them by trading partners (generally, pharmacies and hospitals) prior to redistribution. These returns represent 2-4% of overall drug volume, and, provided that they have not expired, are usually put back into commercial distribution by wholesalers.
As such, the postponement mostly affects wholesaler-distributors. However, the new guidance emphasizes that manufacturers still have a November 2019 deadline for complying with other parts of DSCSA: that products have unique identifiers applied to them; or to be able to verify authenticity upon request. Wholesaler distributors still must only accept returned product when the return can be associated with a transaction.