Surprise!/No surprise: FDA grants a one-year delay for the salable-returns requirement of DSCSA

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.