Drug Supply Chain Security Act in Effect as of January 1
- By BSTQ Staff
On Jan. 1, Title II of the Drug Quality and Security Act (DQSA), known as the Drug Supply Chain Security Act (DSCSA), took effect. However, the U.S. Food and Drug Administration (FDA) will not be enforcing implementation of the transaction information, history and statements requirements until May 1. The DSCSA establishes a 10-year timeline for achieving an interoperable track-and-trace system for prescription drugs at the individual package level, as well as strengthens licensure requirements for wholesale distributors and third-party logistics providers and establishes nationwide drug serial numbers.
As of May 1, manufacturers and repackagers are required to capture the transaction history and movement of a pharmaceutical product through the supply chain by placing a unique product identifier on drug packages such as a bar code that can be read electronically. And, they are required to store that information for at least six years. They can choose, based on their facility’s requirements, to maintain their records by 1) keeping packing slips, 2) maintaining shipping notification emails or 3) registering with Life Sciences Cloud, Tracelink’s cloud-based technology platform (see Leadership Corner on page 56). Eventually, however, manufacturers and repackagers will be required to store the information in electronic format.
At the same time, wholesale distributors, dispensers and repackagers must develop verification methods to determine whether a product is a valid, suspect or illegitimate product. If they determine they are in possession of such a product, they must quarantine and promptly investigate it, and they must notify FDA and other stakeholders to prevent further circulation of potentially compromised medication. They also must respond within 48 hours to requests from federal or state officials — in the event of a recall or for the purpose of investigating a suspect product or an illegitimate product — for the transaction history of the pharmaceutical product.
The DQSA was signed into law on Nov. 27, 2013, to protect U.S. patients from ineffective, counterfeit, low-quality and unsafe drugs that pose serious public health safety concerns entering the market. The Act contains two parts: Title I applies to the compounding of human drugs pursuant to a prescription, while Title II pertains to the tracking and tracing of these drugs.
