On November 27, 2014 new FDA regulations went into effect. The Drug Quality and Security Act (DQSA) was designed to further regulate the handling and traceability of pharmaceutical products throughout the supply chain. As there are many links in the supply chain, the new regulations apply to not only the manufacturers, but to re-packagers, wholesale distributors, dispensers and third party logistics providers (3PLs).
3PL providers face different regulatory changes than other supply chain providers. The FDA is now strictly defining what qualifies as a 3PL. A 3PL is defined as a business that: coordinates logistics services in interstate commerce, the entity does not own the product and does not have the responsibility to sell the product. Under DQSA 3PLs are now required to obtain federal licensing to handle pharmaceutical grade products. These businesses will no longer be able to operate under state licensing that may be in conflict with the new federal regulations. Third party logistics providers will also now be required to provide documentation detailing product traceability and transaction verification details. In addition to this detailed product information, 3PLs must also report facility identification and licensure information, as well as some recommended contact and facility data.
The purpose of this new regulation is to assist in preventing counterfeit and contaminated product from reaching consumers. When developing DQSA, the FDA took into consideration both internal and external threats to quality to guarantee product safety.
Datex provides a wide variety of tools to assist in obtaining DQSA compliance for your 3PL business. To learn more about the solutions available contact Datex representatives today at www.datexcorp.com or 800.922.2839 ext. 243.