FDA grants drug makers 'track and trace' reprieve until May
- The Drug Supply Chain Security Act (DSCSA) was slated to go into effect on January 1, but the FDA has issued drug manufacturers a reprieve until May 15, in-Pharma Technologist reports. After that, however, all product-tracing information will need to be incorporated in order to ensure supply-chain efficiency and integrity under the law.
- The reprieve came in the form of additional draft guidance from the FDA after some manufacturers expressed concerns that "unforeseen complications with the exchange of the required information may result in disruptions in the supply chain."
- The DSCSA includes several provisions related to tracking and tracing that go beyond simply having manufacturers incorporate tracking information. Third-party logistics providers are also affected and have new responsibilities under the act.
In November 2013, the DSCSA was signed into law in order to minimize the risk of falsified or contaminated medicinal products from entering the supply chain. Given the deadline, companies had only a little more than a year to comply.
Although the FDA has issued a five-month reprieve on comprehensive implementation of all necessary requirements of the law, third-party logistics providers and wholesale distributors are already required to report licensure and other information to the FDA.
- in-Pharma Techologist Not prepared for track & trace? US FDA grants amnesty until May