The FDA introduced DSCSA as the federal framework to address supply chain security for prescription drugs distributed in the United States. DSCSA aims to protect consumers from counterfeit and/or contaminated drugs by aiding in the detection and removal of danger substances from the supply chain.
DSCSA outlines the steps to build an electronic, interoperable system in order to track and trace certain prescription drugs throughout their distribution. The regulation is being implemented in phases. By November 2020, product tracking and verification requirements for specific supply chain entities, including maintaining transaction history, must be in place.
DSCSA requires trading partners to maintain standardized transaction information; including the business name and address of any facility that takes ownership of a prescription drug. The Health Industry Number (HIN) is already used by trading partners in the healthcare supply chain as a standard location identifier, and can aid in meeting these requirements. For more information regarding the HIN system, click here.
To learn more about how HIN can be used for DSCSA contact HIBCC at (602) 381-1091 or by email at email@example.com.
- 28 Jul 2020Register now for our second HIBCC UDI Webinar
- 27 Jul 2020EC releases conformity assessment procedures for manufacturers of protective equipment
- 15 Jun 2020Register now for our HIBCC UDI Webinar
- 03 Jun 2020MedTech Europe releases guidance on Basic UDI-DI assignment for the EU MDR
- 28 May 2020United Kingdom (UK) regulatory agency publishes HIBCC UDI template for use in medical device corrective action communications