“Only one day before the product-tracing provisions of the Drug Supply Chain Security Act (“DSCSA”) were set to take effect for dispensers, FDA issued a Guidance Document for immediate implementation that signals FDA’s intention to delay any use of enforcement for failure to comply with the DSCSA’s two major product-tracing requirements for dispensers until November […]
Category: DSCSA
Wholesale Distributor & Third-Party Logistics Providers Reporting – FDA Requirement
“The Federal Food, Drug, and Cosmetic Act as amended by the DSCSA, requires third-party logistics providers to begin reporting this information annually to FDA on November 27, 2014, while wholesale distributors are required to begin on January 1, 2015. FDA has issued a draft guidance, “DSCSA Implementation: Annual Reporting by Prescription Drug Wholesale Distributors and […]
FDA Announces Exercise of Enforcement Discretion on Imminent Track and Trace Requirements – FDA Law Blog
“On December 24th, in response to industry requests, FDA issued a guidance document indicating that it will not enforce product tracing requirements of the Drug Supply Chain Security Act (“DSCSA”) prior to May 2015. The guidance, states in relevant part:” . . . Read the full article: via FDA Law Blog: In Keeping With the […]
FDA > Are you ready for the Drug Supply Chain Security Act?
Become familiar with the law There are new requirements under the Drug Supply Chain Security Act (DSCSA) for manufacturers, repackagers, wholesale distributors, dispensers, and third-party logistics providers (trading partners). Some requirements began in November 2014 and several key requirements begin at various stages in 2015. The new requirements, development of standards, and the system for […]
FDA Law Blog: FDA Speaks at Annual HDMA Track-and-Trace Conference
“Throughout the conference, manufacturers, distributors, and other members of the drug supply chain expressed concern over the current lack of guidance from FDA regarding compliance with federal product tracing laws with only 49 days until the DSCSA is set to begin to take effect. Dr. Connie Jung, Acting Associate Director for Policy and Communications for […]
FDA publishes Q&A on DSCSA provisions – SecuringIndustry.com
“The FDA has published a draft question-and-answer document to help guide the implementation of the US’s traceability system for medicines. The guidance – which is aimed at wholesalers and third-party logistics (3PL) companies – is the latest information from the US regulatory on the Drug Supply Chain Security Act (DSCSA) and is open for comment […]