FDA published guidance DSCSA

In June 2017 the FDA published a draft guidance, “Product Identifier Requirements under the Drug Supply Chain Security Act – Compliance Policy” https://www.fda.gov/Drugs/DrugSafety/DrugIntegrityandSupplyChainSecurity/DrugSupplyChainSecurityAct/ucm565358.htm, which should aid in fulfilling the regulations for product identification. The document is not legally binding for any person, for the FDA or the general public. It describes the FDA’s intention regarding the enforcement of certain requirements related to product identifiers under the Drug Supply Chain Security Act.

 

Additionally, the FDA announced three public meetings that provide members of the pharmaceutical distribution supply chain and other interested stakeholders with an opportunity to discuss with the FDA, and to provide input on strategies and issues related to the enhanced drug distribution security provisions of the DSCSA.  The first meeting was on August 23rd, the next meeting will be on December 5th & 6th, 2017.

For further information, please refer to this site: https://www.fda.gov/Drugs/NewsEvents/ucm559090.htm