US: Draft DSCSA guidance on exchanging product tracing info
On November 28, the U.S. FDA released a draft guidance entitled “DSCSA Standards for the Interoperable Exchange of Information for Tracing of Certain Human, Finished, Prescription Drugs: How to Exchange Product Tracing Information -- Guidance for Industry.”
The Drug Supply Chain Security Act (DSCSA) requires certain trading partners to exchange transaction information, transaction history, and a transaction statement when engaging in transactions involving certain prescription drugs. Related lot-level requirements go into effect January 1, 2015 for manufacturers, wholesalers and repackagers, and July 1, 2015 for hospital and retail pharmacies (GS1 News Alert, 11 December 2014).
Click here for the full GS1 news alert.
Click here for the draft guidance (99 kB).
On 18 June traceability will be one of the subjects of Security and pharmaceutical packaging - Module of NVC E-Course Pharmaceutical Packaging (online).
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