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2:00PM Water Cooler 7/16/2021 | naked capitalism

2:00PM Water Cooler 7/16/2021 | naked capitalism
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Navigating DSCSA Implementation Key Requirements 4 New FDA Guidances


Navigating DSCSA Implementation: Key Requirements & 4 New FDA Guidances
By Madeleine Giaquinto, Manager of Regulatory Affairs, Greenleaf Health, Inc.
In its seventh year of implementation, trading partners involved in manufacturing, distributing, and dispensing prescription drugs in the U.S. (Industry) continue to grapple with requirements of the Drug Supply Chain Security Act (DSCSA), working to set up a fully interoperable electronic system for securing and tracing products across Industry sectors by November 2023. The goal of the DSCSA is to produce a system that enhances national pharmaceutical supply chain security; achieving this goal has required two phases of implementation. In the first phase, traceability requirements at the lot level were implemented beginning in 2015. In the second phase, interoperability requirements allowing for product tracing at the package level are scheduled to become effective in November 2023. ....

Madeleine Giaquinto , Greenleaf Health Inc , Regulatory Affairs , Healthcare Distribution Alliance , National Drug Code , Drug Administration , Greenleaf Health , Drug Supply Chain Security Act , Under Section , Federal Food , Cosmetic Act , Draft Guidance , Enhanced Drug Distribution Security , Package Level Under , Drug Supply Chain Security Act Implementation , Suspect Product , Illegitimate Product , Verification Obligations Under , Product Identifiers Under , ம்யாடலெந் ஜியாகிண்டோ , பச்சை இலை ஆரோக்கியம் இன்க் , ஒழுங்குமுறை வாழ்க்கைத்தொழில்கள் , சுகாதாரம் விநியோகம் கூட்டணி , தேசிய மருந்து குறியீடு , பச்சை இலை ஆரோக்கியம் , மருந்து விநியோகி சங்கிலி பாதுகாப்பு நாடகம் ,