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DSCSA is in Effect, and Supply Chains Must Keep Up

Given the great risk if anything goes wrong, every element of the pharmaceutical supply chain must be held to extremely high standards. By Maureen Perroni



If your company is affected by the Food and Drug Administration's Drug Supply Chain Security Act, which is Title II of the Drug Quality and Security Act, failure to catch up with the relevant regulations may result in damaging fines and other legal action.

Still rolling out

One factor to keep in mind about the DSCSA is that it is not a one-and-done implementation.

Its first few provisions came into effect in 2014 and 2015, but baked into the law is a roll-out process that will last through 2023.

In that time, the FDA plans to work with businesses such as manufacturers, distributors, wholesalers, repackagers and dispensers to add more provisions.

Unique product identification, tracing, and verification top the FDA's list of what's to come. Supply chain transparency at all levels is the endgame.

The agency hopes that in the future, it will be easier to determine immediately whether drug products are real and counterfeit. Recalls will also become more precise and efficient.

Current provisions

Since 2015, several elements of the DSCSA have been in effect. Product tracing at the lot level has been required since January 1, 2015, all in line with FDA standards. Since then, a trading partner authorization requirement has also applied.

This means every part of the supply chain must have approval from the appropriate bodies.

Working with labels

Barcode labels and the related software are essential for companies making their products trackable up to FDA standards. As laws evolve over the next seven years, there will inevitably be more changes required of manufacturers, distributors and pharmacies.

And if their labeling systems are flexible and comprehensive, they will respond to these rolling modifications with ease.




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