DSCSA Timeline, Requirements, Delays

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By Rakib Sarwar

On November 27, 2013, the president of the USA, Barack Obama, signed the DSCSA law (Drug Supply Chain Security Act). The purpose of DSCSA was to give more authority to FDA to monitor and regulate the manufacturing of compounded drugs and make things easy regarding tracing of drugs throughout the pharmaceutical supply chain.

Drug Supply Chain Security Act requires manufacturers, wholesale distributors, re-packagers, and dispensers to provide information regarding the transaction to purchasers for certain prescription drugs. These prescription drugs are considered finished drugs by DSCSA and are intended for human use.

What is DSCSA Timeline 2021?

There is no DSCSA timeline for 2021 in reality. In November 2020, FDA announced a 3-year delay, but this doesn’t mean manufacturers can relax. From 2020 to 2023, they need to do follow all FDA regulations to meet the end goal of DSCSA.

DSCSA Compliance Timeline

The DSCSA came into effect in 2015, but it hasn’t been fully implemented yet. The 10-year plan of the FDA will help the U.S health care supply chain by creating an electronic, interoperable system for tracking and tracing prescription drugs. Furthermore, this 10-year plan will also help in identifying and removing counterfeit drugs.

In 2023, DSCSA’s phase II will be implemented, and it will fully mandate unit-level traceability in the entire pharma supply chain.

Whatever the product you buy, it is required on your end to check serial number, expiration date, lot number, GS1, and 2D barcodes.  You have to keep an eye on all the products in the supply chain so that you can identify potentially counterfeit, harmful, or stolen drugs and eliminate them from the supply chain.

To be fully compliant with the DSCSA before the deadline, what you need is a proper system to exchange information with trading partners.

FDA has already suspended many of those who didn’t obey DSCSA requirements. You should review the progress of your organization regarding DSCSA compliance and take all the necessary steps.

Non-compliance will lead to suspension of your license and fines or in the worst possible case, civil penalties or imprisonment.

DSCSA Serialization Timeline

DSCSA’s first major deadline was 2015. Since 2017, all the RX products in homogenous cases needed to be compliant and serialized with the SNI guidance of the FDA. However, due to insufficient industry readiness and lack of qualified vendors, there was a 1-year delay in the enforcement of DSCSA serialization requirements.

DSCSA Aggregation Timeline

The US market’s drugs and transport units that integrate these drugs have been serialized. However, what does DSCSA wanting hierarchical aggregation of transport units means?

To put it simply, a virtual connection of serialized drugs and serialized transport units is known as aggregation in the pharmaceutical industry.

This virtual connection’s purpose is to create hierarchical data with a parent-child relationship. Once this data is linked to serialized transport unit, the aggregation is done.

Aggregation is the end goal of DSCSA. By November 27, 2023, supply chain members and pharmaceutical manufacturers have to complete interoperable track-and-trace aggregation. To ensure smooth sailing, it’s best that pharmaceutical manufacturers and supply chain members set things in motion early. 

What Are The DSCSA Timeline Requirements?

  • January 1, 2015

DSCSA’s phase I began by making it necessary for all the pharma manufacturers to print lot numbers on all prescription drugs’ packaging.

  • November 27, 2018

In 2018, according to DSCSA, it was made necessary for re-packagers and pharmaceutical manufacturers to put unique serial numbers and expiry dates on prescription drug packaging.

The information is supposed to be in human-readable form, in GS1 barcodes, and should be included in 2D codes. For at least six years, manufacturers and re-packagers are also required to record and store TI (transaction information), TH (transaction history), TS (transaction statements) in their databases.

  • November 27, 2019

In 2019, according to DSCSA, pharma wholesalers had to authenticate and verify prescription drugs before they can resell them. It is necessary for them to buy and sell only those products that come with serial numbers and barcodes.

Apart from this, they are required to create proper documents for product tracking, and that is why they have to record TI (transaction information), TH (transaction history), TS (transaction statements). Furthermore, they are also required to authenticate and verify saleable returns by using the VRS (Verification Router Service).

  • November 27, 2020

In 2020, according to DSCSA, dispensers had to authenticate and verify all the medicines they purchase before they can resell them to consumers.  For product tracking and tracing, they will need to record TI (transaction information), TH (transaction history), TS (transaction statements) data. 

  • November 27, 2023

The entire supply chain, by the end of 2023, should be DSCSA compliant. Aggregation is the end goal of 2023.

What Are The DSCSA Timeline Delays?

In 2019, there was a 1-year delay by the FDA regarding enforcement of the DSCSA requirement for wholesale distributors to verify a PI (product identifier) before further distributing the returned product.

In 2020, FDA released new guidance for immediate implementation and announced an additional 3-year delay, until 27 November 2023.

Final words

DSCSA came into action in 2015 but hasn’t been fully implemented. The main goal of DSCSA is to protect consumers from drugs that may be stolen, counterfeit or harmful in any way.

In this DSCSA article, we tried to summarize some of the important things regarding DSCSA in the best way possible. Hope it helps!

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