DSCSA Serialization and Track & Trace Requirements and Their Impact

The DSCSA (Drug Supply Chain Security Act) sets out serialization and track and trace requirements for the  US drug supply chain: from manufacturer to dispensers.

Main Requirements and Deadlines of the DSCSA

The first major deadline of the DSCSA was January, 2015 which required manufacturers to print lot numbers on packaging of all prescription drugs, as well as supply chain partners to exchange 3T documents (transaction information, transaction history, and a transaction statement) at each transfer of liability. In order for pharmacies to comply with the new regulations, they were required to capture the 3T documentation and maintain these records for 6 years.

 

Since November 2017, all RX products in homogenous cases need to be serialized and compliant with the FDA’s SNI guidance. However, taking into account a lack of qualified vendors and insufficient industry readiness, enforcement of DSCSA serialization requirements were postponed for one year.

 

Subsequent DSCSA deadlines will impact repackagers (November 2018), wholesale distributors (November 2019) and dispensers (November 2020). From 2023, full unit level traceability including aggregation will be mandatory.

See an Overview of the Global Serialization Landscape

Deadline

Impacted

Requirements

January, 1st 2015

Manufacturers

Lot number printed on packaging of Rx drugs

November, 27th 2017

Manufacturers

GTIN + serial number + lot number + expiry date in human-readable format and GS1 datamatrix

Serialization requirements’ enforcement postoned until 11/2018

November, 27th 2018

Repackagers

Serialization for repackaged medicines

November, 27th 2019

Wholesalers

Authentication & verification

November, 27th 2020

Dispensers

Authentication & verification

November, 27th 2023

Whole pharma supply chain

Complete unit level traceability incl aggregation throughout the whole supply chain

DSCSA impacts on the different supply chain players

In the end, DSCSA means serialization, aggregation, exchanging transaction information all along the supply chain in addition to authentication for recalls, resales, returns and, last but not least, risk-based verification of each product that might appear suspect to ensure that only safe medicines arrive at the patient. To help those impacted by the Drug Supply Chain Security Act, the FDA published several DSCSA guidance documents to clarify certain requirements. 

Pharma companies have to generate unique serial numbers to be able to put product to market. Managing the massive volumes of data and data exchange complexities introduced by the DSCSA poses another challenge. Manufacturers also have to upgrade production sites or integrate with CMO partners to ensure serialization requirements are met and need to make decisions on when to integrate aggregation, which is likely to be a trading partner requirement before 2023. All this without compromising operational speed and budget.

 

Repackagers will need to be able to generate unique serial numbers for their repackaged medicines as well, and have a way to maintain the relationship between the parent and repurposed products.

 

With serialized products entering the market, wholesalers will need to manage hybrid inventory for some time as they receive serialized medicines but will have to use up non-serialized stock until November 2019 (unless grandfathered). Further, they will have to address DSCSA verification requirements concerning saleable returns.

 

At the other end of the supply chain, dispensers will need necessary equipment, train staff and put processes in place to ensure verification of medicines.

 

Ensuring Long Term Compliance

At Adents, we are committed to you: to ensure that you get the best in class equipment and software to guarantee long-term DSCSA compliance. Our powerful, centrally configurable Level 3 serialization solution, Adents Seriza ensures compliance at the manufacturing level. Adents Prodigi helps you manage unique serial numbers and the immense amount of data track & trace processes create across all your entities. With DSCSA requirements calling for unprecedented connectivity, Adents Prodigi is the ideal way to onboard all your supply chain partners easily and connect you to HDA Origin, the central master data database created by the US organization Healthcare Distribution Alliance (HDA). Adents is currently the only provider with a working connection to HDA Origin.

LEARN MORE ON DSCSA

On September 19, 2018, FDA issued new guidance documents related to DSCSA requirements. 

What will postponing the DSCSA November 2017 enforcement deadline entail? The Adents Expert View. 

Listen to an interview of Perry Fri, Executive VP of Industry Relations, Membership & Education and COO at the HDA.

All you need to know about Verification Router Service (VRS) to comply with FDA’s DSCSA requirements. 

The US organization Healthcare Distribution Alliance (HDA), has come up with the idea of creating a central product master data repository.

Case Study: Implementing serialization in record time for a US CMO to address DSCSA requirements.

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