Drug counterfeiting is a long-standing global problem, and the USA perhaps has the worst of it. According to the PSI (Pharma Security Institute), cases of drug counterfeiting, theft, and illegal diversion rose to an all-time high of 4,405 worldwide in 2019, twice the number reported in 2014. North America saw the largest number of seizures (1,750) due to counterfeit drugs in the year, followed by Asia.

To combat this growing problem and to reinforce the security of the drug distribution chain, the FDA introduced the Drug Supply Chain Security Act (DSCSA). Signed by then President Obama on November 27, 2013, the law follows a 10-year, phased implementation plan with yearly compliance deadlines. Some costly and challenging deadlines are already behind us. However, the most complicated ones are yet to arrive.

If you’re part in the pharmaceutical industry, an understanding of this critical law and its implications is essential to gauge your organization’s DSCSA readiness.

We present a complete guide to DSCSA, crucial timelines, and the mandated requirements.

 

WHAT IS THE DRUG SUPPLY CHAIN SECURITY ACT (DSCSA)?

In 2004, the State of California took the first steps towards making prescription drugs safe for patients, with serialization being at the center of these efforts. All pharmaceutical manufacturers and suppliers in the state were required to serialize individual packages and provide electronic proof of origin for every product that traveled through the supply chain.

The idea behind this initiative was to make it easy to detect forgeries and initiate recalls if need be.

Witnessing the success of the method in California, the FDA filed for a nationwide solution against drug counterfeiting in the form of the Drug Supply Chain Security Act (DSCSA).

Essentially, the law outlines vital requirements towards building a complete electronic system for tracking and identifying prescription drugs on sale in the US. The law envisions:

  • Interoperable, electronic exchange of Transactional Statements and Transactional Information between members of a pharmaceutical supply chain
  • Interoperable tracing of Transactional Statements and Transactional Information back to the manufacturer for each unit sold
  • Interoperable verification of the Product Identifier, including the serial number, lot number, GTIN/NDC, and expiration date

The focus here is interoperability. DSCSA strives to provide a smooth, secure, and confidential data flow amongst trading partners.

 

WHY IS DSCSA IMPORTANT FOR YOU TO UNDERSTAND?

Ready or not, the DSCSA will be in full force come November 2023. Though it may seem like a typical compliance requirement, it can save the Pharmaceutical industry significant time and resources. How? With easily accessible data, tracking packages across the supply chain becomes easy, allowing a secure, trustworthy, and efficient distribution.

Although the FDA has suspended prosecution for those who don’t abide by the DSCSA requirements, it can crackdown on defaulters at the end of the suspension.

So, it’s important to review your organization’s progress regarding compliance and take the necessary steps.

Non-compliance can lead to fines, suspension of your license, or in the worst of cases, imprisonment or civil penalties.

DSCSA

UNDERSTAND THE CHRONOLOGY OF THE PROGRESSION OF THE ACT

Over its 10-year implementation period, the DSCSA promises to accomplish three goals.

  • Create an end-to-end verification system to validate the legitimacy of a drug, all the way down to the package level.
  • This, in turn, achieves the second proposed objective – easy detection of illegitimate products in the pharmaceutical supply chain.
  • Finally, towards the end of the implementation phase, it pledges to accomplish an interoperable, self-sufficient system with chain-wide traceability, allowing for easy identification and recall.

HERE’S THE COMPLETE TIMELINE OF THE 10-YEAR IMPLEMENTATION PHASE:

 

November 27, 2013

President Obama signs into law the DQSA (Drug Quality and Security Act). The law has two articles, the second of which pertains to the DSCSA.

 

January 1, 2015

This date marks the first milestone in the implementation phase. Now, manufacturers, wholesalers, and packagers must provide batch-level/lot-level transaction data to supply chain partners every time a product exchanges hands.

The 3T documentation requirement is also put into effect.

Whom it affects: Repackagers, Manufacturers and Distributors

 

November 27, 2017

This marks the onset of the serialization phase. Initially, only manufacturers are required to fulfill these requirements. This includes serializing products and verifying the serial numbers. 3T documentation is now to be electronically transferred.

Whom it affects: Manufacturers

 

November 27, 2018

It becomes was mandatory for repackagers to serialize, verify, and associate the SNIs (Standardized Numeric Identifiers) for all packages and shipments.

Whom it affects: Repackagers

 

November 27, 2019, and November 27, 2020

These two dates mark the deadline for wholesalers and dispensers, respectively, to incorporate serialization into their operations. It’s mandatory to ship and receive serialized products and verify the SNIs.

Whom it affects: Wholesalers and Dispensers

 

November 27, 2023

The final deadline in the DSCSA journey. By this date, a complete, interoperable system must be ready, using which, all members in a supply chain can exchange tracking and serialization information seamlessly.

Whom it affects: Repackagers, Manufacturers, Distributors, and Dispensers

 

WHAT IS 3T DOCUMENTATION?

In the pharmaceutical supply chain, all trading partners are licensed either by the FDA or a State Board of Pharmacy. Members of the supply chain can buy or sell products only to those parties with active licenses.

This effectively means that each partner in the supply chain is regularly evaluating the licenses of its customers and suppliers.

Along with the licenses, the seller must provide standardized transaction documents to their customers for each shipment. These documents include:

 

TRANSACTIONAL INFORMATION (TI)

This document describes the specifics of the current transaction. It includes:

  • The name of the product
  • Dosage and strength of the product
  • NDC (National Drug Code)
  • Lot number
  • Date of transaction
  • Date of shipment
  • Container information
  • Number of containers

If more than 24 hours have passed since the transaction date, the Date of shipment is to be included.

 

TRANSACTIONAL HISTORY (TH)

The TH outlines all the transactions a product has gone through, starting from the manufacture. This is essentially a bunch of TIs attached together for reviewing a product’s entire supply chain journey.

 

TRANSACTIONAL STATEMENT (TS)

The TS is a declaration confirming that the seller:

  • Is authorized and registered
  • Has received the product from a registered and authorized party
  • Did not purposefully change the transaction history
  • Did not purposefully ship any ineligible, counterfeit, or suspicious product
  • Has acknowledged the transaction statement and information from the previous seller in the supply chain

 

WHAT ARE THE SERIALIZATION REQUIREMENTS UNDER DSCSA?

By November 27, 2020, all key players in the pharma supply chain, including repackagers, manufacturers, distributors, and dispensers, must generate, authenticate, and verify serial numbers for all packages traveling through the chain.

As for the serial numbers themselves, the Standardized Numeric Identifiers (SNI) must be generated as per the 2009 FDA directive.

SNIs consist of the 20-character NDC (National Drug Code) and serial number.  Apart from SNIs batch/lot number, Global Trade Item Number (GTIN), and expiration date are required.

Also, the smallest saleable unit needs to be packaged with a 2D Barcode Matrix with human-readable text. Shipping cases also require an SNI with a Serial Shipping Container Code (SSCC).

 

WHAT ARE THE AGGREGATION REQUIREMENTS UNDER DRUG SUPPLY CHAIN SECURITY ACT (DSCSA)?

DSCSA’s end goal is aggregation. What is it? With both drugs and transport units (bundle, pallets, and containers) serialized, a system of hierarchical serialization is achieved.

In a bundle of cartons carrying bottles, for instance, each bottle features a unique serial number, as does the carton. This forms an aggregate relationship between the carton and the bottle.

 

REASON FOR AGGREGATION

The hierarchical serialization makes it possible to identify items accurately in the supply chain and to detect suspicious activities. However, that’s not it.

Aggregation also confers time and cost-saving benefits on pharmaceutical manufacturers and packagers. For instance, repackagers don’t need to spend time scanning every smallest saleable unit, and can only scan the parent. This, naturally, results in substantial time savings.

 

REQUIREMENT AND TIMELINE

Pharmaceutical manufacturers and supply chain members must achieve complete, interoperable track-and-trace aggregation by November 27, 2023. However, it’s better to set things in motion early so you have enough time to resolve operational roadblocks and ensure smooth sailing.

 

HOW TO MANAGE DATA EXCHANGE WITH TRADE PARTNERS

Once the DSCSA is in full effect, serialization compliance will affect your business far beyond the production line. In reality, you will have to exchange data with different organizations, each with its own system and data formats.

To build such an interoperable system, you’ll need:

  • Processes and systems to inspect the product down to the item-level
  • Systems to reliably process transaction history
  • To handle various file formats such as CSV, XML, EPCIS
  • An interoperable tracing system
  • Data exchange protocols such as EDI, SFTP, or APIs
  • A system to exchange 3T documentation

Investing in intelligent supply chain software can help you achieve robust serialization, traceability, and aggregation capabilities and prepare you for the final DSCSA deadline.

 

EXEMPTIONS UNDER DSCSA

Not all medical products fall into the DSCSA jurisdiction. Here are some medical products exempt from the requirements of the Act:

  • Intracompany distributions
  • Distribution of product samples
  • Distribution of over-the-counter drugs
  • Medical convenience kits
  • Anesthetics, Anti-coagulants, Vasopressor, IV solutions, Sympathomimetics
  • Approved animal drugs
  • Medical gas distribution
  • Blood and blood components for transfusion

If you want to understand more and how to put the systems in place to meet these compliance requirements. Our expert will be more than happy to assist you.

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