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.