This post is Part 2 of the Series: Understanding The Drug Supply Chain Security Act and What it Means for Pharmaceutical Distribution Companies. Click here for Part 1.
The requirement to track products is not new to the pharmaceutical industry. For years there have been various requirements around tracking lot numbers (batches) of products and their expiry dates and Pedigree management (tracking of supply chain members involved with the purchase and sale of product). For the most part, it has always been the responsibility of the manufacturer, repackager and primary distributor to keep track of specific information. This, combined with information in the previous legislation, made it difficult or near impossible to track back through other trading partners that took ownership of the product throughout the supply chain in order to easily manage a recall. Furthermore, there was little ability to determine if a product was legally or illegally injected into the pharmaceutical marketplace. With the advent of the Drug Supply Chain Security Act and more specific regulations, traceability has improved. In the second installment of this Series around the DSCSA, we will provide information on the specific traceability requirements small-medium size pharmaceutical distribution businesses must comply with in order to run their business.
As of July 1st, 2015 the “Drug Supply Chain Security Act (DSCSA)”, Section 582 requires that all “Trading Partners” including manufacturers, repackagers, wholesale distributors, and dispensers not accept pharmaceutical products unless the trading partner they receive the product from can provide specific information about the product. This specific requirement dictates that every shipment moving through the supply chain include a Transaction Report or T3. Essentially, where Pedigree tracks historical information about a specific lot and the trading partners involved, a T3 or Transaction Report includes the same information in addition to more details about the product and a statement of legitimacy. Pedigree details are part of the Transaction Report which passes from the existing owner to trading partners downstream. Every time product changes ownership, the new owner gets added to the Transaction Report and there is only one Transaction Report required per product/lot number. This allows each trading partner to verify that the movement of product is legitimate and legal.
The Transaction Report breaks into 3 distinct pieces:
The T3 Report requires the following transaction information:
- Name of the product
- Strength and dosage
- Specific NDC#
- Number of containers
- Lot number of the specific product
- Date of transaction and shipment
- Business name and address of the trading partner sending/receiving the product
The T3 Report requires the recording of the product’s entire transaction history (Pedigree) starting with the manufacturer. Details in the DSCSA and associated FDA generated documents, provide guidance on when a product’s ownership is transferred and when the corresponding T3 needs to be updated to include the transaction.
The transaction statement records the following information and requires that the trading partner transferring ownership of the specific product adhere to the following information.
- Is authorized under the DSCSA
- Received the product from a trading partner that is also authorized under the DSCSA
- Received the transaction information and statement from the trading partner
- Did not knowingly ship a suspect or illegitimate product
- Has systems in place to comply with verification requirements
- Did not provide false transaction information or knowingly alter the transaction history
For the most part, the industry has combined the above information into one document. When a product has a change of ownership, the trading partner must provide all applicable information for each lot of the product to the new owner of the product. The DSCSA dictates that a product shall not be received into the receiving trading partner’s inventory until a complete and accurate Transaction Report is provided by the trading partner shipping the product.
Currently, there no requirements around a business managing this information electronically, however, the time it takes to manually enter and record the data and keep accurate records makes this task very time-consuming and error-prone. The best way to manage this information is to find a full inventory and accounting system that also has specific pharmaceutical industry functionality such as the above. This is especially important as regulatory parties add new information to the list for tracking and recording. For example, starting in 2017 for manufacturers and 2019 for distributors, serialization per unit will need to be recorded and trading partners should expect more enhanced product tracking in 2023.
Keep your eyes open for next week’s installment of the Series where we will discuss the requirements for how trading partners handle “suspect products”.
Information in this post was taken from DSCSA Implementation: Product Tracing Requirements — Compliance Policy and other various presentations provided by the FDA. The information contained herein is provided as a summary and guidance only. For specific requirements go to “Drug Supply Chain Security Act (DSCSA)” and associated FDA Guidance Documents.