Do I Need to Enter the Lot Number: DSCSA Answers for Dispensers

As we speak to thousands of dispensers preparing for DSCSA, the top question we hear is “Do I have to enter the lot number?” What does this really mean, what does the law say, and what are the business and compliance implications of whatever decision you make?

Will I receive lot number from my suppliers?

Whether or not you receive lot number depends upon product origin and the role your supplier plays in the supply chain:

• The original manufacturer must include lot number in the T3 documentation they provide to customers. 
• However, the wholesale distributor who purchased the product directly from the manufacturer is not required to provide lot number or initial transaction date to their customers. Some may include lot number in their compliance documentation but others will not. 
• Subsequent wholesale distributors who purchase product from someone other than the manufacturer are required to provide lot number to their customers. 

Whenever lot number is included in compliance documentation, you will store it as part of that documentation. When it is not included, you have a decision to make: should you locate it from another source and manually enter it into your compliance system?

What does the law say?

The law focuses on the circumstances under which you will receive lot number. It makes it optional for wholesale distributors who have purchased product directly from the manufacturer to include it in their outbound compliance documentation. When they do not include it, there is nothing in the law that says dispensers need to enter it from another source.

DSCSA also mandates that you archive T3 documentation for six years and stipulates that if the lot number is provided, you need to capture and archive it along with other data. However, there is no archival requirement for lot number if it has not been sent to you as part of the compliance documentation.

While the law does not require you to enter lot number when it is not sent as part of the T3, there are strong compliance and business reasons to consider it.

Why might it be beneficial for me to enter lot number even when it’s not part of the T3?

There are two primary circumstances in which having the lot number will help you streamline your business processes and facilitate compliance:

• Reselling product: If you ever resell product you will need to provide T3 compliance documentation, including the lot number, which means you must be able to find the right T3 to match what you are selling. It is much more operationally efficient to capture the lot number and associate it with the compliance documentation on the inbound side, rather than trying to figure out lot number after you have comingled inventory. If you do not capture lot number upon product receipt, can you be confident that you have the correct T3 on the outbound side? If you cannot accurately match product to T3, you will not be compliant. 
  
  
• Responding to an investigation: In the event of a request for information from a government official investigating potentially suspect product, you have two business days to provide compliance documentation. In addition, you could also receive a verification inquiry asking you to verify details about a product’s Transaction History and information in your compliance repository. 

Without lot number, you will need to manually search all products on your shelves to locate the suspect product whereas if you had consistently captured it on the inbound - whether it was provided to you or not – the search process would be greatly expedited. And without lot number, you may end up having to quarantine all products with the given NDC, which will have an impact on your inventory and potentially on your ability to serve patients.

If I do choose to manually enter lot number that is not included in my T3, where can I source it?

The lot number is printed on the product package in human readable format. Some packing slips will include it, as well.

The bottom line is that the law gives you latitude to decide how you want to handle lot number when it is not part of the compliance documentation. Understand the business and compliance implications of manually entering versus omitting, and make the decision that will best allow your business to remain operationally efficient and in compliance.