This post is Part 4 of the Series: Understanding The Drug Supply Chain Security Act and What it Means for Pharmaceutical Distribution Companies. For a full list of all the topics in this series, please see the bullet points at the end of this post.
One of the key requirements as part of the Drug Supply Chain Security Act is the addition of a Serialized Numerical Identifier (SNI) to be included on products at the smallest usable amount unit. This information will provide additional identification of products in order to help keep illegitimate products from entering the supply chain. This requirement is key for product verification and the ultimate goal of managing all information and movement of a single unit of product along the supply chain. The plan is to have an “interoperable” system that will allow any authorized trading partner to verify and ensure if a product is legitimate. This is the ultimate goal of the DSCSA with it being fully operable by November 2023.
According to the FDA Final Guidance on “Serialized Numerical Identifier” (SNI), a product’s SNI will include the item’s National Drug Code (NDC) and unique Serial Number (SN). SNI is also referred to as sNDC or Serialized National Drug Code. This information will be required along with the already existing lot number and lot expiry date. These sets of information combined, make up a product’s Unique Product Identifier.
In summary, the Unique Product Identifier will consist of four pieces of information about the product:
- (1) a product’s National Drug Code (NDC) and (2) serial number (SN) – which makes up the SNI – plus (3) the product’s lot number and (4) lot expiry date.
The DSCSA requires that a product’s SNI be available in both human and computer readable format. The SNI, lot number and lot expiration date will be provided on a 2D bar code.
In an FDA public meeting on the “Progress Towards Implementing the Product Identification Requirements of the DCSCA” held on October 14, 2016, confirmation of the DSCSA timeline for affixing the SNI by manufacturers and re-packagers and the required use of the SNI by the entire supply chain were presented. As such, the SNI must be placed on certain products by manufacturers no later than November 27, 2017 and re-packagers no later than November 27, 2018.
2021 UPDATE: Although most products now have the SNI information on each saleable unit, some product with very long expiration dates still do not have the SNI. These products are approved to be “grandfathered”. Once the grandfathered products are depleted, new quantities are expected to have SNI information.
Once the new SNI is added to the packaging of products, trading partners will be required to only buy and sell products encoded with product identifiers (unless grandfathered under section 582(a)(5)) of the DSCSA). The table below shows the timeframes required for each phase of the implementation.
|Trading Partner||Apply Standardized Numerical Identifier (SNI)||Only Buy and Sell Products with SNI Information||Verification of Product at Package Level including SNI|
|Manufacturers||No Later than November 27, 2017. ||Starting November 27, 2017.|
|Re-Packagers||No Later than November 27, 2018. ||Beginning November 27, 2018.||Starting November 27, 2018.|
|Wholesale Distributors||Beginning November 27, 2019.||Starting November 27, 2019.|
|Dispensers||Beginning November 27, 2020.||Starting November 27, 2020.|
As per the deadlines above, a Readiness Survey released by the HDA Research Foundation Manufacturer Serialization Readiness Survey Executive Summary conducted at the time, concludes that 89% of manufacturers surveyed will meet the November 2017 deadline with at least some of their products. However, the survey continues to say that only 66% of manufacturers surveyed will have 100% of their branded and generic products serialized by the deadline.
One of the most significant questions posed by the survey, “when do you anticipate being able to provide serialized data to your wholesale distributor customers upon shipment?” shows that less than 50% will be ready for the November 2017 deadline. One-third indicated between November 2017 and 2023. Another 20% were unsure when the data would be available.
It is important for pharmaceutical wholesale distribution companies to be ready with processes and have systems in place to buy and sell product with SNI information. The implementation of software to manage these new requirements is not mandatory, however, the addition of the SNI adds another layer of complexity that will make it virtually impossible to manage without proper ERP software with pharmaceutical functionality in place.
2021 UPDATE: The logistics of implementing this requirement across the supply chain was far more complex than expected. During the implementation of this requirement, there were many issues stemming from “invalid” lot expiration dates to the size and clarity of the information. As these issues continue to be addressed, the industry continues to get closer to compliance of this requirement.
Learn more about the Drug Supply Chain Security Act (DSCSA) and Pharmaceutical Distribution Software.
- Blog: Part 1 – Drug Supply Chain Security Act (DSCSA) and Pharmaceutical Distribution
- Blog: Part 2 – Drug Supply Chain Security Act (DSCSA) Transaction Report (T3)
- Blog: Part 3 – DSCSA: Suspect and Illegitimate Product Handling and Notification
- Blog: Part 4 – Serialized Numerical Identifier (SNI) and the Drug Supply Chain Security Act
- Blog: Part 5 – Drug Supply Chain Security Act (DSCSA) – Annual Reporting
- Blog: Part 6 – How to Manage DSCSA Requirements with Pharmaceutical Software