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 certain products at the individual package level. 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 a unified database which records all product information and movement along the supply chain. The plan is to have this database be fully operable by 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; a product’s National Drug Code (NDC), and serial number (SN) – which makes up the SNI – plus the product’s lot number and lot expiry date.
The DSCSA requires that a product’s SNI be available in both human and computer readable format. It is expected that the SNI, lot number and lot expiration date will be provided on a 2D bar code. However, at this point in time, there does not seem to be a standard on the numbering or presentation of the code and readable information.
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 drug products by manufacturers no later than November 27, 2017. Re-packagers have an additional year to comply with the requirement as the deadline for them is November 27, 2018.
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 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.
Although manufacturers may not meet the required deadlines, 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.
Stay tuned for installment 5 of the Series in which we will discuss the requirements for trading partners to maintain accurate information about those they buy from and sell to.