FDA Issued a guidance document titled “Product Identifier Requirements Under the Drug Supply Chain Security Act – Compliance Policy” (here) late last week that described the FDA’s position on enforcement discretion of certain key provisions of the Act that were set to take effect on November 27, 2017 relative to inclusion of product identifiers The guidance explains what a product identifier is and how enforcement discretion will be applied.
FDA addresses the fundamental issue of what a product identifier is and why some firms will likely not be able to meet the initial full implementation date for having this information on the individual product labels. The Agency provides the following information in this guidance:
What is a product identifier?
- A unique identity for individual prescription drug packages and cases, which will allow trading partners to easily trace drug packages as they move through the supply chain.
- Includes the product’s lot number, expiration date, national drug code (or NDC), and a serial number. The serial number is different for each package or case. This creates a unique identifier – human and machine readable – to enable product tracing throughout the supply chain and enable all trading partners to better detect illegitimate products within the supply chain.
The compliance policy outlined in the draft guidance applies solely to products without a product identifier that are introduced into commerce by a manufacturer between November 27, 2017 and November 26, 2018.
While manufacturers work to meet product identifier requirements, they must comply with other DSCSA requirements.
The FDA also notes that, based on comments received, it appears that industry-wide readiness will not be feasible by the original implementation date for several reasons:
- a limited number of vendors that have the expertise to provide solutions related to information technology systems for data management or specific equipment for packaging or manufacturing lines
- capabilities and readiness of contract facilities that perform manufacturing operations on behalf of the manufacturer.
While some firms are already meeting these requirements in anticipation of the original implementation date, lead times for equipment and expertise (as noted by the comments) make implementation unwise now. I don’t believe that anyone should be surprised by the delay in enforcement as so many firms will not be prepared. I would not be surprised to see another delay come November 2018 but we will have to wait and see. The Agency also notes in the guidance that additional information relative to grandfathered products under section 582(a)(5)(A) of the FD&C Act will be provided at a later date.
Firms should read this guidance as well as the other newly issued documents published on the CDER website on Friday that relate to the product identifier enforcement policy which can be found here.