FDA Delays Enforcement of DSCSA Transaction Information until November 26, 2018
On June 30, 2017, FDA issued a draft guidance for industry, Product Identifier Requirements Under the Drug Supply Chain Security Act – Compliance Policy. This guidance informs manufacturers and other supply chain stakeholders that although manufacturers are to begin including a product identifier on prescription drug packages and cases on November 27, 2017, the FDA is delaying enforcement of those requirements until November 2018 to provide manufacturers additional time and avoid supply disruptions.
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The compliance policy outlined in the draft guidance applies solely to products without a product identifier that are introduced into commerce by a manufacturer between November 27, 2017 and November 26, 2018.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.
Under the newly issued draft guidance, FDA says it will consider packages and homogenous cases of drugs to be “in the pharmaceutical distribution supply chain” if they were packaged by the manufacturer before 27 November 2018.
FDA says that packages or homogenous cases of product that do not bear a product identifier should be accompanied by documentation that it was packaged before 27 November 2018. “Manufacturers retain packaging date information in the ordinary course of business and as a part of batch recordkeeping, and they should provide the packaging date to subsequent trading partners if they request it,” FDA writes.
The guidance goes on to detail the specific requirements that grandfathered products are exempted from for manufacturers, wholesale distributors, dispensers and repackagers to clarify each parties’ responsibilities in a transaction involving grandfathered products.
Additionally, the guidance clarifies that saleable returned packages and homogenous cases of product are exempt from certain product identifier requirements if they were in distribution prior to 27 November 2018.