FDA Delays Enforcement of Product Identifier Requirements

Regulatory News

In a draft guidance published Friday, the US Food and Drug Administration (FDA) says it does not intend to take action against manufacturers who do not affix or imprint a product identifier to each package and homogenous case of products intended to be introduced in a transaction into commerce before 26 November 2018.

"This represents a one year delay in enforcement of the requirement for manufacturers to affix or imprint product identifiers. For the products that manufacturers introduce in a transaction into commerce before November 26, 2018, without a product identifier, FDA also does not intend to take action against manufacturers who do not use a product identifier to verify such product at the package level," the draft says.

Background

As part of the Drug Supply Chain Security Act requirements, manufacturers are required to begin affixing or imprinting a product identifier to each package and homogenous case of a product intended to be introduced in a transaction into commerce no later than 27 November 2017. Repackagers are required to do the same no later than 27 November 2018.

The Act requires that each package and homogenous case of product in the pharmaceutical distribution supply chain include a product identifier in both a human-readable form and on a machine-readable data carrier. The product identifier includes the product’s standardized numerical identifier, lot number and expiration date.

Draft Guidance

The draft also addresses requirements of the Food Drug & Cosmetic Act (FD&C Act) that, beginning 27 November 2017, manufacturers must:

1. Use the standard numerical identifier, which is part of the product identifier, to verify product at the package level, when investigating suspect product or upon receiving a verification request from FDA
2. Verify the product identifier of product in the possession or control of an authorized repackager, wholesale distributor or dispenser who believes that such product was manufactured by the manufacturer and who submits a request for verification to the manufacturer
3. Verify the product identifier on each package or sealed homogenous case of such product that they intended to further distribute as a saleable return

In addition, the draft addresses requirements for wholesale distributors, dispensers and repackagers related to engaging in transactions involving product with a product identifier and product verification, as well as addressing the requirements for wholesale distributors and repackagers related to saleable returns.

In the future, FDA says it intends to issue additional guidance that will outline FDA’s current thinking on the "grandfathering product" provision of section 582(a)(5)(A) of the FD&C Act regarding products not labeled with a product identifier that are in the pharmaceutical distribution supply chain at the time of the effective date of the requirements of section 582.

Product Identifier Requirements Under the Drug Supply Chain Security Act – Compliance Policy Draft Guidance for Industry