The QMN Weekly Bulletin
Pharmaceuticals / Regulatory Affairs

FDA Delays Enforcement of Supply Chain Identifier Requirements for One Year

July 7, 2017

The FDA will give manufacturers an extra year before it begins enforcing new requirements for individual serial codes in drug packaging, according to a new draft guidance.

The Drug Supply Chain Security Act, passed in November 2013, required manufacturers to apply product identifiers to all of their packaging, beginning Nov. 27 this year.

Responding to industry’s concerns over their ability to comply with the November deadline, the agency said it does not intend to take action against manufacturers that do not affix a product identifier to new packages between Nov. 27 and Nov. 26, 2018.

After November 2018, products that do not contain the identifier — in both human- and machine-readable forms — will be considered misbranded.

Manufacturers must also be able to verify the product, upon request by the FDA, using the package’s standardized number. Additionally, the identity of any returned products must be verified before reselling or distribution.

Starting Nov. 27, 2018, repackagers may only engage in transactions involving products encoded with an identifier. The same requirements begin applying to wholesale distributors Nov. 27, 2019, and to dispensers Nov. 27, 2020.

However, the FDA also plans to postpone enforcing verification of suspected packages, including in response to requests from the agency, as well as requests from industry trading partners or when reselling returned products, over the same time period.

Stakeholders’ main challenges included dealing with a limited number of vendors able to provide the necessary IT solutions or specific equipment, as well as the assessing the readiness of contract manufacturing facilities.

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