The US Food and Drug Administration (FDA) announced that it is extending the effective date of certain product tracing requirements of the Federal Food, Drug, and Cosmetic Act (FD&C Act) as added by the Drug Supply Chain Security Act (DSCSA) from January 1, 2015 to May 1, 2015. The FDA announced the change in a guidance, DSCSA Implementation: Product Tracing Requirements—Compliance Policy. It applies to manufacturers, wholesale distributors, and repackagers and requires them to provide or capture the transaction information, transaction history, and transaction statement under the DSCSA, which sets forth new definitions and requirements related to product tracing.
This guidance addresses the readiness of the pharmaceutical distribution supply chain to comply with the provisions in section 582 of the FD&C Act related to the exchange of product tracing information. Requirements for the tracing of products through the pharmaceutical distribution supply chain go into effect on January 1, 2015, for manufacturers, wholesaledistributors, and repackagers, and on July 1, 2015, for dispensers. However, the agency said that "FDA recognizes that some manufacturers, wholesale distributors, and repackagers may need additional time beyond January 1, 2015, to work with trading partners to ensure that all of the product tracing information required under section 582 of the FD&C Act is provided to and captured by the recipient trading partner. To minimize possible disruptions in the distribution of prescription drugs in the United States, FDA does not intend to take action against trading partners who do not, prior to May 1, 2015, provide or capture the product tracing information required by section 582(b)(1), (c)(1), and (e)(1) of the FD&C Act. This compliance policy is limited to the requirements that trading partners provide and capture product tracing information; it does not extend to other requirements in section 582 of the FD&C Act, such as verification related to suspect and illegitimate product (including quarantine, investigation, notification and recordkeeping) and requirements related to engaging in transactions only with authorized trading partners.information) for transaction of certain human, finished prescription drugs that are covered in the statute."
The DSCSA outlines critical steps to build an electronic, interoperable system by November 27, 2023, which will identify and trace certain prescription drugs as they are distributed within the United States. The system is intended to enhance FDA’s ability to improve detection and removal of potentially dangerous products from the pharmaceutical distribution supply chain. Starting in 2015, trading partners are required under section 582(b)(1), (c)(1), (d)(1), and (e)(1) of the FD&C Act to provide the subsequent purchaser with product tracing information when engaging in transactions involving certain prescription drugs. Trading partners are also required to capture the product tracing information and maintain the applicable information for not less than six years after the date of the transaction. FDA, in consultation with other appropriate federal officials and pharmaceutical distribution supply chain stakeholders, published a draft guidance, DSCSA Standards for the Interoperable Exchange of Information for Tracing of Certain Human, Finished, Prescription Drugs: How to Exchange Product Tracing Information in November 2014. This draft guidance established initial standards for the interoperable exchange of the product tracing information related to each transaction of certain human, finished, prescription drugs covered by the statute, in paper or electronic format, through the extension and/or use of current systems and processes.
The product tracing requirements in sections 582(b), (c), and (e) of the FD&C Act take effect for manufacturers, wholesale distributors, and repackagers on January 1, 2015, but the FDA said that some trading partners expressed concern that unforeseen complications with the exchange of the required information may result in disruptions in the supply chain, and therefore, the FDA does not intend to take action against trading partners who do not, prior to May 1, 2015, provide or capture the product tracing information required by section 582(b)(1), (c)(1), and (e)(1) of the FD&C Act.