FDA Issues Product Tracing Guidance


From DCAT Value Chain Insights (VCI)

By Regulatory News posted 06-30-2015 14:02

  

The US Food and Drug Administration (FDA) has issued final guidance, DSCSA Implementation: Product Tracing Requirements for Dispensers—Compliance Policy, to announce that it will not take action against dispensers who, prior to November 1, 2015, accept ownership of product without receiving the product tracing information under provisions of the The Drug Supply Chain Security Act (DSCSA). The product tracing requirements took effect July 1, 2015, and FDA noted that some dispensers had expressed concern that electronic systems used to exchange, capture, and maintain product tracing information will not be operational by this effective date, and thus the FDA issued its final guidance allowing compliance byl November 1, 2015.

The DSCSA was signed into law in November 2013. Section 202 of the DSCSA added new sections 581 and 582 to th Federal Food, Drug, and Cosmetic Act (FD&C Act), which set forth new definitions and requirements related to product tracing. The DSCSA outlined 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. Starting in 2015, trading partners (manufacturers, wholesale distributors, dispensers and repackagers) 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.

The FDA, in consultation with other appropriate federal officials and pharmaceutical distribution supply chain stakeholders, published a draft guidance as required under section 582(a)(2)(A) of the FD&C Act, entitled DSCSA Standards for the Interoperable Exchange of Information for Tracing of Certain Human, Finished, Prescription Drugs: How to Exchange Product Tracing Information. The draft guidance established initial standards for the interoperable exchange of the product tracing information related to each transaction of certain human, finished,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.

The product tracing requirements in sections 582(d)(1) of the FD&C Act took effect for dispensers on July 1, 2015. However, the FDA noted that some dispensers had expressed concern that electronic systems used to exchange, capture, and maintain product tracing information will not be operational by this effective date. "Although the DSCSA allows product tracing information to be exchanged through paper in certain circumstances, FDA understands that many dispensers intend to use electronic systems to capture and maintain product tracing information. Thus, FDA recognizes that some dispensers may need additional time beyond July 1, 2015, to work with trading partners to ensure that the product tracing information required by section 582 is captured and maintained by dispensers," said FDA in its final guidance.

The FDA said it does not intend to take action against dispensers who, prior to November 1, 2015, accept ownership of product without receiving the product tracing information, as required by section 582(d)(1)(A)(i) of the FD&C Act. This compliance policy does not extend to the requirements under section 582(b)(1), (c)(1), and (e)(1) that other trading partners (manufacturers, wholesale distributors, and repackagers) provide product tracing information to dispensers. In addition, this compliance policy does not extend to transactions in which dispensers must provide the subsequent owner with product tracing information, including transaction history, as required by section 582(d)(1)(A)(ii). If a dispenser has not received product tracing information prior to or at the time it takes ownership of a product, the FDA recommends that the dispenser work with the previous owner to receive this information. The FDA said it believes that product tracing information serves as an important tool for dispensers to meet their obligation under section 582(d)(4) to identify suspect product, quarantine the product, and investigate whether that product is illegitimate.

Prior to November 1, 2015, FDA also does not intend to take action against dispensers who do not capture and maintain the product tracing information, as required by section 582(d)(1)(A)(iii) of the FD&C Act.

The final guidance, DSCSA Implementation: Product Tracing Requirements for Dispensers—Compliance Policy, addresses the readiness of dispensers in the pharmaceutical distribution supply chain to comply with the provisions in section 582 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360eee-1(d)(1)) related to the exchange of transaction information, transaction history, and transaction statements (product tracing information). For dispensers, requirements for the tracing of products through the pharmaceutical distribution supply chain under section 582(d)(1) of the FD&C Act went into effect on July 1, 2015.

The final guidance,DSCSA Implementation: Product Tracing Requirements for Dispensers—Compliance Policy, announces the FDA’s intention with regard to enforcement of the product tracing information requirements under section 582(d)(1) of the FD&C Act. The FDA does not intend to take action against dispensers who, prior to November 1, 2015, (1) accept ownership of product without receiving product tracing information, prior to or at the time of a transaction, as required by section 582(d)(1)(A)(i) of the FD&C Act, or (2) do not capture and maintain the product tracing information, as required by section 582(d)(1)(A)(iii) of the FD&C Act. The guidance provides further detail about the scope of this compliance policy and FDA’s expectations for dispensers and trading partners involved in transactions with dispensers.

Source: FDA

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