July 6 -- The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “DSCSA Standards for the Interoperable Exchange of Information for Tracing of Certain Human, Finished, Prescription Drugs.” This guidance identifies the standards necessary to facilitate adoption of secure, interoperable, electronic data exchange among the pharmaceutical distribution supply chain, and clarifies the trading partners, products, and transactions subject to such standards. This guidance is a revision of the draft guidance for industry entitled “DSCSA Standards for the Interoperable Exchange of Information for Tracing of Certain Human, Finished, Prescription Drugs: How to Exchange Product Tracing Information,” issued in November 2014 as required by the Federal Food, Drug, and Cosmetic Act (FD&C Act).
Submit either electronic or written comments on the draft guidance by September 6, 2022 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.
FDA is announcing the availability of a revised draft guidance for industry entitled “DSCSA Standards for the Interoperable Exchange of Information for Tracing of Certain Human, Finished, Prescription Drugs.” The Drug Supply Chain Security Act (DSCSA) outlines requirements for enhanced drug distribution security, which include the steps to achieve interoperable, electronic tracing of products at the package level. These requirements for enhanced drug distribution security go into effect on November 27, 2023. Section 582(g)(1) of the FD&C Act (21 U.S.C. 360eee-1(g)(1)) sets forth enhanced drug distribution security requirements for trading partners, including adherence to standards established by FDA for the exchange of transaction information and transaction statements in a secure, interoperable, electronic manner and the verification of product at the package level. Additionally, section 582(h)(4)(A) of the FD&C Act specifies that FDA issue a draft guidance, and revise the draft guidance as appropriate, to identify and make recommendations with respect to the standards necessary for adoption in order to support the secure, interoperable, electronic data exchange among the pharmaceutical distribution supply chain that comply with a form and format developed by a widely recognized international standards development organization.
In this revised draft guidance, FDA considered the standards established pursuant to sections 505D of the FD&C Act (21 U.S.C. 355e) and 582(a)(2) of the FD&C Act in the November 2014 draft guidance entitled “DSCSA Standards for the Interoperable Exchange of Information for Tracing of Certain Human, Finished, Prescription Drugs: How to Exchange Product Tracing Information” (available at:
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/dscsa-standards-interoperable-exchange-information-tracing-certain-human-finished-prescription-drugs). The pilot projects conducted per section 582(j) of the FD&C Act also informed revisions made to this draft guidance.
This revised draft guidance updates the policy articulated in the November 2014 draft guidance to reflect the enhanced drug distribution security requirements that will go into effect on November 27, 2023, including that paper-based methods of product tracing will no longer be permitted and verification of product at the package level will be required, unless a waiver, exception, or exemption applies. This revised draft guidance is intended to facilitate the creation of a uniform methodology for product tracing while ensuring the protection of confidential commercial information and trade secrets. FDA also published other guidances describing recommendations for enhanced drug distribution security, including the attributes necessary for enhanced product tracing and verification, which should be read in conjunction with this draft guidance (see FDA's Drug Supply Chain Security Law and Policies web page at
https://www.fda.gov/drugs/drug-supply-chain-security-act-dscsa/drug-supply-chain-security-act-law-and-policies).
Draft industry guidance:
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/dscsa-standards-interoperable-exchange-information-tracing-certain-human-finished-prescription-drugs
FRN:
https://www.federalregister.gov/d/2022-14342