FDA finalizes guidance on standards for tracing products through supply chain

The US Food and Drug Administration (FDA) will allow trading partners to track drug products through the pharmaceutical supply chain using portals and email exchanges to accommodate the needs of smaller pharmacies who may not have the encrypted Internet connections for exchanging of Electronic Product Code Information Services (EPCIS) information.

This pronouncement was made in FDA’s final guidance on the use of electronic standards for tracing products through the pharmaceutical supply chain. The Drug Supply Chain Security Act (DSCSA) mandates that enhanced drug tracking requirements go into effect on 27 November 2023, though FDA recently announced that this requirement will not go into effect until a year later. (RELATED: FDA gives firms one-year reprieve from DSCSA track and trace requirements, Regulatory Focus 25 August 2023).

The guidance, which is largely similar to the draft version, recommends that trading partners use GSI’s EPCIS standard to transmit information through the supply chain. (RELATED: FDA publishes two critical DSCSA draft guidances, Regulatory Focus 5 July 2022.)

FDA said that “this guidance finalizes the policy articulated in the July 2022 revised draft guidance to reflect the enhanced drug distribution security requirements in section 582(g)(1) of the FD&C Act that will go into effect on November 27, 2023, including that only electronic methods of product tracing will be permitted and verification of product at the package level will be required, unless a waiver, exception, or exemption applies.”

Three industry groups including the Association for Accessible Medicines (AAM), the Pharmaceutical Research and Manufacturers of America (PhRMA) and the Healthcare Distribution Alliance (HDA) requested that the guidance explicitly state that trading partners can continue to use internet-based platforms such as email and web portals to exchange product transaction information; these groups also questioned why this language allowing these methods in an earlier 2014 draft guidance was omitted in the later revision. (RELATED: Pharma groups: FDA should allow portals, emails for tracing products under DSCSA, Regulatory Focus 8 September 2022)

FDA acceded to this request; the guidance states that “internet-based platforms such as email and web portals that utilize EPCIS could be technological approaches that enable DSCSA compliance, as could other technological approaches that utilize EPCIS.”

AAM had noted in its comments last year that these alternative methods are an “integral part” of members’ compliance strategy for exchanging data with its smaller trade partners, which include community pharmacies, other smaller dispensing organizations, and practitioners. These entities “do not have systems and processes to use or accept EPCIS events, nor do they have encrypted Internet connections such as AS2, as most larger manufacturers, repackagers, wholesalers, 3PLs and large pharmacy chains typically would have to enable the exchange of EPCIS information.”

PhRMA had also recommended the final guidance include “explicit acknowledgment that web portals are an acceptable method to exchange information.”

HDA similarly wanted FDA to include in the final guidance language similar to the 2014 draft guidance that endorsed portals as an “acceptable means to transmit or access the product tracing information, as long as the information is captured, maintained, and provided in compliance with section 582.”

DSCSA amended the Federal Food, Drug and Cosmetic Act by adding a new section 582 requiring manufacturers establish product identifiers for product tracing and verification requirements.

The guidance has also been revised to state that the document should be read in conjunction with two additional guidances that provide more details for trading partners on the one-year extension from enforcement of requirements for tracking products electronically. (RELATED: FDA publishes additional guidances on delay of enforcing DSCSA electronic tracking requirements, Regulatory Focus 1 September 2023).

Final guidance, Comments

FDA finalizes guidance on standards for tracing products through supply chain

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