FDA publishes two critical DSCSA draft guidances

Regulatory NewsRegulatory News | 05 July 2022 |  By 

The US Food and Drug Administration (FDA) on 5 July issued two draft guidances covering the implementation of the Drug Supply Chain Security Act (DSCSA); one addresses the use of electronic standards for tracing products through the pharmaceutical supply chain, while the other guidance pertains to identifying trading partners that are authorized to track products though the supply chain.
The agency announced that “these documents are critical steps toward implementing the DSCSA enhanced drug distribution security requirements that will go into effect on November 27, 2023.”
DSCSA was signed into law in November 2013 and outlines the necessary steps to build an electronic, interoperable system to identify and trace prescription drugs through the supply chain to ward off drug counterfeiting.
FDA revises draft standards guidance yet again
The agency first published the standards guidance in November 2014, yet it was never finalized. FDA said the revised draft guidance updates the earlier version to reflect that paper-based methods of product tracing “will no longer be permitted and verification of product at the package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.”
The guidance, which is largely similar to the previous version, recommends that trading partners use GSI’s Electronic Product Code Information Services (EPCIS) standard to transmit information through the supply chain.
The guidance states that “use of EPCIS can support and enable electronic and interoperable interfaces used by trading partners to help ensure compliance with the DSCSA requirements and is compatible with a range of different technological approaches. FDA believes that EPCIS is an appropriate globally recognized standard, and FDA understands there is considerable agreement among stakeholders that EPCIS is a suitable standard to adopt for the enhanced drug distribution security requirements.”
The pharmaceutical industry has been urging FDA to endorse EPCIS for tracing products through the supply chain, at a recent meeting, industry representatives said the agency’s inaction on this topic will mean that these systems will not be tested until they go live next November. (RELATED: FDA urged to endorse EPCIS to spur manufacturers’ uptake of DSCSA, Regulatory Focus 17 November 2021)
Guidance on trading partners notes confusion
The revised draft guidance on trading partners aims to help industry, state and local governments categorize the entities involved in tracing drugs through the supply chain. The 26-page guidance, like the 2017 draft version, notes the confusion related to defining wholesale distributors, as well as confusion over what an affiliate of a manufacturer means. (RELATED: FDA Offers Draft Guidance to Further Secure Drug Supply chain, Regulatory Focus, 21 August 2017)
In response to public comments, FDA announced the revision has “added or revised its current thinking on the status of some entities as trading partners, including private label distributors, salvagers, and returns processors and reverse logistics providers.”
The agency has also “provided clarification on certain drug distribution scenarios, including distribution for emergency medical use, office use, non-human research purposes, and research in humans under an investigational new drug application.”
In another area, FDA said until it issues final rules governing licensing standards for third-party logistics providers, such providers will be considered licensed if they are certified by the state “unless the Secretary has made a finding that the third-party logistics provider does not utilize good handling and distribution practices and publishes notice thereof.”  
FDA published licensing rules for drug distributors and 3PLs in February, yet a final rule may not be out in time by the time DSCSA takes effect next November. (REALTED: FDA issues long-awaited licensing rules for drug distributors and 3PLs, Regulatory Focus 3 February 2022)
The Healthcare Distribution Alliance (HDA) had requested the change, in their comments. The group said that “in order to minimize the risk of confusion for state law enforcement, we ask that FDA specifically acknowledge that 3PLs are deemed authorized until FDA issues licensure standards.”
The deadline for commenting on both documents is 5 September 2022.
FDA standards guidance
FDA guidance on authorized trading partners


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