FDA releases two critical DSCSA draft guidelines

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Posted on July 05, 2022 | By Joanne S. Eglovitch

FDA releases two critical DSCSA draft guidelines


The United States Food and Drug Administration (FDA) released two draft guidelines on July 5 covering the implementation of the Drug Supply Chain Security Act (DSCSA); one deals with the use of electronic standards for tracking products throughout the pharmaceutical supply chain, while the other guidance concerns the identification of trading partners authorized to track products throughout the pharmaceutical supply chain. Supply Chain.

The agency announced that “these documents are essential steps toward implementing the DSCSA’s enhanced drug delivery security requirements that will take effect November 27, 2023.”

The DSCSA was signed into law in November 2013 and outlines the steps needed to create an interoperable electronic system to identify and track prescription drugs throughout the supply chain to prevent drug counterfeiting.

FDA revises draft standards guidelines yet again

The agency first released the standards guidelines in November 2014, but they were never finalized. The FDA said the revised draft guidance updates the previous version to reflect that paper-based product tracing methods “will no longer be permitted and product verification at the package level will be required, unless derogation, exception or exemption does not apply”.

The guidelines, which are largely similar to the previous version, recommend that trading partners use GSI’s Electronic Product Code Information Services (EPCIS) standard to convey information throughout the supply chain.

The guidelines state that “Use of EPCIS can support and enable electronic and interoperable interfaces used by trading partners to help ensure compliance with DSCSA requirements and is compatible with a range of different technology approaches. The FDA believes that EPCIS is an appropriate globally recognized standard, and the FDA understands that there is considerable agreement among stakeholders that EPCIS is an appropriate standard to adopt for enhanced security requirements of drug distribution.

The pharmaceutical industry has urged the FDA to approve EPCIS for tracing products throughout the supply chain. At a recent meeting, industry representatives said the agency’s inaction on the matter would mean these systems will not be tested until they go live next November. (RELATED: FDA Urged to Approve EPCIS to Boost Manufacturers’ Adoption of DSCSARegulatory guidance November 17, 2021)

Guidance on trading partners cites confusion

The revised draft guidance on Commercial Partners aims to help industry, states and local governments categorize entities involved in drug tracing throughout the supply chain. The 26-page guide, like the 2017 draft, notes confusion over the definition of wholesale distributors, as well as confusion over what a subsidiary of a manufacturer means. (RELATED: FDA Proposes Draft Guidelines to Strengthen Drug Supply Chain Security, Regulatory guidanceAugust 21, 2017)

In response to public comments, the FDA announcement the review “added or revised its current thinking on the status of certain entities as business partners, including private label distributors, collectors, returns processors, and reverse logistics providers.”

The agency also “provided clarification on certain drug distribution scenarios, including distribution for emergency medical purposes, office purposes, non-human research, and human research in as part of an Investigational New Drug Application”.

In another area, the FDA said that until it issues final rules governing licensing standards for third-party logistics providers, these providers will be considered approved if they are certified by the FDA. State “unless the Secretary has determined that the third-party logistics provider is not using good handling and distribution practices and publishes a notice.”

The FDA released licensing rules for drug distributors and 3PLs in February, but a final rule may not be released in time when the DSCSA takes effect next November. (REALIZED : FDA releases long-awaited licensing rules for drug distributors and 3PLsRegulatory guidance February 3, 2022)

The Healthcare Distribution Alliance (HDA) had called for the change, in its comments. The group said that “to minimize the risk of confusion to state law enforcement, we are asking the FDA to specifically acknowledge that 3PLs are deemed permitted until the FDA issues standards for ‘permission”.

The deadline to comment on both documents is September 5, 2022.

Guide to FDA Standards

FDA Guidelines on Authorized Business Partners

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