FDA In Brief: FDA provides new guidance to further enhance the security of prescription drugs in the U.S. supply chain

June 03, 2021

The following quote is attributed to Donald D. Ashley, J.D., Director of the Office of Compliance for FDA’s Center for Drug Evaluation and Research

“Ensuring the quality of prescription drugs and safeguarding the integrity of pharmaceutical distribution are crucial roles the FDA plays in protecting the health of the American public. Illegitimate and unsafe products must be kept out of the U.S. drug supply chain.

Since 2013, when the FDA began phasing in new requirements added by the Drug Supply Chain Security Act (DSCSA), we have helped create a supply chain that is better at preventing and detecting the introduction of illegitimate products. The new requirements can also enable stakeholders and the FDA to respond rapidly when such products are found.

To help our stakeholders understand these requirements, we are issuing guidance documents intended to assist trading partners in complying with the law and achieving a safer, more secure and more trusted drug supply chain. We are also soliciting feedback for further improving the way our drug supply chain operates within the DSCSA framework. We view these guidance recommendations as an important part of implementing the robust enhanced system envisioned under DSCSA.

We look forward to continuing open conversations on DSCSA-related issues and providing future guidance to stakeholders as part of our efforts to protect American patients and the drug supply chain we all rely on.”

Additional Information

  • Today, the U.S. Food and Drug Administration is finalizing two guidance documents and making available two draft guidance documents to help ensure that prescription drugs are identified and traced properly as they move through the supply chain. These guidance documents lay out the FDA’s recommendations for how to comply with applicable DSCSA requirements, including those for enhanced drug distribution security at the package level that go into effect in November 2023.
  • As part of the DSCSA, manufacturers and repackagers are required to put a product identifier on drug packages. This includes the product national drug code (NDC), serial number, lot number and expiration date on each package and homogenous case of product, in human- and machine-readable form. The machine-readable form is generally a two-dimensional data matrix barcode. Industry questions are clarified in the final guidance, Product Identifiers Under the Drug Supply Chain Security Act, Questions and Answers.
  • Additionally, the final guidance Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification is intended to aid certain trading partners in identifying a suspect product and specific scenarios that could significantly increase the risk of a suspect product entering the pharmaceutical distribution supply chain. The guidance also describes how trading partners should notify the FDA of illegitimate product and sets forth a process for terminating notifications of illegitimate product in consultation with the FDA. In addition, this guidance describes when manufacturers should notify the FDA of a high risk that a product is illegitimate. This guidance responds to comments from stakeholders to clarify certain points and finalizes the remaining draft portion of the otherwise final guidance for industry, Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification issued in December 2016.
  • The revised draft guidance, Definitions of Suspect Product and Illegitimate Product for Verification Obligation under DSCSA, lays out the FDA’s current understanding of terms used to define “suspect” and “illegitimate” products. These include “counterfeit,” “diverted,” “stolen,” “fraudulent transaction” and “unfit for distribution.” In response to comments received from stakeholders, this draft guidance revises the March 2018 draft guidance.
  • The new draft guidance, Enhanced Drug Distribution Security at the Package Level under DSCSA, is intended to assist supply chain stakeholders, particularly trading partners, with requirements for enhanced drug distribution security at the package level that go into effect on November 27, 2023. This guidance provides recommendations on the system attributes necessary for enabling the secure tracing of product at the package level.
  • Congress enacted the Drug Supply Chain Security Act on November 27, 2013. DSCSA outlines steps to build an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed in the United States. Additionally, DSCSA directs the FDA to establish national licensure standards for wholesale distributors and third-party logistics providers and requires these entities to report licensure and other information to the FDA annually.

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The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

We Will Be Presenting at This Year’s GS1 Connect Conference

GS1 Connect 2021 Digital Edition: Move Beyond Supply Chain Challenges
Date: June 8-10, 2021 (Register by June 3, 2021)
Website: https://gs1connect.gs1us.org/

Session 701: An Automated Approach to Drug Traceability Readiness
Speaker: Gary Lerner President Gateway Checker Corporation
Conference Track: Tech

This presentation will examine enhanced drug distribution security requirements and what it means for industry participants from an information exchange perspective. In short, the enhanced drug distribution security aspect of DSCSA mandates the exchange of a transaction record it each change of ownership.

By 2023, U.S. pharmaceutical manufacturers will need to send serialized data, along with shipped product, to meet DSCSA traceability requirements. However, assessing drug traceability readiness can be inexact, time-consuming, and resource intensive. To achieve accurate, rapid, robust, and reliable connectivity with minimal errors, conformance to accepted standards is essential and can identify gaps in preparedness and inform compliance planning. Join this session to hear about an automated solution that can evaluate pharmaceutical manufacturers’ readiness.

  • What information must be captured and exchange?
  • What standards exist to support this?
  • What are the challenges?
  • How can an automated approach more effectively assure drug traceability readiness?

Gary Lerner, founder of Gateway Checker, is an accomplished architect of supply integrity solutions. An expert in item-level serialization, Gary has developed successful supply chain and channel integrity solutions for nearly 100 leading brands around the world, serving the needs of pharmaceutical, medical device, packaged food, electronics and apparel manufacturers. Over the past 18 years, he has worked with more than 60 leading brands, serving the needs of pharmaceutical, medical device, packaged food, electronics, consumer, and apparel manufacturers. He has been actively involved in facilitating FDA regulatory compliance and enabling supply network interoperability. Gary is an active participant in medical device and pharmaceutical GS1 industry initiatives, starting in 2010. A member of the GS1 Healthcare industry workgroup, Gary helped to craft the Implementation Guidelines for Applying GS1 Standards for DSCSA and Traceability, published in 2016.

More about GS1 Connect 2021: Move Beyond Supply Chain Challenges

Join innovators and business leaders at this year’s supply chain conference as they identify breakthrough possibilities for the future.

Gain insights from industry peers, innovators, and industry leaders on:

  • Meeting shifting consumer demands with complete and accurate data
  • Driving engaging customer experience through unique identification
  • Enabling end-to-end supply chain visibility using GS1 Standards
  • Connecting digital and physical supply chains through technology
  • How to drive supply chain innovation, agility, and resilience in a COVID-19 world

https://gs1connect.gs1us.org/

VRS System Verification at HDA 2020 Traceability Seminar

As you know, the FDA recently extended saleable returns verification until 2023.

Please join Gateway Checker CEO and Founder Gary Lerner at the HDA 2020 Virtual Traceability Seminar where he is hosting a VRS System Verification roundtable on Tuesday, November 3 at 10:00 AM ET.

We will address the FDA’s saleable returns verification extension and have a lively discussion on data integrity challenges facing drug manufacturers, wholesalers, and dispensers as the deadline extends out to 2023.

During the session we will address a key industry question:
How are pharmaceutical manufacturers, distributors, and dispensers viewing the need to establish, test, and deploy VRS given the extended FDA enforcement discretion for saleable returns verification?

Topics for discussion:
What are your plans for VRS given the recent FDA announcement?
What factors are driving your decision?
What actions would you like to see from the VRS solution providers?

If there are additional topics you’d like us to cover, please contact us.

Click here to register.

Methods to Ensure EPCIS Drug Traceability Standards

Pharmaceutical Commerce | July 3, 2020 | Updated: July 28, 2020

By Gary Lerner, Gateway Checker Corp

Within the next 30 months, some US pharmaceutical wholesalers are planning to be traceability-ready in accordance with the Drug Supply Chain Security Act (DSCSA). To some that might sound like plenty of time. To those of us with years of experience in the industry, it sounds more like a sprint to the finish line rather than a pleasant jog. Even now, the US drug supply network is struggling with electronic, interoperable traceability without alignment around a common set of application standards. A report from the Office of Inspector General of HHS, while evaluating the current status of DSCSA traceability, recommended that “FDA offer educational outreach to trading partners about required drug product tracing information and data standardization guidelines.” [1]

There is a broadly (but not universally) accepted standard for trading-data communication: the EPCIS standard of the GS1 organization. But to ensure that EPCIS is being effectively employed by pharma trading partners, and the software vendors serving them, a testing protocol has been developed and sanctioned by GS1. This article will explain its justification and application.

Read Article >