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DSCSA Saleable Returns: Industry Plan for Best Using the Enforcement Discretion Period

Posted by Justine Freisleben

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It has been clear for some time that the pharmaceutical supply chain has been concerned with meeting the November 27, 2019, saleable returns milestone. As the HDA’s Research Foundation’s annual Serialization Readiness Survey (conducted in May) notes, 79 percent of manufacturers have concerns with the viability of the Verification Router Service (VRS), while 82 percent of distributors are unsure about meeting the requirement.

Given the complexity of the effort and the technological challenges of building a new verification network, HDA and other organizations requested enforcement discretion from the Food and Drug Administration (FDA), which, on September 24, granted the request in a limited scope for wholesale distributors.

While alleviating some critical concerns about verification requirements for wholesale distributors, this compliance policy simultaneously raised additional questions regarding how to effectively finish development, test as well as scale the network to a production environment capable of handling millions of returns verification requests a year. As a result, the supply chain convened to discuss challenges faced by verification network users and appropriate industry alignment on how to effectively scale up during the enforcement discretion period.

On October 21, manufacturers and wholesale distributors met with two main goals:

  • To discuss network challenges and the appropriate way to prioritize and address those challenges going forward; and,

  • To define the scale-up period in a way that works for manufacturers and distributors, including a rough timeline, milestones and report outs to industry and, if necessary, the FDA.

Attendees conducted a robust discussion of these goals and potential approaches to achieve them. Key agreements reached during the meeting are summarized below.

Network Challenges

Numerous network challenges were defined before the meeting. They ranged from onboarding, controls to help ensure authorized trading partner access to the network, credentialing, service provider roles and managing alerts between trading partners. The group agreed these issues need to be prioritized and comprehensively assessed by item.

Scaling Up the Network

The bulk of the discussion was focused on developing a timeline for scaling up the network. Below is a high-level description of what was agreed to. A smaller group will further define industry’s coordinated efforts and plan to develop, test, scale up and implement the verification network during a period of enforcement discretion. The goal is to do the work necessary to ensure a robust and stable verification network by November of 2020.

VRS Blog Chart

Future meetings will add detail to this approach. The goal is to begin testing in a quality environment as soon as the network is ready and transition to a production environment as individual companies are ready. There was an initial discussion of approaches that could be used to undertake more controlled testing (in either a quality or production environment) by limiting the number of Global Trade Item Numbers (GTINs) manufacturers load into the Lookup Directory or possibly limit the period of time GTINs are loaded in the Lookup Directory.

Testing is key to allow for finding and resolving issues. Manufacturers and distributors are aligned on testing in a quality environment before moving to a production environment. Once the network is "ready," a more fruitful discussion on metrics and readiness tracking can take place. The experience in a production environment during the enforcement discretion period will help manufacturers and distributors scale up volume as they are confident, as well as understand and identify scenarios and common issues, giving their teams’ experience resolving those issues in a real-world environment.

When an approach is solidified, it will be shared with solution providers so that they can provide input and meet to discuss challenges. HDA offered to provide a forum for solution providers to collaborate and communicate on a more regular basis as a group. Pharmaceutical manufacturer associations have been invited to participate. Solution providers are critical to the success of this network by helping their clients carry out their preferred scale-up approaches.

HDA is committed to convening manufacturers, distributors and solution providers to discuss these important issues and align on a path forward to make the most of this year. Communication with the VRS Task Force and the broader industry through this blog will occur on an ongoing basis and consist of meeting updates, key issues to be aware of, readiness of the network and any other information that task force members recommend. For questions on this meeting, contact Justine Freisleben at jfreisleben@hda.org or (703) 885-0277.

ABOUT THE HEALTHCARE DISTRIBUTION ALLIANCE

The Healthcare Distribution Alliance (HDA) represents primary pharmaceutical distributors — the vital link between the nation’s pharmaceutical manufacturers and pharmacies, hospitals, long-term care facilities, clinics and others nationwide. Since 1876, HDA has helped members navigate regulations and innovations to get the right medicines to the right patients at the right time, safely and efficiently. The HDA Research Foundation, HDA’s non-profit charitable foundation, serves the healthcare industry by providing research and education focused on priority healthcare supply chain issues.

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