Part 2: Pharmacy "DSCSA Stuff" - Know Your Partners
What Does All This "DSCSA Stuff" Mean to a Pharmacy?
Part 2: Know Your Trading Partners
With the interoperability requirements of DSCSA just around the corner on November 27, 2023, continue to share thoughts for the diverse and dedicated pharmacists of the United States around this important federal law.
A key part of DSCSA is ensuring your organization understands the term used throughout the law known as ATP (Authorized Trading Partners). Dispensers, as well as other roles in the supply chain, have been required since 2015 to ensure that all their trading partners are authorized trading partners. DSCSA law has specific definition for “authorized” and the types of evidence that should be considered for each role that includes manufacturer, repackager, wholesale distributor, dispenser and 3PL (third-party logistics provider).
Most dispenser organizations are aware that they should only procure products from distributors who are properly licensed and registered following state and federal regulations. Our belief is this authorization should be considered in both physical movement of product during ownership changes as well as electronic interactions that may be with indirect trading partners as interoperability unfolds. This becomes a bit more complicated as the requirements of serialized packaging level interoperability comes into effect on November 27, 2023.
Knowing Your Partners Is A Foundation For Protecting Your Data and Your Patients
These areas require further engagement and input from dispensers as we have found many are not yet aware that there are instances where your organization may be required to share data with indirect trading partners such as manufacturers, repackagers or any partners who supply your suppliers. This may include initiating electronic product verifications with manufacturers or initiating/responding to product tracing requests with any indirect authorized trading partner. The data exchanged can include confidential business data, such as sold from/sold to, so you should ensure that your organization’s leadership, IT, security, regulator and any legal counsel are consulted where appropriate.
There are also significant related discussions underway as it relates to the recently published proposed rule from the FDA known as the National Standards for the Licensure of Wholesale Drug Distributors and Third–PartyLogistics Providers. This rule is intended to preempt States and localities from establishing or continuing requirements for these roles that are different from the developing national standard. The FDA has asked for feedback by June 6, 2022 and is expected to produce a final rule after considering comments submitted.
We encourage pharmacy stakeholders who may be responsible for DSCSA compliance to consider joining industry discussions in groups such as PDG and GS1 US to further discuss with peers and understand the potential options that are taking shape for addressing these important and still evolving requirements.
We are glad to provide advisory DSCSA service for all sectors of the supply chain and are available to help plan your organization's DSCSA compliance journey.
Feel free to reach out to us through TenCountConsulting.com/contact if you have any questions or just want to chat!