If you are a pharmaceutical company serious about meeting the requirements of Phase II of the DSCSA, there are two organizations you must join.
The first is the Partnership for DSCSA Governance, or the PDG. It is an organization formed by manufacturers, wholesalers, dispensers, and solution providers that are working to solve the interoperability requirements for the DSCSA for 2023. The PDG is a 501(c)(6) nonprofit business association requiring a yearly membership fee to join.
The other is the Healthcare Distribution Alliance, or HDA, which is a long-running organization that represents many members of the pharma supply chain in a quest to advocate for public policy that supports patient access to medical products through safe, efficient, and effective distribution. The HDA also requires a yearly membership fee.
Today’s post will look at both organizations, profile what they do, and then let you know why joining them is crucial for getting the most out of the DSCSA.
Some members of the US pharmaceutical supply chain are not waiting for the FDA to make the next move (see “DSCSA: Will 2020 Be FDA’s Year To Leap Forward?”). Instead, they are proactively organizing and setting the standards that will most likely be used to meet the requirements of the Enhanced Drug Distribution Security (EDDS) phase of the Drug Supply Chain Security Act (DSCSA), which goes into effect on November 27, 2023. Forward motion has been made over the last month on two fronts: The DSCSA governance organization and the Verification Router Service (VRS).
Every year I look forward to the Healthcare Distribution Alliance (HDA) Traceability Seminar. It’s the one event in the US that is attended by everyone connected with pharma serialization and traceability, including those from manufacturers, 3PLs, repackagers, wholesale distributors, dispensers and solution providers. In that one time and place I can get answers to burning questions about what is going on in the industry and a sense for what people are thinking about a wide range of issues that appear here in RxTrace. The sessions are helpful, but the real goldmine are the hallway conversations. Of course, I’ve written about this before (see “2014 Fall Conference Season Preview” and “Terminology: Track and Trace, and Pedigree”).
Increasingly, I’ve heard the opinion expressed that there will surely be multiple approaches adopted for exchanging data, and so it will be necessary for all of those approaches to be made interoperable with each other. Proponents of this idea claim it is unrealistic to expect a single approach to be accepted by all companies in the supply chain and therefore, having to deal with multiple approaches is inevitable. This kind of talk makes me nervous. Here’s why.
Last October the FDA published a draft guidance called “Verification Systems Under the Drug Supply Chain Security Act (DSCSA) for Certain Prescription Drugs” (see “DSCSA: Verification Systems Draft Guidance”). Near the end of the comment period in December, the Healthcare Distribution Alliance (HDA) submitted comments containing proposed changes. Like other comments submitted by the HDA for other FDA DSCSA guidance, these are well worth reading. Once again, the HDA demonstrates their thorough understanding of the DSCSA and their ability to clearly and crisply explain where the FDA’s draft language fails to reflect the language in the original law.
For companies in the US pharma supply chain, 2019 is going to be the year of an important milestone of the Drug Supply Chain Security Act (DSCSA). In November, wholesale distributors will be required to begin issuing verification requests to manufacturers, at the Standardized Numerical Identifier (SNI) level, for any returned drug that is still saleable, before they resell it. I’ve written a lot about this change in the past.
…a comprehensive exploration of the intersection between healthcare supply chains, track and trace technology, standards and global regulatory compliance
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