Bob Celeste will be holding a Workshop at this year's Pharmaceutical Traceability Forum (May 23-25, Philadelphia). The workshop is titled “Breaking Down Pilot Programs and Their Effect on Your Implementation of Serialization”.
The Drug Supply Chain Security Act (DSCSA) is unique in that it calls for an "interoperable system" for the whole supply chain to take part in. Also, the law is self-implementing. Meaning that, implementation is expected regardless of FDA guidance.
These two facts mean that the industry itself must come together and create this interoperable system. There are many operational and technical decisions to be made. Companies and healthcare providers are often surprised by what is contained and what is not contained in the law. During the recent FDA workshop on the Pilot Program, it became apparent that there are just as many myths as facts known about individual requirements under the law.
A number of early adopters have points of view on what needs to piloted and why. While others are confused as to why there is a sudden push to pilot, what to pilot and how participation might be beneficial to preparing for the next phases of the DSCSA.
We will discuss these close term issues and others that need to be resolved along the way toward 2023 and full compliance.