One of the most intense questions about any serialization mandate is whether or not manufacturers would be required to pass “aggregation data” to their customers. “Aggregation data” is the serial number-based packaging hierarchy of the shipment. That is, a list of the package-level serial numbers that are contained in each serialized bundle, and then which bundles are contained within which serialized cases and then which cases are contained on which serialized pallet, etc.
You can’t expect to give a couple of workers a handheld barcode reader and expect them to produce six sigma aggregation data. It is possible to collected highly accurate aggregation data (see “Pharma Aggregation: How Companies Are Achieving Perfection Today”), but it requires systems specifically designed to do so. The now obsolete California pedigree law did not explicitly require manufacturers to provide aggregation data, but downstream trading partners would have had difficulty complying with the law without it. Consequently, one of the unwritten goals of industry when negotiating to create the Drug Supply Chain Security Act (DSCSA), Title II of the Drug Quality and Security Act (DQSA), was to defer the need to collect and pass aggregation data as long as possible so that companies would have time to develop and deploy those systems.
In my view, the DSCSA does exactly that. It delays the mandate for companies to provide aggregation data for at least ten years, until the enhanced drug distribution security system—or phase 2 of the DSCSA—kick in. However, the big 3 wholesale distributors say they are going to ask their suppliers to provide it anyway, as I documented in the recent essay “DQSA: Will U.S. Pharma Distributors Mandate Aggregation Data In Phase 1?”. The big-3 seemed to agree that it is not a legal requirement to pass the data, but they just want the data anyway.
There are lots of opinions about what is going to happen regarding aggregation data. One of the questions asked in the 2014 RxTrace U.S. Pharma Traceability Survey, sponsored by Frequentz, was the interpretation of the DSCSA regarding “aggregation data” during the first 10 years. Here are the results:
QUESTION 7: What is your interpretation of the Federal DSCSA regarding “aggregation data” during the first 10 years (phase 1)?
the response was fairly mixed. However, several themes can be identified:
- Most agree that the law does not require manufacturers to collect or pass aggregation data during phase 1 (combined 69%).
- However, included in that percentage are 28% of respondents who believe that manufacturers will discover that they must pass aggregation data along to their customers in order to meet other requirements in the law (this was the top response). That would mean that supplying aggregation data is an implied requirement in the law. Perhaps the FDA will eventually make their interpretation explicit so that companies can be confident in their implementation decisions.
- Only about 1% of the respondents seem to agree with my opinion that the manufacturer’s customers will not even want their aggregation data during phase 1. We’ll see about that in the next year or so.
This was just one of the many interesting questions asked in the survey. Download a free copy of the results here. You will need to create an account on the Frequentz site to get to the download link.
Does your opinion fall within one of these? If not, leave a comment below with your thoughts on what will happen regarding aggregation data during phase 1 of the DSCSA.