There is an interesting dialog going on in the Food and Drug Serialization Professionals group in LinkedIn that was kicked off by a recent RxTrace essay. Click here to see the conversation. It got real interesting when Marc Rosenblatt, Director of Sales at Veracity Network, related an experience his company had in a recent pilot. He said:
“…An unsettling example occurred during one of our distributor pilot programs. Our system detected a number of counterfeit products (9% of the total sample to be exact) that were sent back as returns. This means that the molecular structure or product signature didn’t match up with the legitimate product standard. Upon further examination, it was discovered that the sealed bottles contained counterfeit replacements for the valid product. What makes this even a more difficult pill to swallow (pun intended) is the fact that these products would in most cases be restocked and sold again. The returns areas are the most overlooked link in the supply chain and from reading the DSCSA text, it continues to be (at least for the next 4 years).”
Marc’s reading of the Drug Supply Chain Security Act (DSCSA), which is Title II of the Drug Quality and Security Act (DQSA), gives him some comfort that the returns area will get some much needed attention in about 4 years. He’s apparently referring to sections:
- 582(b)(4)(E) for manufacturers,
- 582(c)(1)(B)(i) for wholesale distributors,
- 582(d)(1)(C)(i) for dispensers, and
- 582(e)(4)(E) for repackagers.
The sections for manufacturers and repackagers specify that they will be required to verify the product identifier, including the standardized numeric identifier (SNI), of the returned product, at the case level (for unopened homogeneous cases) or at the package level (for opened or mixed cases). This takes effect in 4 years for manufacturers and in 5 years for repackagers.
As you might expect, the section for wholesale distributors is a little different. In 6 years, wholesale distributors will be required to “…associate the returned product with the transaction information and transaction statement associated with that product.” In addition, section 582(c)(4)(D) requires wholesale distributors to verify the product identifier of saleable returned product, just like the manufacturer and repackager, but after 6 years.
The section for dispensers is also a little different. That section simply states that they may return product to the trading partner from which they obtained the product without providing any of the transaction information, transaction history or transaction statements.
AND IN 10 YEARS…
Ten years after enactment of the DQSA, things tighten up a little. At that point, the four sections dealing with returns as discussed above are sunsetted [no longer in effect…see section 582(k)], and they are replaced by a single requirement that all segments must follow: Section 582(g)(1)(F).
“Each person accepting a saleable return shall have systems and processes in place to allow acceptance of such product and may accept saleable returns only if such person can associate the saleable return product with the transaction information and transaction statement associated with that product.”
Why is the transaction history not included in what they must associate? Because after 10 years, transaction histories go away too. No one needs to provide or receive transaction histories after that point in time [see section 582(k)(1)]. Transaction histories (sometimes referred to as “pedigrees”, or “trace” data) are only required during the first 10 years—the years before serial numbers must be included in the transaction information that is passed to the buying party.
Why is that? From the perspective of the companies in the supply chain, in the first 10 years, the DSCSA is a lot-based “pedigree” law where the transaction histories—the pedigrees—must be provided to the buying party. But at the 10 year point it transforms into a serialization-based “one-up, one-down data retention” law. The serial number data for the drugs you receive and those you ship must be retained just in case of a recall, or in case someone later becomes suspicious of those drugs. In that case, you will be able to look up your serialization-based receiving and shipping transaction information for those drugs and provide it to the investigating regulator, all within 24 hours of the request [see section 582(m)], so they can piece together the supply chain history of those drugs.
I’m not sure why this all seems to give Mr. Rosenblatt comfort, considering that none of these new requirements will lead to the detection of the kind of counterfeit drug his recent pilot uncovered. I suppose the new record-keeping requirements could cause a counterfeiter to hesitate before returning a counterfeit drug inside of a real package because it might mean that the trail would lead back to them more quickly and positively if someone ever became suspicious, but that’s not much of a comfort.
The DSCSA within the DQSA is a very complex beast and what affect it will have on the number and type of supply chain crimes in the future is difficult to assess. How do you think it will affect the security of returns? Are you comfortable that the DSCSA will solve the returns security problem, or do you think it just dances around the real problems?