Another week has gone by with no official movement in the Senate on the compromise pharmaceutical compounding and track & trace bill, H.R. 3204, the Drug Quality and Security Act (DQSA) (see “Waiting For The Senate To Act On A Track & Trace Bill, Again”). With the focus of the Congress rightly on reopening the government I think we should expect to wait a little longer. You can bet that the supporters and the opposition are both developing their strategy as time goes by.
The California pedigree law requires manufacturers to serialize the smallest package of drugs that will be bought by a dispenser. For some manufacturers targeting the U.S. market, that may require serialization and e-pedigree at a lower unit of measure than they might have thought. For products that manufacturers package into multi-packs and sell to wholesalers packaged only that way, you might assume that your “smallest package or immediate container” is the multi-pack. Think again.
One of the complexities of the modern pharmaceutical supply chain occurs when a pharmaceutical dispensing organization “outsources” the management of their on-premises inventory to their supplier, or “vendor”. This is known as Vendor Managed Inventory, or VMI. There are several good reasons this might be done, including eliminating the need to deal with issues that have more to do with supply chain execution mechanics and fluctuating supply and demand than they do with the core competency of dispensing drugs.
When VMI is used in the pharma supply chain the supplier is typically a wholesaler whose core competency is in dealing with those exact issues. That’s just what they do. The wholesaler benefits from the VMI relationship because they become the exclusive supplier to the VMI customer. VMI can be a “win-win” proposition as long as costs are kept in-check.
Most prescription pharmaceuticals distributed in California pass from manufacturer to pharmacy through wholesale distributors, but a small percentage are sold by the manufacturer directly to doctors and clinics. An even smaller percentage are sold through small companies licensed as kit manufacturers or distributors to dental offices, fire departments, ambulance companies and other carriers of emergency medical kits. These transactions are just as open to the introduction of illegitimate products as the larger transactions that we normally think of when we talk about the use of drug pedigrees, but because they are outside of the ordinary, they are at risk of falling between the cracks. That is, they might be a lot more complex, or not even possible, under the California pedigree law. Continue reading Falling Between The Cracks Of The California Pedigree Law→
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DISCLAIMER: RxTrace contains some of the personal thoughts, ideas and opinions of Dirk Rodgers. The material contained in RxTrace is not legal advice. Dirk Rodgers is not a lawyer. The reader must make their own decisions about the accuracy of the opinions expressed in RxTrace. Readers are encouraged to consult their own legal counsel and trading partners before taking any actions based on information found in RxTrace. RxTrace is not a vehicle for communicating the positions of any company, organization or individual other than Dirk Rodgers.