The U.S. FDA just published a docket asking for public input into standards for the interoperable exchange of information for tracing of human, finished, prescription drugs in paper or electronic format. Ironically, they will accept responses to the docket in either paper or electronic format. Comments should be submitted to the FDA within 60 days. If my calculation is correct, you have until April 21st to submit your comments.
“…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).”
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.
…a comprehensive exploration of the intersection between healthcare supply chains, track and trace technology, standards and global regulatory compliance
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.