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(b) The UDI must include a device identifier segment. Whenever a device label includes a lot or batch number, a serial number, a manufacturing date, an expiration date, or for a human cell, tissue, or cellular or tissue-based product (HCT/P) regulated as a device, a distinct identification code as required by § 1271.290(c) of this chapter, the UDI must include a production identifier segment that conveys such information.
Today companies who repackage pharmaceuticals for the U.S. market do a wide variety of repackaging operations to fill an even wider number of needs for the industry. (This essay is not about repackaging in other countries which is often done for other reasons including localization of label language, numbering and other regulatory requirements.) These may include:
In California, an entity that repackages prescription drugs is licensed as a manufacturer. (B&P § 4033(a); H&S § 109970.) When a drug is repackaged, it may typically (but not always) acquire a new National Drug Code (NDC) number, a new lot number and perhaps a new expiration date.
The pedigree law mandates that a single pedigree shall include every change of ownership of a given dangerous drug from its initial manufacture through to its final transaction to a pharmacy or other person for furnishing, administering, or dispensing the drug, regardless of repackaging or assignment of another NDC number. (B&P § 4034(c).)
Accordingly, the repackager must receive (from the manufacturer, wholesaler, or other source of the drug) a pedigree with the prescription drug documenting all transactions resulting in a change of ownership up through receipt by the repackager, and all of the new pedigree information (e.g., new NDC number, etc.) must be documented on the original pedigree, certified under penalty of perjury, and passed on/ continue with the newly repackaged prescription drug.
The Q&A document was published in January of 2008, but in the fall of 2008 the California Legislature passed the Ridley-Thomas bill (SB 1307) that, among a few other things, set the current enforcement schedule. While the California Business and Professions Code, as quoted above, defines a drug repackager as a drug manufacturer, the enforcement schedule enacted in the Ridley-Thomas bill explicitly sets the enforcement time for repackagers to be the same as the distributors: six months after the last date for compliance by manufacturers. This makes sense because repackagers can only comply with the regulations if they are able to receive valid pedigrees with the serialized drugs they purchase for repackaging. The six month delay gives repackagers the time necessary to obtain drugs that are serialized and pedigreed from the manufacturers before they are required to comply.
One possible solution to this problem is to link all input package serial numbers that have been placed into the hopper/bowl/dispenser prior to each output package being filled. Those serial numbers would represent every possible input package up to the moment that an output package is filled. Each successive output package would end up being linked to more and more input packages to the point where the last package filled by the hopper/bowl/dispenser would be linked to every single input package that had been deposited into it.
So how does serialization play into this scenario? Prior to unit dose repackaging, the drugs are purchased and thus removed from the supply chain and will never re-enter the supply chain. They are not sold in unit dose form as the hospital pharmacy buys the drug and then pays for the service side in a separate invoice? 2b1af7f3a8
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