text: The board is interested in further data and information on the repackaging industry, particularly on the topic of compliance with the requirement of maintenance of a single pedigree.”
  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.
  There is some confusion in the industry about how to link the NDC and serial number of the repackaged drugs with the original manufacturer’s NDC and serial number on the source drug packages. This linkage cannot be done within an RFID tag or a barcode. That’s because these data carriers are not “the pedigree”. The linkage can only be done properly within the external electronic pedigree itself. For example, the GS1 Drug Pedigree Messaging Standard (DPMS) includes a repackaging pedigree layer with all of the data fields necessary to link these NDCs and serial numbers.
  By the way, for those of you counting the ways that GS1’s Electronic Product Code Information Services (EPCIS) standard alone won’t work for compliance with the California pedigree law, here’s another one. There is currently no standard way to link incoming package EPC’s to outgoing repackaged EPC’s on drugs using that standard. There has been talk behind the scenes but nothing has been published in a standard or even otherwise. (See my earlier essays “Why GS1 EPCIS Alone Won’t Work For California Pedigree, Part 1” and “Part 2”.)
  The use of hoppers, filler bowls or automatic bulk dispensers in the Multiple-to-Multiple repackaging scenario may be problematic under a serialization regulation. The need to link the original manufacturer’s NDC and serial number to the repackager’s NDC and serial number becomes complex when exact boundaries of input packages to output packages cannot realistically be determined. The hopper/bowl/dispenser acts as a buffer so that the operation can be done at high speed. But this is exactly what causes the package boundaries to be indeterminable. Drugs from multiple input packages can mix and intermingle with those of other input packages before a unique mix is deposited into the output packages.
  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.
  That might be a lot of packages, and correspondingly, a lot of serial numbers. As long as all of those input packages share the identical pedigree it might not be too bad, but if every input package has a different pedigree, the resulting output pedigrees could get very complex. In fact, I’m not even sure at this moment if DPMS can properly document that complexity.
  Hoppers, filler bowls and automatic bulk dispensers are critical to a significant portion of the repackaging business of most repackagers. If they can’t use those components under a serialization regulation it would significantly change their business formula. Fortunately it appears that the California Board of Pharmacy recognizes issues like this. Note the last sentence in the answer to Question 58 above. Repackagers should take advantage of that invitation and work with the board to work out this and any other issues before the regulation goes into effect.
  Ordinarily the non-binding FDA guidance on Standardized Numeric Identifiers (SNI) wouldn’t offer any particular guidance on compliance with a California state law, but the SNI guidance document contains a very logical example of repackaging that I think certain repackagers should pay close attention to. Here is the example:
  “…For the purpose of this guidance, FDA considers the prescription drug package to be the smallest unit placed into interstate commerce by the manufacturer or the repackager that is intended by that manufacturer or repackager, as applicable, for individual sale to the pharmacy or other dispenser of the drug product. Evidence that a unit is intended for individual sale, and thus constitutes a separate ‘package’ for purposes of this guidance, would include the package being accompanied by labeling intended to be sufficient to permit its individual distribution. For example, if a manufacturer’s smallest unit of sale package is a container holding six drug-filled syringes, a single SNI would be the package-level identifier for the container holding the six drug-filled syringes; there would be no SNIs for the individual syringes, not intended by the manufacturer for individual sale. If a repackager then breaks that container down and repackages each syringe for individual sale, then the repackager must ensure that appropriate labeling accompanies each individual syringe and a new and unique SNI would be the package-level identifier for each individual syringe and a new and unique SNI would be the package-level identifier for each new package (e.g., each individual drug-filled syringe). SNIs applied to each new package by the repackager are to be linked back to the manufacturer’s SNI for the container of six drug-filled syringes (505D(b)(2)). …”
  This example may be very instructive for repackagers who perform this specific type of unit-dose repackaging. This may include companies who are in the business of building emergency response kits for dental and doctor’s offices. These kits are commonly composed of single doses of various medications (like Epinephrine, Atropine and Solumedrol injections for example) that are most often needed for unexpected reactions by patients in those kind of offices.