The Federal Register’s (FR) pre-publication page today contained an interesting proposed renewal for the collection of information for Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution (here).  The notice states that:

Establishment registration information helps FDA identify who is manufacturing, repacking, relabeling, and salvaging drugs and where those operations are performed.  Drug listing information gives FDA a current inventory of drugs manufactured, repacked, relabeled, or salvaged for commercial distribution.  Both types of information facilitate implementation and enforcement of the FD&C Act and are used for many important public health purposes.

The notice goes on to say that “Unless otherwise exempt under section 510(g) of the FD&C Act or § 207.13, all manufacturers, repackers, relabelers, and salvagers must register each domestic establishment that manufactures, repacks, relabels, or salvages a drug, or an animal feed bearing or containing a new animal drug, and each foreign establishment that manufactures, repacks, relabels, or salvages a drug, or an animal feed bearing or containing a new animal drug, that is imported or offered for import into the United States” as well as listing all products distributed within five days of introduction into distribution.  The FR notice indicates that private label distributors that do not manufacture, label, repackage, or salvage drug are not required to drug list and that the actual manufacturer may do so on their behalf.

The information is to be submitted to the FDA electronically and new entries, as well as biannual updates and certification of drug listing information, must be conducted by the listing organization.  While most in the industry know and comply with these provisions, the FR notice provides some interesting estimates of the number of activities that sponsors must perform, as well as the government’s time estimates associated with each of the activities.  According to the notice, the estimates are based on the FDA’s experience with the electronic registration and listing process since June 2009.

Here are some of what I find to be interesting estimates according to the Agency:

  • 2,960 initial establishment registrations at 1 hour each
  • 10,000 annual reviews and updates of registration information at .5 hours each
  • 12,470 initial listings including NDC numbers at 1.5 hours each
  • 106,000 June and December review/updates or certification of listings at .75 hours each
  • 1,000 preparations of SOP for uploading SPL at 40 hours each

This represents a significant burden on the industry that must be dealt with each year.  It also represents part of the cost of doing business in this arena.  The reason I have focused on this FR is to try to get a sense from my readers of whether these time estimates are anywhere near accurate or whether you have a better and more efficient idea of how to deal with these requirements.  Please drop me a note at if you have any comments.  All comments will, of course, be treated as confidential and any use of the comments will not be attributed to any person or firm.