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Hey all,

All of my experience has been in medical device regulatory, with no experience in the drug industry. We are currently trying to source an OTC drug (listed in monograph) to include in a kit. As I understand it, we can outsource all aspects of manufacturing of the drug (and cGMP) to the contract manufacturing company outside of final release of product correct? If all manufacturing is done at their facility and a quality agreement has been created assigning all cGMP responsibility to that facility, is there still a registration requirement for our facility?

Secondly, if a company has done an ANDA, can we "re-label" their drug for use in our kit? In this case, are there any different registrations required on our part?

I have spent several hours researching the subject, but haven't found a single place that this situation is addressed directly, so any help would be appreciated. Drug regulations are very new and very confusing to me.



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There is a distinction between repacker, relabeler, and private label distributor in pharmaceuticals. These terms can be used a little differently than they are used in the medical device industry. Repackers and relabelers have to register and list, private label distributors do not. Sounds like you're a private label distributor and not a relabeler.

The FDA just released a final rule here regarding this topic which goes into effect on November 29th. The following is copied from page 13 of the federal register with the final rule.

The term ‘‘private label distributor’’ is defined in §207.1 of this final rule to mean, with respect to a particular drug, a person who did not manufacture, repack, relabel, or salvage the drug but under whose label or trade name the drug is commercially distributed.

Private label distributors do not—by reason of their status as private label distributors—have an obligation to register establishments or list drugs. They must have labeler codes, obtained under new §207.33(c), and they may submit drug listing information or establishment registration information if acting as the authorized agent of a registrant on whose behalf the information is submitted.

Relabelers and repackers do have to register and list.

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