Distributor listings are done where the marketing category is any of the other marketing categories other than bulk ingredient, drug for further processing, or manufactured under contract (OTC Monograph Final/Not Final, any of the application type marketing categories such as NDA, or any one of the “unapproved” marketing categories such as unapproved medical gas). The NDCs in drug product information use the distributor’s labeler code. If the manufacturer is the distributor, only the distributor’s listing is done. Under certain circumstances, a product distributed by a domestic manufacturer that is produced by the manufacturer at a foreign site that it fully owns may have both listings for import reasons – the manufacturer’s listing for the domestic manufacturer’s foreign site and the distributor’s listing for the domestic manufacturer/distributor that distributes the product. When a manufacturer fully manufactures and commercially distributes its products, the listings are normally handled by the manufacturer or someone with whom they contract. In our experience, the only exception is the drug sponsor who takes on that responsibility, but they need to make sure the manufacturer is aware of that. In all other cases the various parties (manufacturer, US agents, and distributors) need to know who is handling the listings. As indicated previously, there are manufacturer and distributor listings handled by a party other than the manufacturer. In other cases, the distributor listing are contractually assigned by the distributor to the manufacturer. If a company is already tracking whatever listings it is handling, all is well and good. They are having a relatively easy time of making any updates or submissions this year. In practice, though, we are finding that many companies have not been doing that tracking. See 21CFR207.41, (c)(1) for additional information.