Manufacturers and Wholesale Drug Distributors:  In the past, West Virginia licensed non-resident manufacturers as wholesale drug distributors when they distributed their product into the state.  Federal law requires a new scheme.  Anyone manufacturing prescription-only drugs in West Virginia must be licensed by the state as a manufacturer to do so.  Likewise, if you are a drug manufacturer located outside of West Virginia, but distribute any of your product into West Virginia, either yourself or through the use of a Third-Party Logistics Provider (3PL), you must be licensed by this state as a manufacturer (in other words, if you distribute or have your product distributed into West Virginia on your behalf, you must be licensed).

If you are a virtual manufacturer (you own the product, but someone else manufacturers it for you on contract or otherwise at their facility), if any of that product is to be manufactured in West Virginia, or shipped in or into West Virginia on your behalf, you must get a manufacturer's license.  Of course, the actual manufacturer will have to be licensed as a manufacturer if it is in West Virginia.  If the actual manufacturer is outside West Virginia, it does not need licensed if it never sends the product into West Virginia on your behalf (i.e., it transfers it to a 3PL or wholesaler outside of West Virginia, and it is that other entity that actually sends it into West Virginia).  If it is manufacturing the drugs on behalf of a virtual manufacturer, and it sends that product into West Virginia on behalf of the virtual manufacturer or otherwise, it must be licensed as a manufacturer.  In other words, if it is located outside of West Virginia and it distributes any of the product into West Virginia, it must get a manufacturers license.  

If controlled substances are involved, the actual manufacturer must have a controlled substances handling permit as well. If you are a virtual manufacturer which does not handle the product, then you do not have to also get the CS handling permit since you won't actually touch the product.

If you are a virtual manufacturer and use a 3PL to distribute your product in or into West Virginia, you must have a manufacturer's license,  and your 3PL must have a 3PL distributor's license.  If controlled substances are involved, the 3PL must have a controlled substances handling permit as well.  If you do not handle the product, then you do not have to also get the CS handling permit since you won't actually touch the product.

Wholesale Drug Distributors:  If you are a wholesale drug distributor and distribute drugs in or into West Virginia, you must be licensed as a wholesale drug distributor.  In the past, West Virginia licensed 3PL's as a wholesale drug distributor.  However, federal law requires a new scheme.  West Virginia will now have a 3PL distributor's license category to distribute any drug products in or into West Virginia as a 3PL. If controlled substances are involved, the 3PL must have a controlled substances handling permit as well.  For any product you are shipping in on behalf of a virtual or actual manufacturer or other party who actually owns title to and control over the drug, that virtual manufacturer, actual manufacturer, or other party must be properly licensed as a manufacturer.