For more information regarding the statutes and rules regulating wholesale drug distribution, please review them below. For legal interpretations, please refer to your legal counsel.
Wholesale Drug Distributor License
The Board shall issue a wholesale drug distributor ("WDD") license to a facility that submits:
→ If you have responded in the affirmative ("yes") to one of the questions on the application, then you must explain fully, including all related details, in a signed and notarized statement. You must also submit documentation regarding the incident(s) in question.
There are no VAWD exemptions for facilities that are required to hold a WDD license
If you are required to be licensed as a Wholesale Drug Distributor in Indiana, then you must be VAWD accredited. There is no legal basis to be exempted out from the VAWD requirement.
If you are physically shipping legend drugs into or within Indiana, you must be licensed and obtain VAWD unless you are explicitly excepted out of the licensure requirement by statute; as such, any company that does not take physical possession of the legend drugs or is exempted as referenced below does not need a license in Indiana.
Indiana law requires wholesale drug distributors (WDD) of legend drugs to obtain and maintain accreditation from the National Association of Boards of Pharmacy®’s (NABP®) under Section 46, IC 25-26-14-1 et seq. A VAWD application form and instructions can be obtained on NABP’s Web site at http://www.nabp.net/.
The following entities are not required to obtain licensure or comply with the requirements of IC 25-26-14:
1. FDA-approved manufacturers;
2. medical gas manufacturers or distributors, that manufacture or distribute only medical gases; and
3. veterinary supply distributors that distribute legend drugs that are FDA approved for animal use only.
If Indiana law does not require you to hold the WDD license, then we will not issue a license to you.
Change of Location
If you have a change of location, then you need to submit a new WDD application, $100 application fee, and application requirements in order to update the address on your license. Please indicate in a letter attached that it is a change of location application and provide your current license number. You must also submit verification that your VAWD accreditation has also been updated to your new location.
Change of Ownership
If you have a change of ownership, then you need to submit a new WDD application, $100 application fee, and application requirements in order to update change the ownership of the WDD. Please indicate in a letter attached that it is a change of ownership application and provide the current license number of the facility; a new number will be issued. You must also submit verification that you have VAWD accreditation under the new ownership, or that you have applied for the accreditation with NABP.
For more information on the VAWD accreditation as well as the VAWD application process, please visit NABP’s website at http://www.nabp.net/.
For questions regarding the Indiana WDD license, please contact our office by e-mail at pla4@pla.IN.gov.