Wholesale Drug Distributor Renewal Information
Documentation Required to Accompany Renewal Application
Please provide verification of your Verified-Accredited Wholesale Distributors accreditation or, in the alternative, proof that you have timely applied for VAWD certification (i.e. on or before September 30, 2008) with your renewal. 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 may be obtained on NABP’s Web site at http://www.nabp.net/.
There are No VAWD Exemptions for Facilities Required to Hold a WDD License
During the 2006 renewal cycle, licensees were asked to present documentation and a legal argument in support of a VAWD exemption. After a review of the multiple fact scenarios and legal opinions submitted, the Board of Pharmacy determined that there is no legal basis to be VAWD exempt in Indiana; therefore, if you are required to be licensed as a Wholesale Drug Distributor in Indiana, then you must be VAWD accredited.
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.
The following entities are not required to obtain licensure or comply with the requirements of IC 25-26-14
(a) FDA-approved manufacturers;
(b) medical gas manufacturers or distributors, that manufacture or distribute only medical gases; and
(c) veterinary supply distributors that distribute legend drugs that are FDA approved for animal use only.
If you currently hold a license that you are no longer required to have, then you simply need to allow your WDD license expire. No other action needs to be taken on your part.
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; you must also submit the renewal application and renewal fee in order to renew your license.
Renewal Due Date
All WDD licenses expire on September 30, 2008. If you renew during the last few days of the renewal period, please be reminded that a late fee of $50.00 will be assessed if your remittance is not postmarked on or before September 30, 2008.
It is recommended that you submit your completed renewal application (don’t forget to sign the form and answer the questions!), renewal fee of $100, and VAWD documentation as soon as possible so that you receive the renewed license prior to the September 30 expiration date.
Laws Governing WDDs
IC 25-26-14: Wholesale Legend Drug Distributors
856 IAC 3: Wholesale Legend Drugs
Questions
Please contact our office at pla4@pla.IN.gov with any questions you may have.
