Wholesaler Distributor General Information
Every wholesaler, wherever located, that engages in wholesale distribution into, out of, or within Iowa must be licensed by the Board in accordance with the laws and regulations of Iowa before engaging in wholesale distribution of prescription drugs. An Iowa wholesale drug license expires on December 31 of each year. A Third Party Logistics Provider is not eligible for a wholesale distributor license and is currently not required to be licensed in Iowa.
EFFECTIVE January 1, 2018, EVERY wholesaler, regardless of location, engaged in the distribution of controlled substances in Iowa is required to have a Controlled Substance Act (CSA) registration.
Where operations are conducted at more than one location by a single wholesale distributor, each location must be licensed.
"Wholesale distribution" means distribution of prescription drugs to persons other than a consumer or patient, but does not include:
- The sale, purchase, or trade of a drug or an offer to sell, purchase or trade a drug for emergency medical reasons. Emergency medical reasons include transfers of prescription drugs by a pharmacy to another pharmacy to alleviate a temporary shortage.
- The sale, purchase or trade of a drug, an offer to sell purchase or trade a drug, or the dispensing of a drug pursuant to a prescription;
- The lawful distribution of drug samples by manufacturers' representatives or wholesale salespersons;
- The sale, purchase or trade of blood and blood components intended for transfusion; or
- Intracompany sales.
"Wholesale distributor" means anyone engaged in wholesale distribution of prescription drugs, including but not limited to, manufacturers; repackers; own-label distributors; private-label distributors; jobbers; brokers; warehouses, including manufacturers' and distributors' warehouses, chain drug warehouses, and wholesale drug warehouses; independent wholesale drug traders; reverse distributors; and pharmacies that conduct wholesale distributions exceeding five percent of gross annual sales of prescription drugs.
The application for Wholesale Drug License is available by clicking here or you may contact the Board office to request an application be mailed or faxed. If your out-of-state facility has not been inspected within the past 12 months by your home state licensing board, additional information will be required. Contact the Board office for further information. New applicants located in Iowa will be inspected before the license is issued.
For more information, see 657 IAC Chapter 17.