Wholesale Drug Distributors in Indiana

Wholesale drug distributors operating in Indiana must obtain a license from the Indiana Board of Pharmacy before engaging in the wholesale distribution of prescription drugs within or into the state. Indiana requires both resident and non-resident distributors to meet statutory standards covering facility operations, designated representative qualifications, and recordkeeping. Third-party logistics providers (3PLs) that warehouse or distribute prescription drugs on behalf of others are also subject to licensing requirements.

The Indiana Board of Pharmacy (ISBP) regulates wholesale drug distributors under the authority of Indiana Code 25-26-14 (Wholesale Drug Distribution) and 856 IAC 1-38 (administrative rules governing wholesale drug distributor licensing and operations). The Board is part of the Indiana Professional Licensing Agency (IPLA) and maintains jurisdiction over licensing, inspection, and enforcement for all entities engaged in wholesale prescription drug distribution within Indiana.

Website: https://www.in.gov/pla/professions/indiana-board-of-pharmacy/

The following entity types must obtain an Indiana wholesale drug distributor license:

The following entities are generally not required to obtain a wholesale drug distributor license:

Exemption applicability should be verified with the Indiana Board of Pharmacy based on specific business operations.

Applications for an Indiana wholesale drug distributor license must include:

Indiana requires at least one designated representative (DR) for each licensed facility. The DR serves as the responsible person overseeing compliance with state and federal wholesale drug distribution requirements.