Does a Wholesale Drug Distributor need to be licensed in Montana when using a third party to distribute product?

• A. No
• B. Only if distributing within Montana
• C. Only if distributing out of state
• D. Yes

Answer: (D)

Yes. In Montana, a wholesale drug distributor must hold a license if they are involved in wholesale distribution of prescription drugs within the state, even when a third party is used to handle the actual distribution. The licensing requirement applies to the entity that controls the distribution into Montana, and outsourcing the work does not erase the obligation. The licensed distributor remains responsible for compliance with state laws—proper records, storage, security, recalls, and overall oversight of the distribution chain—and must ensure the third party distributor is authorized to operate in Montana if they are the ones handling distribution there.