Wholesale Drug Distributors in Montana

Wholesale drug distributors operating in or shipping into Montana must obtain a license from the Montana Board of Pharmacy. The state regulates both resident distributors with physical facilities in Montana and non-resident distributors shipping prescription drugs across state lines into Montana. Montana's licensing framework aligns with federal Drug Supply Chain Security Act (DSCSA) requirements while maintaining state-specific operational standards.

The Montana Board of Pharmacy (MT BOP) regulates wholesale drug distribution under the Montana Pharmacy Act. Statutory authority is established in Montana Code Annotated (MCA) Title 37, Chapter 7, with specific licensing requirements for wholesale distributors in MCA § 37-7-301. Out-of-state distributors are addressed under MCA § 37-7-304. Administrative rules governing distributor operations, facility standards, and recordkeeping are codified in Montana Administrative Rules (ARM) Title 24, Chapter 174.

The Board is responsible for issuing licenses, conducting facility inspections, enforcing compliance with state and federal pharmacy law, and taking disciplinary action against licensees who violate regulations.

Montana requires wholesale drug distributor licenses for:

Entities uncertain about whether their operations require licensure should contact the Board directly for a determination.

Montana wholesale drug distributor license applications require:

1. Obtain the application packet from the Montana Board of Pharmacy website (https://boards.bsd.dli.mt.gov/pharmacy — verify current URL) or by contacting the Board office directly