Wholesaler/Nonresident Wholesaler License
A Wholesaler License is required before any firm or organization may distribute, broker or transact the sale or return of dangerous drugs or dangerous devices in California. Wholesalers sell and distribute dangerous drugs and dangerous devices (also called "legend" items or prescription-required drugs and devices) to other business entities who are authorized by law to purchase the items or to licensed health care providers who are authorized by law to possess the dangerous drugs and dangerous devices. Wholesalers are not authorized to sell or distribute these items directly to patients unless the wholesaler is delivering dialysis drugs and devices to home dialysis patients in case(s) or full shelf package lots (see section 4054 of the California Business & Professions Code).
A Wholesaler License is also required of customs brokers who sell for resale or negotiate for distribution any dangerous drug or device included in section 4022 of the Business and Professions Code. A wholesaler permit is also required for reverse distributors who arrange for the destruction of outdated or damaged dangerous drugs or devices.
The designated representative-in-charge must file a separate application with the board if he or she is not already licensed in California as a pharmacist or designated representative. The application form is available by selecting the following link Designated Representative Application.
Wholesaler/Nonresident Wholesaler Requirements
- Section 4022 Definition of Dangerous Drugs and Dangerous Devices
- Section 4043 Definition of Wholesaler
- Section 4160 Requirements for a Wholesaler License
- Section 4161 Requirements for a Nonresident Wholesaler License
- Section 4162 Surety Bond Requirements
- Section 4053 Requirements for a Designated Representative License
- Section 4022.5 Designated Representative, Designated Representative-in-Charge
- Section 1780 Minimum Standard for wholesale
- Reference the Pharmacy Law Book for additional laws and regulations.
Application
- California Wholesaler License Application
- Nonresident Wholesaler License Application
- Surety Bond Information
- Surety Bond - Questions and Answers