Pharmacy/Nonresident Pharmacy License
The licensure of a pharmacy is a critical process. The board is authorized to issue a pharmacy license to an individual, a firm, association, partnership, corporation, limited liability company, state government agency, trust, or political subdivision. There are some exceptions to who can own a pharmacy. The board actively regulates these sites. The board performs a thorough investigation of every application for a pharmacy license, which includes collecting all ownership and financial information, criminal background checks for beneficial owners and individuals with management and control, thorough documentation of all owners (whether or not they actively participate in the pharmacy’s daily activities), etc. Every pharmacy must have a pharmacist-in-charge who is responsible for the day to day operations (Business and Professions Code section 4054).
A nonresident pharmacy that ships, mails or delivers prescription medications to California residents must hold a current and valid license in the resident state, and also hold a nonresident pharmacy license issued by the board. The pharmacy must maintain an 800 number for consumer access to a pharmacist, must comply with patient-centered prescription labeling requirements (to include interpreter services and translation of directions of use, as specified), and the pharmacy must comply with requirements to report to CURES.
A pharmacist practicing in a nonresident pharmacy is NOT required to hold a California pharmacist license. The nonresident pharmacy must have a pharmacist-in-charge who is responsible for ensuring that the pharmacy complies with all California requirements for medications dispensed or shipped to California patients.
Controlled Substance Utilization Review and Evaluation System (CURES) Reporting
California pharmacies and nonresident pharmacies are required to comply with California Health Code Safety Code, Section 11165(d) as specified, “For each prescription for a Schedule II, Schedule III, or Schedule IV controlled substance, as defined in the controlled substances schedules in federal law and regulations, specifically Sections 1308.12, 1308.13, and 1308.14, respectively, of Title 21 of the Code of Federal Regulations, the dispensing pharmacy, clinic, or other dispenser shall report the following information to the California Department of Justice as soon as reasonably possible, but not more than seven days after the date a controlled substance is dispensed, in a format specified by the California Department of Justice”.
Community Pharmacy/Nonresident Pharmacy License Requirements
- Section 4022 Definition of Dangerous Drugs and Dangerous Devices
- Section 4110 Pharmacy License Required; Temporary Permit Upon Transfer of Ownership; Mobile Pharmacy Requirements
- Section 4111 Restrictions on Prescriber Ownership
- Section 4112 Nonresident Pharmacy Requirements
- Section 4113 Pharmacist-in-Charge Required, Notification to Board
- Section 4120 Nonresident Pharmacy Registration Required
ApplicationThe board may require additional documentation to confirm or substantiate the ownership structure reported at any time during the application process.