California Code of Regulations
Title 16 - Professional and Vocational Regulations
Division 17 - California State Board of Pharmacy
Article 10 - Dangerous Drub Distributors
Section 1783 - Manufacturer, Wholesaler, or Third-Party Logistics Provider Furnishing Drugs and Devices

Universal Citation: 16 CA Code of Regs 1783

Current through Register 2024 Notice Reg. No. 12, March 22, 2024

(a) A manufacturer, wholesaler, or third-party logistics provider shall furnish dangerous drugs or devices only to an authorized person; prior to furnishing dangerous drugs and devices to a person not known to the furnisher, the manufacturer, wholesaler, or third-party logistics provider shall contact the board or, if the person is licensed or registered by another government entity, that entity, to confirm the recipient is an authorized person.

(b) "Authorized person" means a person to whom the board has issued a permit which enables the permit holder to purchase dangerous drugs or devices for use within the scope of its permit. "Authorized person" also means any person in this state or in another jurisdiction within the United States to the extent such furnishing is authorized by the law of this state, any applicable federal law, and the law of the jurisdiction in which that person is located. The manufacturer, wholesaler, or third-party logistics provider furnishing to such person shall, prior to furnishing the dangerous drugs and devices, establish the intended recipient is legally authorized to receive the dangerous drugs or devices.

(c) Dangerous drugs or devices furnished by a manufacturer, wholesaler, or third-party logistics provider shall be delivered only to the premises listed on the permit; provided that a manufacturer, wholesaler, or third-party logistics provider may furnish drugs to an authorized person or an agent of that person at the premises of the manufacturer, wholesaler, or third-party logistics provider if (1) the identity and authorization of the recipient is properly established and (2) this method of receipt is employed only to meet the immediate needs of a particular patient of the authorized person. Dangerous drugs or devices may be furnished to a hospital pharmacy receiving area provided that a pharmacist or authorized receiving personnel signs, at the time of delivery, a receipt showing the type and quantity of the dangerous drugs or devices so received. Any discrepancy between the receipt and the type and quantity of dangerous drugs and devices actually received shall be reported to the delivering manufacturer, wholesaler, or third-party logistics provider by the next business day after the delivery to the pharmacy receiving area.

(d) A manufacturer, wholesaler, or third-party logistics provider shall not accept payment for or allow the use of an entity's credit to establish an account for the purchase of dangerous drugs or devices from any person other than:

(1) the owner(s) of record, chief executive officer, or chief financial officer listed on the permit for the authorized person; and

(2) on an account bearing the name of the permittee.

(e) All records of dangerous drugs or devices furnished by a manufacturer, wholesaler, or third-party logistics provider to an authorized person shall be preserved by the authorized person for at least three years from the date of making and shall, at all times during business hours, be open to inspection by authorized officers of the law at the licensed premises. The manufacturer, wholesaler, or third-party logistics provider shall also maintain all records of dangerous drugs or devices furnished pursuant to this section for at least three years from the date of making and shall, at all times during business hours, keep them open to inspection by authorized officers of the law at the premises from which the dangerous drugs or devices were furnished.

1. New section filed 8-25-99; operative 9-24-99 (Register 99, No. 35). For prior history see Register 84, No. 10.
2. Amendment of section heading, section and NOTE filed 2-22-2021; operative 4-1-2021 (Register 2021, No. 9).

Note: Authority cited: Section 4005, Business and Professions Code. Reference: Sections 4025, 4043, 4059, 4059.5, 4080, 4081, 4105, 4120, 4160, 4161, 4163, 4165 and 4304, Business and Professions Code; and Section 11209, Health and Safety Code.

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