California Code of Regulations
Title 16 - Professional and Vocational Regulations
Division 17 - California State Board of Pharmacy
Article 2 - Pharmacies
Section 1707 - Waiver Requirements for off-Site Storage of Records

Universal Citation: 16 CA Code of Regs 1707

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

(a) Pursuant to subdivision (e) of Section 4105 of the Business and Professions Code and subdivision (c) of Section 4333 of the Business and Professions Code, a waiver may, on a case-by-case basis, be granted to any entity licensed by the board for storage of the records outside the licensed area of the pharmacy described in subdivisions (a), (b) and (c) of Section 4105 of the Business and Professions Code. The board may consider space limitations within the pharmacy, cost, previous compliance with records requirements, ease of access to records stored outside of the licensed area, and any other factor presented by the licensee in making its determination.

(b) An entity that is granted a waiver pursuant to subdivision (a) shall:

(1) maintain the storage area so that the records are secure, including from unauthorized access; and

(2) be able to produce the records within two business days upon the request of the board or an authorized officer of the law.

(c) In the event that a licensee fails to comply with the conditions set forth in subdivision (b), the board may cancel the waiver without a hearing. Upon notification by the board of cancellation of the waiver, the licensee shall maintain all records at the licensed premises.

(d) A licensee whose waiver has been cancelled pursuant to the provisions set forth in subsection (c) may reapply to the board when compliance with the conditions set forth in subsection (b) can be confirmed by the board.

(e) Notwithstanding any waiver granted pursuant to subdivision (a), all prescription records for non controlled substances shall be maintained on the licensed premises for a period of one year from the date of dispensing.

(f) Notwithstanding any waiver granted pursuant to subdivision (a), all prescription records for controlled substances shall be maintained on the licensed premises for a period of two years from the date of dispensing.

(g) Notwithstanding the requirements of this section, any entity licensed by the board may store the records described in subdivisions (a), (b) and (c) of Section 4105 of the Business and Professions Code in a storage area at the same address or adjoining the licensed premises without obtaining a waiver from the board if the following conditions are met:

(1) The records are readily accessible to the pharmacist-in-charge (or other pharmacist on duty, or designated representative) and upon request to the board or any authorized officer of the law.

(2) The storage area is maintained so that the records are secure and so that the confidentiality of any patient-related information is maintained.

1. New section filed 9-20-2000; operative 10-20-2000 (Register 2000, No. 38). For prior history, see Register 82, No. 2.
2. Change without regulatory effect amending subsection (g)(1) filed 12-18-2007 pursuant to section 100, title 1, California Code of Regulations (Register 2007, No. 51).
3. Amendment of subsection (a) filed 5-18-2021; operative 7-1-2021 (Register 2021, No. 21). Filing deadline specified in Government Code section 11349.3(a) extended 60 calendar days pursuant to Executive Order N-40-20 and an additional 60 calendar days pursuant to Executive Order N-71-20.

Note: Authority cited: Section 4005, Business and Professions Code. Reference: Sections 4081, 4105 and 4333, Business and Professions Code.

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