California Code of Regulations
Title 3 - Food and Agriculture
Division 5 - Livestock Drugs
Chapter 2 - Sales of California Prescription Drugs
Article 3 - Additional Requirements
Section 5013 - Pharmacist Oversight

Universal Citation: 3 CA Code of Regs 5013

Current through Register 2024 Notice Reg. No. 38, September 20, 2024

(a) Each restricted livestock drug licensee shall either retain a consulting pharmacist or employ a pharmacist on staff.

(b) If a restricted livestock drug licensee chooses to retain a consulting pharmacist, the consulting pharmacist shall complete the following on a quarterly basis:

(1) Review, approve, and revise the restricted livestock drug licensee's store-specific written operating procedures as defined in Section 5012(a) of this chapter.

(2) Ensure the restricted livestock drug licensee is following all written procedures and is maintaining all records required pursuant to Sections 5004 and 5011(f).

(3) Issue a signed, written certification stating whether or not the restricted livestock drug licensee is operating in compliance with California law and regulations regarding California prescription drugs.

(c) The consulting pharmacist shall notify the Department within ten (10) days if the restricted livestock drug licensee is not in compliance with California law and regulations regarding California prescription drugs.

(d) If a restricted livestock drug licensee chooses to employ a pharmacist on staff, the staff pharmacist shall:

(1) Review, approve, and revise the restricted livestock drug licensee's store-specific written operating procedures as defined in Section 5012(a) of this chapter.

(2) Ensure the restricted livestock drug licensee is following all written procedures and is maintaining all records required pursuant to Sections 5004 and 5011(f).

(3) A pharmacist employed by a restricted livestock drug licensee shall be exempt from the following provisions of this chapter:
(A) Prohibition on the sale of a California prescription drug on the basis of an oral order as specified in Section 5010(b).

(B) Prohibition on the sale of a California prescription drug for an extralabel use as specified in Section 5010(b)(1).

(e) The restricted livestock drug licensee shall disclose to the Department if the consulting or staff pharmacist has an ownership or financial interest in the location.

(f) All records pertaining to this section:

(1) Shall be retained for a period of not less than three (3) years from the date of creation.

(2) Are subject to audit by the Department and shall be made available to the Department upon request.

1. New section filed 8-16-2018; operative 8-16-2018 pursuant to Government Code section 11343.4(b)(3) (Register 2018, No. 33).

Note: Authority cited: Sections 407, 14231, 14403 and 14405, Food and Agricultural Code. Reference: Sections 14295, 14327, 14330, 14403 and 14405, Food and Agricultural Code.

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