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 5011 - Storage and Inventory Requirements

Universal Citation: 3 CA Code of Regs 5011

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

(a) Each restricted livestock drug licensee shall store California prescription drugs in a secure, lockable area that shall only be accessible to the qualified individual(s) identified to the Department pursuant to section 5002(a)(2)(F) or section of Title 35002(e) of Title 3 of the California Code of Regulations.

(b) Each restricted livestock drug licensee shall maintain on the premises fixtures and equipment in a clean and orderly condition. California prescription drugs shall be stored in accordance with the storage conditions indicated on the manufacturer's label.

(c) No restricted livestock drug licensee shall sell a California prescription drug except in the container in which it is packaged by the manufacturer or distributor.

(1) A restricted livestock drug licensee may break down case lots of California prescription drugs, so long as the seals on the individual containers are not broken.

(2) A restricted livestock drug licensee shall not open an individual container and count out or measure out any quantity of California prescription drugs.

(d) Each restricted livestock drug licensee shall adhere to the following procedures for handling damaged or outdated California prescription drugs:

(1) California prescription drugs that are outdated, damaged, misbranded or adulterated shall be placed in a quarantine area and physically separated from other drugs until they are disposed of in the manner indicated in the written procedures developed in accordance with Section 5012.

(2) Any California prescription drugs whose immediate or sealed outer or sealed secondary containers have been opened or used shall be identified as such, and shall be placed in a quarantine area and physically separated from other drugs until they are disposed of in the manner indicated in the written procedures developed in accordance with Section 5012.

(e) Each restricted livestock drug licensee shall maintain an inventory of California prescription drugs, shall verify that inventory records are free from errors and inaccuracies, and shall identify and record losses or thefts of California prescription drugs.

(f) All records related to the receipt, storage, inventory, sale, and disposition of California prescription drugs:

(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, 14358 and 14403, Food and Agricultural Code.

Disclaimer: These regulations may not be the most recent version. California may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the state site. Please check official sources.
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