Cal. Code Regs. tit. 3 § 5007

Current through Register 2024 Notice Reg. No. 45, November 8, 2024

Section 5007 - Definitions

For purposes of this chapter, the following definitions apply:

(a) "California prescription drug" means a medically important antimicrobial drug intended for use on livestock that is federally labeled for over the counter sale but requires a prescription to be sold in California pursuant to Chapter 4.5 of Division 7 of the Food and Agricultural Code.

(b) "Extra label use" means actual use or intended use of a drug in an animal in a manner that is not in accordance with the approved labeling. This includes, but is not limited to, use in species not listed in the labeling, use for indications (disease or other conditions) not listed in the labeling, use at dosage levels, frequencies, or routes of administration other than those stated in the labeling, and deviation from the labeled withdrawal time based on these different uses.

(c) "Federal prescription drug" means a drug intended for use on livestock that is labeled with the statement: "Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian."

(d) "Livestock" includes all animals and poultry, including aquatic and amphibian species, that are raised, kept, or used for profit. Livestock does not include bees or those species which are usually kept as pets, such as dogs, cats, and pet birds. "Species that are raised, kept, or used for profit" means:

(1) Livestock that are used for financial gain, commercial use, breeding, competition, or show; or

(2) Livestock whose owners are engaged in business using animals for financial gain, commercial use, breeding, competition, or show.

(e) "Medically important antimicrobial drug" means an antimicrobial drug listed in Appendix A of the federal Food and Drug Administration's Guidance for Industry #152, including critically important, highly important, and important antimicrobial drugs, as that appendix may be amended.

(f) "Pharmacist" means a natural person to whom a license has been issued by the State Board of Pharmacy under Section 4200 of the Business and Professions Code.

(g) "Prescription" means an oral, written, or email order issued by a veterinarian that includes at least the following information:

(1) The name and address of the livestock owner;

(2) The name and quantity of the drug or device prescribed and the directions for use;

(3) The date of issue;

(4) The name, address, and telephone number of the prescribing veterinarian, and;

(5) If in writing, the signature of the prescribing veterinarian.

(h) "Qualified individual" means a person who meets the requirements of Section of Title 35009 of Title 3 of the California Code of Regulations.

(i) "Restricted livestock drug" means any livestock drug which is sold in such form that it might be administered to humans and if so administered would be dangerous to the health of such humans or any livestock drug which if improperly administered to livestock is dangerous to the health of such livestock or to humans who consume products from such livestock. Restricted drugs include all of the following:

(1) Arsenic compounds and preparations;

(2) Diethylstilbestrol and other substances which have a hormonelike action;

(3) Sulfanilamide or substitute sulfanilamides;

(4) Antibiotic preparations, including those medically important antimicrobial drugs federally labeled for over the counter sale listed in Appendix A of the federal Food and Drug Administration's Guidance for Industry #152, including critically important, highly important, and important antimicrobial drugs, as that appendix may be amended;

(5) Type A Medicated Articles as defined in Section 558.3(b)(2) of Title 21 of the Code of Federal Regulations (8/24/2016), which is hereby incorporated by reference, and

(6) Any drug that has a withdrawal period.

(j) "Restricted livestock drug licensee" is a location licensed pursuant to Article 3 of Chapter 1 of Division 5 of Title 3 of the California Code of Regulations where sales of restricted livestock drugs occur.

Cal. Code Regs. Tit. 3, § 5007

1. New chapter 2 (articles 1-4, sections 5007-5015), article 1 (section 5007) and 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 14203, 14321, 14400, 14403 and 14405, Food and Agricultural Code.

1. New chapter 2 (articles 1-4, sections 5007-5015), article 1 (section 5007) and section filed 8-16-2018; operative 8/16/2018 pursuant to Government Code section 11343.4(b)(3) (Register 2018, No. 33).