Today's Law As Amended

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SB-835 Food animals: medically important antimicrobial drugs.(2013-2014)



SECTION 1.

 Section 14288 of the Food and Agricultural Code is amended to read:

14288.
 The director secretary  shall refuse to register a livestock drug if he or she  finds any of the following is true of the drug:
(a) It is of little or no value for the purpose for which it is intended to be used.
(b) It is dangerous to the health of livestock if used in accordance with the instructions.
(c) The instructions for use do not contain adequate warnings against use in those conditions, whether pathological or normal, under which its use may be dangerous to the health of livestock or humans who consume products from such the  livestock, or against unsafe dosage, unsafe duration of use, or unsafe methods of administration.
(d) If the application and the accompanying material, data, and information do not comply with the requirements of this chapter or are insufficient to permit the director secretary  to make the determinations which that  are required by this section.
(e) It is a medically important antimicrobial drug, as defined in Section 18770, that is administered to food animals, as defined in Section 4825.1 of the Business and Professions Code, through feed or drinking water, unless the drug complies with Section 18771.

SEC. 2.

 Article 4.5 (commencing with Section 18770) is added to Chapter 4 of Part 3 of Division 9 of the Food and Agricultural Code, to read:

Article  4.5. Medically Important Antimicrobial Drugs
18770.
 For purposes of this article, the following definitions apply:
(a) “FDA” means the federal Food and Drug Administration.
(b) “Food animal” has the same meaning as defined in subdivision (c) of Section 4825.1 of the Business and Professions Code.
(c) “Medically important antimicrobial drug” means an antimicrobial drug listed in Appendix A of the FDA Guidance for Industry #152, including a critically important, highly important, and important antimicrobial drug, as that appendix may be amended, unless the secretary determines that the amendment to the appendix includes a drug that is not a critically important, highly important, or important antimicrobial drug.
(d) “Veterinary feed directive” is the directive described in Section 354 of Title 21 of the United States Code.
18771.
 To comply with FDA Guidance for Industry #213, dated December 2013, a medically important antimicrobial drug, including a combination drug incorporating a medically important antimicrobial drug, shall meet all of the requirements in the guidance document, including, but not limited to, the following:
(a) To reflect the need for professional oversight by a licensed veterinarian, the manufacturer shall remove from the approved production uses on the label of the medically important antimicrobial drug or combination drug the production indications, including, but not limited to, “increased rate of weight gain” or “improved feed efficiency.”
(b) The manufacturer shall revise the condition of the use of the medically important antimicrobial drug or combination drug from over the counter availability to a marketing status requiring veterinary prescription, including, but not limited to, the following:
(1) For medicated feed products, a change from over the counter to veterinary feed directive.
(2) For medicated drinking water products, a change from over the counter to veterinary prescription.
(c) When administered through feed or drinking water, the medically important antimicrobial drug may only be used to treat, prevent, or control disease under the supervision of, or by prescription from, a licensed veterinarian.
18772.
 A person shall not administer a medically important antimicrobial drug through feed or drinking water except pursuant to a veterinarian-client-patient relationship to ensure the drug is used in a manner that is consistent with professionally accepted best practices. For the purposes of this section, a “veterinarian-client-patient relationship” is a relationship meeting the requirements of Section 2032.1 of Title 16 of the California Code of Regulations.
18773.
 (a) (1) If a medically important antimicrobial drug, or combination drug, for use in food animals is registered with the department as of January 1, 2015, and the drug does not comply with Section 18771, the manufacturer of the medically important antimicrobial drug, or combination drug, shall have until January 1, 2017, to reregister the drug with the secretary. The secretary shall refuse to reregister the drug unless it complies with Section 18771.
(2) Notwithstanding paragraph (1), if a drug label reviewed by the FDA under the Guidance for Industry #213 is delayed beyond January 1, 2017, the secretary shall have the authority to continue registering the drug during the FDA’s review period.
(3) If revisions to the veterinary feed directive cause the FDA to delay implementation of the Guidance for Industry #213, the secretary shall have the authority to extend the time period by which a manufacturer is required to reregister the drug pursuant to paragraph (1) to be consistent with the delay in the implementation of the guidance. If the secretary extends the time period for reregistration, the extension shall not be later than the federal implementation date of the guidance.
(b) If revisions to the veterinary feed directive cause the FDA to revise the Guidance for Industry #213, the secretary shall have the authority to promulgate regulations to ensure that California law is consistent with the revisions to the guidance.
SEC. 3.
 No reimbursement is required by this act pursuant to Section 6 of Article XIII B of the California Constitution because the only costs that may be incurred by a local agency or school district will be incurred because this act creates a new crime or infraction, eliminates a crime or infraction, or changes the penalty for a crime or infraction, within the meaning of Section 17556 of the Government Code, or changes the definition of a crime within the meaning of Section 6 of Article XIII B of the California Constitution.