Antimicrobial Use and Stewardship

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Livestock: Use of Antimicrobial Drugs

There is growing concern that antimicrobial use in livestock is associated with the development of antimicrobial resistance in human pathogenic bacteria. While there is deficient evidence to support or deny antimicrobial use in livestock as the source for antimicrobial resistance in humans, resistance is a real and natural event that is accelerated with the use of antibiotics. California Senate Bill 27 (Hill) was signed by Governor Brown on October 10, 2015 with the intent to preserve the efficacy and ensure current and future availability of antibiotics for use in livestock while minimizing the potential public health impact. The bill resulted in additions to the California Food and Agricultural Code (Division 7, Chapter 4.5, Sections 14400-14408) that address use of medically important antimicrobial drugs in livestock, development of antimicrobial drug stewardship programs and best management practices, and surveillance of antimicrobial use and practices as well as antimicrobial resistance patterns in bacteria.

In California, effective January 1st of 2018, over the counter injectable and all other medically important antimicrobials must be administered with a prescription or veterinary feed directive (VFD) ordered by a California licensed veterinarian with a valid veterinarian-client-patient relationship (VCPR). The law requires the California Department of Food & Agriculture to ensure that livestock producers in rural areas continue to have timely access to antimicrobials. Note that these changes are separate from the federal regulations regarding antimicrobials in feed and water that became effective on January 1, 2017. For more information on the current FDA regulations read the following section and links under the VFD tab.


FDA’s current regulations regarding Medicated Feed and Drinking Water

Through efforts initiated by the FDA (as described in GFI #213, link provided under Documents (GFIs) tab) drug sponsors have voluntarily agreed to remove production uses from labels for medicated feeds and drink water products containing medically important antimicrobial drugs. Further, the sponsors have added to the label the need for veterinary oversight. In the case of medically important drugs used in or on feed this means a VFD order from a veterinarian with a valid VCPR is required. For medicated drinking water containing medically important antimicrobial drugs a prescription written by a California licensed veterinarian with a valid VCPR is required. These new requirements went into effect as of January 1, 2017. FDA has required information for a VFD order but not a required form. VFD order templates are available and companies are offering electronic services for VFDs. A key point regarding the VFD order is that it is nonverbal; oral communication will not be accepted by FDA. Note the veterinarian must sign the VFD. Find specific information under the Drug Order, Drug Label & Recordkeeping Requirements tab. For more information regarding these changes please look at the VFD tab and if your question is not answered then contact FDA: AskCVM@fda.hhs.gov

GFI #152 Appendix A identifies Medically, Highly, and Critically important antimicrobials. If an antimicrobial you use fits within a named class then FDA will consider it important. FDA also considers sulfonamides as important. GFI #209 Introduces veterinary oversight and only necessary use as guiding principles. GFI #213 Explains the changes FDA wants to see for the mass use of antimicrobial drugs (Feed and Water).
Livestock: Use of Antimicrobial Drugs (FAC § 14400 – 14408) California law effective as of January 1st, 2018. AUS Strategic Plan CDFA AUS finalized and approved plan to implement the aforementioned law.
Postcard (Letter) Printable mailer for distribution to producers (A5) Leaflet (Legal) Printable pocket sized brochure for distribution to producers. Poster (Letter) Printable poster for sale yards, feed stores, or producers.
VFD Regulations The Federal Register VFD Regulations Q & A GFI #120: VFD regulation Q&A VFD Requirements for Producers FDA material that can be printed as a brochure VFD Requirements for the Veterinarian FDA material that can be printed as a brochure VFD Distributor Notification List Who plans to sell VFD feed VFD Requirements for the Distributor that also manufactures VFD feed FDA material that can be printed as a brochure VFD Requirements for the Distributor that does not manufacture feed FDA material that can be printed as a brochure VFD Overview Video VFD Video for the Veterinarian VFD Video for Distributors Questions for FDA: AskCVM@fda.hhs.gov



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