Latest News From Veterinary Regulations

Iowa Governor Announces Funding for ISU Veterinary Diagnostic Lab

Iowa Gov. Kim Reynolds announced $40 million in funding to help complete Phase 2 of Iowa State University’s Veterinary Diagnostic Laboratory. Here's why it matters to all of animal agriculture.

FDA to Resume Enforcement of all Federal VCPR Requirements for Veterinary Telemedicine

The effective date of the decision is Feb. 21, which means that the FDA will again hold veterinarians to the federal requirements for the veterinarian-client-patient relationship beginning on that date

FDA Issues Draft Guidance on Donor Eligibility and Manufacturing of Cellular Therapies for Animals

“ACTPs have the potential to make significant changes in how we treat diseases and may provide novel therapies for unmet therapeutic needs of animals,” reports Dr. Janet Woodcock, Acting Commissioner of the FDA.

New Online Resource for Animal Drug Label Updates From FDA

The agency says the information is being provided “in an effort to improve transparency and communication with veterinarians and the public.”

USDA Hands Responsibility of RFID Traceability Efforts to APHIS

The agency announced it will not finalize a plan introduced by the Trump Administration, instead handing control of rulemaking to its Animal and Plant Health Inspection Service.

Changes to the use conditions of these products will be based on science and available evidence, and the FDA believes this RFA will help generate such information.
FDA Offers Funds for Duration of Use Studies

Research needed to help define duration of use for certain medically important antimicrobial drugs for food animals.

FDA’s 2018 Summary Report on Antimicrobials Sold or Distributed for Use in Food-Producing Animals showed domestic sales and distribution increased 9% between 2017 and 2018.
Antibiotic Rules Continue to Evolve

Market forces and regulatory actions will drive emphasis on disease prevention and antibiotic stewardship.

Most livestock antibiotics now sold over the counter will require a veterinarian's prescription in the near future.
Prepare for More Antibiotic Rules

Market forces and regulatory actions will drive emphasis on disease prevention and antibiotic stewardship.

John Maday
New Year, Same Issue

As we enter a new year and a new decade, antibiotic stewardship remains on the top of issues affecting food-animal veterinarians.

Sales of antimicrobial products for use in food animals dropped dramatically during 2017, the first full year of implementation for FDA’s Guidance for Industry 213 and veterinary feed directive (VFD) rules.
Antimicrobial Sales Post Moderate Increase in 2018

FDA’s annual summary report on antimicrobial sales for use in food animals shows a small year-over-year increase in 2018, but the total remains well below pre-VFD levels.

The Animal Health Regulatory Affairs Graduate Certificate combines the knowledge of animal science and veterinary medicine with skills needed to navigate governmental processes and regulations throughout the product lifecycle.
K-State Offers Regulatory Affairs Certificate  

Kansas State University's Olathe campus is now offering a premier graduate certificate designed for the regulatory affairs sector of the animal health industry.

Cattle producers using ECTR to report ownership changes and out-of-state movement could save up to 39 percent compared to using traditional livestock inspections.
Washington Streamlines Cattle Transaction Reporting

The Washington State Department of Agriculture (WSDA) is now offering Washington ranchers a quicker, more cost-effective way to report cattle sales and out-of-state movement of their cattle.

Cannabidiol (CBD) is a non-psychoactive  component of cannabis plants
FDA Cracks Down on Unapproved CBD Products

Over the past few years, cannabidiol (CBD) has become wildly popular as a dietary supplement and “natural” treatment for a laundry list of health conditions in humans and animals.

The new draft guidance is titled “Compounding Animal Drugs from Bulk Drug Substances.”
FDA Hosts Webinar on Animal Drug Compounding

On November 21, 2019, at 1:00-2:30 p.m. EST, the FDA's Center for Veterinary Medicine will hold a public webinar about the agency’s newly-released draft Guidance for Industry #256.

FDA previously published a draft guidance (Draft GFI #230) on this issue in 2015, but withdrew the draft based on stakeholder comments, intending release a revised draft at a later date.
FDA Revises Draft GFI on Compounding Animal Drugs

Animal drug compounding can provide tailored treatments for patients or conditions not easily addressed with FDA-approved drugs, but the practice also entails some risks.

GVL updated the workflows for digital certificates including CVIs and VFDs.
GVL Redesigns its Veterinary Software Platform

Updates to navigation and functionality affect all GVL users.

The program hosts at least 30 different committee and subcommittee meetings with hundreds of experts speaking throughout the seven-day annual event.
123rd U.S. Animal Health Association Meeting Kicks Off

The United States Animal Health Association (USAHA), the nation's animal health forum for over a century, is holding its 123rd annual meeting in Providence, Rhode Island, from Oct. 24-30. I

Some labels don’t have specified duration of use and FDA is working to collect more information for science-based duration-of-use guidelines.
Five Animal Health Topics to Think About

Behind the scenes, animal health officials are working on behalf of producers and the livestock industry.

The site includes graphic illustrations showing trends associated with the five-year plan.
FDA Announces Veterinary AMR Performance Measures on FDA-TRACK

Performance measures track the progress of the Center of Veterinary Medicine’s (CVM) Five-Year Plan for Supporting Antimicrobial Stewardship in Veterinary Settings.

The U.S. Food and Drug Administration this week released draft Guidance for Industry, entitled “Eligibility Criteria for Expanded Conditional Approval of New Animal Drugs.”
FDA Issues Draft GFI on Conditional Drug Approvals

Expanded conditional approval has the potential to incentivize drug development and provide veterinarians with legally marketed new animal drugs.

The new guidance would include dosage forms including injectable or intra-mammary antibiotic products now available over the counter for use in beef and dairy cattle.
FDA Releases Draft GFI to End OTC Sales of Most Animal Antibiotics

Proposal would bring remaining approved over-the-counter medically important antimicrobial drugs used for animals under veterinary oversight.

The draft guidance covers dosage forms such as injectable or intra-mammary antibiotic products now available over the counter for use in beef and dairy cattle.
FDA Releases Draft GFI to End OTC Sales of Most Animal Antibiotics

The proposal would bring remaining approved over-the-counter medically important antimicrobial drugs used for animals under veterinary oversight.

The comment period will now close on January 6, 2020.
FDA Extends Comment Period on Withdrawal Times

On September 11, 2019, the FDA extended the comment period for its request for public input on zero-day withdrawal periods and zero-day milk discard times for animal drugs.

Before and after the current Veterinary Feed Directive rules took full effect in January, 2017, the FDA focused primarily on education and outreach.
FDA Reports on VFD Compliance

On August 29, FDA released its first report on inspection and compliance activities.

John Maday
New FDA Guidance Clarifies Labeling for Drugs Used in Feed

The FDA has issued a new Guidance for Industry (GFI #181), which provides content and format regulations for the representative “Blue Bird” labeling to be used for Type B and Type C medicated feeds.

The final rule does not establish new tolerances.
FDA issues Final Rule on Residue-Tolerance Standards

The FDA’s Center for Veterinary Medicine this week issued a final rule, “New Animal Drugs; Updating Tolerances for Residues of New Animal Drugs in Food.”

FDA has approved Monovet 90 for use in cattle fed in confinement for slaughter for improved feed efficiency; and prevention and control of coccidiosis.
FDA Approves Generic Monensin Product

The U.S. Food and Drug Administration has approved Monovet 90, manufactured by Huvepharma EOOD, the first generic monensin for use in cattle and goats.

Individual samples would be required for most trichomoniasis testing under the proposed TAHC rules.
TAHC Proposes New Rules for Trich, BVD

The Texas Animal Health Commission (TAHC) has proposed a Bovine Viral Diarrhea Virus (BVDV) control program, including designating BVDV as a reportable disease.

Ionophores and chlortetracycline were the antimicrobials fed on the highest percentages of feedlots.
NAHMS Reports Baseline Data on Antimicrobial Stewardship

New data from the National Animal Health Monitoring System (NAHMS) provides a baseline for antibiotic trends in food animal during 2016, prior to implementation of key rule changes.

After reviewing comments, APHIS made considerable effort to address all concerns while maintaining program integrity.
APHIS Finalizes CWD Herd Certification Program Standards

The USDA's Animal and Plant Health Inspection Service has finalized the Chronic Wasting Disease Herd Certification Program Standards that were originally published on March 29, 2018 for stakeholder feedback.

If animals change ownership but remain under the care of the same caretakers, the existing VFD remains valid.
Part 2: Webinar Addresses VFD Questions

In late March, FDA released its draft Guidance for Industry 120, which aims to address questions that emerged since implementation of the current Veterinary Feed Directive rules in 2017.

FDA will accept comments on the draft GFI until May 28.
Part 1: Webinar Addresses VFD Questions

When the FDA issued its final VFD rules back in 2015, they also released a draft guidance for industry offering answers to anticipated questions regarding application of the rules in common and unusual circumstances.

These courses are RACE Approved for CE credits for Veterinarians and Veterinary Technicians.
CFSPH Updates Immunology and Vaccinology Courses

The Center for Food Security and Public Health at the Iowa State University College of Veterinary Medicine has launched updated versions of two of its online veterinary immunology and principles of vaccinology courses.

The site contains web links for obtaining premises identification numbers (PIN) and location identifiers (LID) within livestock producers' respective States.
USDA APHIS Launches Interactive Map for Premises ID

The United States Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) launched an interactive website that provides livestock producers with important information.

The first webinar, scheduled for Tuesday, May 14, 2019, at 12:00 pm Central Time, will focus on questions and answers as they apply to veterinarians.
Webinar to Outline FDA’s Update to VFD Policies

Earlier this year, the FDA provided updates to its Draft Guidance for Industry (GFI) 120, based on stakeholder questions regarding details around the veterinary feed directive (VFD) rules.

The new standards aim to speed approval of new technology in official identification devices.
APHIS Revises Standards for ADT Tags

In recent months, APHIS has revised the Animal Disease Traceability program standards for approving new tags entering the market.

The single-tier system should help streamline the vaccine approval process while making labels easier to understand.
USDA Simplifying Vaccine Labels

For years, the USDA has used a “tiered” system for claims on vaccine labels, which added complexity to pre-license trials and tended to create confusion for users.

Wildlife populations can serve as reservoirs for brucellosis and tuberculosis, but extensive surveillance entails significant costs.
USDA Withdraws Proposed Change to TB, Brucellosis Programs

Based on comments received regarding a proposed rule, USDA’s Animal and Plant Health Inspection Service (APHIS) announced this week it will partially withdraw the proposal.

The revised draft guidance adds 53 new Q&As and revises 14 on a wide range of topics related to the VFD final rule.
FDA Draft Guidance Updates VFD Q&A

When the FDA issued its final veterinary feed directive (VFD) rules back in 2015, they also released a draft guidance for industry (GFI) offering answers to anticipated questions.

Scientific studies show that sheep with certain genotypes are resistant to or less susceptible to classical scrapie and are unlikely to get the disease.
USDA Updates Scrapie Regulations and Program Standards

The U.S. Department of Agriculture’s (USDA) Animal Plant Health and Inspection Service (APHIS) is updating its scrapie regulations and program standards. 

Use of antimicrobials for growth promotion has declined from 60 to 45 countries since the last round of data collection.
OIE Report Shows Global Progress on Use of Antibiotics in Animals

Efforts toward improving stewardship of antibiotics in livestock production have gained momentum worldwide, with more countries regulating antibiotic use and collecting data to document trends.

John Maday
"And Now for Something Completely Different"

Our editorial team has developed a comprehensive package of content focused on Cannabis and its potential across U.S. agriculture.

John Maday
Headed in the Right Direction

U.S. sales of medically important antimicrobials for use in food animals dropped considerably last year according to the latest summary report from the FDA. The decline in 2017 accelerated a trend that began in 2016.

John Maday
Headed in the Right Direction

U.S. sales of medically important antimicrobials for use in food animals dropped considerably last year according to the latest summary report from the FDA. The decline in 2017 accelerated a trend that began in 2016.

APHIS has required permanent identification for imported Mexican cattle to improve traceability and help prevent spread of tuberculosis and brucellosis, which remain endemic in parts of Mexico.
USDA Modifies Branding Requirements for Mexican Cattle

The USDA’s Animal and Plant Health Inspection Service (APHIS) has published a final rule updating requirements for identifying cattle imported to the United States from Mexico.

The Minor Use and Minor Species Animal Health Act of 2004 helps veterinary pharmaceutical companies and others overcome the financial roadblocks they face in providing animal drugs for a limited market.
FDA Taking Grant Applications for Minor Use and Minor Species Drugs

The FDA this week announced an open period for applications for grants to support the development of new animal drugs intended to treat uncommon diseases (minor uses) in major species, or to treat minor species (MUMS).

USDA will phase out free metal tags for official ID, and initiate a cost-sharing program for radio-frequency tgs.
USDA Outlines Steps for Advancing Animal Disease Traceability

Plan includes cost-sharing for electronic ID, birth-to-slaughter traceability.

FDA audits typically begin with the feed distributor, with follow-up visits with veterinarians and producers when inspectors find inconsistencies. (John Maday)
VFD Audits: What to Expect

Follow the rules, keep good records and you shouldn’t have to worry about FDA audits.

AVMA joins several professional organizations in supporting stronger, standardized licensure requirements for veterinarians and technicians.
Veterinary organizations support strong licensure requirements

The AVMA, AAVSB, AAVMC and NAVTA have released a statement of support for licensing requirements. These groups are working to standardize and improve licensure standards for veterinarians and veterinary technicians.

AVMA sees the act as vital for increasing veterinary access to drugs approved by the U.S. Food and Drug Administration (FDA).
AVMA Welcomes Passage of Animal Drug User Fee Legislation

​The American Veterinary Medical Association (AVMA) applauds House and Senate lawmakers for their passage of the Animal Drug and Animal Generic Drug User Fee Amendments of 2018 (H.R. 5554/S.2434.