Federal Regulatory

06 July

FDA highlights potential health risks to people exposed to altrenogest products for horses or pigs

wsvma   |   Federal Regulatory, One Health

The U.S. Food and Drug Administration is alerting veterinary medical professionals, as well as those who work with horses and pigs, that a synthetic progesterone product commonly used in these animals may cause reproductive system disorders and other adverse effects in people who become exposed to the drug. The FDA is providing this alert because of the nature of the adverse events, some of which have occurred in teenage girls. Altrenogest belongs to the class of drugs called progestins and is...

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27 April

FDA Answers VFD Audit Questions in Upcoming Webinar

wsvma   |   Federal Regulatory

With implementation of the Veterinary Feed Directive (VFD) changes now over a year underway, the FDA inspection process is expected to happen more frequently in the coming months. GlobalVetLINK (GVL®) is hosting VFD Audit Process Q&A, a free webinar to help the industry better understand the VFD inspection process, on Wednesday, May 9, 2018 at 10:00 pa.m. (PDT). The VFD Audit webinar will address the inspection process, documentation concerns, challenges with implementation, and the FDA’s responses to questions from the industry. The...

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19 January

Certificate of Veterinary Inspection APHIS Form 7001 for interstate travel no longer approved

wsvma   |   Federal Regulatory

Effective immediately, APHIS Form 7001 "United States lnterstate and lnternational Certificate of Health Examination for Small Animals" is no longer approved for the purpose of interstate movement of animals. Please be aware that numerous other states, in addition to Washington, no longer accept this form due to the free access to the public for download off the internet without any accountability as to who uses the form. The Department will still accept paper copies of the APHIS Form 7001, as long as...

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10 November

FDA Withdraws Draft Guidance for Animal Drug Compounding

wsvma   |   Federal Regulatory

The U.S. Food and Drug Administration is withdrawing draft Guidance for Industry (GFI) #230, “Compounding Animal Drugs from Bulk Drug Substances” in order to clarify that the agency does not plan to finalize the current draft, but instead intends to issue a new draft for public comment next year. The draft guidance issued in May 2015 proposed conditions under which the FDA generally would not intend to take action against the compounding of animal drugs from bulk drug substances, with the...

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28 July

Update to original FDA warning about labeling changes to critical care medications for people

wsvma   |   Federal Regulatory

July 27, 2017 – The FDA alerts veterinarians and veterinary pharmacologists that the strength of epinephrine might be expressed differently on the labeling on certain human and animal epinephrine products. To avoid dosing errors in animals, the FDA recommends that veterinarians carefully review an epinephrine product’s labeling before administering the drug to determine if strength is expressed as mg/mL or as a ratio. The FDA also recommends that veterinary emergency dosage charts include epinephrine products that are labeled both ways...

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22 June

Important Labeling Changes to Critical Care Medications for People

Sherri Dean   |   Federal Regulatory

The U.S. Food and Drug Administration is requiring labeling changes to three critical care medications that are approved for use in people and are also used in animals in the practice of veterinary medicine. Veterinarians who use these products in animals should be aware of these changes. The labeling changes affect epinephrine injection, isoproterenol hydrochloride injection, and neostigmine methylsulfate injection for use in people. The FDA is requiring drug manufacturers to remove ratio expressions of strength (such as 1:1,000 and 1:10,000)...

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27 January

Be careful when issuing International Health Certificates

wsvma   |   Federal Regulatory, Uncategorized

Finding current requirements for correctly issuing International Health Certificates for movement of pets to foreign destinations is an essential task for USDA accredited veterinarians. Because these requirements are determined by the country to which the animals are destined, and not by USDA APHIS Veterinary Services, they can change, and may do so on a frequent basis due to disease outbreaks, or political or economic factors. For that reason, specific requirements based on the country of destination, type of animal, and...

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13 January

Ban on powdered gloves takes effect January 18

wsvma   |   Federal Regulatory, Uncategorized

Under a rule issued by the U.S. Food and Drug Administration (FDA), powdered gloves will no longer be available for use in veterinary medicine beginning January 18. According to FDA officials, the ban includes powdered patient examination gloves, powdered surgeon’s gloves, and also the absorbable powder for lubricating a surgeon’s glove. The FDA made good on their promise by finalizing the ban on powdered gloves used in surgery and medicine because of the dangers they pose to human health. Many health...

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06 January

Veterinary Feed Directive Module – Now Available

wsvma   |   Federal Regulatory, Uncategorized

USDA’s Animal and Plant Health Inspection Service’s (APHIS) National Veterinary Accreditation Program (NVAP) is announcing the availability of a new training, Module 29 Veterinary Feed Directive. NVAP worked with the Food and Drug Administration’s (FDA) Center for Veterinary Medicine and Iowa State’s Center for Food Security and Public Health to create this training. Upon completion of this module, participants will be able to: Describe the need for antibiotic stewardship in regard to antibiotic resistance; Understand the FDA's regulatory oversight of animal drugs; Describe...

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16 December

FDA bans powdered gloves

wsvma   |   Federal Regulatory, Uncategorized

The FDA made good on their promise by finalizing a proposed ban on powdered gloves used in surgery and medicine because of the dangers they pose to human health. Many health systems already ban the gloves and professional societies and clinicians have advocated for the ban due to potentially serious adverse events that include severe airway inflammation, lung inflammation and damage, allergic reactions including asthma, hypersensitivity reactions, granulomas and peritoneal adhesions. While most device removals stem from the manufacturer, this is...

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