Federal Regulatory

FDA Withdraws Draft Guidance for Animal Drug Compounding

  |   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The U.S. Food and Drug Administration is withdrawing draft Guidance for Industry (GFI) #230, “Compounding Animal Drugs from Bulk Drug Substances” in order to clarify that the agency does not plan to finalize the current draft,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 The draft guidance issued in May 2015 proposed conditions under which the FDA generally would not intend to take action against the compounding of animal drugs from bulk drug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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Update to original FDA warning about labeling changes to critical care medications for people

  |   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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Important Labeling Changes to Critical Care Medications for People

  |   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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Be careful when issuing International Health Certificates

  |   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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Ban on powdered gloves takes effect January 18

  |   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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Veterinary Feed Directive Module – Now Available

  |   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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FDA bans powdered gloves

  |   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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Are you prepared for the Veterinary Feed Directive?

  |   Federal Regulatory, Uncategorized

The new Veterinary Feed Directive (VFD) requirement, which is intended to control the development of drug resistant organisms by decreasing antimicrobial use, kicks in Jan. 1. The VFD eliminates the use of medically-important antibiotics for growth promotion in livestock and poultry, although these medications will still be available for the use of prevention, treatment and control of diseases under the supervision of a veterinarian. Veterinarians must write a VFD whenever medications are to be administered in food or water. The...

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Federal overtime rule blocked by Texas court

  |   Federal Regulatory, Uncategorized

In U.S. District Court in Texas, the judge granted a preliminary injunction in a lawsuit that challenges the Dept. of Labor’s authority to raise the salary threshold. The federal overtime exemption rule that was due to take effect Dec. 1 expanded time and a half pay for salaried employees in the public and private sectors who work more than 40 hours per week. It’s unclear what the outcome will be for the rule. The injunction is not permanent and the...

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Minimum wage climbing to $11 in 2017 as a result of November election

  |   Federal Regulatory, Uncategorized

The minimum wage in Washington will increase to $11 an hour starting on Jan. 1, 2017. The new minimum wage, a result of the passage of Initiative 1433, applies to all jobs, including those in agriculture. Workers under 16 years old can be paid 85 percent of the adult minimum wage, or $9.35 per hour, in 2017. In addition to minimum wage, the initiative addresses paid sick leave. Seattle, Tacoma, and the City of SeaTac have higher minimum wage rates for...

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