Federal Regulatory

FDA releases new draft guidance on compounded animal drugs

  |   Federal Regulatory

The FDA is requesting public comment on new draft guidance for industry (GFI) #256, “Compounding Animal Drugs from Bulk Drug Substances.” The new guidance, if finalized, would guide veterinarians on situations where FDA does not intend to take action for certain violations when pharmacists and veterinarians compound animal drugs from bulk substances. In 2015, FDA published draft guidance on the issue of compounding animal drugs, but after receiving comments from veterinary groups and other stakeholders, they withdrew the draft guidance to...

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New DEA reporting system for suspicious orders of controlled substances

  |   Federal Regulatory

On October 23, 2019, the Drug Enforcement Administration (DEA) announced the launch of the Suspicious Orders Report System (SORS) Online, a new centralized database, where DEA registrants, including veterinarians, must report suspicious orders of controlled substances. The announcement has confused veterinarians as to what they’re required to report. Staff at the AVMA’s Governmental Relations Division contacted the DEA and received clarification on what the new reporting system means for veterinarians. The good news is that the impact is minimal, but...

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Keep your controlled drug house in order or the DEA might be paying you a visit

  |   Federal Regulatory

As reported by the American Animal Hospital Association, the Drug Enforcement Administration (DEA) released its 2020 work plan to diversion investigators on October 1. In response to the opioid crisis, the plan outlines increased enforcement and the use of administrative resources that will be dedicated to identifying prescribers – including veterinarians – that are dispensing disproportionately large amounts of controlled drugs. With recent charges against a growing number of veterinarians for noncompliance and failure to prevent diversion, the profession has...

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Take action now on prescription mandate legislation – every letter will make a difference

  |   Federal Regulatory

Important news: Prescription mandate legislation, the misleadingly-named Fairness to Pet Owners Act (H.R. 1607/S.1290), has now been introduced in the House and Senate. This legislation is gaining momentum and we urgently need you to tell your lawmakers to oppose this bill.  This legislation would require veterinarians to provide clients with copies of all companion-animal prescriptions, regardless of whether the client wants one or whether the prescription is ultimately dispensed by the veterinarian or filled by a pharmacy. This proposed prescription mandate is...

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FDA Commissioner’s statement on the agency’s regulation of products containing cannabis and cannabis-related compounds

  |   Federal Regulatory

The Agriculture Improvement Act of 2018 was signed into law in December. Among other things, this new law changes certain federal authorities relating to the production and marketing of hemp, defined as cannabis (Cannabis sativa L.), and derivatives of cannabis with extremely low (less than 0.3 percent on a dry weight basis) concentrations of the psychoactive compound delta-9-tetrahydrocannabinol (THC). These changes include removing hemp from the Controlled Substances Act, which means that it will no longer be an illegal substance...

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FDA approves new opioid safety policy – what it means for veterinarians

  |   Federal Regulatory

The FDA has announced new safety measures for opioids in the Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS). Earlier this fall, the U.S. Food and Drug Administration approved the new REMS that requires opioid manufacturers to provide training opportunities to health care providers who are involved in the management of patients with pain, as well as prescribers, to assist in raising awareness of the risks associated with these medications and the existence of training materials.. Prescribers, including veterinarians, and other...

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FDA releases opioids resources for veterinarians

  |   Federal Regulatory

The epidemic of opioid abuse is affecting medical and health professionals such as physicians and pharmacists, but also veterinarians. Prescription opioids are powerful pain-reducing medications that include oxycodone, hydrocodone, and morphine, among others, and they have both benefits as well as potentially serious risks, such as addiction, abuse, and overdose. While opioids are a small part of the veterinarian’s medical arsenal for treating pain in animals, stocking and administering these drugs also makes it important for veterinarians to understand how they can...

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

  |   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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FDA Answers VFD Audit Questions in Upcoming Webinar

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

  |   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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