Federal Regulatory

APHIS Updates Accredited Veterinarian Regulations

  |   Federal Regulatory

The United States Department of Agriculture's (USDA) Animal and Plant Health Inspection Service (APHIS) is updating its regulations for the accredited veterinarian program, in order to clarify program definitions. These administrative changes will ensure the terminology in the regulation is consistent with how the terms are being used in the accreditation program. They will also ensure the regulation contains an accurate list of all the programs covered under the Animal Health Protection Act. The specific changes include: Adding definitions for accreditation...

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FDA Provides Additional Time to Comment on Revised Draft Guidance on Animal Drug Compounding

  |   Federal Regulatory

In response to requests to extend the comment period for the revised draft guidance, “Compounding Animal Drugs from Bulk Drug Substances,” the FDA plans to provide an additional 120 days for the public to submit comments. The initial comment period was scheduled to end on February 18, 2020, but FDA will be reopening the comment period using the same docket number. Otherwise, the submission process remains unchanged. The new deadline to receive comments will be June 17, 2020. WSVMA members who...

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Comments needed on new Draft FDA guidance for Industry #256, Compounding Animal Drugs from Bulk Substances

  |   Federal Regulatory

The U.S. Food and Drug Administration (FDA) has released new draft Guidance for Industry (GFI), titled #256 “Compounding Animal Drugs from Bulk Substances.” In May 2015, the FDA CVM introduced draft guidance for animal drug compounding that did not meet the needs of veterinarians. Following significant feedback from the AVMA, other veterinary organizations, and individual veterinarians, the agency formally withdrew that guidance in November 2017. The FDA intends for its new guidance to balance its concerns regarding safety, effectiveness, and...

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FDA releases new draft guidance on compounded animal drugs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The FDA is requesting public comment on new draft guidance for industry (GFI) #256, “Compounding Animal Drugs from Bulk Drug Substances.”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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