Federal Regulatory

16 October

AVMA weighs in on compounding guidance, provides new FAQ resource

wsvma   |   Federal Regulatory, Medicine

The AVMA has submitted comments to the FDA on the agency’s proposed guidance on compounding from bulk substances, and a new AVMA website resource answers commonly asked questions about the guidance. AVMA’s formal comments on Draft Guidance for Industry #256: Compounding Animal Drugs from Bulk Substances were sent on October 8, 2020, and are based on input from AVMA members, volunteers, state and allied veterinary groups, and other stakeholders. They cite provisions that AVMA supports in the draft guidance, as well as...

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18 September

AVMA prepares response to FDA draft compounding guidance

wsvma   |   Federal Regulatory, Medicine

Based on feedback from member veterinarians and other stakeholders, the AVMA has compiled a list of key points to share with the FDA in our formal comments on the proposed FDA Draft Guidance for Industry #256: Compounding Animal Drugs from Bulk Substances. The deadline for commenting on the draft guidance is October 15, 2020. The AVMA has been gathering input from members and others since the proposed guidance was released in November 2019. AVMA’s formal comments to the FDA will include, among others,...

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12 June

FDA draft guidance deadline for comments extended and new AVMA webinar explains proposed rules on bulk compounding

wsvma   |   Federal Regulatory, Medicine

There’s still time to comment on FDA draft guidance. The FDA deadline for commenting on Draft Guidance for Industry #256 was extended on June 11. AVMA will collect member comments on the proposal through August 15, 2020. A new on-demand webinar on AVMA Axon shares more information about the U.S. Food and Drug Administration’s (FDA) Draft Guidance for Industry #256, which addresses veterinary drug compounding from bulk substances. The webinar, presented by an FDA veterinarian, gives important background to help veterinarians provide...

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29 May

Veterinarian-sponsored dog importation bill introduced in Congress

wsvma   |   Federal Regulatory

This week, the Healthy Dog Importation Act was introduced in Congress to ensure that all dogs entering the country are healthy and not at risk to spread dangerous diseases that could adversely impact animal and public health. To meet the U.S. demand for pet dogs, the U.S. Centers for Disease Control and Prevention (CDC) estimates that more than one million dogs are imported into the U.S. each year. An increasing number of unhealthy dogs entering the U.S is alarming public and...

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22 May

Be sure to report animal drug shortages

wsvma   |   COVID-19, Federal Regulatory

FDA has been closely monitoring the animal drug supply chain for supply disruptions or shortages in the United States during the COVID-19 pandemic. The agency is issuing guidance to ensure the availability of drug products during the pandemic and to assist sponsors in providing FDA timely, informative notifications about changes in the production of animal drugs that will, in turn, help the Agency in its efforts to prevent or mitigate shortages of these products. Submit comments here.   Posted May 22, 2020...

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06 March

APHIS Updates Accredited Veterinarian Regulations

wsvma   |   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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28 February

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

wsvma   |   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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24 January

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

wsvma   |   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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22 November

FDA releases new draft guidance on compounded animal drugs

wsvma   |   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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31 October

New DEA reporting system for suspicious orders of controlled substances

wsvma   |   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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