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    Subject Term: "Veterinary medicine"

    2 publications with a total of 4 open recommendations including 1 priority recommendation
    Director: Steve D. Morris
    Phone: (202) 512-3841

    3 open recommendations
    Recommendation: To help ensure that FDA has relevant and timely information to support management decisions, including the critical information necessary to ensure the safety and effectiveness of drugs compounded for animals, the Secretary of Health and Human Services should direct the Commissioner of the FDA to modify the voluntary reporting form FDA uses to obtain information on adverse events to ask whether drugs involved in adverse events were compounded.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: As of July 2017, FDA has drafted a notice for publication in the Federal Register that seeks comment on editorial revisions to Form FDA 1932a to clarify how to report adverse drug events associated with compounded products using that form. The publication of the notice was issued in July 2017. After a 60-day public comment period, the revisions to Form FDA 1932a will be submitted to OMB for review and approval under the Paperwork Reduction Act.
    Recommendation: To help ensure that FDA has relevant and timely information to support management decisions, including the critical information necessary to ensure the safety and effectiveness of drugs compounded for animals, the Secretary of Health and Human Services should direct the Commissioner of the FDA to develop policy or guidance for agency staff that specifies circumstances under which FDA will or will not enforce compounding regulations for animals and clearly define key terms.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: In July 2017, FDA notified us that they are still in the process of developing guidance for agency staff that specifies circumstances under which FDA will enforce compounding regulations for animals. According to FDA, the agency received more than 150 comments regarding the draft Guide For Industry #230 and 280 nominations of bulk drug substances for use in compounding office stock; information necessary for updating the guidance. In addition, FDA is reviewing the substances that were nominated for use in compounding office stock. Officials did not provide a specific timeline for completing this work, but stated that developing updated guidance on compounding for animals continues to be a high priority for FDA.
    Recommendation: To help ensure that FDA has relevant and timely information to support management decisions, including the critical information necessary to ensure the safety and effectiveness of drugs compounded for animals, the Secretary of Health and Human Services should direct the Commissioner of the FDA to consistently document the bases for FDA's decisions about how or whether it followed up on warning letters, adverse event reports, and complaints about drug compounding for animals.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: As of July 2017, FDA reported that it is still developing an enforcement strategy for compounded animal drugs that includes a process for documenting the Agency's actions with respect to follow-up on warning letters, adverse event reports, and complaints.
    Director: John Neumann
    Phone: (202) 512-3841

    1 open recommendations
    including 1 priority recommendation
    Recommendation: To improve the ability of the federal veterinarian workforce to carry out its activities, and to prepare for an emergency involving a large-scale animal disease outbreak, the Secretary of Agriculture should direct the Administrator of the Animal and Plant Health Inspection Service to assess the veterinarian workforce needs under possible scenarios for an emergency response to a large-scale animal disease outbreak. Building on the Talent Management Advisory Council's (TMAC) efforts to determine the veterinarian workforce needed to respond to an animal disease outbreak, the assessment should include the number and types of veterinarians needed, the sources required to have a sufficient workforce to respond, and the training needed to carry out their roles.

    Agency: Department of Agriculture
    Status: Open
    Priority recommendation

    Comments: USDA provided information in April 2017 on steps taken to partially address this recommendation. According to USDA, the agency uses its experiences with real-world animal disease outbreaks, such as recent outbreaks of highly pathogenic avian influenza, to assess its veterinarian workforce needs. To fully implement this recommendation, APHIS needs to develop an estimate of the number of veterinarians necessary to respond to large-scale animal disease outbreaks, such as a nationwide foot-and-mouth disease outbreak in livestock.