Category Archives: FDA

On December 19, 2016, the Center for Devices and Radiological Health at the U.S. Food and Drug Administration issued a final rule banning all powdered surgeon’s gloves, powdered patient examination gloves, and absorbable powder for lubricating surgical gloves intended for use by humans because these devices present an unreasonable and substantial risk of illness or injury that cannot be corrected or eliminated by a change in labeling. The FDA’s Center for Veterinary Medicine is issuing this update to ensure that veterinary stakeholders are aware that the ban applies to all powdered medical gloves used by humans except powdered radiographic protection gloves, including powdered medical gloves used in the practice of veterinary medicine. [Source: FDA CVM, 1/13/2017]

“FDA approved!”Maybe you saw those words on a company’s website, or in a commercial promoting a new product or treatment. Some marketers may say their products are “FDA approved,” but how can you know for sure what the U.S. Food and Drug Administration approves?

The Food and Drug Administration has issued Guidance Document #233 (GFI #233) to describe a suggested common format for VFD forms. Drug sponsors are required to provide a VFD form to FDA as part of the VFD drug approval process and make this form available for veterinary use following approval. Veterinarians, however, are not required to use the form provided by the drug sponsor and may create a form of their choosing as long as it contains the required information. GFI #233 also provides guidance concerning the elements that must be included on the VFD and the elements that may be included on the VFD. In addition, GFI #233 provides examples of a suggested VFD format.

The Food and Drug Administration has issued Guidance Document #233 (GFI #233) to describe a suggested common format for VFD forms. Drug sponsors are required to provide a VFD form to FDA as part of the VFD drug approval process and make this form available for veterinary use following approval. Veterinarians, however, are not required to use the form provided by the drug sponsor and may create a form of their choosing as long as it contains the required information. GFI #233 also provides guidance concerning the elements that must be included on the VFD and the elements that may be included on the VFD. In addition, GFI #233 provides examples of a suggested VFD format.

The Food and Drug Administration has issued Guidance Document #233 (GFI #233) to describe a suggested common format for VFD forms. Drug sponsors are required to provide a VFD form to FDA as part of the VFD drug approval process and make this form available for veterinary use following approval. Veterinarians, however, are not required to use the form provided by the drug sponsor and may create a form of their choosing as long as it contains the required information. GFI #233 also provides guidance concerning the elements that must be included on the VFD and the elements that may be included on the VFD. In addition, GFI #233 provides examples of a suggested VFD format.

The Food and Drug Administration has issued Guidance Document #233 (GFI #233) to describe a suggested common format for VFD forms. Drug sponsors are required to provide a VFD form to FDA as part of the VFD drug approval process and make this form available for veterinary use following approval. Veterinarians, however, are not required to use the form provided by the drug sponsor and may create a form of their choosing as long as it contains the required information. GFI #233 also provides guidance concerning the elements that must be included on the VFD and the elements that may be included on the VFD. In addition, GFI #233 provides examples of a suggested VFD format.

The U.S. Food and Drug Administration (FDA) today released the Foods and Veterinary Medicine (FVM) Program’s Strategic Plan for fiscal years 2016-2025, which outlines goals and objectives for the next 10 years. The FVM program encompasses the Office of Foods and Veterinary Medicine, the Center for Food Safety and Applied Nutrition, and the Center for Veterinary Medicine, as well as the related activities under the Office of Global Regulatory Operations and Policy and the Office of Regulatory Affairs. [Source: FDA Constituent Update, July 14, 2016]

The Food and Drug Administration (FDA) has implemented a pilot project designed to help train FDA compliance personnel on the new VFD rules and to identify gaps in stakeholder education regarding the impending changes. The goal of the project is to target educational outreach to address those knowledge gaps. This project is currently ongoing and involves the random selection of three VFD forms at feed distributors and tracking those forms back to the veterinarian and forward to the producer. The investigator will evaluate all aspects of the process including paperwork accuracy, recordkeeping, proper manufacturing, distribution and administration of the VFD feed and compliance with the regulation. The goal of this pilot project is to enhance education and promote compliance during the VFD implementation.

The U.S. Food and Drug Administration (FDA) has issued a letter reminding retail establishments that sell medically important antimicrobials for use in feed or water for food animals that the marketing status of those products will change from over-the-counter (OTC) to prescription (Rx) or to veterinary feed directive (VFD) at the end of calendar year 2016. Once the changes are in place, distributors of those medically important antimicrobials will need to comply with appropriate requirements for Rx and VFD drugs when dispensing these products. The letter also provides retail establishments with recommendations for addressing current and future inventory of medically important antimicrobials for use in feed or water for food animals. [Source: FDA, June 20, 2016]

The U.S. Food and Drug Administration (FDA) has issued revised Guidance for Industry (GFI) #120, “ Veterinary Feed Directive Regulation Questions and Answers.” The FDA has also posted to its website a list of states that have veterinarian-client-patient-relationship (VCPR) requirements for Veterinary Feed Directives (VFDs) and include the key elements of the Federally-defined VCPR, as well as those states that do not. This list was developed by FDA working together with state regulatory authorities. Veterinarians in states that do not require a VFD to be issued within the context of a VCPR that includes federally-defined key elements will be required to follow the federal VCPR requirements. The list may change over time as states update their veterinary practice requirements. [Source: FDA, 9/29/2015]