FDA-CVM Releases Draft Guidance for Bringing Remaining Approved OTC Medically Important Antimicrobial Drugs for Animals Under Veterinary Oversight
Monday, the Food and Drug Administration, Center for Veterinary Medicine (FDA, CVM) released draft guidance for industry (GFI) #263 that outlines the process for voluntarily bringing the remaining approved medically-important antimicrobial drugs for human medicine that are being used in animals under the oversight of licensed veterinarians by changing the approved marketing status from over-the-counter (OTC) to prescription only (Rx). This action is part of the agency’s Five-Year Plan for Supporting Antimicrobial Stewardship in Veterinary Settings https://www.fda.gov/files/animal%20&%20veterinary/published/Supporting-Antimicrobial-Stewardship-in-Veterinary-Settings–Goals-for-Fiscal-Years-2019-2023.pdf and is consistent with judicious use practices outlined in the National Action Plan to Combat Antibiotic Resistant Bacteria https://obamawhitehouse.archives.gov/sites/default/files/docs/national_action_plan_for_combating_antibotic-resistant_bacteria.pdf .
In January 2017, FDA implemented GFI #213 and the enhanced Veterinary Feed Directive to voluntarily change OTC marketed medically important antimicrobial drugs used in the feed and water of food-producing animals to be under the oversight of licensed veterinarians. Currently, a limited number of dosage forms of medically important antimicrobial drugs, such as injectables and boluses, are marketed as OTC products for food-producing and companion animals. A list of the OTC drugs affected by GFI #263 can be found at https://www.fda.gov/animal-veterinary/judicious-use-antimicrobials/list-approved-new-animal-drug-applications-affected-draft-gfi-263. At this time, FDA is planning a two year implementation period with the release of a proposed timeline with draft guidance in September 2019, final guidance in September 2020, and implementation by September 2022. FDA plans to engage with affected stakeholders at public events, such as meetings and conferences, to hear feedback and answer questions about the changes proposed in the draft guidance document. FDA is accepting public comments on draft GFI #263 for 90 days or no later than 11:59 pm on December 24, 2019.
The complete draft GFI #263 can be found at https://www.fda.gov/media/130610/download and will be published in the Federal Register at www.regulations.gov under Docket Number FDA-2019-D-3614 in the search box. To electronically submit comments to the docket FDA-2019-D-3614, visit www.regulations.gov enter the docket number in the search box and follow the prompts for comment submission by December 24, 2019 to ensure that FDA takes comment information into consideration before beginning work on the final version of GFI #263.
Should you have any questions, please contact National Cattlemen’s Beef Association’s Chief Veterinarian, Dr. Kathy Simmons, at 202-879-9131 or email@example.com .