§360ccc–1 Index of Legally Marketed Unapproved New Animal Drugs for Minor Species

Summary

Creates an FDA list of certain unapproved new animal drugs for minor species and sets how to get on and stay on that list. The list is only for drugs for minor species that people will not eat and for drugs used only in contained places (like hatcheries or tanks) in an early, non-food life stage of a food-producing minor species, if they meet the human-safety standard in section 360b(d). Drugs from transgenic animals are not allowed. Anyone who plans to ask to be on the list can meet with the FDA first. To ask if a drug is eligible, you must give the FDA information about the need, species, intended use and amount, composition, how you will make it, an environmental review, safety for people who handle it, and any other needed data. The FDA must decide an eligibility request within 90 days for non-food-minor-species requests and within 180 days for early-life-stage food-producing requests. The FDA will approve eligibility only if the drug is not already approved, fits one of the two allowed categories, has proper manufacturing controls, won’t harm the environment, and is safe for people exposed to it. If denied, the requester gets notice and a chance for an informal meeting, and a final denial can be reviewed by a court. After eligibility, the requester may ask the FDA to add the drug to the index. That request must include the eligibility letter, a report from an outside qualified expert panel that reviews safety and effectiveness and helps write labeling, a proposed index entry and labeling, distribution estimates, and commitments to follow good manufacturing and labeling practices. The FDA must decide within 180 days whether to list the drug, based on the panel report and other information, and may deny with notice and a meeting opportunity. The published index will show the holder’s name and address, the drug and its allowed uses, labeling, and any limits the FDA sets, and the FDA will update it periodically. The FDA can remove or suspend a listing if the panel or data fail requirements, risks outweigh benefits, manufacturing or labeling rules are broken, conditions of use are not followed, or false statements were made. The FDA may suspend a listing immediately if there is a reasonable chance the drug risks human or animal health, but the holder will get prompt notice and a chance for a meeting. Holders must keep records and report experience as the FDA requires. Safety and effectiveness data submitted for indexing can be released to the public unless specific conditions apply. If scheduling under the Controlled Substances Act is being considered, a listing decision won’t take effect until the interim control rule is issued.