Deslorelin acetate (Suprelorin) is not approved by the U.S. Food and Drug Administration (FDA) for use in birds and is not included in the FDA’s Index of Legally Marketed Unapproved New Animal Drugs for Minor Species (the “Index”). In the United States, Suprelorin is approved only for use in ferrets to manage adrenal disease. It is not approved for avian species or any other species outside those explicitly listed in the Index. Under federal law, indexed drugs may not be used extralabel under any circumstance. According to 21 CFR § 530.41(c), “A drug listed in the index is not approved for use in any other species, and extralabel use of indexed drugs is prohibited.” This prohibition applies to all veterinarians and institutions, including nonprofit rescue settings. FDA Guidance for Industry #201 reiterates that indexed drugs are subject to more restrictive controls than FDA-approved drugs and are legally limited to the specific species, indications and conditions for which they are indexed.
This position is endorsed by the American Veterinary Medical Association, which explicitly notes in its guidance on extralabel drug use that indexed drugs “may not be used in species other than those listed on the label,” and by the California Veterinary Medical Board, which reminds licensees that off-label use of indexed products is a violation of both federal law and state professional standards.
As such, the use of deslorelin in birds without an FDA-sanctioned investigational exemption constitutes a breach of federal regulation and professional ethics.
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