CVM Update

February 23, 2000

FDA RESCINDS HCG ENFORCEMENT DISCRETION GUIDANCE

In April 1998, FDA issued a level two guidance for industry (GFI) entitled, "Use of Human Chorionic Gonadotropin (HCG) as a Spawning Aid for Fish" (GFI #71.) This guidance stated that the Center for Veterinary Medicine (CVM) is not likely to object to the use of HCG as a spawning aid for fish if certain conditions are met.

CVM has determined that now it does object to the use of HCG products as a spawning aid for fish if such products have not been approved for that purpose. Therefore, GFI #71 is rescinded. Distribution and use of any HCG product as a spawning aid other than a product approved for that purpose would cause that HCG to be adulterated under section 501(a)(5) of the Federal Food, Drug, and Cosmetic Act. Extralabel use of a HCG product as a spawning aid is not permitted under the Animal Medicinal Drug Use Clarification Act (AMDUCA) because this is a production rather than a therapeutic use.

CVM notes that there is a new animal drug HCG approved for use as a spawning aid in fish (NADA 140-927.) That product, Chorulon Human Chorionic Gonadotropin, is sponsored and marketed by Intervet, Inc., Millsboro, DE.

Additional information on this subject is available from Frances Pell, Center for Veterinary Medicine, (HFV-235), Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855, 301-827-0188.

Issued by:
FDA, Center for Veterinary Medicine,
Office of Management and Communications, HFV-12
7519 Standish Place, Rockville, MD 20855
Telephone: (301) 827-3800 FAX: (301) 827-4065
Internet Web Site: http://www.fda.gov/cvm

horizonal rule