April 01, 2000

 
​TAKE NOTICE

 Regulatory update on HCG - April 1, 2000

Posted Mar. 15, 2000

 

The FDA-CVM has rescinded its policy of discretionary enforcement regarding the use of unlabeled human chorionic gonadotropin as a spawning aid for fish.

In April 1998, the CVM issued an industry guidance stating the agency would not likely object to the use of HCG as a spawning aid for fish if certain conditions were met. The agency announced in February that it now objects to the use of HCG as a spawning aid if such products have not been approved for that purpose.

There is, however, a new animal drug approved for use as a spawning aid in fish (NADA 140-927). The product is chorulon human chorionic gonadotropin.

Because Guidance for Industry No. 71 has been rescinded, distribution and use of any HCG product as a spawning aid, other than a product approved for that purpose, would cause that HCG to be adulterated under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 an HCG product as a spawning aid is not permitted under the Animal Medicinal Drug Use Clarification Act because that would be a production rather than a therapeutic use.

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