Guideline No. 22
Guideline Labeling of Arecoline Base Drugs Intended for Animal Use
Revised --
U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
PUBLIC HEALTH SERVICE
FOOD AND DRUG ADMINISTRATION
CENTER FOR VETERINARY MEDICINE
BACKGROUND
Drugs containing arecoline intended for treating animals are to be limited to use by or on the order of a licensed veterinarian and should bear the label statement specified in 21 CFR 201.105(b)(1), "Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian," because of toxicity and since adequate directions for use cannot be written by which the layman can use such drugs safely for the purposes for which they are intended.
It is a possible abortifacient and is contraindicated in pregnant animals. The drug is unsafe in kittens and cats under one year of age.
Upon request, the administration will review the marketing status of any specific product and permit over-the-counter marketing only where it is shown by adequate studies that such product is safe for use by the layman.
POLICY
Drugs containing arecoline intended for use in treating animals are limited to use by or on the order of a licensed veterinarian. Arecoline-containing drugs labeled for over-the-counter use are misbranded under 502(f)(1) of the Food, Drug and Cosmetic Act and are subject to regulatory action.
|
||||||
 |
||||||
|
||||||