Implantation or Injectable Dosage Form New Animal Drugs; Xylazine
other · Food and Drug Administration · Rule · Published 2003-05-15 · Effective 2003-05-15 · 68 FR 26205
Document
Document number
03-12120
Federal Register citation
68 FR 26205
CFR reference
21 CFR 522
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2003-05-15
Effective date
2003-05-15
Abstract
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Lloyd, Inc. The supplemental NADA provides for use of a 300 milligram per milliliter strength of xylazine hydrochloride solution in elk and wild deer to produce sedation, accompanied by a shorter period of analgesia. A food safety cautionary statement regarding the use of xylazine in elk and wild deer (Cervidae) is also being codified for currently approved products.