21 C.F.R. § 529.1115 Halothane.
Title 21 - Food and Drugs
(a) Specifications. The drug is a colorless, odorless, nonflammable, nonexplosive, heavy liquid containing 0.01 percent thymol as a preservative. (b) Sponsor. See 000856 and 012164 in §510.600(c) of this chapter. (c) Conditions of use—(1) Amount. Two to 5 percent of inhaled atmosphere for induction of anesthesia; 0.5 to 2 percent for maintenance of anesthesia.1 1 These conditions have been reviewed by FDA and found effective. NADA's for similar products for these conditions of use need not include effectiveness data as specified by §514.111 of this chapter, but may require bioequivalency and safety information. (2) Indications for use. For nonfood animals for the induction and maintenance of anesthesia.1 (3) Limitations. Administered by inhalation. May be administered with either oxygen or a mixture of oxygen and nitrous oxide. Place drug vaporizer between the gas supply and breathing bag to prevent overdosage. Not recommended for obstetrical anesthesia except when uterine relaxation is required. Do not use in pregnant animals; information on possible adverse effects on fetal development is not available. Operating rooms should have adequate ventilation to prevent accumulation of anesthetic gases. Not for use in animals intended for food. Federal law restricts this drug to use by or on the order of a licensed veterinarian.1 [46 FR 27915, May 22, 1981, as amended at 62 FR 29014, May 29, 1997]
Title 21: Food and Drugs
PART 529—CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS
§ 529.1115 Halothane.
