[Federal Register Volume 60, Number 99 (Tuesday, May 23, 1995)]
[Rules and Regulations]
[Page 27223]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-12506]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Part 522
[Docket No. 95N-0096]
Implantation or Injectable Dosage Form New Animal Drugs;
Guaifenesin
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
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SUMMARY: The Food and Drug Administration (FDA) is amending the animal
drug regulations to reflect the change of the animal drug name from
glyceryl guaiacolate to guaifenesin. This amendment is an
administrative change to redesignate glyceryl guaiacolate products as
guaifenesin products.
EFFECTIVE DATE: May 23, 1995.
FOR FURTHER INFORMATION CONTACT: Mohammad I. Sharar, Center for
Veterinary Medicine (HFV-216), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-594-1722.
SUPPLEMENTARY INFORMATION: In the Federal Register of June 30, 1972 (37
FR 12936) and November 5, 1976 (41 FR 48732), FDA published final rules
which reflected approval of injectable glyceryl guaiacolate products.
In the Federal Register of December 10, 1984 (49 FR 48038), FDA
published a final rule which reflected approval of a guaifenesin powder
for injection. Guaifenesin is the newer chemical name for glyceryl
guaiacolate. At the time of the December 10, 1984, approval, the prior
approvals were not amended to reflect the newer chemical name. FDA is
amending the regulations in part 522 (21 CFR part 522) to reflect the
newer chemical name by removing Secs. 522.1060, 522.1060a, and
522.1060b; by adding a new sponsor to Sec. 522.1085; and by adding new
Sec. 522.1086 Guaifenesin injection.
FDA has determined under 21 CFR 25.24(a)(9) that this action is of
a type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.
List of Subjects in 21 CFR Part 522
Animal drugs.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs and
redelegated to the Center for Veterinary Medicine, 21 CFR part 522 is
amended as follows:
PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
1. The authority citation for 21 CFR part 522 continues to read as
follows:
Authority: Sec. 512 of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 360b).
Sec. 522.1060 [Removed]
2. Section 522.1060 Glyceryl guaiacolate implantation or injectable
dosage forms is removed.
Sec. 522.1060a [Removed]
3. Section 522.1060a Glyceryl guaiacolate sterile powder is
removed.
Sec. 522.1060b [Removed]
4. Section 522.1060b Glyceryl guaiacolate injection is removed.
Sec. 522.1085 [Amended]
5. Section 522.1085 Guaifenesin sterile powder is amended in
paragraph (b) by removing ``000031'' and adding in its place the phrase
``000031 and 037990''.
6. New Sec. 522.1086 is added to read as follows:
Sec. 522.1086 Guaifenesin injection.
(a) Specifications. Each milliliter of sterile aqueous solution
contains 50 milligrams of guaifenesin and 50 milligrams of dextrose.
(b) Sponsor. See No. 037990 in Sec. 510.600(c) of this chapter.
(c) Conditions of use. (1) The drug is used intravenously in horses
as a skeletal muscle relaxant.
(2) Administer rapidly at a dosage of 1 milliliter per pound of
body weight.
(3) No to be used in horses intended for food.
(4) Federal law restricts this drug to use by or on the order of a
licensed veterinarian.
Dated: May 5, 1995.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 95-12506 Filed 5-22-95; 8:45 am]
BILLING CODE 4160-01-F
