21 CFR 522.1085 - Guaifenesin powder for injection.

§ 522.1085 Guaifenesin powder for injection.
(a) Specifications. The product is a sterile powder containing guaifenesin. A solution is prepared by dissolving the drug in sterile water for injection to make a solution containing 50 milligrams of guaifenesin per milliliter of solution.
(b) Sponsors. See Nos. 037990 and 054771 in § 510.600(c) of this chapter.
(c) Conditions of use in horses—
(1) Amount. Administer 1 milliliter of prepared solution per pound of body weight by rapid intravenous infusion.
(2) Indications for use. For use as a muscle relaxant.
(3) Limitations. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
[79 FR 16189, Mar. 25, 2014]
Beta! The text on the eCFR tab represents the unofficial eCFR text at ecfr.gov.
§ 522.1085 Guaifenesin powder for injection.

(a) Specifications. The product is a sterile powder containing guaifenesin. A solution is prepared by dissolving the drug in sterile water for injection to make a solution containing 50 milligrams of guaifenesin per milliliter of solution.

(b) Sponsors. See Nos. 037990 and 054771 in § 510.600(c) of this chapter.

(c) Conditions of use in horses -

(1) Amount. Administer 1 milliliter of prepared solution per pound of body weight by rapid intravenous infusion.

(2) Indications for use. For use as a muscle relaxant.

(3) Limitations. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[79 FR 16189, Mar. 25, 2014]

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United States Code
U.S. Code: Title 21 - FOOD AND DRUGS

Title 21 published on 2015-04-01

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR Part 522 after this date.

  • 2015-12-09; vol. 80 # 236 - Wednesday, December 9, 2015
    1. 80 FR 76384 - New Animal Drugs; Approval of New Animal Drug Applications; Withdrawals of Approval of New Animal Drug Applications; Changes of Sponsorship
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule; technical amendments.
      This rule is effective December 9, 2015, except for the amendments to 21 CFR 520.446, 520.2043, 558.625, and 558.630, which are effective December 21, 2015.
      21 CFR Parts 510, 520, 522, 524, and 558