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]

This is a list of United States Code sections, Statutes at Large, Public Laws, and Presidential Documents, which provide rulemaking authority for this CFR Part.

This list is taken from the Parallel Table of Authorities and Rules provided by GPO [Government Printing Office].

It is not guaranteed to be accurate or up-to-date, though we do refresh the database weekly. More limitations on accuracy are described at the GPO site.


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

Title 21 published on 10-May-2017 03:43

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

  • 2017-05-10; vol. 82 # 89 - Wednesday, May 10, 2017
    1. 82 FR 21688 - New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal 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; correcting amendments.
      This rule is effective May 10, 2017, except for amendatory instruction 3 to 21 CFR 510.600, and amendatory instruction 10 to 21 CFR 522.1002, which are effective May 22, 2017.
      21 CFR Parts 510, 520, 522, 524, and 558

Pages