21 CFR 529.2503 - Tricaine methanesulfonate.

§ 529.2503 Tricaine methanesulfonate.

(a)Specifications. The drug is ethyl-m-amino-benzoate methanesulfonate.

(b)Sponsor. See Nos. 050378 and 051212 in § 510.600(c) of this chapter.

(c)Conditions of use -

(1)Amount. It is used as follows:

(i)Fish. The drug is added to ambient water at a concentration of from 15 to 330 milligrams per liter depending upon the degree of anesthetization or sedation desired, the species and size of the fish, and the temperature and softness of the water. Preliminary tests of solutions must be made with small numbers of fish to determine the desired rates of sedation or anesthesia and the appropriate exposure times for the specific lots of fish under prevailing conditions.

(ii)Amphibians and other aquatic coldblooded animals. The drug is added to ambient water in concentrations of from 1:1000 to 1:20,000 depending upon species and stage of development.

(2)Indications for use. For the temporary immobilization of fish, amphibians, and other aquatic coldblooded animals (poikilotherms) as an aid in handling during manual spawning (fish stripping), weighing, measuring, marking, surgical operations, transport, photography, and research.

(3)Limitations. Do not use within 21 days of harvesting fish for food. Use in fish intended for food should be restricted to Ictaluridae, Salmonidae, Esocidae, and Percidae, and water temperature exceeding 10 °C (50 °F). In other fish and in coldblooded animals, the drug should be limited to hatchery or laboratory use.

[ 79 FR 10974, Feb. 27, 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].

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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 529 after this date.

  • 2017-03-01; vol. 82 # 39 - Wednesday, March 1, 2017
    1. 82 FR 12167 - New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of a New Animal Drug Application; Change of Sponsor; Change of Sponsor's Name
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule; technical amendment.
      This rule is effective March 1, 2017, except for amendments 2.a and 2.c to 21 CFR 510.600, and the amendments to 21 CFR 522.313c and 529.1186, which are effective March 13, 2017.
      21 CFR Parts 510, 516, 520, 522, 529, and 558