21 CFR 522.1160 - Insulin.

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There are 12 Updates appearing in the Federal Register for 21 CFR 522. View below or at eCFR (GPOAccess)
§ 522.1160 Insulin.
(a) Specifications—
(1) Each milliliter (mL) of porcine insulin zinc suspension contains 40 international units (IU) of insulin.
(2) Each mL of protamine zinc recombinant human insulin suspension contains 40 IU of insulin.
(b) Sponsors. See sponsors in § 510.600 of this chapter for use as in paragraph (c) of this section.
(1) No. 000061 for use of product described in paragraph (a)(1) of this section as in paragraphs (c)(1), (c)(2)(i)(A), (c)(2)(ii), and (c)(2)(iii) of this section.
(2) No. 000010 for use of product described in paragraph (a)(2) of this section as in paragraphs (c)(2)(i)(B), (c)(2)(ii), and (c)(2)(iii) of this section.
(c) Conditions of use—
(1) Dogs—
(i) Amount. Administer an initial once-daily dose of 0.5 IU per kilogram of body weight by subcutaneous injection concurrently with or right after a meal. Adjust this once-daily dose at appropriate intervals based on clinical signs, urinalysis results, and glucose curve values until adequate glycemic control has been attained. Twice-daily therapy should be initiated if the duration of insulin action is determined to be inadequate. If twice-daily treatment is initiated, the two doses should be 25 percent less than the once daily dose required to attain an acceptable nadir.
(ii) Indications for use. For the reduction of hyperglycemia and hyperglycemia-associated clinical signs in dogs with diabetes mellitus.
(iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(2) Cats—
(i) Amount—
(A) Porcine insulin zinc. Administer an initial dose of 1 to 2 IU by subcutaneous injection. Injections should be given twice daily at approximately 12-hour intervals. For cats fed twice daily, the injections should be concurrent with or right after a meal. For cats fed ad libitum, no change in feeding is needed. Adjust the dose at appropriate intervals based on clinical signs, urinalysis results, and glucose curve values until adequate glycemic control has been attained.
(B) Protamine zinc recombinant human insulin. Administer an initial dose of 0.1 to 0.3 IU/pound of body weight (0.2 to 0.7 IU/kilogram) every 12 hours. The dose should be given concurrently with or right after a meal. Re-evaluate the cat at appropriate intervals and adjust the dose based on both clinical signs and glucose nadirs until adequate glycemic control has been attained.
(ii) Indications for use. For the reduction of hyperglycemia and hyperglycemia-associated clinical signs in cats with diabetes mellitus.
(iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
[69 FR 25827, May 10, 2004, as amended at 73 FR 21042, Apr. 18, 2008; 74 FR 61517, Nov. 25, 2009; 74 FR 66048, Dec. 14, 2009]

Title 21 published on 2013-04-01

The following are only the Rules published in the Federal Register after the published date of Title 21.

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  • 2014-04-15; vol. 79 # 72 - Tuesday, April 15, 2014
    1. 79 FR 21126 - New Animal Drugs; Ceftiofur Sodium; Gentamicin; Xylazine
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      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule; technical amendment.
      This rule is effective April 15, 2014.
      21 CFR Part 522

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

Title 21 published on 2013-04-01

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

  • 2014-04-15; vol. 79 # 72 - Tuesday, April 15, 2014
    1. 79 FR 21126 - New Animal Drugs; Ceftiofur Sodium; Gentamicin; Xylazine
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule; technical amendment.
      This rule is effective April 15, 2014.
      21 CFR Part 522