21 CFR 522.1182 - Iron injection.

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There are 4 Updates appearing in the Federal Register for 21 CFR 522. View below or at eCFR (GPOAccess)
§ 522.1182 Iron injection.
(a) Specifications. See § 510.440 of this chapter. Each milliliter (mL) of solution contains the equivalent of:
(1) 100 milligrams (mg) of elemental iron derived from:
(i) Ferric hydroxide;
(ii) Ferric oxide; or
(iii) Elemental iron.
(2) 200 mg of elemental iron derived from ferric hydroxide.
(b) Sponsors and conditions of use. It is used in baby pigs by sponsors in § 510.600(c) of this chapter as follows:
(1) Nos. 000859 and 042552 for use of product described in paragraph (a)(1)(i) of this section as follows:
(i) For prevention of iron deficiency anemia, inject 100 mg (1 mL) by intramuscular injection at 2 to 4 days of age.
(ii) For treatment of iron deficiency anemia, inject 100 mg (1 mL) by intramuscular injection. Dosage may be repeated in approximately 10 days.
(2) No. 000856 for use of product described in paragraph (a)(1)(i) of this section as follows:
(i) For the prevention of anemia due to iron deficiency, administer an initial intramuscular injection of 100 mg at 2 to 4 days of age. Dosage may be repeated in 14 to 21 days.
(ii) For the treatment of anemia due to iron deficiency, administer an intramuscular injection of 200 mg.
(3) Nos. 000061 and 062408 for use of product described in paragraph (a)(1)(i) of this section as follows:
(i) For the prevention of iron deficiency anemia, administer intramuscularly an amount of drug containing 100 to 150 mg of elemental iron to animals from 1 to 3 days of age.
(ii) For the treatment of iron deficiency anemia, administer intramuscularly an amount of drug containing 100 to 200 mg of elemental iron per animal. Dosage may be repeated in 10 days to 2 weeks.
(4) Nos. 051311 and 053501 for use of product described in paragraph (a)(1)(ii) of this section as follows:
(i) For prevention of iron deficiency anemia, administer 1 mL by intramuscular injection at 2 to 5 days of age. Dosage may be repeated at 2 weeks of age.
(ii) For treatment of iron deficiency anemia, administer 1 to 2 mL by intramuscular injection at 5 to 28 days of age.
(5) No. 053501 for use of product described in paragraph (a)(1)(iii) of this section as follows:
(i) For prevention of anemia due to iron deficiency, administer 100 mg by intramuscular or subcutaneous injection at 2 to 4 days of age.
(ii) For treatment of anemia due to iron deficiency, administer 100 mg by intramuscular or subcutaneous injection up to 4 weeks of age.
(6) Nos. 000859 and 058005 for use of product described in paragraph (a)(1)(iii) of this section as follows:
(i) For prevention of anemia due to iron deficiency, administer 100 mg by intramuscular injection at 2 to 4 days of age.
(ii) For treatment of anemia due to iron deficiency, administer 100 mg by intramuscular injection. Treatment may be repeated in 10 days.
(7) Nos. 000859 and 042552 for use of product described in paragraph (a)(2) of this section as follows:
(i) For prevention of baby pig anemia due to iron deficiency, intramuscularly inject 200 mg of elemental iron (1 mL) at 1 to 3 days of age.
(ii) For treatment of baby pig anemia due to iron deficiency, intramuscularly inject 200 mg of elemental iron at the first sign of anemia.
(8) No. 062408 for use of product described in paragraph (a)(2) of this section as follows:
(i) For prevention of iron deficiency anemia, administer 200 mg intramuscularly on or before 3 days of age.
(ii) For treatment of iron deficiency anemia, administer 200 mg intramuscularly.
[73 FR 12635, Mar. 10, 2008, as amended at 73 FR 14385, Mar. 18, 2008; 78 FR 17597, Mar. 22, 2013]

Title 21 published on 2014-04-01

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

For a complete list of all Rules, Proposed Rules, and Notices view the Rulemaking tab.

  • 2014-09-08; vol. 79 # 173 - Monday, September 8, 2014
    1. 79 FR 53134 - New Animal Drugs; Buprenorphine; Carprofen; Danofloxacin; Follicle Stimulating Hormone; Ractopamine; Salinomycin; Tylosin
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule; technical amendment.
      This rule is effective September 8, 2014.
      21 CFR Parts 520, 522, and 558

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

Title 21 published on 2014-04-01

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

  • 2014-09-08; vol. 79 # 173 - Monday, September 8, 2014
    1. 79 FR 53134 - New Animal Drugs; Buprenorphine; Carprofen; Danofloxacin; Follicle Stimulating Hormone; Ractopamine; Salinomycin; Tylosin
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule; technical amendment.
      This rule is effective September 8, 2014.
      21 CFR Parts 520, 522, and 558