CFR - Code of Federal Regulations Title 21

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For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

[Code of Federal Regulations]

[Title 21, Volume 6]

[CITE: 21CFR522.1503]

TITLE 21--FOOD AND DRUGS

CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES

SUBCHAPTER E - ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS

PART 522 -- IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

Sec. 522.1503 Neostigmine.

(a) Specifications. Each milliliter of solution contains 2 milligrams (mg) neostigmine methylsulfate.

(b) Sponsor. See No. 000061 in § 510.600(c) of this chapter.

(c) Conditions of use - (1) Amount. Administer to cattle and horses at a dosage level of 1 mg per (/) 100 pounds (lbs) of body weight subcutaneously. Administer to sheep at a dosage level of 1 to 1 1/2 mg/100 lbs body weight subcutaneously. Administer to swine at a dosage level of 2 to 3 mg/100 lbs body weight intramuscularly. These doses may be repeated as indicated.

(2) Indications for use. For treating rumen atony; initiating peristalsis which causes evacuation of the bowel; emptying the urinary bladder; and stimulating skeletal muscle contractions.

(3) Limitations. Not for use in animals producing milk, since this use will result in contamination of the milk. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[40 FR 13858, Mar. 27, 1975, as amended at 62 FR 61625, Nov. 19, 1997; 79 FR 16192, Mar. 25, 2014]