21 CFR 522.1362
§ 522.1362 Melarsomine powder for injection.
United States · 21 CFR — Food and Drugs · Status: effective
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- Citation
- 21 CFR 522.1362, § 522.1362 Melarsomine powder for injection, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/87482
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Full text
(a) Specifications. The drug consists of a vial of lyophilized powder containing 50 milligrams of melarsomine dihydrochloride which is reconstituted with the provided 2 milliliters of sterile water for injection.
(b) Sponsor. See Nos. 000010 and 086073 in § 510.600(c) of this chapter.
(c) Conditions of use—(1) Amount. Administer only by deep intramuscular injection in the lumbar muscles (L3-L5).
(2) Indications. Treatment of stabilized, class 1, 2, and 3 heartworm disease (asymptomatic to mild, moderate, and severe, respectively) caused by immature (4 month-old, stage L5) to mature adult infections of Dirofilaria immitis in dogs.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.