21 CFR 520.1900
§ 520.1900 Primidone.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 520.1900, § 520.1900 Primidone, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/87290
- Permanent ID
ys:prov:87290@1- SHA-256
44e80f8bc490a2edef7580baf21f5ca137a5b715bd0c182334e4b2d8c43320ca
The hash is SHA-256 of this version's text, with every run of whitespace collapsed to a single space and the ends trimmed. The ID always leads back here, and checking it says whether the text you cited is still the current version.
Full text
(a) Specifications. Each tablet contains 50 or 250 milligrams of primidone.
(b) Sponsors. See sponsor numbers in § 510.600(c) of this chapter.
(1) No. 069043 for use of 250 milligram tablets.
(2) No. 054771 for use of 50 and 250 milligram tablets.
(c) Conditions of use in dogs—(1) Amount. Twenty-five milligrams of primidone per pound of body weight (55 milligrams per kilogram of body weight) daily.
(2) Indications for use. For the control of convulsions associated with idiopathic epilepsy, epileptiform convulsions, viral encephalitis, distemper, and hardpad disease that occurs as a clinically recognizable lesion in certain entities 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.