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21 CFR § 520.38a - Albendazole suspension.

---
identifier: "/us/cfr/t21/s520.38a"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 520.38a - Albendazole suspension."
title_number: 21
title_name: "Food and Drugs"
section_number: "520.38a"
section_name: "Albendazole suspension."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "E"
subchapter_name: "ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS"
part_number: "520"
part_name: "ORAL DOSAGE FORM NEW ANIMAL DRUGS"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 360b."
regulatory_source: "40 FR 13838, Mar. 27, 1975, unless otherwise noted."
cfr_part: "520"
---

# 520.38a Albendazole suspension.

(a) *Specifications.* Each milliliter of suspension contains 45.5 milligrams (mg) (4.55 percent) or 113.6 mg (11.36 percent) albendazole.

(b) *Sponsor.* See No. 054771 in § 510.600 of this chapter.

(c) *Related tolerances.* See § 556.34 of this chapter.

(d) *Special considerations.* See § 500.25 of this chapter.

(e) *Conditions of use*—(1) *Cattle.* Administer 11.36 percent suspension:

(i) *Amount.* 4.54 mg/pound (lb) body weight (10 mg/kilogram (kg)) as a single oral dose using dosing gun or dosing syringe.

(ii) *Indications for use.* For removal and control of adult liver flukes (*Fasciola hepatica*); heads and segments of tapeworms (*Moniezia benedeni* and *M. expansa*); adult and 4th stage larvae of stomach worms (brown stomach worms including 4th stage inhibited larvae (*Ostertagia ostertagi*), barberpole worm (*Haemonchus contortus* and *H. placei*), small stomach worm (*Trichostrongylus axei*)); adult and 4th stage larvae of intestinal worms (thread-necked intestinal worm (*Nematodirus spathiger* and *N. helvetianus*), small intestinal worm (*Cooperia punctata* and *C. oncophora*)); adult stages of intestinal worms (hookworm (*Bunostomum phlebotomum*), bankrupt worm (*Trichostrongylus colubriformis*), nodular worm (*Oesophagostomum radiatum*)); adult and 4th stage larvae of lungworms (*Dictyocaulus viviparus*).

(iii) *Limitations.* Do not slaughter within 27 days of last treatment. Do not use in female dairy cattle of breeding age: Do not administer to female cattle during first 45 days of pregnancy or for 45 days after removal of bulls.

(2) *Sheep.* Administer 4.45 or 11.36 percent suspension:

(i) *Amount.* 3.4 mg/lb body weight (7.5 mg/kg) as a single oral dose using dosing gun or dosing syringe.

(ii) *Indications for use.* For removal and control of adult liver flukes (*Fasciola hepatica* and *Fascioloides magna*); heads and segments of common tapeworms (*Moniezia expansa*) and fringed tapeworm (*Thysanosoma actinioides*); adult and fourth stage larvae of stomach worms (brown stomach worm (*Ostertagia circumcinta* and *Marshallagia marshalli*), barberpole worm (*Haemonchus contortus*), small stomach worm (*Trichostrongylus axei*)); adult and fourth stage larvae of intestinal worms (thread-necked intestinal worm (*Nematodirus spathiger* and *N. filicollis*), Cooper's worm (*Cooperia oncophora*), bankrupt worm (*Trichostrongylus colubriformis*), nodular worm (*Oesophagostomum columbianum*), and large-mouth bowel worm (*Chabertia ovina*)); adult and larval stages of lungworms (*Dictyocaulus filaria*).

(iii) *Limitations.* Do not slaughter within 7 days of last treatment. Do not administer to ewes during first 30 days of pregnancy or for 30 days after removal of rams.

(3) *Goats.* Administer 11.36 percent suspension:

(i) *Amount.* 4.54 mg/lb body weight (10 mg/kg) as a single oral dose using dosing gun or dosing syringe.

(ii) *Indications for use.* For the treatment of adult liver flukes (*Fasciola hepatica*) in nonlactating goats.

(iii) *Limitations.* Do not slaughter within 7 days of last treatment. Do not administer to does during the first 30 days of pregnancy or for 30 days after removal of bucks.

[73 FR 11027, Feb. 29, 2008. Redesignated at 78 FR 66264, Nov. 5, 2013, as amended at 79 FR 28816, May 20, 2014]