21 C.F.R. § 530.41

Drugs prohibited for extralabel use in animals

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(a) The following drugs, families of drugs, and substances are prohibited for extralabel animal and human drug uses in food-producing animals.

(1) Chloramphenicol;

(2) Clenbuterol;

(3) Diethylstilbestrol (DES);

(4) Dimetridazole;

(5) Ipronidazole;

(6) Other nitroimidazoles;

(7) Furazolidone.

(8) Nitrofurazone.

(9) Sulfonamide drugs in lactating dairy cattle (except approved use of sulfadimethoxine, sulfabromomethazine, and sulfaethoxypyridazine);

(10) Fluoroquinolones; and

(11) Glycopeptides.

(12) Phenylbutazone in female dairy cattle 20 months of age or older.

(13) Cephalosporins (not including cephapirin) in cattle, swine, chickens, or turkeys:

(i) For disease prevention purposes;

(ii) At unapproved doses, frequencies, durations, or routes of administration; or

(iii) If the drug is not approved for that species and production class.

(b) The following drugs, families of drugs, and substances are prohibited for extralabel animal and human drug uses in nonfood-producing animals: [Reserved]

(d) The following drugs, or classes of drugs, that are approved for treating or preventing influenza A, are prohibited from extralabel use in chickens, turkeys, and ducks:

(1) Adamantanes.

(2) Neuraminidase inhibitors.

[62 FR 27947, May 22, 1997, as amended at 67 FR 5471, Feb. 6, 2002; 68 FR 9530, Feb. 28, 2003; 68 FR 14134, Mar. 24, 2003; 71 FR 14377, Mar. 22, 2006; 77 FR 745, Jan. 6, 2012]

Notes of Decisions

Cited in 3 cases, 2008–2013 · leading case: Piazza's Seafood World, LLC v. Odom, 6 So. 3d 820 (La. Ct. App. 2008).

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Piazza's Seafood World, LLC v. Odom, 6 So. 3d 820 (La. Ct. App. 2008). “See 21 C.F.R. 530.41 (a)(l0). 3 . Louisiana Administrative Code 7:XXXV.”

Bayer Healthcare, LLC v. United States Food & Drug Admin., 942 F. Supp. 2d 17 (D.D.C. 2013). “See 21 C.F.R. § 530.41 (a)(10); 21 C.F.R. § 522.”

United States v. Rhody Dairy, L.L.C., 812 F. Supp. 2d 1239 (W.D. Wash. 2011). “Extra-label use is permitted in limited circumstances, including (1) a prescription by a licensed veterinarian in the context of a valid veterinarian-client-patient relationship; (2) the drug is not prohibited from extra-label use under 21 C.F.R. § 530.41 ; and (3) the use does…”

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