Regulatory Information

Subpart E—Safe Levels for Extralabel Use of Drugs in Animals and Drugs Prohibited From Extralabel Use in Animals

See. 530.40 Safe Levels and Availability of Analytical Methods.

  1. In accordance with Sec. 530.22, the following safe levels for extralabel
  2. use of an approved animal drug or human drug have been established: [Reserved]
  3. in accordance with Sec. 530.22, the following analytical methods have been
  4. accepted by FDA: [Reserved]

See. 530.41 Drugs Prohibited For Extralable Use in Animals.
The following drugs are prohibited for extralabel animal and human drug uses in food-producing animals:
(a) Chloramphenicol;
(b) Clenbuterol;
(c) Diethylstilbestrol (DES);
(d) Dimetridazole;
(e) Ipronidazole;
(f) Other nitroimidazoles;
(g) Furazolidone (except for approved topical use);
(h) Nitrofurazone (except for approved topical use); and
(i) Sulfonamide drugs in lactating dairy cattle (except approved use of sulfadimethoxine, sulfabromomethazine and sulfaethoxypyridazine).

NOTE TO READERS: Section 530.21 of AMDUCA clearly states that the FDA Center for Veterinary Medicine (CVM) may prohibit certain types of extra-label use in food animals for a variety of reasons. A partial list of certain prohibited drugs is contained within the text of AMDUCA. It is important to note however, that additional drugs have been added to that list, specifically the fluoroquinolones and glycopeptides. For a complete and current list of drugs which may not be used in an extra-label fashion in food animals please see Prohibited List and recent FARAD Digest, which is frequently updated.


Dated: October 22, 1996.
William B. Schultz, Deputy Commissioner for Policy.
[FR Doc. 96-28662 Filed 11-6-96; 8:45 am] BILLING CODE 4160-01-F