[Code of Federal Regulations]
[Title 21, Volume 6]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR510.110]

[Page 40-41]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 510--NEW ANIMAL DRUGS--Table of Contents
 
        Subpart B--Specific Administrative Rulings and Decisions
 
Sec.  510.110  Antibiotics used in food-producing animals.

    (a) The Food and Drug Administration in the interest of fulfilling 
its responsibilities with regard to protection of the public health has 
requested an evaluation of the public health aspects of the use of 
antibiotics in veterinary medical and nonmedical uses. There is 
particular concern with regard to the potential hazards associated with 
the extensive use of antibiotics administered to food-producing animals. 
Accordingly, an ad hoc committee on the Veterinary Medical and 
Nonmedical Uses of Antibiotics was established by the Food and Drug 
Administration to study and advise the Commissioner of Food and Drugs on 
the uses of antibiotics in veterinary medicine and for various 
nonmedical purposes as such uses may affect the enforcement of the 
Federal Food, Drug, and Cosmetic Act with respect to their safety and 
effectiveness.
    (b) Based upon an evaluation of the conclusions of said Committee 
and other relevant material, Sec.  510.112 was published in the Federal 
Register of August 23, 1966 (31 FR 11141), asking sponsors of drugs 
containing any antibiotic intended for use in food-producing animals to 
submit data to establish whether such antibiotic and its metabolites are 
present as residues in edible tissues, milk, and eggs from treated 
animals. The data on the residues of antibiotics in milk from 
intramammary infusion preparations were requested within 60 days and the 
data on all other products were requested within 180 days following the 
date of publication of Sec.  510.112 in the Federal Register.
    (c) An evaluation of the data now available shows that use of many 
antibiotic preparations cause residues in edible products of treated 
animals for varying and, in some cases, for long periods of time 
following the last administration. Because of the accumulation of new 
information with regard to the development of resistance of bacteria to 
antibiotics, the ability of bacteria to transfer this resistance, and 
the development of sensitivity to antibiotics in humans, unauthorized 
and unsafe residues of antibiotics cannot be permitted in food obtained 
from treated animals.
    (d) Based on evaluation of information available, including the 
conclusions of the aforementioned ad hoc

[[Page 41]]

Committee, the Commissioner concludes that antibiotic preparations 
intended for use in food-producing animals, other than topical and 
ophthalmic preparations, are not generally recognized among qualified 
experts as having been shown to be safe for their intended use(s) within 
the meaning of section 201(s) of the Federal Food, Drug, and Cosmetic 
Act.
    (e) Therefore, all exemptions from the provisions of section 409 of 
the act for use of antibiotics in food-producing animals based on 
sanctions or approvals granted prior to enactment of the Food Additives 
Amendment of 1958 (Pub. L. 85-929; 72 Stat. 1784) will be revoked and 
the uses which are concluded to be safe will be covered by food additive 
regulations. On those products for which there are inadequate residue 
data, actions will be initiated to withdraw approval of new-drug 
applications under the provisions of section 505 of the act. Antibiotic 
preparations, other than those for topical and ophthalmic application in 
food-producing animals, which are not covered by food additive 
regulations will be subject to regulatory action within 180 days after 
publication of the forthcoming revocation order.
    (f) Because of the variation in the period of time that antibiotic 
residues may remain in edible products from treated animals, all 
injectable, intramammary infusion, intrauterine, and oral preparations, 
including medicated premixes intended for use in food-producing animals, 
are deemed to be new drugs as well as food additives.

[40 FR 13807, Mar. 27, 1975, as amended at 54 FR 18280, Apr. 28, 1989; 
64 FR 403, Jan. 5, 1999]