[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: 21CFR558.5]

[Page 362]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS--Table of Contents
 
                      Subpart A--General Provisions
 
Sec.  558.5  New animal drug requirements for liquid Type B feeds.

    (a) Information available to the Commissioner of Food and Drugs 
shows that certain drugs are unstable when added to some liquid Type B 
medicated feeds. The demonstrated instability of these drugs gives rise 
to the question of the stability of other drugs when added to liquid 
Type B medicated feeds, except where specific approval has been granted 
for such use. Therefore, the labeling of a drug to provide for its use 
in a liquid Type B medicated feed causes the drug to be a new animal 
drug for such use for which an approved new animal drug application is 
required pursuant to section 512(b) of the Federal Food, Drug, and 
Cosmetic Act.
    (b) The addition of a drug to a liquid Type B medicated feed causes 
such Type B feed to become an animal feed bearing or containing a new 
animal drug for which an approved application is required pursuant to 
section 512(m) of the act.
    (c) Each drug product, intended for oral administration to animals, 
which contains any of the drugs listed in paragraph (d) of this section 
and which bears labeling for its use in animal feed and/or drinking 
water shall also include in such labeling the following statement: ``FOR 
USE IN ------ ONLY. NOT FOR USE IN LIQUID TYPE B MEDICATED FEEDS,'' the 
blank being filled in with the words ``DRY FEEDS,'' ``DRINKING WATER,'' 
``DRY FEEDS AND DRINKING WATER'' as applicable, unless:
    (1) Such drug product is the subject of an approved new animal drug 
application providing for its use in liquid Type B medicated feeds, or;
    (2) The labeling provisions of this paragraph have been waived on 
the basis of approval of a petition which includes a copy of the product 
label; a description of the formulation; and information which 
establishes that the physical, chemical, or other properties of the 
particular drug product are such that it cannot reasonably be expected 
to be diverted for use in liquid Type B medicated feeds. Such petitions 
shall be submitted to the Food and Drug Administration, Center for 
Veterinary Medicine, 7500 Standish Pl., Rockville, MD 20855.
    (d) The labeling provisions of paragraph (c) of this section apply 
to all forms of bacitracin, oxytetracycline, and chlortetracycline.
    (e) For any drug which is the subject of an approved new animal drug 
application, the labeling provisions of paragraph (c) of this section 
may be implemented without prior approval as provided for in Sec.  
514.8(d) and (e) of this chapter.

[40 FR 13959, Mar. 27, 1975, as amended at 52 FR 2684, Jan. 26, 1987; 57 
FR 6475, Feb. 25, 1992]