[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: 21CFR510.455]

[Page 45-46]
 
                        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 E--Requirements for Specific New Animal Drugs
 
Sec.  510.455  New animal drug requirements regarding free-choice administration in feeds.

    (a) For the purpose of this section, free-choice administration of 
animal drugs in feeds involves feeds that are placed in feeding or 
grazing areas and are not intended to be consumed fully at a single 
feeding or to constitute the entire diet of the animal. Such methods of 
administering drugs include, but

[[Page 46]]

are not limited to, medicated blocks (agglomerated feed compressed or 
rendered into a solid mass and cohesive enough to hold its form), 
mineral mixes, and liquid feed tank supplements (``lick tank'' 
supplements) containing one or more animal drugs. The manufacture of 
medicated free-choice feeds is subject to the current good manufacturing 
practice regulations for medicated feeds.
    (b) The Food and Drug Administration has concluded that there are 
questions about the safety and effectiveness of drugs when administered 
in free-choice feeds. Therefore, such methods of administration cause 
the drugs so administered to be new animal drugs, for which approved new 
animal drug applications (NADA's) are required. (See Sec.  510.3(i)). In 
addition, the exemption from the requirement of an approved medicated 
feed application provided in Sec.  558.4 of this chapter does not apply 
to any free-choice medicated feed.
    (c) An NADA or supplemental NADA for products for free-choice 
feeding submitted for approval under section 512(b) of the act shall 
provide for:
    (1) The manufacture of a finished product for the free-choice 
administration of a new animal drug. Such an approval will not provide a 
basis upon which an application can be approved under section 512(m) of 
the act; or
    (2) The manufacture of a Type A medicated article for use in the 
subsequent manufacture of a free-choice medicated feed. The approved 
NADA will provide a basis upon which an application can be approved 
under section 512(m) of the act. Data for a specific free-choice product 
may, if desired, be generated and submitted to the Food and Drug 
Administration by the manufacturer of the free-choice feed in the form 
of a master file which can be referenced in the NADA or supplemental 
NADA submitted by the new animal drug sponsor.
    (d) Approval of the NADA or supplemental NADA submitted under 
paragraph (c) of this section will be reflected in a regulation in part 
558 of this chapter published under section 512(i) of the act. The 
regulation will either state the formulation of the approved free-choice 
product or specify the specific free-choice administration products in 
which the drug is approved for use. If the approval is for a Type A 
medicated article, the regulation in part 558 of this chapter will 
indicate that each use of the Type A medicated article in a free-choice 
product must be the subject of an approved supplemental NADA.
    (e) An application submitted under section 512(m) of the act to 
provide for manufacture of a specific free-choice feed from an approved 
Type A medicated article will be approved if, in addition to the 
information required by the medicated feed application, it includes a 
reference to the exact formula of the product to be manufactured as 
follows:
    (1) The formula is the same as the one published in the new animal 
drug regulations; or
    (2) The data in a master file have been referenced in an NADA or 
supplemental NADA; and
    (3) Use of the Type A medicated article in the specific formulation 
has been approved on the basis that:
    (i) The formula is the same as the one for which acceptable data 
have been submitted in a master file by the medicated feed applicant; or
    (ii) The medicated feed applicant has written authority to reference 
a master file that has acceptable data for the formula in question.

[51 FR 19827, June 3, 1986, as amended at 67 FR 9586, Mar. 4, 2002]