[Code of Federal Regulations]
[Title 21, Volume 4]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR225.1]

[Page 137-138]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                                SERVICES
 
PART 225--CURRENT GOOD MANUFACTURING PRACTICE FOR MEDICATED FEEDS--Table of Contents
 
                      Subpart A--General Provisions
 
Sec. 225.1  Current good manufacturing practice.


    (a) Section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act 
provides that a drug (including a drug contained in a medicated feed) 
shall be deemed to be adulterated if the methods used in, or the 
facilities or controls used for, its manufacture, processing, packing, 
or holding do not conform to or are not operated or administered in 
conformity with current good manufacturing practice to assure that such 
drug meets the requirement of the act as to safety and has the identity 
and strength, and meets the quality and purity characteristics, which it 
purports or is represented to possess.
    (b)(1) The provisions of this part set forth the criteria for 
determining whether the manufacture of a medicated feed is in compliance 
with current good manufacturing practice. These regulations shall apply 
to all types of facilities and equipment used in the production of 
medicated feeds, and they shall also govern those instances in which 
failure to adhere to the regulations has caused nonmedicated feeds that 
are manufactured, processed, packed, or held to be adulterated. In such 
cases, the medicated feed shall be deemed to be adulterated within the 
meaning of section 501(a)(2)(B) of the act, and the nonmedicated feed 
shall be deemed to be adulterated within the meaning of section 
402(a)(2)(D) of the act.

[[Page 138]]

    (2) The regulations in Secs. 225.10 through 225.115 apply to 
facilities manufacturing one or more medicated feeds for which an 
approved medicated feed mill license is required. The regulations in 
Secs. 225.120 through 225.202 apply to facilities manufacturing solely 
medicated feeds for which an approved license is not required.
    (c) In addition to the recordkeeping requirements in this part, Type 
B and Type C medicated feeds made from Type A articles or Type B feeds 
under approved NADA's and a medicated feed mill license are subject to 
the requirements of Sec. 510.301 of this chapter.

[41 FR 52618, Nov. 30, 1976, as amended at 51 FR 7389, Mar. 3, 1986; 64 
FR 63203, Nov. 19, 1999]