[Code of Federal Regulations]
[Title 21, Volume 4]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR225.65]

[Page 167]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 225_CURRENT GOOD MANUFACTURING PRACTICE FOR MEDICATED FEEDS--Table of Contents
 
                    Subpart C_Product Quality Control
 
Sec.  225.65  Equipment cleanout procedures.

    (a) Adequate cleanout procedures for all equipment used in the 
manufacture and distribution of medicated feeds are essential to 
maintain proper drug potency and avoid unsafe contamination of feeds 
with drugs. Such procedures may consist of cleaning by physical means, 
e.g., vacuuming, sweeping, washing, etc. Alternatively, flushing or 
sequencing or other equally effective techniques may be used whereby the 
equipment is cleaned either through use of a feed containing the same 
drug(s) or through use of drug free feedstuffs.
    (b) All equipment, including that used for storage, processing, 
mixing, conveying, and distribution that comes in contact with the 
active drug component, feeds in process, or finished medicated feed 
shall be subject to all reasonable and effective procedures to prevent 
unsafe contamination of manufactured feed. The steps used to prevent 
unsafe contamination of feeds shall include one or more of the 
following, or other equally effective procedures:
    (1) Such procedures shall, where appropriate, consist of physical 
means (vacuuming, sweeping, or washing), flushing, and/or sequential 
production of feeds.
    (2) If flushing is utilized, the flush material shall be properly 
identified, stored, and used in a manner to prevent unsafe contamination 
of other feeds.
    (3) If sequential production of medicated feeds is utilized, it 
shall be on a predetermined basis designed to prevent unsafe 
contamination of feeds with residual drugs.