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| [Code of Federal Regulations] |
| [Title 21, Volume 4] |
| [CITE: 21CFR225] |
TITLE 21--FOOD AND DRUGS CHAPTER I--FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER C - DRUGS: GENERAL
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| PART 225 | CURRENT GOOD MANUFACTURING PRACTICE FOR MEDICATED FEEDS |
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Subpart B - Construction and Maintenance of Facilities and Equipment
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(a) The location, design, construction, and physical size of the buildings and other production facilities are factors important to the manufacture of medicated feed. The features of facilities necessary for the proper manufacture of medicated feed include provision for ease of access to structures and equipment in need of routine maintenance; ease of cleaning of equipment and work areas; facilities to promote personnel hygiene; structural conditions for control and prevention of vermin and pest infestation; adequate space for the orderly receipt and storage of drugs and feed ingredients and the controlled flow of these materials through the processing and manufacturing operations; and the equipment for the accurate packaging and delivery of a medicated feed of specified labeling and composition.
(b) The construction and maintenance of buildings in which medicated feeds are manufactured, processed, packaged, labeled, or held shall conform to the following:
(1) The building grounds shall be adequately drained and routinely maintained so that they are reasonably free from litter, waste, refuse, uncut weeds or grass, standing water, and improperly stored equipment.
(2) The building(s) shall be maintained in a reasonably clean and orderly manner.
(3) The building(s) shall be of suitable construction to minimize access by rodents, birds, insects, and other pests.
(4) The buildings shall provide adequate space and lighting for the proper performance of the following medicated feed manufacturing operations:
(i) The receipt, control, and storage of components.
(ii) Component processing.
(iii) Medicated feed manufacturing.
(iv) Packaging and labeling.
(v) Storage of containers, packaging materials, labeling and finished products.
(vi) Routine maintenance of equipment.
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(a) Equipment which is designed to perform its intended function and is properly installed and used is essential to the manufacture of medicated feeds. Such equipment permits production of feeds of uniform quality, facilitates cleaning, and minimizes spillage of drug components and finished product.
(b)(1) All equipment shall possess the capability to produce a medicated feed of intended potency, safety, and purity.
(2) All equipment shall be maintained in a reasonably clean and orderly manner.
(3) All equipment, including scales and liquid metering devices, shall be of suitable size, design, construction, precision, and accuracy for its intended purpose.
(4) All scales and metering devices shall be tested for accuracy upon installation and at least once a year thereafter, or more frequently as may be necessary to insure their accuracy.
(5) All equipment shall be so constructed and maintained as to prevent lubricants and coolants from becoming unsafe additives in feed components or medicated feed.
(6) All equipment shall be designed, constructed, installed and maintained so as to facilitate inspection and use of cleanout procedure(s).
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Sec. 225.35 Use of work areas, equipment, and storage areas for other manufacturing and storage purpose.
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(a) Many manufacturers of medicated feeds are also involved in the manufacture, storage, or handling of products which are not intended for animal feed use, such as fertilizers, herbicides, insecticides, fungicides, rodenticides, and other pesticides. Manufacturing, storage, or handling of nonfeed and feed products in the same facilities may cause adulteration of feed products with toxic or otherwise unapproved feed additives.
(b) Work areas and equipment used for the manufacture or storage of medicated feeds or components thereof shall not be used for, and shall be physically separated from, work areas and equipment used for the manufacture of fertilizers, herbicides, insecticides, fungicides, rodenticides, and other pesticides unless such articles are approved drugs, indexed drugs, or approved food additives intended for use in the manufacture of medicated feed.
[41 FR 52618, Nov. 30, 1976, as amended at 72 FR 69120, Dec. 6, 2007]
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Authority: 21 U.S.C. 351, 352, 360b, 371, 374.
Source: 41 FR 52618, Nov. 30, 1976, unless otherwise noted.
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