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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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The information on this page is current as of Jul 20, 2022.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

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[Code of Federal Regulations]
[Title 21, Volume 4]
[CITE: 21CFR225.20]



TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER C - DRUGS: GENERAL

PART 225 -- CURRENT GOOD MANUFACTURING PRACTICE FOR MEDICATED FEEDS

Subpart B - Construction and Maintenance of Facilities and Equipment

Sec. 225.20 Buildings.

(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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