§ 115.19 Physical Facilities, Equipment and Processing.
RCNY § 115.19
(a)Rooms and equipment used to prepare prescription formula shall be organized, cleaned and sanitized so as to prevent contamination, including cross-contamination by food substances, such as allergens, that the ordering physician or other health care practitioner has indicated may compromise an patient's health and safety.
(b)Facilities shall consist of separate rooms for preparation of infant and adult prescription formula and a separate room or rooms for washing and sanitizing containers and utensils. Such rooms shall not be used for any other purpose.
(c)During prescription formula preparation no other activities shall take place in the preparation room, doors leading to prescription formula preparation rooms shall be kept securely closed during preparation and only authorized personnel shall be allowed access to the prescription formula preparation room(s).
(d)Rooms shall be of such size as to prevent contamination of equipment and utensils.
(e)A preparation room shall have no exposed overhead water, steam or sewage piping and shall have an adequate number of conveniently located hand wash sinks operated by foot, knee or elbow controls.
(f)Floor drains of a washing room shall be separate from the drains of preparation rooms. A washing room shall have facilities and equipment and a supply of hot and cold running water adequate to enable proper cleaning and sterilization of containers and utensils. Racks shall be provided for the storing of clean containers and utensils.
(g)Equipment and apparatus used for preparation of prescription formula shall be of sanitary design and construction and allow effective cleaning and sanitizing. Equipment and apparatus shall be made of stainless steel or other impervious materials which will not rust, corrode or result in contamination. Sterilization equipment shall be equipped with recording and indicating thermometers.
