Section 390.1900 Preparation of Infant Formula

a)         Formula may be prepared by either the facility or by approved outside resources. Approved outside resources are:

1)         Those infant formula services which are approved to prepare infant formula for sale or distribution by the health department of the state in which the plant is located if the formula is sold interstate; or

2)         If sold only in Illinois, the infant formula service is approved by a local, full-time health department under an ordinance dealing specifically with infant formula preparation to prepare infant formula for sale or distribution.

b)         Facilities electing to utilize approved outside sources, must develop procedures to provide for aseptic preparation of formulas during emergency periods. (B)

c)         All facilities which prepare their own formula shall provide suitable facilities and equipment for the preparation of milk or milk substitute feedings and water for infants. (B)

d)         Formula preparation facilities must be in a medically clean area. Acceptable locations include a "special" formula room and the dietary department. Other areas may be used if isolated from any source of contamination. (B)

e)         If the kitchen is used, formulas must be prepared in such a way that food preparation and serving activities do not interfere. (B)

f)         There shall be suitable equipment for cleaning and sterilizing formula bottles, nipples, and utensils for cleaning formula bottles, nipples, and utensils for the preparation of formula. Preparation of formulas must be physically or functionally separated from the cleaning of equipment. (B)

g)         The formulas shall be prepared by or under the supervision of a registered nurse or the Director of Food Service. (B)

h)         Personnel assigned to formula preparation duties shall not be assigned to other duties until the complete cycle (formula preparation through proper storage) has been completed. Personnel not assigned to formula preparation shall be excluded from the immediate preparation area during the period of time formulas are being prepared, bottled, and capped. (B)

i)          In the cleanup process, all bottles, caps and nipples shall be thoroughly washed with a bottle brush or mechanical washing unit. Nipples should be inverted in the cleaning process and rinsed in running water, then boiled for five minutes. (B)

j)          A 24 hour supply of formula shall be prepared at one time and the formula not used within 24 hours after preparation shall be discarded. Formula shall be poured into individual bottles, nippled, and properly covered at the time of preparation. (B)

k)         Bottles and nipples must be washed and sterilized before being returned to the formula preparation room or area. (B)

l)          Formulas shall be prepared according to one of three techniques: Terminal Heating Methods, Standard Clean Technique Method, or Aseptic Sterilization. (B)

m)        Adequate refrigeration facilities must be provided for storing formulas. Formulas shall be stored at a temperature of 40 degrees Fahrenheit (B)

n)         Periodic bacteriological examination of formula is recommended.

(Source: Amended at 13 Ill. Reg. 6301, effective April 17, 1989)