§ 115.21 Packaging and Sterilization.
RCNY § 115.21
(a)Prescription formula shall be packaged in individual single service food grade containers.
(b)Immediately after filling, a container shall be closed with a cover or cap which effectively seals and protects the mouth of the container. Containers with prepared infant prescription formula may be closed with new, unused, incised nipples which shall be protected with suitable outside fitted caps.
(c)Only sterile water shall be used in infant prescription formula preparation.
(d)Sterile water used to prepare infant prescription formula from a powder base shall be cooled to a temperature no lower than 158 degrees Fahrenheit (70 degrees Celsius) during preparation.
(e)Containers of prescription formula shall be sterilized in an autoclave unless the physician or other health care practitioner's order states that such formula shall not be sterilized, or if the label on a container of a commercially manufactured infant formula base advises that such formula should not be sterilized after preparation.
(f)Prepared infant prescription formula shall be properly cooled to and maintained at or below 40 degrees Fahrenheit (4.4 degrees Celsius) within one hour of preparation, except that prescription infant formula prepared from a powdered food base shall be cooled to 37 degrees Fahrenheit (2.8 degrees Celsius) within one hour of preparation, and maintained at or below 40 degrees Fahrenheit (4.4 degrees Celsius).
(g)Formula intended for persons other than infants shall be cooled to and maintained at temperatures recommended by the manufacturer of the formula base product, or 24 RCNY Health Code Article 81, whichever temperature is lower.
(h)All prescription infant formula prepared from a powder base, or liquid containing amendments, shall be used or discarded within 24 hours of preparation. All other formula preparations shall be consumed or discarded within 48 hours of preparation.
