§ 115.17 Labeling of Containers.

Each container of prepared prescription formula for an individual shall be labeled with the following information:

   (a)   The name and telephone number of the prescription formula preparation facility;

   (b)   The words "INFANT FORMULA" "CHILD FORMULA" OR "ADULT FORMULA" as applicable, or other words acceptable to the Department;

   (c)   The patient's name, medical record number or other institutional identification, and name of medical facility;

   (d)   If the prescription formula is prepared using commercially available infant formula, the infant formula brand name and additives, if any;

   (e)   Caloric density/volume;

   (f)   Expiration date and time;

   (g)   A statement that the prescription formula shall be kept under refrigeration at or below 40 degrees Fahrenheit (4.4 degrees Celsius);

   (h)   Prescription formulas for infants made from a powdered food base or a liquid base that has been modified shall be labeled to identify powder content, and shall include a statement that such prescription formulas shall be consumed or discarded no later than 24 hours after preparation. Other formula preparations shall include statement that such prescription formulas shall be discarded no later than 48 hours after preparation.

§ 115.19 Physical Facilities, Equipment and Processing .

   (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.

§ 115.21 Packaging and Sterilization.

   (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.

§ 115.23 Records.

The following records, in a form provided or approved by the Department, shall be retained for at least three months:

   (a)   Orders received and prescription formulas prepared in accordance with such orders.

   (b)   For each sterilization procedure, equipment calibration readings, processing time and temperatures maintained during sterilization.

   (c)   Reports of bacteriological or other microbiological laboratory analyses conducted by or on behalf of the permittee.

Article 116: Infant Formula in Hermetically Sealed Containers [Repealed]

Article 117: Dairy Food Products [Repealed]

Article 121: Other Food Establishments: Dry Warehouses; Edible Egg Breaking; Bakeries; Mineral, Spring and Other Waters; Carbonated and Other Beverages [Repealed]

Part B: Control of Environment