§ 115.01 Scope.

This Article applies to the individual preparation of formula in accordance with a physician's or other health care practitioner's prescription in a non-retail food processing establishment, as defined in 24 RCNY Health Code Article 81. It shall not apply to preparation of such formula in

   (1)   a maternity and newborn service operating pursuant to Article 28 of the Public Health Law,

   (2)   any other institution giving care to children, or

   (3)   a dwelling unit for the use of a person residing within the unit.

§ 115.03 Definition.

When used in this Article, "prescription formula" means a food that is prepared for an individual, in accordance with the prescription of a physician or other health care practitioner, using a commercially manufactured powder or liquid food with a basic ingredient of milk, milk constituent, soy, or other liquid or powdered protein. This definition shall not limit the ingredients which may be added to any formula prepared pursuant to this Article.

§ 115.05 Permit.

No person shall prepare prescription formula for sale or distribution or offer for sale, sell, give away or distribute prescription formula in or from a prescription formula preparation facility without a permit issued by the Commissioner.

§ 115.07 Compliance with Code.

A prescription formula preparation facility shall be operated, constructed and maintained in the manner specified for non-retail food processing establishments by 24 RCNY Health Code Article 81 and for buildings generally pursuant to applicable provisions of this Code.

§ 115.09 Preparation and Sale on Physician's or Other Health Care Practitioner's Order .

No prescription formula preparation facility permittee shall prepare, offer for sale, sell, give away or distribute prescription formula except on the order of a physician or other health care practitioner authorized by State law to prescribe therapeutic diets. The order may be transmitted to the permittee orally or in writing.

§ 115.11 Standards; Ingredients.

Food products used in the preparation of prescription formula shall be wholesome and obtained from sources approved in accordance with applicable federal and state law.

§ 115.13 Standards; Sterilization and Purity of Prescription Formula Preparations .

   (a)   Prescription formula preparations shall be safe for human consumption and produced under sanitary conditions using aseptic technique.

   (b)   Samples of prepared prescription formula shall be submitted to a certified laboratory for bacteriological and other microbiological analysis in accordance with a schedule established by the permittee and approved by the Department.

   (c)   When bacteriological sampling or other investigation reveals that the prescription formula preparation fails to meet the requirements of this Code, the Department may embargo and exclude such prescription formula from sale or distribution in accordance with 24 RCNY Health Code Articles 3 and 71.