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













