(1) Each milk bank shall develop and ensure the implementation of policies and procedures consistent with professional association guidelines or the requirements of this act.

(2) No donor milk or donor-milk-derived product may be distributed by a milk bank without:

(3) Each milk bank shall be operated by a managing director responsible for the day-to-day operations of the milk bank.

(4) A board of directors or similar body shall oversee the milk bank's operating, regulatory and compliance efforts and the work of the managing director, the medical director and the medical advisory committee.

(5) A milk bank shall have a medical director who is a licensed physician with a minimum of four years' experience in neonatology, pediatrics, blood banking, infectious disease or a related field.

(6) A milk bank shall establish a medical advisory committee to consult on milk bank operations, which shall be composed of physicians and other allied health personnel with experience in neonatology, blood or tissue banking, nutrition and other related expertise. At least one member of the committee must have experience in the field of infectious diseases or biologics manufacturing.

(7) A milk bank shall provide to the department on an annual basis a summary of the amount of milk donated, processed and distributed by the milk bank within this Commonwealth.

(1) An individual file on each milk donor, including the donor's consent to participate in the program and the result of each laboratory test performed prior to donation and during the duration of the donation. Direct or indirect identifying information for an individual donor may not be disclosed except with the written consent of the individual donor. The information in this subsection is exempt from access under the act of February 14, 2008 (P.L. 6, No. 3),³ known as the Right-to-Know Law.

(2) Records providing for the tracing of each donated milk container from donor to distribution shall include the following:

(3) The dates that the donor milk was pasteurized, distributed and used.

(4) Identifying information for milk pooled from multiple donors, which shall also be separately recorded and maintained.

(5) Bacteriological testing and dates for each batch of donor milk.

(6) Refrigeration and freezer temperatures.

(7) Tracking and shipping information for the distribution of donor milk by facility or by specific outpatient use.

(8) Upon the request of the department, the milk bank shall provide information to be included in the department's report on the operation of milk banks required under section 11.⁴