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§ 5015. Operation of milk bank

Purdon's Pennsylvania Statutes and Consolidated StatutesTitle 35 P.S. Health and SafetyEffective: August 10, 2020

Purdon's Pennsylvania Statutes and Consolidated Statutes
Title 35 P.S. Health and Safety (Refs & Annos)
Chapter 24A. Keystone Mothers' Milk Bank Act (Refs & Annos)
Effective: August 10, 2020
35 P.S. § 5015
§ 5015. Operation of milk bank
(a) Licensee requirements.--
(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:
(i) testing to address associated risks as identified by the guidelines of the milk bank under section 7(c);1 and
(ii) otherwise satisfying the provisions of section 6.2
(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.
(b) Record retention.--A licensee shall maintain the following records in a manner determined by the department in an easily accessible location:
(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:
(i) Each donor identified by an identification number.
(ii) The information from each container's affixed identification tag.
(iii) If used, the identity of the satellite milk depot, the time and date of receipt by the satellite milk depot and the information relating to the transportation of the milk.
(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
(c) Disclosure of relationships.--A licensee shall notify the department within 10 days of establishing a relationship with a dispensary or satellite milk depot.
(d) License display.--A licensee shall display the license in a prominent place at the milk bank's main location.


2020, Feb. 12, P.L. 13, No. 7, § 5, effective in 180 days [Aug. 10, 2020].


35 P.S. § 5017.
35 P.S. § 5016.
65 P.S. § 67.101 et seq.
35 P.S. § 5021.
35 P.S. § 5015, PA ST 35 P.S. § 5015
Current through Act 13 of the 2024 Regular Session. Some statute sections may be more current, see credits for details.
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