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§ 5016. Donation, processing and distribution of donor milk

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. § 5016
§ 5016. Donation, processing and distribution of donor milk
(a) Donor qualifications.--Potential donors of donor milk shall:
(1) Be medically screened initially and periodically reassessed to determine conditions and behaviors that may affect the quality or nutritional value of the donor's milk or do harm to the donor herself.
(2) Provide consent for the milk bank to contact:
(i) The potential donor's health care providers and medically screen and blood test the potential donor to ensure the health of the potential donor and to ensure the donor milk is free of any chemical, disease or substance that could injure an infant receiving the milk.
(ii) The health care providers of the donor's biological baby to verify that the baby is achieving adequate growth, except in cases of bereavement, surrogacy or adoption.
(3) Be excluded from donation for a documented infection by a bloodborne pathogen or for other acute or chronic infectious diseases.
(4) Be temporarily precluded from donating milk if the donor:
(i) Uses medications contraindicated during breastfeeding or tobacco or other substances as may be identified by the department.
(ii) Has a systemic chronic disease or nutritional deficiency as identified by the donor's or the donor's infant's health care provider.
(iii) Has a history of exposure to possible environmental contaminants, including lead or mercury.
(iv) Lacks the ability to understand and follow directions regarding the sanitary collection and storage of donor milk.
(b) Donor milk processing.--Donor milk shall be processed in accordance with the following:
(1) An approved pasteurization or processing method, including the Holder and vat pasteurization method or another method approved by the department, the United States Food and Drug Administration or a professional association, shall be used to inactivate pathogens in donor milk.
(2) Post-pasteurization bacteriologic cultures shall be performed.
(3) Containers of unprocessed donor milk shall be labeled with the donor's identification number and the date of collection or the bar code that supplies the information required under this paragraph.
(4) Frozen, unprocessed donor milk held at a satellite milk depot shall identify the location, along with the date and time of receipt and transportation.
(5) Each container of processed donor milk shall be properly labeled with the expiration date, batch number and name of the milk bank specific to the milk contained in the bottle.
(c) Storage.--Donor milk shall be stored in accordance with the following:
(1) Proper refrigeration and freezer capability shall be available at each milk bank, with appropriate thermometer calibration performed no less frequently than annually. The thermometer on each refrigerator and freezer used for the storage of donor milk shall be visually or mechanically monitored daily for possible fluctuations in temperature that could impact the quality of the donor milk. The temperatures shall be recorded and maintained by each milk bank for a period of one year.
(2) Packing of processed milk shall be documented using containers that are approved by the United States Food and Drug Administration as food safe vessels for both heating and freezing.
(3) Donor milk shall be stored and transported frozen at a proper temperature and under conditions that protect the milk from contamination, thawing and refreezing.
(4) Donor milk shall be shipped in clean, insulated containers using packing material to minimize contamination of the outside of the bottles during transportation, or as otherwise required by the department.


2020, Feb. 12, P.L. 13, No. 7, § 6, effective in 60 days [Aug. 10, 2020].
35 P.S. § 5016, PA ST 35 P.S. § 5016
Current through Act 13 of the 2024 Regular Session. Some statute sections may be more current, see credits for details.
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