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§ 5017. Duties of department

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
Effective: August 10, 2020
35 P.S. § 5017
§ 5017. Duties of department
Currentness
(a) Licensure of milk banks.--The department shall:
(1) Regulate the operation of milk banks that handle and distribute donor milk in this Commonwealth.
(2) Issue licenses to milk banks deemed compliant with this act.
(b) Review of professional association guidelines.--
(1) The department shall review and approve professional association guidelines to ensure that the guidelines in use maintain the necessary requirements and standards of review for the safe operation and accreditation of licensees in this Commonwealth, and shall transmit to the Legislative Reference Bureau for publication in the Pennsylvania Bulletin a list of professional associations that have approved guidelines. If, at any time, the department determines that the professional association guidelines do not maintain necessary requirements and standards of review for the safe operation and accreditation of licensees, licensees must satisfy the requirements under paragraph (2).
(2) The department shall adopt standards and requirements for licensure separate from those of the professional association guidelines referenced in paragraph (1) which the department determines are sufficient to maintain the safe operation and accreditation of licensees.
(c) Milk bank compliance.--To be licensed by the department, a milk bank must satisfy the professional association guidelines referenced in subsection (b)(1) or the standards and requirements established by the department under subsection (b)(2), as applicable.
(d) Application requirements.--The department shall develop a standard written application for a license, which shall include at least the following:
(1) The name and location of the milk bank.
(2) The name and address of the managing director responsible for the milk bank's day-to-day operations and of the medical director of the milk bank.
(3) The education and experience of each person in a supervisory or technical role in the operation of the milk bank.
(4) A description of the physical facilities, locations, equipment, sources of materials and methods of processing, storage and distribution of donor milk.
(5) A description of each technical procedure used in the routine operation of the milk bank.
(6) Any relationship between the applicant and either a dispensary or satellite milk depot.
(7) Any other information required by the department.
(e) Inspection of facilities and documentation.--The following shall apply:
(1) Whenever the department receives a complaint or has other reasonable grounds to believe that a violation of this act has occurred, the department may, without notice to the licensee, survey any service, facility or portion of the licensee related to the suspected violation.
(2) For either issuance of a new license or renewals, the department need not inspect the milk bank if the milk bank meets at least two of the following:
(i) the milk bank has a valid license or accreditation from another state and the department is satisfied that the other state's license addresses appropriate health and safety concerns;
(ii) the milk bank is registered and in good standing with the United States Food and Drug Administration, and the department has received confirmation that the facility has satisfactorily addressed all observations raised in previous inspections.
(iii) The milk bank has been accredited by a professional association that is a nationally recognized accrediting body to the extent the association's standards are determined to be acceptable by the department.
(f) Contents of license.--A license shall display the following information:
(1) The name and address of the licensee and the location of all facilities, dispensaries and affiliated satellite milk depots authorized under the license.
(2) The name and address of the managing director responsible for the milk bank's day-to-day operations and of the medical director of the milk bank.
(3) The signature of the secretary.
(g) Submission of professional association accreditation.--
(1) A licensee belonging to a professional association shall submit the licensee's professional association certification information to the department within 30 days of each inspection and accreditation by the professional association.
(2) A licensee belonging to a professional association shall notify the department within 72 hours when membership in a professional association is terminated for any reason.
(h) Revocations.--Before the department suspends or revokes a license issued under this act, the department shall provide written notification to the licensee specifying the reasons for the revocation or suspension and indicating a time and place for a hearing to be held within 30 days of the notification.

Credits

2020, Feb. 12, P.L. 13, No. 7, § 7, effective in 180 days [Aug. 10, 2020].
35 P.S. § 5017, PA ST 35 P.S. § 5017
Current through 2023 Regular Session Act 1. Some statute sections may be more current, see credits for details.
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