H1001B1126A03688 MAB:JMT 11/06/19 #90 A03688
AMENDMENTS TO HOUSE BILL NO. 1001
Sponsor: SENATOR BROOKS
Printer's No. 1126
Amend Bill, page 3, line 2, by inserting after "the"
donor
Amend Bill, page 3, lines 5 through 8, by striking out all of
said lines
Amend Bill, page 3, lines 15 through 18, by striking out all
of said lines
Amend Bill, page 3, line 28, by striking out "5(a)" and
inserting
5(a)(6)
Amend Bill, page 4, line 5, by striking out "or" and
inserting a comma
Amend Bill, page 4, line 6, by inserting after "facility"
or directly to an outpatient
Amend Bill, page 4, line 8, by striking out "A" and inserting
Subject to the provisions of section 10, a
Amend Bill, page 4, line 13, by striking out "Human" and
inserting
Subject to the provisions of section 10, human
Amend Bill, page 4, line 14, by inserting after "donated"
without remuneration
Amend Bill, page 4, lines 16 and 17, by striking out all of
said lines
Amend Bill, page 5, line 20, by striking out "The term
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includes HMBANA."
Amend Bill, page 6, line 10, by striking out "7" and
inserting
7(d)
Amend Bill, page 6, lines 12 through 14, by striking out all
of lines 12 and 13 and "(ii)" in line 14 and inserting
(i)
Amend Bill, page 6, line 16, by striking out the period after
"banks" and inserting
; or
Amend Bill, page 6, line 17, by striking out "(iii)" and
inserting
(ii)
Amend Bill, page 6, line 17, by inserting after "Is"
otherwise
Amend Bill, page 6, line 19, by striking out all of said line
and inserting
(c) Initial inspection.--
(1) Prior to the issuance of a license,
Amend Bill, page 6, by inserting between lines 21 and 22
(2) Notwithstanding the requirement of paragraph (1),
the department need not inspect the facility if:
(i) the facility 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; or
(ii) the facility 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.
Amend Bill, page 6, lines 23 through 25, by striking out all
of lines 23 and 24 and "(2)" in line 25 and inserting
(1)
Amend Bill, page 6, line 29, by striking out "(3)" and
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inserting
(2)
Amend Bill, page 6, line 29, by striking out "which is
denied" and inserting
that is denied a license
Amend Bill, page 7, lines 1 and 2, by striking out "or within
30 days of the deemed denial if no written explanation is
received"
Amend Bill, page 7, line 17, by striking out "7" and
inserting
7(h)
Amend Bill, page 7, line 19, by striking out "Written" and
inserting
The department shall provide written
Amend Bill, page 7, line 21, by inserting after "revocation"
of a license
Amend Bill, page 7, line 24, by striking out "its
application" and inserting
the milk bank's application or pending decision on whether
the exemption specified in section 10 applies
Amend Bill, page 8, by inserting between lines 5 and 6
(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); and
(ii) otherwise satisfying the provisions of section
6.
Amend Bill, page 8, line 6, by striking out "(2)" and
inserting
(3)
Amend Bill, page 8, by inserting between lines 8 and 9
(4) A board of directors or similar body shall oversee
the milk bank's operating, regulatory and compliance efforts
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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.
Amend Bill, page 8, line 9, by striking out "(3)" and
inserting
(6)
Amend Bill, page 8, lines 16 through 24, by striking out all
of said lines
Amend Bill, page 8, line 25, by striking out "Each licensed
milk bank" and inserting
A licensee
Amend Bill, page 8, line 27, by striking out "at the milk
bank"
Amend Bill, page 9, line 27, by striking out "licensed milk
bank" and inserting
licensee
Amend Bill, page 9, line 30, by striking out "licensed milk
bank" and inserting
licensee
Amend Bill, page 10, lines 9 through 15, by striking out all
of said lines and inserting
(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.
Amend Bill, page 11, line 5, by inserting after "Holder"
and vat
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Amend Bill, page 11, line 13, by striking out the period
after "collection" and inserting
or the bar code that supplies the information required
under this paragraph.
Amend Bill, page 13, line 24, by striking out all of said
line and inserting
(e) Inspection of facilities and documentation.--The
following shall apply:
(1) The
Amend Bill, page 13, by inserting between lines 29 and 30
(2) Notwithstanding the requirement of paragraph (1),
the department need not inspect the facility if:
(i) the facility 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 facility 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.
Amend Bill, page 14, line 28, by striking out "person" and
inserting
milk bank
Amend Bill, page 14, lines 29 and 30, by striking out "an
entity" and inserting
a milk bank
Amend Bill, page 14, line 30, by striking out "9(c)" and
inserting
10
Amend Bill, page 14, by inserting after line 30
(4) The sale or distribution of donor milk or any donor-
milk-derived product in violation of section 5(a)(2).
Amend Bill, page 15, line 12, by striking out "approved" and
inserting
accredited
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Amend Bill, page 15, lines 12 and 13, by striking out ", if
necessary," and inserting
approved
Amend Bill, page 15, by inserting between lines 13 and 14
Section 10. Exemptions.
Amend Bill, page 15, line 14, by striking out "(c) Donor
remuneration" and inserting
(a) General rule
Amend Bill, page 15, line 16, by inserting after "provide"
donor
Amend Bill, page 15, line 17, by inserting after
"voluntarily"
and
Amend Bill, page 15, lines 17 through 28, by striking out
"determining whether to grant" in line 17 and all of lines 18
through 28 and inserting
order to be granted this exemption, the milk bank must
satisfy the following:
(1) The milk bank may not sell, donate or distribute
donor milk and donor-milk-derived products for which the
donor has been remunerated without testing for controlled
substances as determined by the department. The department
may, at any time, require additional testing for donor milk
and donor-milk-derived products.
(2) The milk bank may not sell, donate or distribute
donor milk and donor-milk-derived products for which the
donor has been remunerated without obtaining medical
verification that the donor's biological infant is achieving
adequate growth.
(3) The milk bank must meet or exceed any additional
standards required by the department reasonably necessary to
protect public health and the recipient of the donor milk,
the donor and the donor's baby.
(b) Construction.--If the milk bank is exempt under
subsection (a), the donor of the human milk shall be considered
a "donor" as defined in section 3 and the human milk provided by
the donor shall be considered "donor milk" as defined in section
3.
(c) Penalties.--A violation of this section shall constitute
a misdemeanor of the third degree.
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(d) Applicability.--The provisions of subsection (a)(1) and
(2) shall not apply to milk banks that do not remunerate donors.
Amend Bill, page 15, line 29, by striking out "10" and
inserting
11
Amend Bill, page 16, lines 19 through 28, by striking out all
of said lines and inserting
Section 12. Licensure application.
Upon the effective date of this section, the department shall
create an application for the licensure of milk banks. The
department shall begin accepting applications for licensure of
milk banks 120 days after the effective date of this section.
Section 13. Regulations.
The department may promulgate rules and regulations to
administer and enforce this act.
Amend Bill, page 16, line 29, by striking out "12" and
inserting
14
Amend Bill, page 17, lines 1 and 2, by striking out all of
said lines and inserting
(1) The following provisions shall take effect
immediately:
(i) This section.
(ii) Section 12.
(iii) Section 13.
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