New York Codes, Rules and Regulations (NYCRR)

Title 10 Part 52

Department of Health

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Source versions current through May 31, 2021 - Sep 30, 2026 across sections

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10 NYCRR 52-1.1 - Definitions

Related State Register notice: Proposed rule HLT-09-26-00001-P. Published Mar 4, 2026.

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10 NYCRR 52-2.1 - Licensure

Related State Register notice: Proposed rule HLT-09-26-00001-P. Published Mar 4, 2026.

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10 NYCRR 52-2.2 - Provisional licensure

Related State Register notice: Proposed rule HLT-09-26-00001-P. Published Mar 4, 2026.

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10 NYCRR 52-2.3 - Ownership or controlling interest reporting requirements

Related State Register notice: Proposed rule HLT-09-26-00001-P. Published Mar 4, 2026.

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10 NYCRR 52-2.4 - Special criteria for tissue bank licensure

Related State Register notice: Proposed rule HLT-09-26-00001-P. Published Mar 4, 2026.

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10 NYCRR 52-2.5 - License issuance and denial

Related State Register notice: Proposed rule HLT-09-26-00001-P. Published Mar 4, 2026.

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10 NYCRR 52-2.6 - Financial disclosure and fees for services

Related State Register notice: Proposed rule HLT-09-26-00001-P. Published Mar 4, 2026.

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10 NYCRR 52-2.7 - Administration and direction

Related State Register notice: Proposed rule HLT-09-26-00001-P. Published Mar 4, 2026.

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HLT-09-26-00001-P · Proposed rule
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10 NYCRR 52-2.8 - Administration of a tissue transplantation facility

Related State Register notice: Proposed rule HLT-09-26-00001-P. Published Mar 4, 2026.

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10 NYCRR 52-2.9 - Required records

Related State Register notice: Proposed rule HLT-09-26-00001-P. Published Mar 4, 2026.

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10 NYCRR 52-2.10 - Compliance with standards

Related State Register notice: Proposed rule HLT-09-26-00001-P. Published Mar 4, 2026.

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10 NYCRR 52-3.1 - Compliance with FDA regulations and manufacturers' instructions

Related State Register notice: Proposed rule HLT-09-26-00001-P. Published Mar 4, 2026.

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10 NYCRR 52-3.2 - Sterilization of instruments

Related State Register notice: Proposed rule HLT-09-26-00001-P. Published Mar 4, 2026.

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HLT-09-26-00001-P · Proposed rule
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10 NYCRR 52-3.3 - Qualifications of donors

Related State Register notice: Proposed rule HLT-09-26-00001-P. Published Mar 4, 2026.

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10 NYCRR 52-3.4 - Selection and testing requirements for tissue donors

Related State Register notice: Adopted rule HLT-18-23-00014-A. Published Mar 20, 2024. Notice effective date: Mar 20, 2024.

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HLT-18-23-00014-A · Adopted rule
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Mar 20, 2024
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10 NYCRR 52-3.5 - Quality assurance and safety requirements

Related State Register notice: Proposed rule HLT-09-26-00001-P. Published Mar 4, 2026.

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10 NYCRR 52-3.6 - HIV antibody testing and notification

Related State Register notice: Proposed rule HLT-09-26-00001-P. Published Mar 4, 2026.

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10 NYCRR 52-3.7 - Reporting requirements

Related State Register notice: Proposed rule HLT-09-26-00001-P. Published Mar 4, 2026.

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10 NYCRR 52-3.8 - Special circumstances

Related State Register notice: Proposed rule HLT-09-26-00001-P. Published Mar 4, 2026.

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10 NYCRR 52-4.1 - Definitions

Related State Register notice: Proposed rule HLT-09-26-00001-P. Published Mar 4, 2026.

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10 NYCRR 52-4.2 - Construction

Related State Register notice: Proposed rule HLT-09-26-00001-P. Published Mar 4, 2026.

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10 NYCRR 52-4.3 - Tissue procurement services

Related State Register notice: Proposed rule HLT-09-26-00001-P. Published Mar 4, 2026.

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10 NYCRR 52-4.4 - Donor qualifications

Related State Register notice: Proposed rule HLT-09-26-00001-P. Published Mar 4, 2026.

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HLT-09-26-00001-P · Proposed rule
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10 NYCRR 52-4.5 - Retrieval of tissue

Related State Register notice: Proposed rule HLT-09-26-00001-P. Published Mar 4, 2026.

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10 NYCRR 52-4.6 - Tissue processing facilities

Related State Register notice: Proposed rule HLT-09-26-00001-P. Published Mar 4, 2026.

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10 NYCRR 52-4.7 - Required laboratory tests on donors and donated tissue

Related State Register notice: Proposed rule HLT-09-26-00001-P. Published Mar 4, 2026.

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10 NYCRR 52-4.8 - Processing and storage of tissue

Related State Register notice: Proposed rule HLT-09-26-00001-P. Published Mar 4, 2026.

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10 NYCRR 52-4.9 - Distribution of tissue products

Related State Register notice: Proposed rule HLT-09-26-00001-P. Published Mar 4, 2026.

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10 NYCRR 52-4.10 - Required records of tissue acquisition, testing, processing and storage

Related State Register notice: Proposed rule HLT-09-26-00001-P. Published Mar 4, 2026.

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10 NYCRR 52-4.11 - Records to be kept by the tissue transplantation facility

Related State Register notice: Proposed rule HLT-09-26-00001-P. Published Mar 4, 2026.

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10 NYCRR 52-4.12 - Disposition of unused tissue

Related State Register notice: Proposed rule HLT-09-26-00001-P. Published Mar 4, 2026.

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10 NYCRR 52-4.13 - Tissue storage facilities

Related State Register notice: Proposed rule HLT-09-26-00001-P. Published Mar 4, 2026.

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10 NYCRR 52-5.1 - Definitions

Related State Register notice: Proposed rule HLT-09-26-00001-P. Published Mar 4, 2026.

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10 NYCRR 52-5.2 - Construction

Related State Register notice: Proposed rule HLT-09-26-00001-P. Published Mar 4, 2026.

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10 NYCRR 52-5.3 - Tissue procurement services

Related State Register notice: Proposed rule HLT-09-26-00001-P. Published Mar 4, 2026.

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10 NYCRR 52-5.4 - Donor qualifications

Related State Register notice: Proposed rule HLT-09-26-00001-P. Published Mar 4, 2026.

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10 NYCRR 52-5.5 - Retrieval of tissue

Related State Register notice: Proposed rule HLT-09-26-00001-P. Published Mar 4, 2026.

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10 NYCRR 52-5.6 - Tissue processing facilities

Related State Register notice: Proposed rule HLT-09-26-00001-P. Published Mar 4, 2026.

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10 NYCRR 52-5.7 - Required laboratory tests on donors and donated tissue

Related State Register notice: Proposed rule HLT-09-26-00001-P. Published Mar 4, 2026.

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10 NYCRR 52-5.8 - Processing and storage of tissue

Related State Register notice: Proposed rule HLT-09-26-00001-P. Published Mar 4, 2026.

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10 NYCRR 52-5.9 - Distribution of tissue products

Related State Register notice: Proposed rule HLT-09-26-00001-P. Published Mar 4, 2026.

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10 NYCRR 52-5.10 - Required records of tissue acquisition, testing, processing and storage

Related State Register notice: Proposed rule HLT-09-26-00001-P. Published Mar 4, 2026.

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10 NYCRR 52-5.11 - Records to be kept by a tissue transplantation facility

Related State Register notice: Proposed rule HLT-09-26-00001-P. Published Mar 4, 2026.

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10 NYCRR 52-5.12 - Disposition of unused tissue

Related State Register notice: Proposed rule HLT-09-26-00001-P. Published Mar 4, 2026.

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10 NYCRR 52-5.13 - Tissue storage facilities

Related State Register notice: Proposed rule HLT-09-26-00001-P. Published Mar 4, 2026.

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10 NYCRR 52-6.1 - Definitions

Related State Register notice: Proposed rule HLT-09-26-00001-P. Published Mar 4, 2026.

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10 NYCRR 52-6.2 - Construction

Related State Register notice: Proposed rule HLT-09-26-00001-P. Published Mar 4, 2026.

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10 NYCRR 52-6.3 - Tissue procurement services

Related State Register notice: Proposed rule HLT-09-26-00001-P. Published Mar 4, 2026.

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10 NYCRR 52-6.4 - Donor qualifications

Related State Register notice: Proposed rule HLT-09-26-00001-P. Published Mar 4, 2026.

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10 NYCRR 52-6.5 - Retrieval of tissue

Related State Register notice: Proposed rule HLT-09-26-00001-P. Published Mar 4, 2026.

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10 NYCRR 52-6.6 - Tissue processing facilities

Related State Register notice: Proposed rule HLT-09-26-00001-P. Published Mar 4, 2026.

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10 NYCRR 52-6.7 - Required laboratory tests on donors and donated tissue

Related State Register notice: Proposed rule HLT-09-26-00001-P. Published Mar 4, 2026.

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10 NYCRR 52-6.8 - Processing and storage of tissue

Related State Register notice: Proposed rule HLT-09-26-00001-P. Published Mar 4, 2026.

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Mar 4, 2026

Current section text is not available here.

10 NYCRR 52-6.9 - Distribution of tissue products

Related State Register notice: Proposed rule HLT-09-26-00001-P. Published Mar 4, 2026.

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10 NYCRR 52-6.10 - Required records of tissue acquisition, testing, processing and storage

Related State Register notice: Proposed rule HLT-09-26-00001-P. Published Mar 4, 2026.

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10 NYCRR 52-6.11 - Records to be kept by a tissue transplantation facility

Related State Register notice: Proposed rule HLT-09-26-00001-P. Published Mar 4, 2026.

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10 NYCRR 52-6.12 - Disposition of unused tissue

Related State Register notice: Proposed rule HLT-09-26-00001-P. Published Mar 4, 2026.

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Current section text is not available here.

10 NYCRR 52-6.13 - Tissue storage facilities

Related State Register notice: Proposed rule HLT-09-26-00001-P. Published Mar 4, 2026.

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10 NYCRR 52-7.1 - Definitions

Related State Register notice: Proposed rule HLT-09-26-00001-P. Published Mar 4, 2026.

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10 NYCRR 52-7.2 - Construction

Related State Register notice: Proposed rule HLT-09-26-00001-P. Published Mar 4, 2026.

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Mar 4, 2026

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10 NYCRR 52-7.3 - Tissue procurement services

Related State Register notice: Proposed rule HLT-09-26-00001-P. Published Mar 4, 2026.

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Current section text is not available here.

10 NYCRR 52-7.4 - Donor qualifications

Related State Register notice: Proposed rule HLT-09-26-00001-P. Published Mar 4, 2026.

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Mar 4, 2026

Current section text is not available here.

10 NYCRR 52-7.5 - Retrieval of tissue

Related State Register notice: Proposed rule HLT-09-26-00001-P. Published Mar 4, 2026.

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Current section text is not available here.

10 NYCRR 52-7.6 - Tissue processing facilities

Related State Register notice: Proposed rule HLT-09-26-00001-P. Published Mar 4, 2026.

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Current section text is not available here.

10 NYCRR 52-7.7 - Required laboratory tests on donors and donated tissue

Related State Register notice: Proposed rule HLT-09-26-00001-P. Published Mar 4, 2026.

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Current section text is not available here.

10 NYCRR 52-7.8 - Processing and storage of tissue

Related State Register notice: Proposed rule HLT-09-26-00001-P. Published Mar 4, 2026.

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Related notice published
Mar 4, 2026

Current section text is not available here.

10 NYCRR 52-7.9 - Distribution of tissue products

Related State Register notice: Proposed rule HLT-09-26-00001-P. Published Mar 4, 2026.

Source version current through May 31, 2021

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Related notice published
Mar 4, 2026

Current section text is not available here.

10 NYCRR 52-7.10 - Required records of tissue acquisition, testing, processing and storage

Related State Register notice: Proposed rule HLT-09-26-00001-P. Published Mar 4, 2026.

Source version current through May 31, 2021

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HLT-09-26-00001-P · Proposed rule
Related notice published
Mar 4, 2026

Current section text is not available here.

10 NYCRR 52-7.11 - Laboratory tests to be performed prior to tissue transplantation

Related State Register notice: Proposed rule HLT-09-26-00001-P. Published Mar 4, 2026.

Source version current through May 31, 2021

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HLT-09-26-00001-P · Proposed rule
Related notice published
Mar 4, 2026

Current section text is not available here.

10 NYCRR 52-7.12 - Records to be kept by a tissue transplantation facility

Related State Register notice: Proposed rule HLT-09-26-00001-P. Published Mar 4, 2026.

Source version current through May 31, 2021

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Related Register notice
HLT-09-26-00001-P · Proposed rule
Related notice published
Mar 4, 2026

Current section text is not available here.

10 NYCRR 52-7.13 - Disposition of unused tissue

Related State Register notice: Proposed rule HLT-09-26-00001-P. Published Mar 4, 2026.

Source version current through May 31, 2021

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Related Register notice
HLT-09-26-00001-P · Proposed rule
Related notice published
Mar 4, 2026

Current section text is not available here.

10 NYCRR 52-8.1 - Definitions

Related State Register notice: Adopted rule HLT-18-23-00014-A. Published Mar 20, 2024. Notice effective date: Mar 20, 2024.

Source version current through May 31, 2021

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Related Register notice
HLT-18-23-00014-A · Adopted rule
Related notice published
Mar 20, 2024
Related notice effective date
Mar 20, 2024

Current section text is not available here.

10 NYCRR 52-8.2 - Licensure

Related State Register notice: Proposed rule HLT-09-26-00001-P. Published Mar 4, 2026.

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Related Register notice
HLT-09-26-00001-P · Proposed rule
Related notice published
Mar 4, 2026

Current section text is not available here.

10 NYCRR 52-8.3 - Administrative responsibility

Related State Register notice: Proposed rule HLT-09-26-00001-P. Published Mar 4, 2026.

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HLT-09-26-00001-P · Proposed rule
Related notice published
Mar 4, 2026

Current section text is not available here.

10 NYCRR 52-8.4 - Direction and medical direction

Related State Register notice: Proposed rule HLT-09-26-00001-P. Published Mar 4, 2026.

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HLT-09-26-00001-P · Proposed rule
Related notice published
Mar 4, 2026

Current section text is not available here.

10 NYCRR 52-8.5 - Donor qualifications

Related State Register notice: Proposed rule HLT-09-26-00001-P. Published Mar 4, 2026.

Source version current through Nov 30, 2021

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Related Register notice
HLT-09-26-00001-P · Proposed rule
Related notice published
Mar 4, 2026

Current section text is not available here.

10 NYCRR 52-8.6 - Required laboratory tests

Related State Register notice: Proposed rule HLT-09-26-00001-P. Published Mar 4, 2026.

HLT-18-23-00014-A

Source version current through Sep 30, 2026

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Mar 20, 2024
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Sep 30, 2026
Related Register notice
HLT-09-26-00001-P · Proposed rule
Related notice published
Mar 4, 2026

HLT-18-23-00014-A

Current section text is not available here.

10 NYCRR 52-8.7 - Collection, storage and disposition of reproductive tissue

Related State Register notice: Proposed rule HLT-09-26-00001-P. Published Mar 4, 2026.

HLT-18-23-00014-A

Source version current through Sep 30, 2026

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Mar 20, 2024
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Sep 30, 2026
Related Register notice
HLT-09-26-00001-P · Proposed rule
Related notice published
Mar 4, 2026

HLT-18-23-00014-A

Current section text is not available here.

10 NYCRR 52-8.8 - Informed consent

Related State Register notice: Proposed rule HLT-09-26-00001-P. Published Mar 4, 2026.

Source version current through May 31, 2021

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Related Register notice
HLT-09-26-00001-P · Proposed rule
Related notice published
Mar 4, 2026

Current section text is not available here.

10 NYCRR 52-8.9 - Required records

Related State Register notice: Proposed rule HLT-09-26-00001-P. Published Mar 4, 2026.

Source version current through Nov 30, 2021

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Related Register notice
HLT-09-26-00001-P · Proposed rule
Related notice published
Mar 4, 2026

Current section text is not available here.

10 NYCRR 52-8.10 - Quality assurance and safety

Related State Register notice: Proposed rule HLT-09-26-00001-P. Published Mar 4, 2026.

Source version current through May 31, 2021

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HLT-09-26-00001-P · Proposed rule
Related notice published
Mar 4, 2026

Current section text is not available here.

10 NYCRR 52-8.11 - Compliance with standards

Related State Register notice: Proposed rule HLT-09-26-00001-P. Published Mar 4, 2026.

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HLT-09-26-00001-P · Proposed rule
Related notice published
Mar 4, 2026

Current section text is not available here.

10 NYCRR 52-9.1 - Definitions

Related State Register notice: Proposed rule HLT-09-26-00001-P. Published Mar 4, 2026.

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HLT-09-26-00001-P · Proposed rule
Related notice published
Mar 4, 2026

Current section text is not available here.

10 NYCRR 52-9.2 - Construction

Related State Register notice: Proposed rule HLT-09-26-00001-P. Published Mar 4, 2026.

Source version current through May 31, 2021

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Related Register notice
HLT-09-26-00001-P · Proposed rule
Related notice published
Mar 4, 2026

Current section text is not available here.

10 NYCRR 52-9.3 - Administrative responsibility

Related State Register notice: Proposed rule HLT-09-26-00001-P. Published Mar 4, 2026.

Source version current through May 31, 2021

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Related notice published
Mar 4, 2026

Current section text is not available here.

10 NYCRR 52-9.4 - Medical direction

Related State Register notice: Proposed rule HLT-09-26-00001-P. Published Mar 4, 2026.

Source version current through May 31, 2021

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Related Register notice
HLT-09-26-00001-P · Proposed rule
Related notice published
Mar 4, 2026

Current section text is not available here.

10 NYCRR 52-9.5 - Donor qualifications

Related State Register notice: Proposed rule HLT-09-26-00001-P. Published Mar 4, 2026.

Source version current through Nov 30, 2021

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Related Register notice
HLT-09-26-00001-P · Proposed rule
Related notice published
Mar 4, 2026

Current section text is not available here.

10 NYCRR 52-9.6 - Collection and storage of human milk

Related State Register notice: Proposed rule HLT-09-26-00001-P. Published Mar 4, 2026.

Source version current through May 31, 2021

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Related Register notice
HLT-09-26-00001-P · Proposed rule
Related notice published
Mar 4, 2026

Current section text is not available here.

10 NYCRR 52-9.7 - Maintenance of records

Related State Register notice: Proposed rule HLT-09-26-00001-P. Published Mar 4, 2026.

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HLT-09-26-00001-P · Proposed rule
Related notice published
Mar 4, 2026

Current section text is not available here.

10 NYCRR 52-9.8 - Distribution of human milk

Related State Register notice: Proposed rule HLT-09-26-00001-P. Published Mar 4, 2026.

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HLT-09-26-00001-P · Proposed rule
Related notice published
Mar 4, 2026

Current section text is not available here.

10 NYCRR 52-10.1 - Definitions

Related State Register notice: Proposed rule HLT-09-26-00001-P. Published Mar 4, 2026.

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HLT-09-26-00001-P · Proposed rule
Related notice published
Mar 4, 2026

Current section text is not available here.

10 NYCRR 52-10.2 - Licensure and compliance with standards

Related State Register notice: Proposed rule HLT-09-26-00001-P. Published Mar 4, 2026.

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HLT-09-26-00001-P · Proposed rule
Related notice published
Mar 4, 2026

Current section text is not available here.

10 NYCRR 52-11.1 - Definitions

Related State Register notice: Proposed rule HLT-09-26-00001-P. Published Mar 4, 2026.

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HLT-09-26-00001-P · Proposed rule
Related notice published
Mar 4, 2026

Current section text is not available here.

10 NYCRR 52-11.2 - Construction

Related State Register notice: Proposed rule HLT-09-26-00001-P. Published Mar 4, 2026.

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HLT-09-26-00001-P · Proposed rule
Related notice published
Mar 4, 2026

Current section text is not available here.

10 NYCRR 52-11.3 - Informed consent

Related State Register notice: Proposed rule HLT-09-26-00001-P. Published Mar 4, 2026.

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Related Register notice
HLT-09-26-00001-P · Proposed rule
Related notice published
Mar 4, 2026

Current section text is not available here.

10 NYCRR 52-11.4 - Retrieval and acquisition of nontransplant anatomic parts

Related State Register notice: Proposed rule HLT-09-26-00001-P. Published Mar 4, 2026.

Source version current through May 31, 2021

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HLT-09-26-00001-P · Proposed rule
Related notice published
Mar 4, 2026

Current section text is not available here.

10 NYCRR 52-11.5 - Use of nontransplant anatomic parts

Related State Register notice: Proposed rule HLT-09-26-00001-P. Published Mar 4, 2026.

Source version current through May 31, 2021

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HLT-09-26-00001-P · Proposed rule
Related notice published
Mar 4, 2026

Current section text is not available here.

10 NYCRR 52-11.6 - Disposition of nontransplant anatomic parts

Related State Register notice: Proposed rule HLT-09-26-00001-P. Published Mar 4, 2026.

Source version current through May 31, 2021

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HLT-09-26-00001-P · Proposed rule
Related notice published
Mar 4, 2026

Current section text is not available here.

10 NYCRR 52-11.7 - Safety

Related State Register notice: Proposed rule HLT-09-26-00001-P. Published Mar 4, 2026.

Source version current through May 31, 2021

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Related Register notice
HLT-09-26-00001-P · Proposed rule
Related notice published
Mar 4, 2026

Current section text is not available here.

10 NYCRR 52-11.8 - Reporting requirements

Related State Register notice: Proposed rule HLT-09-26-00001-P. Published Mar 4, 2026.

Source version current through May 31, 2021

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HLT-09-26-00001-P · Proposed rule
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