Posted on 29 November 2007 | Written by Cord Blood Advisor | Filed under
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All the umbilical Cord Blood banks should meet all the New York State laws and requirements that are established or operate within New York State. The bank should also meet all the requirements if it releases or accepts the collections of Cord Blood units.
Relevant Regulation:
New York State Health Regulations NYCCR Title 10, Volume A-1, Part […]
Posted on 29 November 2007 | Written by Cord Blood Advisor | Filed under
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All the umbilical Cord Blood banks should meet the New Jersey State requirements if they are established or operates within the New Jersey State. The umbilical Cord Blood bank should also meet such requirements and testing if it accepts or releases the collection of the Cord Blood within the state. The rules are established in […]
Posted on 29 November 2007 | Written by Cord Blood Advisor | Filed under
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Any of the umbilical cord banks should meet Maryland State requirements if they operate, supply or accept the collections from the Maryland State. The umbilical cord bank should also meet such state requirements if it releases Cord Blood units to the Maryland State.
Relevant Regulation:
Title 10: Department of Health and Mental Hygiene, Subtitle 50:
Tissue banks
Accreditation required: […]
Posted on 29 November 2007 | Written by Cord Blood Advisor | Filed under
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AABB (formerly known as the “American Association of Blood banks“) is a non-profit international association of organizations and individuals who are involved in activities related to transfusion and transplantation medicine. They were founded in 1947 and are headquartered in Bethesda, Maryland. Originally an “American” association, the AABB is now international in scope and just […]
Posted on 29 November 2007 | Written by Cord Blood Advisor | Filed under
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A PharmaStem license cannot be considered as a medical Accreditation as it strictly refers to patent Law. It is least concerned about the quality of any medical procedures that is performed by any umbilical Cord Blood bank.
However, the umbilical Cord Blood bank, though indirectly, can be affected financially due to the possession of a PharmaStem […]
Posted on 29 November 2007 | Written by Cord Blood Advisor | Filed under
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If the umbilical Cord Blood banks operate within the state if Illinois or they accept, collect or release their Cord Blood units, they must meet the state’s requirements.
Relevant Regulation:
Title 77: Public Health, Chapter I: Department of Public Health, Subchapter d: Lab and Blood Bank, Part 470: Sperm Bank and Tissue Bank Code
Accreditation required: Tissue bank […]
Posted on 29 November 2007 | Written by Cord Blood Advisor | Filed under
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The FDA stands for Food and Drug Administration, the department that governs every food and medicinal product. FDA also regulates the Cord Blood under the category of ‘Human Cells, Tissues, and Cellular and Tissue Based-Products’ known as HCT/P’s. Center for Biologics Evaluation and Research (CBER) is the division of the FDA that regulates HCT/P’s. The […]
Posted on 28 November 2007 | Written by Cord Blood Advisor | Filed under
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Under Investigational New Drug status, the FDA regulates those umbilical Cord Blood transplants that are received from unrelated donors. It is therefore, the public Cord Blood banks should file an IND application.
Many medical communities consider the IND status of unrelated umbilical Cord Blood transplants as interference to their vast use for those transplant patients that […]
Posted on 28 November 2007 | Written by Cord Blood Advisor | Filed under
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Good ManuFACTuring Practice or GMP is an FDA standard, which is stricter as compared to their Good Tissue Practice – GTP. If you see FDA section, latest FDA rules regulate umbilical Cord Blood as an HCT/P and will be requiring it to follow GPT and not GMP. The GMP are generally applied to each of […]
Posted on 28 November 2007 | Written by Cord Blood Advisor | Filed under
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A Cord Blood bank must meet these California State requirements if it operates within this state, accepts collections from the state, or releases Cord Blood units to the state.
Relevant regulation: California Healthy and Safety Code: Division 2, Chapter 4 Accreditation required: Biologics license
Initially this license was required for banks that had a permanent location in […]