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C B E E R R Blood Establishment Registration and Product Listing Jan O’Brien Blood Registration Coordinator DBA, OBRR, CBER September 15, 2009

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Page 1: CBER Blood Establishment Registration and Product Listing Jan O’Brien Blood Registration Coordinator DBA, OBRR, CBER September 15, 2009

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Blood Establishment Registration and Product Listing

Jan O’BrienBlood Registration Coordinator

DBA, OBRR, CBER September 15, 2009

Page 2: CBER Blood Establishment Registration and Product Listing Jan O’Brien Blood Registration Coordinator DBA, OBRR, CBER September 15, 2009

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Outline • What are Establishment Registration and Product

Listing?• Definitions• Why must I register and list with FDA?• Who must register and list with FDA? • How do I register and list with FDA?• What will I be required to do? • Are there any exemptions to registration and/or

listing?• What is the difference between “registration and

listing” and getting a license?

Page 3: CBER Blood Establishment Registration and Product Listing Jan O’Brien Blood Registration Coordinator DBA, OBRR, CBER September 15, 2009

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What are Establishment Registration and Product Listing?• What is Establishment Registration?

− Notification to FDA by an establishment operator of his name, places of business, and all such establishments.

− Section 510(a)(b)− Routinely referred to as “Registration”

• What is product listing?− Filing with the Secretary a list of all drugs …. which are

being manufactured, prepared, propagated, compounded, or processed by him for commercial distribution

− Section 510(j)(1)− Routinely referred to as “Listing”

Page 4: CBER Blood Establishment Registration and Product Listing Jan O’Brien Blood Registration Coordinator DBA, OBRR, CBER September 15, 2009

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Registration• Required under the FD&C Act

• Described in 21 CFR 607.7

• All owners or operators of establishments that engage in the manufacture of blood products must register and submit a list of every blood product in commercial distribution with FDA (21 CFR 607.20)

• Does not permit shipping of blood product in interstate commerce− May engage in intrastate shipment

Page 5: CBER Blood Establishment Registration and Product Listing Jan O’Brien Blood Registration Coordinator DBA, OBRR, CBER September 15, 2009

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Establishments• Defined in 21 CFR 607.3(c)

• A place of business under one management at one general physical location

• Includes blood and plasma centers, blood banks, transfusion services, other blood product manufacturers and independent laboratories that engage in quality control and testing for registered blood establishments

Page 6: CBER Blood Establishment Registration and Product Listing Jan O’Brien Blood Registration Coordinator DBA, OBRR, CBER September 15, 2009

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Manufacture• Defined in 21 CFR 607.3(d)

• Collection, preparation, processing, compatibility testing and other procedures of any blood product that meets the definition of a drug

• Includes testing, control procedures, labeling and repackaging of the blood products

• Manufacturing steps can be performed by entity that owns product or by a contractor

Page 7: CBER Blood Establishment Registration and Product Listing Jan O’Brien Blood Registration Coordinator DBA, OBRR, CBER September 15, 2009

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Blood Product• Defined in 21 CFR 607.3(b)

• A drug which consists of human whole blood, plasma or serum or any product derived from human whole blood, plasma or serum

• Includes those products that meet the definition of a device under the FD&C Act that are licensed under the PHS Act

Page 8: CBER Blood Establishment Registration and Product Listing Jan O’Brien Blood Registration Coordinator DBA, OBRR, CBER September 15, 2009

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Manufacturer• Defined in 21 CFR 600.3(t)

• Legal person or entity engaged in the manufacture of products subject to licensure

• Manufacturer (licensed or unlicensed) assumes responsibility for compliance with applicable product and establishment standards, even if manufacturing is performed by contractor

Page 9: CBER Blood Establishment Registration and Product Listing Jan O’Brien Blood Registration Coordinator DBA, OBRR, CBER September 15, 2009

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Who Must Register & List?21 CFR 607.20

• Facilities− Collection facility

− Community blood bank

− Component preparation facility

− Hospital blood bank

− Plasmapheresis center

− Product testing laboratory

− Distribution center

• Brokers − who take possession and

manipulate and/or relabel product

Page 10: CBER Blood Establishment Registration and Product Listing Jan O’Brien Blood Registration Coordinator DBA, OBRR, CBER September 15, 2009

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How Do I Register & List ?

• Submit registration form to CBER within 5 days after beginning manufacturing operations (21 CFR 607.21 & 607.22)

• FDA Form 2830: Blood Establishment Registration and Product Listing

Page 11: CBER Blood Establishment Registration and Product Listing Jan O’Brien Blood Registration Coordinator DBA, OBRR, CBER September 15, 2009

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How Do I Register & List? (cont.)

• Complete a form for each facility and list all products in commercial distribution.

− Include both licensed and unlicensed products

• Electronic registration (eBER)−Electronic registration may be required in the

future

−http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/EstablishmentRegistration/BloodEstablishmentRegistration/default.htm

Page 12: CBER Blood Establishment Registration and Product Listing Jan O’Brien Blood Registration Coordinator DBA, OBRR, CBER September 15, 2009

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US Food and Drug Administration Home Page

Page 13: CBER Blood Establishment Registration and Product Listing Jan O’Brien Blood Registration Coordinator DBA, OBRR, CBER September 15, 2009

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Blood & Blood Products page

Page 14: CBER Blood Establishment Registration and Product Listing Jan O’Brien Blood Registration Coordinator DBA, OBRR, CBER September 15, 2009

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Blood & Blood Products page (continued)

Page 15: CBER Blood Establishment Registration and Product Listing Jan O’Brien Blood Registration Coordinator DBA, OBRR, CBER September 15, 2009

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Blood Establishment Registration and Product Listing page

Page 16: CBER Blood Establishment Registration and Product Listing Jan O’Brien Blood Registration Coordinator DBA, OBRR, CBER September 15, 2009

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Blood Establishment Registration and Product Listing page

(continued)

Page 17: CBER Blood Establishment Registration and Product Listing Jan O’Brien Blood Registration Coordinator DBA, OBRR, CBER September 15, 2009

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CBER On-Line – Login Screen

Page 18: CBER Blood Establishment Registration and Product Listing Jan O’Brien Blood Registration Coordinator DBA, OBRR, CBER September 15, 2009

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CBER On-Line – Main Menu

Page 19: CBER Blood Establishment Registration and Product Listing Jan O’Brien Blood Registration Coordinator DBA, OBRR, CBER September 15, 2009

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Blood Establishment Registration – Select

Establishment

Page 20: CBER Blood Establishment Registration and Product Listing Jan O’Brien Blood Registration Coordinator DBA, OBRR, CBER September 15, 2009

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Blood Establishment Registration – Registration

Profile

Page 21: CBER Blood Establishment Registration and Product Listing Jan O’Brien Blood Registration Coordinator DBA, OBRR, CBER September 15, 2009

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Blood Establishment Registration and Product

listing

Page 22: CBER Blood Establishment Registration and Product Listing Jan O’Brien Blood Registration Coordinator DBA, OBRR, CBER September 15, 2009

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Responsibilities of Registration & Listing

• Each manufacturer must register Annually between November 15 and December 31 and must update their blood product listing information every June and December. Send updates to FDA through eBER (21 CFR 607.21)

• Manufacturer is responsible for complying with FDA regulations and cGMPs (including labeling, BPD, and fatality reporting)

• Facility will be inspected by FDA every 2 years

Page 23: CBER Blood Establishment Registration and Product Listing Jan O’Brien Blood Registration Coordinator DBA, OBRR, CBER September 15, 2009

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Exemption From Registration & Listing

• Described in 21 CFR 607.65

• Any facility that does not manufacture products

• Any transfusion service that:− Only performs compatibility testing and transfusion

− Does not routinely collect or process products

− Only prepares recovered plasma for further manufacture or RBCs for transfusion from Whole Blood

− Pool platelets or cryoprecipitate immediately before transfusion

Page 24: CBER Blood Establishment Registration and Product Listing Jan O’Brien Blood Registration Coordinator DBA, OBRR, CBER September 15, 2009

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Exemption From Registration & Listing (cont)

− Aliquots or divides components into smaller containers for ease of transfusion

− Thaws frozen plasma or cryoprecipitate to prepare for transfusion

− Are certified under the Clinical Laboratory Improvement Amendments (CLIA) of 1988 or has met equivalent requirements as determined by the Centers for Medicare and Medicaid Services (CMS)

• Brokers who do not take possession or do not manipulate or re-label product

Page 25: CBER Blood Establishment Registration and Product Listing Jan O’Brien Blood Registration Coordinator DBA, OBRR, CBER September 15, 2009

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What Is The Difference Between “Registration & Listing” and Getting A

License?• All blood establishments that manufacture blood

products or perform a manufacturing step must register & list

• Those manufacturers that intend to routinely distribute the blood products across state lines (interstate commerce) must also hold an approved FDA license− Submit application for license and documents for review

− Undergo FDA pre-license inspection

− Approvals are specific for product and facility

− FDA license number on label of approved products

Page 26: CBER Blood Establishment Registration and Product Listing Jan O’Brien Blood Registration Coordinator DBA, OBRR, CBER September 15, 2009

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Registered Blood Establishments That Are Not Licensed

• 10-15% of transfused blood is prepared in unlicensed, registered blood banks

• CBER does not review product manufacturing submissions from facilities that are not licensed unless they:− Request a “alternative procedure” (21 CFR 640.120)

− Apply for licensure (21 CFR 601.2)

Page 27: CBER Blood Establishment Registration and Product Listing Jan O’Brien Blood Registration Coordinator DBA, OBRR, CBER September 15, 2009

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Helpful Website Addresses

•General CBER information http://www.fda.gov/BiologicsBloodVaccines/default.htm/

•Guidance Documentshttp://www.fda.gov/BiologicsBloodVaccines/Guidance

ComplianceRegulatoryInformation/default.htm

•Forms (356h, 2830, 2567)http://

www.fda.gov/AboutFDA/ReportsManualsForms/Forms/default.htm

Page 28: CBER Blood Establishment Registration and Product Listing Jan O’Brien Blood Registration Coordinator DBA, OBRR, CBER September 15, 2009

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General Contact Information• Mailing Address

Director, Division of Blood Applications, OBRR, CBER, FDAHFM-370c/o Document Control Center, HFM-991401 Rockville Pike, Suite 200NRockville, MD 20852-1448

• Telephone – (301) 827-3543• Fax – (301) 827-3534 • Blood and Plasma Branch Consumer Safety

Officers

Page 29: CBER Blood Establishment Registration and Product Listing Jan O’Brien Blood Registration Coordinator DBA, OBRR, CBER September 15, 2009

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Blood Registration & Listing Contact Info Jan O’Brien

Blood Registration Coordinator

Telephone 301-827-3546

E-Mail address: [email protected]