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

2. CBER 2 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?

3. CBER 3 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”

4. CBER 4 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

5. CBER 5 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

6. CBER 6 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

7. CBER 7 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

8. CBER 8 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

9. CBER 9 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

10. CBER 10 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

11. CBER 11 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/Guida nceComplianceRegulatoryInformation/Establishm entRegistration/BloodEstablishmentRegistration/d efault.htm http://www.fda.gov/BiologicsBloodVaccines/Guida nceComplianceRegulatoryInformation/Establishm entRegistration/BloodEstablishmentRegistration/d efault.htm

12. CBER 12 US Food and Drug Administration Home Page

13. CBER 13 Blood & Blood Products page

14. CBER 14 Blood & Blood Products page (continued)

15. CBER 15 Blood Establishment Registration and Product Listing page

16. CBER 16 Blood Establishment Registration and Product Listing page (continued)

17. CBER 17 CBER On-Line – Login Screen

18. CBER 18 CBER On-Line – Main Menu

19. CBER 19 Blood Establishment Registration – Select Establishment

20. CBER 20 Blood Establishment Registration – Registration Profile

21. CBER 21 Blood Establishment Registration and Product listing

22. CBER 22 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

23. CBER 23 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

24. CBER 24 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

25. CBER 25 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

26. CBER 26 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)

27. CBER 27 Helpful Website Addresses General CBER information http:// www.fda.gov/BiologicsBloodVaccines/default.htm / http:// www.fda.gov/BiologicsBloodVaccines/default.htm / Guidance Documents http:// www.fda.gov/BiologicsBloodVaccines/Guidance ComplianceRegulatoryInformation/default.htm Forms (356h, 2830, 2567) http:// www.fda.gov/AboutFDA/ReportsManualsForms/For ms/default.htm

28. CBER 28 General Contact Information Mailing Address Director, Division of Blood Applications, OBRR, CBER, FDA HFM-370 c/o Document Control Center, HFM-99 1401 Rockville Pike, Suite 200N Rockville, MD 20852-1448 Telephone – (301) 827-3543 Fax – (301) 827-3534 Blood and Plasma Branch Consumer Safety Officers

29. CBER 29 Blood Registration & Listing Contact Info Jan O’Brien Blood Registration Coordinator Telephone 301-827-3546 E-Mail address: bloodregis@fda.hhs.gov