Variances for Collection of Blood and Blood Products from Patients with Hemochromatosis
Following is a list of establishments granted approval for a variance to 21CFR640.3(d) and 21CFR640.3(f) in order to collect blood and blood products from patients with hemochromatosis. The approved variances are updated as of March 28, 2008.
Guidance for Industry: Variances for Blood Collection from Individuals with Hereditary Hemochromatosis - 8/22/2001
| Name of Facility | Address | Licensed | Registered-Only | Approvals | Approval Date | |
|---|---|---|---|---|---|---|
| 640.3(d) | 640.3(f) | |||||
| Alle-Kiski Medical Center; Allegany Valley Hospital Blood Bank | 1301 Carlisle Street Natrona Heights, PA 15065 724-226-7081 |
X | X | X | 1/7/2008 | |
| American National Red Cross | 3131 N Vancouver Ave Portland, OR 97227 503-284-1234 |
X | X | X | 3/28/2005 | |
| Anna Jaques Hospital Laboratory | 25 Highland Avenue Newburyport, MA 01950 978-463-1096 |
X | X | X | 7/2/2003 | |
| Anne Arundel Medical Center | 2001 Medical Parkway Annapolis, MD 21401 443-481-4211 |
X | X | X | 10/29/2001 | |
| Aurora Area Blood Bank | 1200 North Highland Ave Aurora, IL 60506 630-892-7055 |
X | X | X | 3/24/2006 | |
| Avera McKennan Hospital and University Health Center |
800 East 21st St Sioux Falls, SD 57117 605-822-7110 |
X | X | X | 3/18/2002 | |
| Belle Bonfils Memorial Blood Center | 717 Yosemite Cir Denver, CO 80220 303-341-4000 |
X | X | X | 5/7/2001 (d) 4/1/2003 (f) |
|
| Bergen Community Regional Blood Services | 970 Linwood Ave West Paramus, NJ 07653 201-444-03900 |
X | X | X | 5/8/2006 | |
| Blood Assurance, Inc | 700 East Third St Chattanooga, TN 37403 423-756-0966 |
X | X | X | 7/2/2002 | |
| Blood Bank of Delaware, Inc | 100 Hygenia Dr Newark, DE 19713 302-737-8406 |
X | X | X | 3/18/2002 | |
| The Blood Center of Central Iowa | 431 East Locust St Des Moines, IA 50309 515-288-0276 |
X | X | X | 1/13/2006 | |
| The Blood Center of New Jersey | 45 South Grove St East Orange, NJ 07018 973-676-4700 |
X | X | X | 11/25/2002 | |
| Blood Centers of the Pacific | 270 Masonic Ave San Francisco, CA 94118 415-567-6400 |
X | X | X | 1/27/2003 | |
| BloodCenter of Wisconsin, Inc | 638 North 18th St Milwaukee, WI 53201 414-933-5000 |
X | X | X | 8/3/2005 | |
| The Blood Connection | 515 Grove Rd Greenville, SC 29605 864-255-5000 |
X | X | X | 1/30/2001 | |
| Blood Systems, Inc | 6220 East Oak St Scottsdale, AZ 85252 480-949-1412 |
X | X | X | 4/10/2002 | |
| Central Blood Bank | 875 Greentree Rd Pittsburgh, PA 15220 412-209-7040 |
X | X | X | 9/23/2002 | |
| Central Illinois Community Blood Center | 1134 South Seventh St Springfield, IL 62703 217-753-1530 |
X | X | X | 10/10/2002 | |
| Central Indiana Regional Blood Center | 3450 North Meridian St PO Box 88206 Indianapolis, IN 46208 317-916-5007 |
X | X | X | 8/7/2003 | |
| Central Kentucky Blood Center | 330 Waller Ave Lexington, KY 40504 859-276-2534 |
X | X | X | 2/14/2001 | |
| Coffee Memorial Blood Center | 1915 Coulter Dr Amarillo, TX 79106 806-358-4563 |
X | X | X | 1/17/2001 | |
| Community Blood Bank of Lancaster County Medical Society | 100 North 84th Street, Suite 200 Lincoln, NE 68505 402-486-9414 |
X | X | X | 11/26/2007 | |
| Community Blood Center | 4406 W. Spencer St Appleton, WI 54914 920-738-3131 |
X | X | X | 10/12/2006 | |
| Community Blood Center of the Carolinas | 4447 South Blvd Charlotte, NC 28209 704-972-4700 |
X | X | X | 11/6/2006 | |
| Community Blood Center of Erie County | 2646 Peach St Erie, PA 16508 814-456-4206 |
X | X | X | 12/4/2001 | |
| Community Blood Center of Greater Kansas City | 4040 Main St Kansas City, MO 64111 816-968-4019 |
X | X | X | 10/8/2003 | |
| Community Blood Center of the Ozarks | 2230 S Glenstone Springfield, MO 65804 417-227-5000 |
X | X | X | 12/2000 | |
| Community Blood Centers of South Florida | 1700 North State Rd #7 Lauderhill, FL 33313 945-735-9600 |
X | X | X | 12/18/2007 | |
| Community Blood Council of New Jersey | 1410 Parkside Ave Trenton, NJ 08638 609-883-9750 |
X | X | X | 3/23/2005 | |
| Coney Island Hospital Blood Bank | 2601 Ocean Pkwy, Rm 6N29 Brooklyn, NY 11235 718-616-3604 |
X | X | X | 5/11/2007 | |
| Cooley Dickinson Hospital Blood Bank | 30 Locust St Northampton, MA 01060 413-582-2162 |
X | X | X | 9/10/2001 | |
| Emerson Hospital Blood Bank | 133 Old Road to Nine Acre Corner Concord, MA 01742 978-287-3360 |
X | X | X | 5/7/2003 | |
| Florida's Blood Centers | 32 West Gore St Orlando, FL 32806 407-849-6100 |
X | X | X | 12/11/2000 | |
| Florida Georgia Blood Alliance | 536 West 10th Street Jacksonville, FL 32206 904-353-8263 |
X | X | X | 8/7/2003 | |
| Gulf Coast Regional Blood Center | 1400 La Concha Houston, TX 77054 713-790-1200 |
X | X | X | 12/24/2003 | |
| HCSC-Blood Center | 1465 Valley Center Pky Bethlehem, PA 18017 610-691-5850 |
X | X | X | 3/29/2004 | |
| Healthcare Provider Services, Inc | 405 Promenade St Providence, RI 12908 401-453-8599 |
X | X | X | 10/10/2000 | |
| Hinsdale Hospital Blood Bank | 120 North Oak Street Hinsdale, IL 60521 630-856-7845 |
X | X | X | 3/22/2004 | |
| Holyoke Hospital, Inc | 575 Beech St Holyoke, MA 01040 413-534-2500 |
X | X | X | 7/22/2002 | |
| Hoxworth Blood Center | 3130 Highland Ave Cincinnati, OH 45267 513-558-1200 |
X | X | X | 6/7/2001 | |
| Inland Northwest Blood Center | 210 W Cataldo Ave Spokane, WA 99204 509-624-0151 |
X | X | X | 8/6/2001 | |
| INOVA Heath Care Services | 45745 Nokes Blvd |
X | X | X | 3/30/2006 | |
| Kaiser Permanente | 9449 E. Imperial Hgwy Downey, CA 90242 562-803-2800 5601 Desoto Ave Woodland Hills, CA 91367 818-719-2647 4647 Zion Avenue San Diego, CA 92129 619-528-5385 1515 N. Vermont Los Angeles, CA 90027 323-783-6667 |
X | X | X | 7/24/2000 | |
| Lenox Hill Hospital Blood Bank | 100 East 77th St New York, NY 10021 212-434-2510 |
X | X | X | 9/24/2001 | |
| LifeShare Blood Centers | 8910 Linwood Ave Shreveport, LA 71106 318-222-7770 |
X | X | X | 9/20/2006 | |
| LifeSource Blood Services | 1205 North Milwaukee Ave Glenview, IL 60025 847-298-9660 |
X | X | X | 6/7/2002 | |
| LifeSouth Community Blood Centers | 1221 NW 13th St Gainesville, FL 32601 352-334-1000 |
X | X | X | 12/18/2000 | |
| Mary Greeley Medical Center | 1111 Duff Ave Ames, IA 50010 515-239-2123 |
X | X | X | 10/22/2001 | |
| Medic, Inc | 1601 Ailor Ave Knoxville, TN 37921 865-524-3074 |
X | X | X | 9/7/2000 | |
| Memorial Blood Centers of Minnesota | 2304 Park Ave Minneapolis, MN 55404 612-871-3300 |
X | X | X | 9/24/2001 | |
| Michigan Community Blood Centers | 1036 Fuller Ave, NE P.O. Box 1704 Grand Rapids, MI 49501 616-774-2300 |
X | X | X | 12/14/2005 | |
| Mid-South Regional Blood Center | 1040 Madison Ave Memphis, TN 38104 901-522-8585 |
X | X | X | 2/3/2000 | |
| Mississippi Valley Regional Blood Center | 3425 E. Locust St Davenport, IA 52803 563-359-5401 |
X | X | X | 12/11/2001 | |
| Montrose Memorial Blood Bank | 800 South 3rd Montrose, CO 81401 970-240-7220 |
X | X | X | 6/5/2003 | |
| Mount Sinai Medical Center | One Gustave L. Levy Pl Blood Bank Box 1024 New York, NY 10029 212-241-8810 |
X | X | X | 11/10/1999 | |
| Warren Grant Magnuson Clinical Center (NIH) | 9000 Rockville Pk, Bld 10, Rm 1C711 Bethesda, MD 20892 301-496-4506 |
X | X | X | 10/13/2000 | |
| New York Blood Center | 310 E 67th St New York, NY 10021 212-570-3151 |
X | X | X | 12/18/2000 | |
| North Country Regional Blood Center | 75 Beekman St Plattsburgh, NY 12901 518-562-7404 |
X | X | X | 5/4/2006 | |
| North Shore University Hospital Blood Bank at Manhasset | 300 Community Dr Manhasset, NY 11030 516-562-0100 |
X | X | X | 7/10/2006 | |
| Northern Illinois Blood Bank | 419 North Sixth St Rockford, IL 61107 915-965-8751 |
X | X | X | 12/10/2007 | |
| Northwest Florida Blood Center | 2201 North 9th St Pensacola, FL 32503 850-434-2535 |
X | X | X | 12/4/2001 | |
| Ogden Medical Center, Inc | 5475 South 500 East Ogden, UT 84405 801-479-2281 |
X | X | X | 5/7/2001 | |
| Oklahoma Blood Institute | 1001 N. Lincoln Blvd Oklahoma City, OK 73104 405-297-5700 |
X | X | X | 4/16/2004 | |
| Our Lady of the Lake Hospital, Inc | 5000 Hennessy Blvd Baton Rouge, LA 70808 225-765-8843 |
X | X | X | 4/6/2001 | |
| Our Lady of Lourdes Regional Medical Blood Center | 611 St. Landry St Lafayette, LA 70506 337-289-2176 |
X | X | X | 5/20/2002 | |
| Path Lab Services Corporation (Adirondack, Seaway & Park Regional Blood Collections) | 4709 Route 9 Plattsburgh, NY 12901 518-562-5483 |
X | X | X | 1/13/2006 | |
| Piedmont Blood Center, Inc. | 175 Dunbar St Spartanburg, SC 29306 864-582-6366 |
X | X | X | 8/31/2006 | |
| Penrose - St. Francis Health Services Blood Bank | 2215 N. Cascade Avenue Colorado Springs, CO 80907 719-630-5160 |
X | X | X | 1/7/2004 | |
| Puodre Valley Hospital Blood Bank | 1024 South Lemay Ave Ft. Collins, CO 80524 970-495-8700 |
X | X | X | 4/28/2005 | |
| Regional Health Resource Center | 1408 W. University Ave
Urbana, IL 61801 217-367-2202 |
X | X | X | 12/5/2005 | |
| Regional West Medical Center | 4021 Avenue B Scottsbluff, NE 69361 308-630-1400 |
X | X | X | 4/20/2005 | |
| Rex Hospital, Inc | 4420 Lake Boone Trail Raleigh, NC 27607 919-784-4750 |
X | X | X | 6/23/2001 | |
| Riverview Hospital Association | 410 Dewey St Wisconsin Rapids, WI 54494 715-421-7438 |
X | X | X | 12/13/2006 | |
| St. John's Mercy Medical Center | 615 S. New Ballas Rd St. Louis, MO 63141 314-569-6398 |
X | X | X | 9/29/2003 | |
| St. Luke's Hospital Blood Bank | 1026 A Ave, NE Cedar Rapids, IA 319-369-7315 |
X | X | X | 12/23/2002 | |
| Sacramento Medical Foundation | 1625 Stockton Blvd Sacramento, CA 95816 916-456-1500 |
X | X | X | 12/24/2003 | |
| Saints Memorial Medical Center | One Hospital Dr Lowell, MA 08152 978-458-1411 |
X | X | X | 3/18/2002 | |
| Scott & White Memorial Hospital | 2401 South 31st St Temple, TX 76508 254-724-8868 |
X | X | X | 3/7/2005 | |
| South Florida Blood Banks, Inc | P.O. Box 078618 933 45th St West Palm Beach, FL 33407 561-845-2323 |
X | X | X | 1/17/2001 | |
| Suncoast Communities Blood Bank, Inc | 1760 Mound Street Sarasota, FL 34236 941-954-1600 |
X | X | X | 2/2/2004 | |
| University Hospital Health Services Center Blood Bank | State University of NY Stony Brook, NY 11794 516-444-2626 |
X | X | X | 5/13/2002 | |
| University Medical Center at Princeton | 253 Witherspoon Street Princeton, NJ 08540 609-497-4353 |
X | X | X | 11/8/2005 | |
| Veterans Administration Medical Center | 130 W Kingsbridge Rd Bronx, NY 10468 718-741-4271 |
X | X | X | 1/6/2000 | |
| Virginia Blood Services | 2201 Westwood Ave Richmond, VA 23230 804-359-5100 |
X | X | X | 10/21/2002 | |
| Wellmont Health System | 130 West Ravine Rd Kingsport, TN 37660 423-224-6740 |
X | X | X | 5/24/2006 | |
| Winter Haven Hospital | 460 First Street North Winter Haven, FL 33881 863-297-1840 |
X | X | X | 5/27/2003 | |
Legend:
640.3(d) = 21 CFR 640.3(d) - blood withdrawn in order to promote the health of a donor otherwise qualified under the provisions of 640.3, shall not be used as a source of Whole Blood unless the container label conspicuously indicates the donor's disease that necessitated withdrawal of blood.
640.3(f) = 21 CFR 640.3(f) - a person may serve as a source of Whole Blood more than once in 8 weeks only if at the time of donation the person is examined and certified by a physician to be in good health, as indicated in 640.3(b).