Vaccines, Blood & Biologics

List of Establishments Granted Approval for a Variance to 21CFR640.3(d) and 21CFR640.3(f)

The approved variances are updated as of October 28, 2014.

List of Establishments Granted Approval for a Variance to 21CFR640.3(d) and 21CFR640.3(f)
Name of Facility Address Licensed Registered-Only 640.3(d)
Approvals
640.3(f)
Approvals
Approval Date
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
Altru Health System 1200 South Columbia Road
Grand Forks, ND 58201
701-780-5000
 
X   X X 8/6/2013
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
Berkshire Medical Center Blood Bank 725 North St
Pittsfield, MA 01201
413-447-2581
 
  X X X 4/8/2013
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
Blood Bank of San Bernardino and Riverside Counties 384 West Orange Show Rd
San Bernardino , CA 92408
909-885-6503
X   X X 3/12/2009
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
Carter BloodCare 2205 Highway 121
Bedford , TX 76021
817-412-5000
X   X X 3/16/2009
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 Jersey Blood Center 494 Sycamore Ave
Shrewsbury , NJ 07702
732-842-5750
X   X X 12/15/2008
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 12/6/2000
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 Blood Services, Inc. 10100 Dr. Martin Luther King, Jr. St N
St. Petersburg, FL 33716
727-568-5433
 
X   X X 4/22/2009
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
Good Samaritan Hospital Blood Bank 255 Lafayette Ave.
Suffern, NY 10901
845-368-5174
  X X X 1/5/2012
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
Sterling , VA 20166
571-434-3600
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
Lane Memorial Blood Bank 2211 Williamette St
Eugene, OR 97405
541-484-9111
 
X   X X 10/18/2011
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
LifeShare Community Blood Services
333 East Bridge St
Elyria, OH 44035
440-322-5700
X   X X 7/8/2011
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
Medical Center of the Rockies

2500 Rocky Mountain Ave. Loveland, CO 80538

970-624-1550

  X X X 6/6/2011
Meek Blood Center 1150 North 18 th St
Abilene , TX 79601
325-670-2946
X   X X 3/12/2009
Memorial Blood Centers of Minnesota 2304 Park Ave
Minneapolis, MN 55404
612-871-3300
X   X X 9/24/2001
Mercy Doctor's Building (dba St. John's Mercy Medical Center)

851 E. St., Suite 100
Washington, MO 63090
314-239-8751
 

  X X X 6/21/2011
Mercy Medical Center Blood Bank 299 Carew St
Springfield, MA 01104
413-748-9510
  X X X 4/30/2013
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 5500 Lakeview Parkway
Davenport, IA 52807
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
NBAH Blood Center Clinical Academic Bldg
125 Paterson St
New Brunswick, NJ 08901
732-235-8100
  X X X 1/26/2009
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 Colorado Medical Center Blood Bank 1801 16 th St
Greeley, CO 80631
970-350-6724
  X X X 1/26/2009
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 California Community Blood Bank 2524 Harrison Avenue
Eureka, CA 95501
707-443-8004
X   X X 12/7/2009
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
Poudre Valley Hospital Blood Bank 1024 South Lemay Ave
Ft. Collins, CO 80524
970-495-8700
  X X X 4/28/2005
Providence Blood Donor Center 501 South Buena Vista St
Burbank, CA 91505
818-847-6001
  X X X 1/18/2011
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
Richmond University Medical Center

355 Bard Ave
Staten Island, NY 10310
718-818-3061
 

  X X X 11/26/2012
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
*San Diego Blood Bank 3535 Gateway Center
Ave, Suite 100
San Diego, CA 92102
619-296-6393
X   X X 10/09/2014
Sanford Medical Center
 
1305 West 18th St
Sioux Falls, SD 57117
605-333-7082
X   X X 10/19/2011 
Scott & White Memorial Hospital 2401 South 31st St
Temple, TX 76508
254-724-8868
  X X X 3/7/2005
Somerset Medical Center

110 Rehill Ave

Somerville, NJ 08876

908-685-2200

  X X X 4/15/2010
Southeastern Community Blood Center 1731 Riggins Rd
Tallahassee , FL 32308
850-877-7181
X   X X 3/3/2004
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
Steward Holy Family Hospital

70 East St.
Methuen, MA 01844
978-687-0151
 

  X X X 6/21/2011
Suncoast Communities Blood Bank, Inc 1760 Mound Street
Sarasota, FL 34236
941-954-1600
X   X X 2/2/2004
Tri-Counties Blood Bank

6210 East Oak St

Scottsdale, AZ 85252

805-965-7037

X   X X 5/11/2010
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
Walter L Shepeard Community Blood Center, Inc. 1533 Wrightsboro Rd
Augusta , GA 30904
706-737-4551
X   X X 3/12/09
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

White Plains Hospital
Center Blood Bank

Davis Ave at E. Post Rd.
White Plains, NY 10601
914-681-1240
 
  X X X 4/3/2012

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).

Contact FDA

(800) 835-4709
(240) 402-8010
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

10903 New Hampshire Avenue

Building 71 Room 3103

Silver Spring, MD 20993-0002

Page Last Updated: 10/29/2014
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