[Code of Federal Regulations]
[Title 21, Volume 7]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR607.7]

[Page 55]
 
                        TITLE 21--FOOD AND DRUGS
 
          DEPARTMENT OF HEALTH AND HUMAN SERVICES--(Continued)
 
PART 607--ESTABLISHMENT REGISTRATION AND PRODUCT LISTING FOR MANUFACTURERS OF HUMAN BLOOD AND BLOOD PRODUCTS--Table of Contents
 
                      Subpart A--General Provisions
 
Sec. 607.7  Establishment registration and product listing of blood banks and other firms manufacturing human blood and blood products.

    (a) All owners or operators of establishments that engage in the 
manufacturing of blood products are required to register, pursuant to 
section 510 of the Federal Food, Drug, and Cosmetic Act. Registration 
and listing of blood products shall comply with this part. Registration 
does not permit any blood bank or similar establishment to ship blood 
products in interstate commerce.
    (b) Forms for registration of an establishment are obtainable on 
request from the Center for Biologics Evaluation and Research (HFB-240), 
8800 Rockville Pike, Bethesda, MD 20892 or at any of the Food and Drug 
Administration district offices.
    (c) The completed form should be mailed to the Center for Biologics 
Evaluation and Research (HFB-240), 8800 Rockville Pike, Bethesda, MD 
20892.

[40 FR 52788, Nov. 12, 1975, as amended at 49 FR 23833, June 8, 1984; 55 
FR 11014, Mar. 26, 1990]

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