[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: 21CFR607.3]

[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. 607.3  Definitions.


    (a) The term act means the Federal Food, Drug, and Cosmetic Act 
approved June 25, 1938 (52 Stat. 1040 et seq., as amended, 21 U.S.C. 
301-392).
    (b) Blood and blood product means a drug which consists of human 
whole blood, plasma, or serum or any product derived from human whole 
blood, plasma or serum, hereinafter referred to as ``blood product.''
    (c) Establishment means a place of business under one management at 
one general physical location. The term includes, among others, human 
blood and plasma donor centers, blood banks, transfusion services, other 
blood product manufacturers and independent laboratories that engage in 
quality control and testing for registered blood product establishments.
    (d) Manufacture means the collection, preparation, processing or 
compatibility testing by chemical, physical, biological, or other 
procedures of any blood product which meets the definition of a drug as 
defined in section 201(g) of the act, and including manipulation, 
sampling, testing, or control procedures applied to the final product or 
to any part of the process. The term includes packaging, labeling, 
repackaging or otherwise changing the container, wrapper, or labeling of 
any blood product package in furtherance of the distribution of the 
blood product from the original place of manufacture to the person who 
makes final delivery or sale to the ultimate consumer.
    (e) Commercial distribution means any distribution of a blood 
product except pursuant to the investigational use provisions of part 
312 of this chapter, but does not include internal or interplant 
transfer of a bulk product substance between registered domestic 
establishments within the same parent, subsidiary, and/or affiliate 
company.
    (f) Any material change includes but is not limited to any change in 
the name of the blood product, in the quantity or identity of the active 
ingredient(s) or in the quantity or identity of the inactive 
ingredient(s) where quantitative listing of all ingredients is required 
pursuant to Sec. 607.31(a)(2) and any significant change in the labeling 
of a blood product. Changes that are not significant include changes in 
arrangement or printing or changes of an editorial nature.
    (g) Bulk product substance means any substance that is represented 
for use in a blood product and when used in the manufacturing of a blood 
product becomes an active ingredient or a finished dosage form of such 
product.
    (h) Advertising and labeling include the promotional material 
described in Sec. 202.1(l) (1) and (2) of this chapter, respectively.
    (i) The definitions and interpretations contained in sections 201 
and 510 of the act shall be applicable to such terms when used in this 
part 607.

[40 FR 52788, Nov. 12, 1975, as amended at 55 FR 11014, Mar. 26, 1990]