[Code of Federal Regulations]
[Title 21, Volume 7]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR610.19]

[Page 72-73]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 610--GENERAL BIOLOGICAL PRODUCTS STANDARDS--Table of Contents
 
                      Subpart B--General Provisions
 
Sec. 610.19  Status of specific products; Group A streptococcus.

    The presence of Group A streptococcus organisms and derivatives of

[[Page 73]]

Group A streptococcus in Bacterial Vaccines and Bacterial Antigens with 
``No U.S. Standard of Potency'' may induce dangerous tissue reactions in 
humans. Available data demonstrate that they are unsafe as ingredients 
in products for human use. Group A streptococcus organisms and 
derivatives of Group A streptococcus are prohibited from Bacterial 
Vaccines and Bacterial Antigens with ``No U.S. Standard of Potency.'' 
Any Bacterial Vaccine or Bacterial Antigen with ``No U.S. Standard of 
Potency'' containing Group A streptococcus organisms or derivatives of 
Group A streptococcus in interstate commerce is in violation of section 
351 of the Public Health Service Act (42 U.S.C. 262).

[44 FR 1549, Jan. 5, 1979]