[Code of Federal Regulations]
[Title 21 Volume 5]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR300.50]

[Page 5]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 300--GENERAL--Table of Contents
 
                      Subpart B--Combination Drugs
 
Sec. 300.50  Fixed-combination prescription drugs for humans.


    The Food and Drug Administration's policy in administering the new-
drug, antibiotic, and other regulatory provisions of the Federal Food, 
Drug, and Cosmetic Act regarding fixed combination dosage form 
prescription drugs for humans is as follows:
    (a) Two or more drugs may be combined in a single dosage form when 
each component makes a contribution to the claimed effects and the 
dosage of each component (amount, frequency, duration) is such that the 
combination is safe and effective for a significant patient population 
requiring such concurrent therapy as defined in the labeling for the 
drug. Special cases of this general rule are where a component is added:
    (1) To enhance the safety or effectiveness of the principal active 
component; and
    (2) To minimize the potential for abuse of the principal active 
component.
    (b) If a combination drug presently the subject of an approved new-
drug application has not been recognized as effective by the 
Commissioner of Food and Drugs based on his evaluation of the 
appropriate National Academy of Sciences-National Research Council panel 
report, or if substantial evidence of effectiveness has not otherwise 
been presented for it, then formulation, labeling, or dosage changes may 
be proposed and any resulting formulation may meet the appropriate 
criteria listed in paragraph (a) of this section.
    (c) A fixed-combination prescription drug for humans that has been 
determined to be effective for labeled indications by the Food and Drug 
Administration, based on evaluation of the NAS-NRC report on the 
combination, is considered to be in compliance with the requirements of 
this section.

[40 FR 13496, Mar. 27, 1975, as amended at 64 FR 401, Jan. 5, 1999]