[Code of Federal Regulations]
[Title 21, Volume 4]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR250.102]

[Page 150-151]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                                SERVICES
 
PART 250--SPECIAL REQUIREMENTS FOR SPECIFIC HUMAN DRUGS--Table of Contents
 
      Subpart B--New Drug or Prescription Status of Specific Drugs
 
Sec. 250.102  Drug preparations intended for human use containing certain ``coronary vasodilators''.

    (a)(1) The Food and Drug Administration finds that the following 
``coronary vasodilators'' are extensively regarded by physicians as safe 
and useful as employed under medical supervision for the management of 
angina pectoris in some patients:

Amyl nitrite.
Erythrityl tetranitrate.
Mannitol hexanitrate.
Nitroglycerin.
Potassium nitrite.
Sodium nitrite.

    (2) Additionally, new-drug applications have been approved for 
products containing:

Inositol hexanitrate.
Isosorbide dinitrate.
Octyl nitrite.
Pentaerythritol tetranitrate.
Triethanolamine trinitrate biphosphate (trolnitrate phosphate).

    (b) The Food and Drug Administration also finds that there is 
neither substantial evidence of effectiveness nor a general recognition 
by qualified experts that such drugs are effective

[[Page 151]]

for any of the other purposes for which some such drugs are promoted to 
the medical profession in labeling and advertising. In particular, 
neither clinical investigations nor clinical experience justify any 
representations that such drugs are effective in the management of 
hypertension; in the management of coronary insufficiency or coronary 
artery disease, except for their anginal manifestations; or in the 
management of the post coronary state, except angina pectoris present 
after coronary occlusion and myocardial infarction.
    (c) Any preparation containing such drugs that is labeled or 
advertised for any use other than management of angina pectoris, or that 
is represented to be efficacious for any other purpose by reason of its 
containing such drug, will be regarded by the Food and Drug 
Administration as misbranded and subject to regulatory proceedings, 
unless such recommendations are covered by the approval of a new-drug 
application based on a showing of safety and effectiveness.
    (d) Any such drug in long-acting dosage form is regarded as a new 
drug that requires an approved new-drug application before marketing.
    (e) Any of the drugs listed in paragraph (a)(2) of this section is 
regarded as a new drug that requires an approved new-drug application. 
Articles for which new-drug approvals are now in effect should be 
covered by supplemental new-drug applications as necessary to provide 
for labeling revisions consistent with this policy statement.