[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: 21CFR201.22]

[Page 17]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                                SERVICES
 
PART 201--LABELING--Table of Contents
 
                 Subpart A--General Labeling Provisions
 
Sec. 201.22  Prescription drugs containing sulfites; required warning statements.

    (a) Sulfites are chemical substances that are added to certain drug 
products to inhibit the oxidation of the active drug ingredient. 
Oxidation of the active drug ingredient may result in instability and a 
loss of potency of the drug product. Examples of specific sulfites used 
to inhibit this oxidation process include sodium bisulfite, sodium 
metabisulfite, sodium sulfite, potassium bisulfite, and potassium 
metabisulfite. Recent studies have demonstrated that sulfites may cause 
allergic-type reactions in certain susceptible persons, especially 
asthmatics. The labeling for any prescription drug product to which 
sulfites have been added as an inactive ingredient, regardless of the 
amount added, must bear the warning specified in paragraph (b) or (c) of 
this section.
    (b) The labeling required by Secs. 201.57 and 201.100(d) for 
prescription drugs for human use containing a sulfite, except 
epinephrine for injection when intended for use in allergic or other 
emergency situations, shall bear the warning statement ``Contains 
(insert the name of the sulfite, e.g., sodium metabisulfite), a sulfite 
that may cause allergic-type reactions including anaphylactic symptoms 
and life-threatening or less severe asthmatic episodes in certain 
susceptible people. The overall prevalence of sulfite sensitivity in the 
general population is unknown and probably low. Sulfite sensitivity is 
seen more frequently in asthmatic than in nonasthmatic people.'' This 
statement shall appear in the ``Warnings'' section of the labeling.
    (c) The labeling required by Secs. 201.57 and 201.100(d) for 
sulfite-containing epinephrine for injection for use in allergic 
emergency situations shall bear the warning statement ``Epinephrine is 
the preferred treatment for serious allergic or other emergency 
situations even though this product contains (insert the name of the 
sulfite, e.g., sodium metabisulfite), a sulfite that may in other 
products cause allergic-type reactions including anaphylactic symptoms 
or life-threatening or less severe asthmatic episodes in certain 
susceptible persons. The alternatives to using epinephrine in a life-
threatening situation may not be satisfactory. The presence of a 
sulfite(s) in this product should not deter administration of the drug 
for treatment of serious allergic or other emergency situations.'' This 
statement shall appear in the ``Warnings'' section of the labeling.

[51 FR 43904, Dec. 5, 1986]