[Code of Federal Regulations]
[Title 21, Volume 4]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR201.22]
[Page 16.17]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
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
[[Page 17]]
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 Sec. Sec. 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 Sec. Sec. 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]
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