[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: 21CFR310.518]

[Page 28]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 310--NEW DRUGS--Table of Contents
 
        Subpart E--Requirements for Specific New Drugs or Devices
 
Sec. 310.518  Drug products containing iron or iron salts.

    Drug products containing elemental iron or iron salts as an active 
ingredient in solid oral dosage form, e.g., tablets or capsules shall 
meet the following requirements:
    (a) Packaging. If the product contains 30 milligrams or more of iron 
per dosage unit, it shall be packaged in unit-dose packaging. ``Unit-
dose packaging'' means a method of packaging a product into a 
nonreusable container designed to hold a single dosage unit intended for 
administration directly from that container, irrespective of whether the 
recommended dose is one or more than one of these units. The term 
``dosage unit'' means the individual physical unit of the product, e.g., 
tablet or capsule. Iron-containing drugs that are subject to this 
regulation are also subject to child-resistant special packaging 
requirements in 16 CFR parts 1700, 1701, and 1702.
    (b) Temporary exemption. (1) Drug products offered in solid oral 
dosage form (e.g., tablets or capsules), and containing 30 milligrams or 
more of iron per dosage unit, are exempt from the provisions of 
paragraph (a) of this section until January 15, 1998, if the sole source 
of iron in the drug product is carbonyl iron that meets the 
specifications of Sec. 184.1375 of this chapter.
    (2) If this temporary exemption is not extended or made permanent, 
such drug products shall be in compliance with the provisions of 
paragraph (a) of this section on or before July 15, 1998.
    (c) Labeling. (1) The label of any drug in solid oral dosage form 
(e.g., tablets or capsules) that contains iron or iron salts for use as 
an iron source shall bear the following statement:

    WARNING: Accidental overdose of iron-containing products is a 
leading cause of fatal poisoning in children under 6. Keep this product 
out of reach of children. In case of accidental overdose, call a doctor 
or poison control center immediately.

    (2)(i) The warning statement required by paragraph (c)(1) of this 
section shall appear prominently and conspicuously on the information 
panel of the immediate container label.
    (ii) If a drug product is packaged in unit-dose packaging, and if 
the immediate container bears labeling but not a label, the warning 
statement required by paragraph (c)(1) of this section shall appear 
prominently and conspicuously on the immediate container labeling in a 
way that maximizes the likelihood that the warning is intact until all 
of the dosage units to which it applies are used.
    (3) Where the immediate container is not the retail package, the 
warning statement required by paragraph (c)(1) of this section shall 
also appear prominently and conspicuously on the information panel of 
the retail package label.
    (4) The warning statement shall appear on any labeling that contains 
warnings.
    (5) The warning statement required by paragraph (c)(1) of this 
section shall be set off in a box by use of hairlines.
    (d) The iron-containing inert tablets supplied in monthly packages 
of oral contraceptives are categorically exempt from the requirements of 
paragraphs (a) and (c) of this section.

[62 FR 2250, Jan. 15, 1997; 62 FR 15111, Mar. 31, 1997]