[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR111.50]
 
[Page 225]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
                           SERVICES--CONTINUED
 
PART 111--CURRENT GOOD MANUFACTURING PRACTICE FOR DIETARY SUPPLEMENTS--Table of Contents
 
Sec. 111.50  Packaging of iron-containing dietary supplements.
 
    (a) The use of iron and iron salts as iron sources in dietary
supplements offered in solid oral dosage form (e.g., tablets or
capsules), and containing 30 milligrams or more of iron per dosage unit,
is safe and in accordance with current good manufacturing practice only
when such supplements are 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.,
tablets or capsules). Iron-containing dietary supplements that are
subject to this regulation are also subject to child-resistant special
packaging requirements in 16 CFR parts 1700, 1701, and 1702.
    (b)(1) Dietary supplements 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
dietary supplement is carbonyl iron that meets the specifications of
Sec. 184.1375 of this chapter.
    (2) If the temporary exemption is not extended or made permanent,
such dietary supplements shall be in compliance with the provisions of
paragraph (a) of this section on or before July 15, 1998.