(1998; 18 pages)
Iron-containing supplements and drugs - small entity compliance guidance available
United States of America. The Food and Drug Administration has announced the availability of a small entity compliance guide entitled "Iron-Containing Supplements and Drugs: Label Warning Statements and Unit-Dose Packaging Requirements; Small Entity Compliance Guide", which is intended to help small entities comply with the final rule requiring label warnings and unit-dose packaging for iron-containing supplements and drug products.
Copies of the guidance may be obtained from the Iron Labeling and Packaging, Industry Activities Staff (HFS-565), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 200 C Street SW., Washington DC 20204, USA (with one self-addressed adhesive label) or from the Internet at: http://vm.cfsan.fda.gov/^dms/secqiron.html.
[See also Pharmaceuticals Newsletter Nos. 5&6, May&June 1996]
Reference: Federal Register 62(239): 65432-3 (1997).