WHO Pharmaceuticals Newsletter 1998, No. 03&04
(1998; 18 pages)
Table of Contents
Open this folder and view contentsRegulatory actions
Open this folder and view contentsDrug surveillance
Open this folder and view contentsNew developments
View the documentRecent approvals
Open this folder and view contentsMedical devices
Close this folderGeneral information
View the documentAdvertising of medicinal drugs in the media - regulations
View the documentContainer and closure testing in lieu of sterility testing - draft guidance available
View the documentExtended release oral dosage forms - draft guidance available
View the documentHuman plasma-derived biological products or animal plasma or serum-derived products - draft guidance available
View the documentIron-containing supplements and drugs - small entity compliance guidance available
View the documentMedication errors - the "look-alike/sound alike" problem: name confusion
View the documentMedication errors: esmolol - another fatal case
Open this folder and view contentsVeterinary medicine
 

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).

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