FOOD AND DRUG ADMINISTRATION ISSUES NOTICE: OVER-THE-COUNTER MONOGRAPH PROCEDURE FOR MINOR CHANGES C001: MINOR CHANGES TO SOLID ORAL DOSAGE FORMS FOR CERTAIN OVER-THE-COUNTER MONOGRAPH DRUGS

WASHINGTON, June 5 -- Food and Drug Administration has issued a notice called: Over-the-Counter Monograph Procedure for Minor Changes C001: Minor Changes to Solid Oral Dosage Forms for Certain Over-the-Counter Monograph Drugs.

The notice was published in the Federal Register on June 5 by Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs.

Summary: The Food and Drug Administration (FDA) is announcing the availability on its website of the proposed administrative order (proposed order) (OTC000038) entitled "Over-the-Counter Monograph Procedure for Minor Changes C001: Minor Changes to Solid Oral Dosage Forms for Certain Over-the-Counter Monograph Drugs." This proposed order, if finalized, will permit mino...