FOOD AND DRUG ADMINISTRATION ISSUES NOTICE: RECOMMENDATIONS FOR COMPLYING WITH OVER-THE-COUNTER MONOGRAPH PROCEDURE FOR MINOR CHANGES C001: MINOR CHANGES TO SOLID ORAL DOSAGE FORMS FOR CERTAIN OVER-THE-COUNTER MONOGRAPH DRUGS; DRAFT GUIDANCE FOR INDUSTRY; AVAILABILITY

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for Minor Changes C001: Minor Changes to Solid Oral Dosage Forms for Certain Over-the-Counter Monograph Drugs; Draft Guidance for Industry; Availability.

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Summary: The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry titled "Recommendations for Complying With Over-the-Counter Monograph Procedure for Minor Changes C001: Minor Changes to Solid Oral Dosage Forms for Certain Over-the-Coun...