FOOD AND DRUG ADMINISTRATION ISSUES NOTICE: OVER-THE-COUNTER MONOGRAPH CONDITION B001: SINGLE-UNIT OR UNIT-DOSE CONTAINERS FOR OVER-THE-COUNTER MONOGRAPH DRUGS IN ORALLY DISINTEGRATING TABLET AND FILM DOSAGE FORMS

WASHINGTON, June 5 -- Food and Drug Administration has issued a notice called: Over-the-Counter Monograph Condition B001: Single-Unit or Unit-Dose Containers for Over-the-Counter Monograph Drugs in Orally Disintegrating Tablet and Film Dosage Forms.

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) (OTC000037) entitled "Over-the-Counter Monograph Condition B001: Single-Unit or Unit-Dose Containers for Over-the-Counter Monograph Drugs in Orally Disintegrating Tablet and Film Dosage Forms." This ...