美国FDA 指导原则 使用列格式标注非处方药人类药品 英文原版.pdfVIP

Guidance for Industry Labeling OTC Human Drug Products Using a Column Format U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) December 2000 OTC Guidance for Industry Labeling OTC Human Drug Products Using a Column Format Additional copies of this Guidance are a vailable from: Office of Training and Communications Division of Communications Management Drug Information Branch, HFD-210 Center for Drug Evaluation and Research Food and Drug Administration 5600 Fishers Lane, Rockville, MD 20857 (Phone 301-827-4573) Internet: /cder/guidance/index.htm. U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) December 2000 OTC TABLE OF CONTENTS I. INTRODUCTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1 II. BACKGROUND . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1 III. USING COLUMNS AS PART OF THE STANDARD LABELING FORMAT . . . . . .2 A. VERTICAL BARLINE/HAIRLINE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2 B. NUMBER OF BOXES PER SIDE . . . . . . . . . . . . . . . . . . . . . . . . . . . . .