Open AccessOver-the-Counter Drugs: Regulatory Analysis of Warning Letters Between Fiscal Years 2015–2019
Author(s) -
Helen K Bai,
Jennifer D Ahearn,
Michael G. Bartlett
Publication year - 2020
Publication title -
therapeutic innovation and regulatory science
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.569
H-Index - 44
eISSN - 2168-4804
pISSN - 2168-4790
DOI - 10.1007/s43441-020-00231-2
Subject(s) - pharmacy , quality (philosophy) , product (mathematics) , over the counter , medicine , food and drug administration , medical prescription , business , actuarial science , accounting , pharmacology , family medicine , philosophy , geometry , mathematics , epistemology
According to 21 Code of Federal Regulation (CFR) Part 211, Over-the-Counter (OTC) drug manufacturers must establish and follow current good manufacturing practices (cGMP) to produce quality products while meeting regulatory standards. The warning letters issued by the U.S. Food and Drug Administration (FDA) reveal quality inadequacies that may impact the safety and effectiveness of these products. This study provides an analysis of warning letters and cited violations to identify the most common areas of quality issues and to understand the FDA's current thinking on regulatory expectations.