Over-the-Counter Drugs: Regulatory Analysis of Warning Letters Between Fiscal Years 2015-2019.

ABSTRACT:

Background

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.

Methods

Warning letters between U.S. fiscal years (FY) 2015-2019 were analyzed by the following steps: extraction of CFR violations, categorization of violations, trend analysi

SUBMITTER: Bai HK 

PROVIDER: S-EPMC7993009 | biostudies-literature | 2021 Mar

REPOSITORIES: biostudies-literature