Company: PBH
Filing Date: 2025-05-09
Form Type: 10-K
Source: 0001295947-25-000017
Chunk: 9

Company: Prestige Consumer Healthcare Inc.
Filing Date: 2025-05-09
Form: 10-K
Item: Item 1
Chunk 9
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 distribution, importation, sale and storage of our products are subject to extensive regulation by various U.S. federal agencies, (including the U.S. Food and Drug Administration ("FDA"), the Federal Trade Commission ("FTC"), the Consumer Product Safety Commission (“CPSC”) and the Environmental Protection Agency (“EPA”)) and various agencies of the states, localities and foreign countries in which our products are manufactured, marketed, distributed and sold.  Our Regulatory and Quality team is guided by a senior member of management and staffed by individuals with appropriate quality and regulatory experience.  Our Regulatory, Quality and Operations teams work closely with our third-party manufacturers and our own manufacturing operations on quality-related matters. We monitor our own manufacturing operations and our third-party manufacturers' compliance with FDA and relevant foreign regulations and perform periodic audits to ensure compliance.  This internal audit process is designed to ensure that our manufacturing processes and products are of high quality and in compliance with known regulatory and quality requirements.  If the FDA or a foreign governmental authority chooses to inspect a particular third-party manufacturing facility, we require the third-party manufacturer to notify us immediately and update us on the progress of the inspection as it proceeds.  If we or our manufacturers fail to comply with applicable regulations, we could be issued a list of deficiencies, which could lead to significant claims or penalties or require us to recall or discontinue the sale and/or manufacturing of the non-compliant products. 

Most of our U.S. OTC drug products are regulated pursuant to the FDA’s monograph system, initially established in 1972.  The monograph system establishes conditions, such as active ingredients, uses or indications, doses, routes of administration, labeling and testing, under which certain broad categories of U.S. OTC drug products are generally recognized as safe and effective for their intended use.  The Coronavirus Aid, Relief, and Economic Security ("CARES") Act, signed into law on March 27, 2020, and the Over-the-Counter Monograph Safety, Innovation, and Reform Act have revised this OTC monograph framework.  Products that comply with monograph requirements do not require pre-market approval from the FDA.  OTC drug products fall under the requirements of the Federal Food Drug and Cosmetic Act ("FDC Act"), as amended by the CARES Act, which includes the Over-the-Counter Monograph Safety, Innovation, and Reform Act.  These new authorities authorize FDA to add, remove or change monographs, and therefore, OTC monograph requirements are expected