The objective of this guideline is to define the minimum stability data package to support the commercial distribution of OTC monograph drug products in the United States per climatic zone.
Under the Dietary Supplement Health And Education Act of 1994 (DSHEA), the U.S. Food and Drug Administration (FDA) was given several post-marketing responsibilities to ensure the safety of dietary supplements.
Find frequently asked questions about OTC oral pain relievers and fever reducers including acetaminophen, aspirin, ibuprofen, ketoprofen, and naproxen sodium.
This Proposed Safety Administrative Order addresses the GRASE status of codeine, codeine phosphate, and codeine sulfate as antitussive active ingredients.
While VOCs can have environmental impacts in aggregate, existing alternatives don’t always provide the consistent therapeutic results needed for OTC products relied upon by millions for. As such, any legislation aimed at further restricting pharmaceutical VOCs must carefully weigh potential unintended consequences on public health.
