CHPA supports the U.S. Food and Drug Administration's (FDA) federal regulations ensuring and enforcing product quality for over-the-counter (OTC) medicine and dietary supplement manufacturers.
CHPA member companies continuously monitor the quality and manufacturing processes of their OTC medicines and dietary supplements. Federal regulations issued by FDA provide the regulatory framework for ensuring product quality, starting with the ingredients in these products and continuing through manufacturing, distribution, and the product’s expiration date. Compliance with federal regulations is evaluated by FDA via regular manufacturing facility inspections. Individual states may also have laws and regulations that impact manufacturing and set standards for product quality. A number of organizations also provide guidelines or standards for ensuring product quality. Taking all these laws and regulations into consideration, a manufacturer develops internal standard operating procedures to document their processes and ensure consistently high-quality products are produced for the marketplace.
CHPA, its educational foundation, and member companies are empowering consumers to practice responsible self-care, providing resources to help respond to this pandemic. We’re guided by these core principles.
Enclosed are comments on “Transdermal and Topical Delivery Systems - Product Development and Quality Considerations”. CHPA and our member companies marketing external analgesic ingredients have an interest, experience, and expertise in this area and appreciate this opportunity to comment.
The proper application/usage, scope, and cause for revisions of the <661> suite of chapters is not clear nor intuitive which is a concern given the potential impact.
We are supportive of the International Pharmaceutical Excipient Council of The Americas' recommendations detailed in their correspondence that USP remove references to dietary supplements and their ingredients.
Letter regarding modernization of the USP compendia for OTC medicines. CHPA supports improving the compendial test methods and establishing product standards for safety.
Our member companies generally support the recommendations found in the guidance but have concerns about the scope of hardness measurements and maximum break strength value.
CHPA supports improving the compendial test methods and establishing product standards for the variety of dosage forms, which can provide an additional measure of safety for OTC products.
CRN, CHPA, and their member companies are concerned with and offer the following comments to the proposed revisions to the USP-NF General Chapter <467> on Residual Solvents.
