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 released the following statement in response to new research published in Clinical Toxicology. The study found nine illegal stimulants, including deterenol, in fraudulently marketed sports and weight loss supplements.
Today’s column in the Los Angeles Times is aligned with calls from responsible manufacturers in the dietary supplement industry who agree that regulations need to be modernized and strengthened.
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.
