Introduction
CHPA members, the manufacturers of OTC medicines and dietary supplements, have made numerous improvements in the industry’s practices regarding labeling and advertising on a voluntary basis. Since 1934, the Association has administered voluntary guidelines established by its member companies. These guidelines affect the way products are developed, packaged, labeled, distributed and advertised. A number of CHPA voluntary guidelines were put in place well before similar federal laws or regulations were adopted. These include:
- Guidelines for Product Identification of Solid Dosage Nonprescription Drug Products: CHPA adopted these voluntary guidelines in 1989. A U.S. Food and Drug Administration (FDA) regulation similar to the industry’s voluntary program was published in 1993 ;
- Program on Alcohol Content of Monographed Nonprescription Medicines Intended for Oral Ingestion: CHPA adopted this voluntary program in 1992. In 1995, FDA published a final regulation that closely paralleled CHPA’s voluntary program ;
- Child-Resistant Packaging for Alcohol-Containing Mouthwash: CHPA’s voluntary program was adopted in 1993. The U.S. Consumer Product Safety Commission (CPSC) published a final regulation in 1995 that was virtually identical to CHPA’s voluntary program ;
- Label Readability Guidelines: CHPA’s label readability guidelines were adopted in 1991. FDA issued a rule on label format and content in 1999. The FDA final rule contains a number of elements that were in the CHPA label readability guidelines ;
- Packaging, Labeling and Formulation of Iron-Containing Dietary Supplements: CHPA’s voluntary program was adopted in 1993. In 1997, FDA issued a final rule, revised in 2003, on labeling of iron-containing drugs and dietary supplements. The final regulation is similar to the industry’s labeling suggestions ;
- Child Safety Closures: Today’s child-resistant packaging requirements built upon and expanded voluntary child safety closure programs developed in the 1960s.
All of the voluntary programs were designed by industry and CHPA to better serve the public.
Highlights
- Advertising Practices for Nonprescription Medicines
- Flag the Label
- Guidelines for Unsolicited Consumer Sampling of Nonprescription Medicines
- Voluntary Programs
- Program on OTC Oral Pediatric Cough and Cold Medicines
- Guideline for the Stability Testing of Nonprescription (OTC) Drug Products Not Regulated by an NDA/ANDA
- Guideline for the Stability Testing in Support of Changes to Nonprescription (OTC) Monograph Drug Products Not Regulated by an NDA/ANDA
Visit www.chpa.org for more informations.