Voluntary Codes and Guidelines

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.

    OTC Drugs - Regulatory

  1. Advertising Practices for Nonprescription Medicines
  2. Flag the Label
  3. Guidelines for Unsolicited Consumer Sampling of Nonprescription Medicines
  4. Standard Terminology and Format for Labeling of Volumetric Measures on OTC Pediatric Orally Ingested Liquid Drug Products
  5. Program on OTC Oral Pediatric Cough and Cold Medicines
  6. Analysis of Reportability of Changes to NDA OTC Product Labeling
  7. OTC Drugs - Quality

  8. Guideline for the Stability Testing of Nonprescription (OTC) Drug Products Not Regulated by an NDA/ANDA
  9. Guideline For the Stability Testing in Support of Changes to Nonprescription (OTC) Monograph Drug Products Not Regulated by an NDA/ANDA
  10. Voluntary Guidelines on Impurities in Monograph OTC Topicals Excluding NDA and ANDA Products
  11. Dietary Supplements

  12. Voluntary Labeling Program for Dietary Supplements: Proposed Pregnancy/NursingLabel Statement
  13. Voluntary Labeling Program for Dietary Supplements: Proposed St. John's Wort Information Statement
  14. Voluntary Program for Dietary Supplements: Adulterant, Known
  15. Voluntary Program for Dietary Supplements: Goldenseal
  16. Voluntary Program for Dietary Supplements: Kava
  17. Voluntary Program for Dietary Supplements Lady's Slipper
  18. Voluntary Program for Pyrrolizidine Alkaloids
  19. Voluntary Program for Dietary Supplements: Stimulant Laxatives
  20. Voluntary Program for Dietary Supplements: Disclosure of Added Constituents
  21. Voluntary Labeling Guidelines for Dietary Supplement Products Containing Probiotics
  22. Voluntary Program for Dietary Supplements: Caffeine