Skip to main content

Advertisement

Log in

Abstract

The last 30 years has brought significant changes to self care through responsible self medication. From being essentially unregulated in the 1960s, over-the-counter (OTC) medicines have been transformed by the evolving statutory and regulatory initiatives into a mature market with a high level of consumer confidence in their safety and expected benefits. This paper reviews the legislative/regulatory achievements that have modernized self care with OTCs, including the statutory and regulatory basis for OTCness, the criteria and studies used as a basis for permitting OTC availability, and the paradigm for interaction between regulators and sponsors, as well as the challenges still facing the industry.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Similar content being viewed by others

References

  1. Soller RW. OTCness. Drug Inf J. 1997;32:555–560.

    Article  Google Scholar 

  2. U. S. Public Law 82-215, 1951.

  3. Hutt P. A legal framework for future decisions on transferring drugs from prescription to nonprescription status. Rx-OTC, New Resources in Self-Medication. Symposium sponsored by the Consumer Healthcare Products Association, 34-39. Washington, 1982.

    Google Scholar 

  4. 21 Code of Federal Regulations 330.10(a)(4)(i).

  5. 21 Code of Federal Regulations 330.10(a)(4)(ii).

  6. 21 Code of Federal Regulations 330.10(a)(4)(iii).

  7. Soller RW. Evolution of self-care with over-the-counter medications. Current Thera Res. 1998: C134–C140.

    Google Scholar 

  8. Lesko S, et al. An assessment of the safety of pediatric ibuprofen. JAMA. 1995:273;929–933.

    Article  CAS  Google Scholar 

  9. 21 Code of Federal Regulations 330.10(a)(4)(v).

  10. Federal Register. 38:31260-69. Washington; 1973.

  11. State of California Assembly Bill 2713, September 12, 1990.

  12. Consumer Healthcare Products Association. Label Readability Guidelines, Washington; 1999.

    Google Scholar 

  13. Federal Register. 57:58369. Washington; 1992.

  14. Federal Register. 58:28216. Washington; 1993.

  15. Federal Register. 64:13254-303. Washington; 1999.

  16. Consumer Healthcare Products Association: Submission to FDA Docket Nos. 98N-0337,96N-0420, 95N-0259, and 90P-0201, November 23, 1999.

  17. Federal Register. 64:13254-303. Washington; 1999.

  18. Watanabe RK. The ability of the geriatric population to read labels on over-the-counter medication containers. J Am Optometric Assoc. 1994;65:32–37.

    CAS  Google Scholar 

  19. National Consumers League. Consumer’s Ability to Read OTC Labels with Different Type Sizes. Washington, DC: National Consumers League; August 5, 1991.

  20. Soller RW. The over-the-counter scientific/regulatory paradigm. Drug Inf J. 1999;33:799–804.

    Article  Google Scholar 

  21. Federal Register. 39:19864. Washington; 1974.

  22. Federal Register. 39:19881. Washington; 1974.

  23. US General Accounting Office. Nonprescription Drugs—Value of a Pharmacist-Controlled Class Has Yet to Be Demonstrated. Report to the Ranking Minority Member, Committee on Commerce, House of Representatives. Washington; 1995.

    Google Scholar 

  24. Francesco S. OTC switch monitoring and compliance research should quality for a 3 year period of market exclusivity plus access to the monograph system. Switch. (Newsletter) May 1995 (10): 1–4, 9.

    Google Scholar 

  25. Consumer Healthcare Products Association. Ingredients & Dosages Transferred From Rx-to-OTC Status (or New OTC Approvals) by the Food and Drug Administration Since 1975. Washington, DC: Consumer Healthcare Products Association; 1999.

    Google Scholar 

  26. Consumer Healthcare Products Association. Rx-to-OTC Switch Workshop Materials. Research & Scientific Development Conference. Washington, DC Consumer Healthcare Products Association; October 28-29, 1999.

    Google Scholar 

  27. Federal Register. 62:55645-55646. Washington; 1997.

  28. Food and Drug Administration. Transcript of the Joint Meeting of the Antiviral Drugs Advisory Committee and Nonprescription Drugs Advisory Committee. Docket No. 94N-0006, January 11-12, 1995.

    Google Scholar 

  29. Food and Drug Administration. Draft guidance for industry on OTC treatment of herpes labialis with antiviral agents, www.fda.gov/cder/guidance/index.htm.

  30. Soller RW. Rx-to-OTC switch—A testable hypothesis. Presented at the Annual AESGP Meeting, Berlin; June 9-11, 1999.

    Google Scholar 

  31. Food and Drug Administration. Managing Risks from medical Product Use: Report to the Commissioner from the Task Group on Risk Management. www.fda.gov/oc/tfrm/riskmanagement.pdf. May 1999.

    Google Scholar 

Download references

Author information

Authors and Affiliations

Authors

Corresponding author

Correspondence to R. William Soller PhD.

Rights and permissions

Reprints and permissions

About this article

Cite this article

Soller, R.W. OTCS 2000: Achievements and Challenges. Ther Innov Regul Sci 34, 693–701 (2000). https://doi.org/10.1177/009286150003400305

Download citation

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1177/009286150003400305

Key Words

Navigation