Drug Distribution and National Uniformity

The U.S. has an efficient national marketplace with goods moving freely and efficiently from state to state. An important segment of this dynamic marketplace is the wide variety of OTC medicines.

Two-Class Drug System

The U.S. drug distribution model is a two-class system of prescription and over-the-counter (OTC) medicines, regulated by the U.S. Food and Drug Administration (FDA).

The U.S. two-class distribution system is fairly unique in the world. Internationally, many nations have a centuries-old pharmacy class system. In these nations, medicines have been available only through pharmacies, effectively creating a pharmacist monopoly on drug distribution. In recent years, a number of these national systems have begun to allow greater access to safe and effective medications available without a prescription. Japan, the Netherlands, Denmark, the United Kingdom, Italy, and Argentina all have been part of this trend toward granting consumers increased access to medicines in more outlets beyond pharmacies.

How the U.S. Drug Distribution System Benefits Every Consumer and Household

• OTC medicines are conveniently sold in a number of retail outlets, including those without pharmacies, and are available when consumers need them. With more than 750,000 retail establishments nationwide, both rural and urban consumers have access 24/7 to treatments for common, everyday conditions.
• The current two-class system of drug distribution empowers consumers with a widening choice of safe and effective self-care options at competitive prices. This emphasis on consumer empowerment in matters of healthcare directly serves two of the most fundamental demands of any workable healthcare system: access and affordability.
• The drug distribution system in the U.S. is a highly regulated safeguard to ensure only those medications that have a wide enough safety margin and that can be safely and effectively used without the help of a healthcare professional are available without a prescription.

Background on a Third Class of Drugs

• FDA has historically rejected a third class or transition class of drugs, saying a public health need for a pharmacy-only class of medicines has not been demonstrated.
• The American Medical Association repeatedly has reaffirmed, as recently as 2012, its support of the present two-class drug distribution system and opposition of an additional class of drugs. A number of other health and consumer organizations also have opposed a third class of drugs in the U.S. over the years.
• In a 2009 U.S. General Accounting Office report, the agency several issues would have to be addressed before an additional class of pharmacy-only medicines could be established in the U.S., including pharmacists' roles and responsibilities, training, ensuring counseling would be provided, sufficiency of the workforce, data infrastructure, physical infrastructure to ensure consumer privacy in counseling, cost issues (including pharmacist compensation), and pharmacist liability.
• According to a 1995 U.S. General Accounting Office report, "Other countries' experiences do not support a fundamental change in the drug distribution of the United States such as creating an intermediate class of drugs, whether fixed or transition, at this time. The evidence that does exist tends to undermine the contention that major benefits are being obtained in countries with a pharmacist or pharmacy-only class."

National Uniformity for OTC Medicines

For decades, FDA has regulated the safety, effectiveness, and proper labeling of OTC medicines. The comprehensive FDA system means we do not need individual state rules that would impose inconsistent regulations or create disruptions in the national marketplace.

The Food and Drug Administration Modernization Act of 1997 included a national uniformity provision that prohibits states from adopting laws or regulations concerning OTC medicines that are different from or in addition to those required by FDA. The landmark legislation received widespread support and passed Congress with overwhelming bipartisan backing.