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Because drugs can produce harmful effects when
manufactured or taken improperly, most governments control drug
development as well as availability. In the United States, the FDA
determines how drugs are produced and how they are sold. Drugs that
can be sold over the counter (OTC)-that is, without a prescription
from a physician-are called proprietary drugs. They are considered
safe for unsupervised use by the general population. Drugs that
must be prescribed by physicians and dispensed by pharmacists are
known as ethical drugs. Their use is monitored closely by medical
personnel.
The FDA regulates the sale and manufacture of drugs in the United
States as outlined in applicable laws enacted over the past century.
Legal standards for composition and preparation of drugs in the
United States are found in the publication known as the United States
Pharmacopeia (USP). Drugs that can be abused, such as the powerful
narcotic heroin, are regulated by the Drug Enforcement Administration
(DEA) of the U.S. Department of Justice to ensure that they are
not prescribed or sold illegally.
Before 1900 any individual could sell a drug and claim it offered
therapeutic benefits without medical proof. This changed after 1906
with the passage of the Pure Food and Drug Act, which required drug
manufacturers to state the content, strength, and purity of each
drug they produced. The Pure Food and Drug Act ended the practice
of including morphine, cocaine, and heroin in drugs without the
public's knowledge. In 1914 the U.S. legislature began to strictly
regulate the trade of narcotics with the enactment of the Harrison
Narcotic Act; in 1937 the government added marijuana to this list
of controlled substances (the Marijuana Tax Act).
The Federal Food, Drug, and Cosmetic Act was enacted in 1938 requiring
that new drugs be safe for humans; however, it did not require that
manufacturers prove their drugs' effectiveness. It would be 24 years
before legislation was passed that would require proof of the efficacy
of new drugs (the Kefaver-Harris Amendments, 1962). Enforcement
of this law was entrusted to the FDA.
Two laws enacted in the 1960s strengthened the FDA's efforts to
reduce drug abuse. The Drug Abuse Control Amendments of 1965 provided
penalties for the illegal sale or possession of stimulants, sedatives,
and hallucinogens, and the Narcotic Addict Rehabilitation Act of
1966 set up a federal program for addicts that provided them with
the option of receiving treatment for their drug problems in place
of a prison sentence.
In 1970 the Comprehensive Drug Abuse Prevention and Control Act
established rules for manufacturing and prescribing habit-forming
drugs. It stipulated that physicians can prescribe all drugs, but
a special license is required to prescribe drugs with a high abuse
potential. This license is issued by the Drug Enforcement Administration.
The Anti-Drug Abuse Acts, signed into law in 1986 and 1988, set
up funding for the treatment of drug abuse and for the creation
of law-enforcement programs to fight the illegal sale of drugs.
These acts also detailed severe punishments for individuals selling
and possessing drugs illegally. Harsh penalties for using anabolic
steroids (hormones that promote the storage of protein and the growth
of tissue that are sometimes abused by competitive athletes) were
included in the 1988 act, along with the requirement that all alcoholic
beverages be labeled with warnings about alcohol's potentially dangerous
effect on the body. The 1988 act also established the Office of
National Drug Control Policy to develop an action plan that would
involve the public, as well as private agencies, in eliminating
the illegal sale of drugs; in helping individuals who use drugs
to stop; and in preventing nonusers from ever starting to use drugs.
The U.S. government and its regulatory agencies continually monitor
the development and use of all drugs sold in the United States to
ensure that the American public has access only to drugs that are
safe and effective. Recently, the FDA introduced legislation requiring
warning labels on all over-the-counter medication after research
indicated that the nonaspirin pain reliever acetaminophen can cause
liver damage when taken in high doses with large quantities of alcohol.
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