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The Prescription Drug Marketing Act (PDMA) of 1987 (P.L. 100-293, 102 Stat. 95) is a law of the United States federal government.It establishes legal safeguards for prescription drug distribution to ensure safe and effective pharmaceuticals and is designed to discourage the sale of counterfeit, adulterated, misbranded, sub potent, and expired prescription drugs.
Title 21 is the portion of the Code of Federal Regulations that governs food and drugs within the United States for the Food and Drug Administration (FDA), the Drug Enforcement Administration (DEA), and the Office of National Drug Control Policy (ONDCP). [1] It is divided into three chapters: Chapter I — Food and Drug Administration
In the United States, regulation of drugs was originally a state right, as opposed to federal right. But with the increase in fraudulent practices due to private incentives to maximize profits and poor enforcement of state laws, the need for stronger federal regulation increased. [7]
Food and Drug Administration (FDA) regulations require all prescription drug promotion to be truthful and not misleading, based on "substantial evidence or substantial clinical experience", to provide a "fair balance" between the risks and benefits of the promoted drug, and to maintain consistency with labeling approved by the FDA. The FDA ...
It requires the FDA to develop standards to secure the drug supply chain against counterfeit, diverted, substandard, adulterated, misbranded, or expired drugs, to prioritize and develop standards for the identification and validation of prescription drugs, to develop a standardized numerical identifier for prescription drugs, and to expand ...
The drug or other substance has a high potential for abuse. The drug or other substance has no currently accepted medical use in treatment in the United States. There is a lack of accepted safety for use of the drug or other substance under medical supervision. The complete list of Schedule I substances is as follows. [1]
In 1990, the Food and Drug Administration (FDA) passed laws banning "gifts of substantial value" of drug companies to doctors, however this has changed the gifts from objects to meals and travel. [5] [16] In 2006, New Hampshire forbid the sale of prescription data to commercial entities. [17] [18]
The Anti-Drug Abuse Acts of 1986 and 1988 increased penalties and established mandatory sentencing for drug violations. The Office of National Drug Control Policy was created in 1989. Although these additional laws increased drug-related arrest throughout the country, they also incarcerated more African Americans than whites. [3]