Prescription Drug Laws – An Overview


The FDA, currently a wing of the United States Department of Health and Human Services, was founded in the year 1906. The responsibility of this administration encompasses the regulation of drugs, food, medical devices, dietary supplements and biological products, in addition to a variety of cosmetics, veterinary products and sanitation standards to help ensure the safety of the American consumer. To oversee the availability and production of prescription medications, the agency depends on two integral items of legislation: the Prescription Drug User Fee Act of 1992 and the Prescription Drug Marketing Act of 1987.




The Wiley Act, also referred to as The Food and Drug Act, not only established the FDA but was the first federal piece of legislation regarding the safety and regulation of medication, Signed into law in 1906 by President Teddy Roosevelt, the law prohibits the sale of adulterated drugs between states while requiring correct labels on all regulated substances.


Prescription Drug Marketing Act


The Prescription Drug Marketing Act was signed into law in 1987, implementing an array of legal requirements to ensure proper distribution of prescription medication. As a result, the act serves to guarantee the authenticity and effectiveness of regulated pharmaceuticals.


Prescription Drug User Fee Act


The Prescription Drug User Fee Act - signed into law in 1992 – has expanded its scope through a fair share of amendments and a 2007 reauthorization. In its original form, the act allowed the Food and Drug Administration to fund measures pertaining to drug approval though fees from drug manufacturers submitted during the New Drug Application process. As a result, the FDA has been afforded increased resources in regard to drug safety, including supervision of product and advertisement monitoring.


Dietary Supplement and Nonprescription Drug Consumer Protection Act


Though dietary supplements are not classified as prescription, many believe their benefits to be quite substantial. The Food and Drug Administration has been authorized to supervise the safety of these products following the Dietary Supplement and Nonprescription Drug Consumer Protection Act passed in 2006.


The law serves to help the FDA in the prevention of adverse reactions causes by the use of dietary supplements and nonprescription substances by requiring accused distributors, packagers and manufacturers to file reports if and when such an event occurs.


The Skinny


With prescription drug abuse at an all-time high, the need for continued legislation and regulation in the area cannot be over stated. And though legal means may not prove enough to curb the issue entirely; combined with proper treatment and education, we still have hope in the fight against prescription addiction on a large scale.


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