Laws and Acts
This act addressed the purity of drugs imported into the U.S and called for an appointment of special examiners at 6 ports of entry. This was the only federal law regulating drugs in the U.S. at this time
What is the Drug Importation Act of 1848?
This act reclassified all products containing the chemical pseudoephedrine and ephedrine and restricted the amount that can be purchased at one time or in any 30-day period
What is the Combat Methamphetamine Epidemic Act of 2005?
Requires that all drug wholesalers be licensed by the states and prohibits the sale, trading, or distribution of drug samples to persons other than those licensed to prescribe them.
What is the Prescription Drug Marketing Act of 1987?
This agency is involved in: new drug development, generic drug review, OTC drug review and post-drug approval activities
What is the Center for Drug Evaluation and Research (CDER)?
This act classified drugs with potential for abuse as controlled substances and created a five level ranking restriction system.
What is the Comprehensive Drug Abuse Prevention and Control Act of 1970 or the Controlled Substances Act (CSA)?
Passage of this act was preceded by the sulfanilamide tragedy of 1937. This act gave the FDA the power to regulate the production, sale, and distribution of food, drugs, medical devices, and cosmetics. It also aimed to protect the public from misbranded and adulterated products.
What is the Food, Drug, and Cosmetic Act of 1938?
This act was designed to expand access to health insurance, reduce healthcare costs, and improve healthcare quality in the U.S.
What is the Patient Protection and Affordable Care Act of 2010 (ACA) (Obamacare)?
Requires that to receive Medicaid funding, each state had to establish a DUR Board and required that pharmacy personnel review drug therapy before each prescription is filled or delivered to an individual
What is the Omnibus Budget Reconciliation Act of 1990 (OBRA '90)?
Responsible for the annual publishing of the Orange Book and two online publications titled the Purple Book and the Green Book
What is the Food and Drug Administration (FDA)?
Streamlined the process to approve equally effective drugs with generic names
What is the Drug Price Competition and Patent Term Restoration Act of 1984 or the Hatch-Waxman Act?
This was an amendment to the FD&C Act of 1938 and established the distinction between prescription drugs and OTC drugs. This amendment also authorized pharmacists to be able to take refill prescriptions for some substances over the phone verbally
What is the Durham-Humphrey Amendment of 1951?
This act created Medicare Part D
What is the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA)?
This act designated anabolic steroids as a Schedule III class of drugs
What is the Anabolic Steroids Control Act of 1990?
The only professional organization that represents all 50 state boards of pharmacy
What is the National Association of Boards of Pharmacy (NABP)?
This act provided the drug manufacturers tax incentives and grants a longer time period to have exclusive licenses to market orphan drugs.
What is the Orphan Drug Act of 1983?
The purpose of this act was to address the use of dangerous ingredients, fake marketing claims, and inaccurate labeling in drug formulations and to prohibit the sale or interstate transportation of adulterated or misbranded food and drugs
What is the Pure Food and Drug Act of 1906?
This was enacted for fast-track approval for drugs treating serious or life-threatening conditions and also allowed more flexibility for drug companies to share off-label use information with healthcare professionals
What is the Food and Drug Administration Modernization Act of 1997?
This act provides definition and guidelines on dietary supplements, including vitamins, minerals, herbs, and nutritional supplements
What is the Dietary Supplement Health and Education Act of 1994?
Primary agency responsible for enforcing the laws regarding potentially addictive controlled substances
What is the Drug Enforcement Administration DEA?
This act was created to prevent accidental childhood drug poisonings and required that most OTC and prescription drugs be packaged in child-resistant containers
What is the Poison and Prevention Packaging Act of 1970?
Passed in response to the birth of thousands of infants with severe abnormalities resulting from pregnant women taking thalidomide. It require drug manufacturers to file an investigational new drug application with the FDA and provide in-depth drug-animal studies before initiating clinical trials in humans.
What is the Kefauver-Harris Amendments of 1962?
This act was passed as a result of a contaminated compounded medication that resulted in patient deaths and injury across the country
What is the Drug Quality and Security Act of 2013 (DQSA)?
This act ensures portability of moving health insurance from one employer to another and protects the confidentiality of patient health records.
What is the Health Insurance Portability and Accountability Act of 1996 (HIPPAA)?
Produces an annual book of standards called US Pharmacopeia-National Formulary (USP-NF)
What is the US Pharmacopeial Convention?
This act gave the FDA the authority to compile a list of currently marketed drugs and assign them each an NDC number
What is the Drug Listing Act of 1972?