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The Pure Food and Drug Act
A United States federal law that provided federal inspection of meat products and forbade the manufacture, sale, or transportation of adulterated food products and poisonous patent medicines. -
The Food, Drug, and Cosmetic Act
Requiring all new drugs to be shown safe when used according to directions on label requiring labels that include; adequate directions for use, warnings of habit-forming drugs contained within,banned interstate commerce of dangerous substances, required "new drugs" to be approved by the FDA through a New Drug Application -
Durham-Humphrey Amendment
This act distinguishes legend drugs (prescription) from the over the counter drugs (OTC). This act requires companies to label legend drugs: "Caution: Federal law prohibits dispensing without a prescription". Refills may only be authorized by the subscriber. -
Kefauver-Harris Amendment
Requires all medications in the U.S. to be pure, safe, and effective, Established procedures for both drug applications and investigational drugs,Drug manufacturers are required to be responsible for Good Manufacturing Process -
Controlled Substances Act
Purpose is to regulate manufacture and sale of Narcotics. Drug Enforcement Agency (DEA) was formed. Introduced a stair step schedule for narcotics based on their abuse potential. Schedule I drugs have the highest abuse potential and Schedule V drugs have the lowest abuse potential -
Drug Listing Act
Authorized the FDA to compile a list of all legal drugs for sale in the US. Assigned a unique identifier to all drugs called the National Drug Code (NDC) 12 digit code. Leading zero on the ones with only 4 digits in first sequence. -
Orphan Drug Act
Created to promote the research and development of drugs needed for the treatment of rare diseases. (less than 200,000) -
Prescription Drug Marketing Act
Enacted to prevent the reimportation of drugs from other countries. This act banned the sale, trade, or purchase of drug samples except by those licensed to prescribe drugs. -
The Omnibus Budget Reconciliation Act
This act requires a pharmacist to conduct a Drug Utilization Review or offer counsel to patients on all new prescriptions. Pharmacist must provide name and description of drug, how much should be taken, side effects, contraindications, interactions, adverse effects, storage, refill information, and what to do if a dose is missed. Administered by State Board of Pharmacies. -
Dietary Supplement Health and Education Act
created rules regarding the privacy/security of patient health information. This act provides limitations on who can access, distribute, and receive patient information. This act also makes health insurance portable for people switching jobs. Violations punishable by fine up to $250,000.00 per incident -
The Health Insurance Portability and Accountability Act
This act created rules regarding the privacy/security of patient health information. This act provides limitations on who can access, distribute, and receive patient information. This act also makes health insurance portable for people switching jobs. Violations punishable by fine up to $250,000.00 per incident -
Medicare Prescription Drug Improvement and Modernization Act of 2003
signed into law by former President George W. Bush.The MMA corrected a major gap in Medicare coverage, adding a new Part D to the program and provided coverage for FDA-approved drugs that had not previously been covered. -
Anabolic Steroid Control Act
New definition of anabolic steroid was created.Act increased the number of known anabolic steroids to 59 substances. Provides requirements for handling substances defined as anabolic steroids including registration, security, labeling and packaging, inventory, record maintenance, prescriptions etc. -
Combat Methamphetamine Epidemic Act
Ephedrine, pseudoephedrine and phenylpropanolaine were placed into the Controlled Substances category. 3.6g/day base product sales limit, 9g/30-day purchase limit. Logbook of each by name, quantity sold, address of purchaser, date and time of sale.
