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Laws

TermDefinition
Pure Food and Drug Act of 1906 prohibited the interstate transportation or sale of adulterated or misbranded medications and food. (Focused on labeling and purity but did not require proof of safety or effectiveness)
Food, Drug, and Cosmetic Act of 1938 enacted to ensure that all medications are pure and safe. Created the Food and Drug Administration (FDA)
Durham-Humphrey Amendment of 1951 requires all products to have adequate directions for use unless they contain the federal legend “Caution: Federal law prohibits dispensing without a prescription.” or “RX Only. Distinguishes prescription meds for OTC meds.
Kefauver-Harris Amendment of 1962 gave the FDA the authority to require proof of efficacy instead of only safety prior to approving new medication therapy.
Comprehensive Drug Abuse Prevention and Control Act of 1970: regulates manufacturing, distribution, prescribing, and dispensing of controlled substances through the Drug Enforcement Administration (DEA). Established the five-tier schedule of controlled substances
Poison Prevention Packaging Act of 1970 overseen by the Consumer Product Safety Commission and requires most prescriptions for oral use to be dispensed in child-resistant containers unless patients or prescribers request otherwise.
Drug Listing Act of 1972 all medications are assigned a specific 11-digit identification number called a national drug code (NDC) number.
Orphan Drug Act of 1983 provided incentives for drug manufacturers to develop medications for the treatment, diagnosis, or prevention of rare diseases.
Omnibus Budget Reconciliation Act of 1990 required patient profiles and pharmacist to offer counseling.
Anabolic Steroid Control Act of 1990 amendment to the controlled substance act that redefined anabolic steroids. Classified anabolic steroids as schedule III controlled substances.
Medicare Modernization Act of 2003 provides voluntary prescription medication (Part D) benefits to Medicare beneficiaries.
Combat Methamphetamine Epidemic Act of 2005 created a new category of products called schedule listed chemical products (SLCP). SLCP includes an product that contains ephedrine, pseudoephedrine, or phenylpropanolamine. Placed limits and monthly sales of these products.
Drug Supply Chain Security Act of 2013 stablished a system to identify and trace prescription medications as they are distributed though the US.
Created by: rgvcpharmtech
 

 



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