Pharmacy Laws and Regulations

Question or Hint Answer or Word

Health Insurance Portability and Accountability Act (HIPAA) guarantees health insurance access, portability, and renewal (limits exclusion or preexisting conditions); regulates the security of protected health information (PHI)
Pure Food and Drug Act of 1906 all manufacturers are required to properly label a drug with truthful information; prohibited the adulteration and misbranding of food and drugs
Food, Drug, and Cosmetic Act of 1938 banned false claims, required package inserts with directions to be included with products, and required exact labeling on the product
Durham-Humphrey Amendment of 1951 added more labeling requirements for drug manufacturers requiring the statement "Caution: Federal Law Prohibits Dispensing without a Prescription"; required prescription and OTC drugs to be distinguished from one another
Kefauver-Harris Amendments of 1962 gave FDA authority to approve or reject a manufacturer's marketing application before the drug was to become available for consumer or commercial use; proof of safety and efficacy of a drug; consent of study subjects in a clinical trial; required all adve
Poison Prevention Packaging Act (PPPA) of 1970 required manufacturers and pharmacies to secure all medication into containers with childproof caps or packaging
Orphan Drug Act of 1983 regulates orphan drugs, which are pharmaceuticals developed specifically for rare diseases; only those who qualify having a rare disease may receive such benefits from the government