Pharmacy Law Flashcards
Legislative law drawn from?
Legislative branch of government (US congress and state legislatures)
Constitutional law drawn from where?
Constitution and bill of rights
Administrative law derived from where?
Executive branch of government (president or state governor and their cabinets)
Common law aka case law drawn from where?
Judicial branch of government (court system)
Criminal law enforced by whom?
Enforced by state rep against persons or companies
Civil law, what happens?
Plaintiff brings suit against alleged defendent
Contract law
Agreement between two or more parties and is typically enforced on civil court
Ethics, what is it?
system of moral values given to a vocation or profession to follow
Pure Food and Drug Act
enacted in 1906, prohibited sale and distribution of adulterated or misbranded food or drugs
Food. Drug, and Cosmetic Act
enacted in 1938, required all drug manufacturers to file a NDA with the FDA before any drug could be approved or disapproved for the market, also had to ensure the purity, safety, packaging, and strength of a medication
Durham-Humphrey Amendment
1951 amendment, each prescription has legend saying “Caution: Federal law prohibits dispensing this medication without a prescription
Kefauver-Harris Amendment
enacted in 1963, required that all medications, both prescription and nonprescription, be pure, effective, and safe to use on humans
Controlled Substance Act
enacted in 1970, required the pharmaceutical industry to keep records and maintain security measures for certain medications, divided controlled substances into five classes
DEA Form 222
form used to order schedule II drugs
Poison Prevention Packaging Act
enacted in 1970, created standards for child-resistant packaging
Drugs that do not need to be in child-resistant packaging
sublingual nitroglycerin tablets
birth control pills
certain corticosteroid tablets
bulky meds, like some of the Potassium effervescent tablets
Occupational Safety and Health Act
enacted in 1970, established to prevent workplace disease and injuries
Drug Listing Act
enacted in 1972, assigns a unique and permanent drug code to each medication, known as the National Drug Code (NDC)
Federal Hazardous Substance Act
enacted in 1960, involves different aspects, including the use and disposal of hazardous material in the pharmacy setting
Orphan Drug Act
enacted in 1983, offers financial incentives to organizations that develop and market medications that were not previously available in the US. medications that treat a small part of the population or a rare disease
Omnibus Budget Reconciliation Act (OBRA)
enacted in 1990, requires pharmacies that fill prescription orders for Medicaid patients to obtain, record, and maintain basic patient information
Anabolic Steroids Control Act
enacted in 1990, allows the CSA to regulate anabolic steroids
Health Insurance Portability and Accountability Act (HIPPA)
enacted in 1996, implemented to improve continuity and portability of health insurance for patients
FDA Modernization Act
enacted in 1997, designed to reform the regulation of cosmetics, food, and medical products, main focus is safe pharmacy compounding and regulation of medical devices
Combat Methamphetamine Epidemic Act
enacted in 2005, intended to stop the use of the illegal drug methamphetamine, regulates drug trafficking and under this act, any person found in violation will have their property seized
DEA enforces what?
federal regulatory body that is responsible for enforcing controlled substance legislation
FDA enforces what?
FDA established to enforce the safety and effectiveness of foods medications, biological products, cosmetics, and radioactive substances
Joint Commission on Accreditation of Healthcare Organization (JCAHO)
body that accredits and certifies healthcare organizations in the US
National Association of the Boards of Pharmacy
assists the boards of pharmacy in each state to protect public heath by developing uniform standards
