Laws Flashcards
Federal Food and Drug Act (FFDA)
-Prohibits the sale of adulterated or mislabeled food, drinks, and drugs
Harrison Narcotic Act
- Limits the transport of Opium
- Must have prescription to purchase Opium
Food Drug and Cosmetic Act (FDCA)
- Prohibits the sale of adulterated or mislabeled food, drinks, drugs, and cosmetics
- Package Inserts
- “May be Habit Forming” Label
- Must be proven safe before selling
Orphan Drug Act
-FDA promotes the research and market of drugs needed for rare diseases
Drug Price Competition and Contract Patent term Restoration Act
- Allows generic drugs
- Gives manufactures incentives to make new drugs by giving patent(contract) extensions
Durham-Humphrey Amendment
- Distinguishes OTC from legend (RX) drugs
- Requires companies to place auxiliary labels “Caution: Federal law prohibits dispensing without a prescription” on every legend drug
- Pharmacist/Physician supervision for purchase of RX drugs
- OTC drugs must have: Product Name, Name/Address of manufacturer/contributor, Active and non active ingredients
Kefauver-Harris Amendment
- All drugs must be proven safe and effective after 1938
- Took place after drug Thalidomide caused many birth defects in Europe
- GMP (Good Manufacturing Practices)
- FTC (Federal Trade Commission) deals with drug advertisement
- Requires a manufacturer to: 1. Register annually
2. Report all adverse reactions 3. Be inspected every 2 years
Comprehensive Drug Abuse Prevention and Control Act (Controlled Substance Act- CSA)
- DEA (Drug Enforcement Agency) was formed
- Controlled substances (narcotics) are now placed in schedules 1-5 based on abuse potential (1=highest potential for abuse, 5=least potential for abuse)
Poison Prevention Packaging Act
- Childproof Packaging
- Nitroglycerin is the only drug exempt from this rule(prevents severity of a heart attack)
Food and Drug Administration Act (FDAA)
- Established FDA as agency of Health and Human Services
- Established Prescription Drug Marketing Act(banned/prohibited sale, trade, and purchase of drug samples)
- All adverse (bad) drug reactions and outcomes should be reported to FDA
Omnibus Budget Reconciliation Act (OBRA)
-Requires a pharmacist to attempt or offer to counsel a patient on any new medication
Health Insurance Portability and Accountability Act (HIPAA)
-Rules and regulations that protects the privacy and security oh PHI (Patient Health Information)
Combat Methamphetamine Epidemic Act (CMEA)
-Limits the purchase of Pseudoephedrine (PSE) products to 3.6gm per day or 9gm per 30 days
Federal Food and Drug Act (FFDA)
1906
Harrison Narcotic Act
1914
Food Drug and Cosmetic Act (FDCA)
1938
Orphan Drug Act
1983
Drug Price Competition and Contract Patent term Restoration Act
1984
Durham-Humphrey Amendment
1951
Kefauver-Harris Amendment
1962
Comprehensive Drug Abuse Prevention and Control Act (Controlled Substance Act- CSA)
1970
Poison Prevention Packaging Act
1970
Food and Drug Administration Act (FDAA)
1988
Omnibus Budget Reconciliation Act (OBRA)
1990
Health Insurance Portability and Accountability Act (HIPAA)
1996
Combat Methamphetamine Epidemic Act (CMEA)
2006
