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
