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MCPHS - Law History
MCPHS - Pharm Law History - Exam 1
| Law/Act/Amendment | Quick Check Facts |
|---|---|
| US Pharmacopeia (1820) | Pub. Book USP - 3 Purposes: 1)Select Drugs w/est. utility 2)Compile Preparations w/Therapeutic Pwrs 3)Determine Definite Names |
| USP/NF | USP: Active Ingredients & NF lists Inactive Ingredients - Pub. Books together in 1980 |
| USP/NF (Today) | Standards for Drugs, labeling, storage, devices, supplements. - Performs Tests & Assays on Drugs |
| Import Drug Act (1848) | 1st Fed Drug Act. Am Troops Died - Bad Quinine - Inspection at Ports to meet USP Standards - Failed |
| Dr. Wiley's Poison Squad (1883 - 1912) | Wiley was USDA's Chemist - Poison Squad est. tests on foods laced w/toxic ingredients (Used Volunteers) |
| Biologics Control Act (1902) | Law Required Lic. & Reg. Interstate Sale (Inspired by death of 12 children on Diptheria Vacine) |
| Pure Food & Drug Act (1906) | Roosevelt/Congress - Mandated Drugs be "pure" - Prohibited sale of Misbranded or Adulterated food, drinks, or drugs. |
| Misbranded | False Label Statements |
| Adulterated | Not as labeled - or - Containing filthy substances |
| US v. Johnson (1911) | Cure for Cancer - False Theraputics not covered by existing Laws (Inspired Sherley Amendment 1912) |
| Sherley Amendment (1912) | Prohibited "Deliberate" False Claims of Therapeutic effacacy |
| Harrison Narcotic Act (1914) | Lic. to Import, Man., sell, & Dispense opium & coca - Req. Rx's to disp. narcotics |
| Elixer of Sulfanilamine (1937) | Sulfa Comp. miracle drugs - Massingill of Bristol, TN made Raspberry Flvr Liq. with Diethylene Glycol Solvent - 6 gal. killed 107 people |
| ENSOL (1938) | ENSOL biologic cancer therapy - 125,000 Bottles Imported (free samples) 6 women died of "tetanus" - Not Sold or Made in US - No Laws Covering this |
| Food, Drug, & Cosmetic Act (1938) | "Caution: " only label - Mandated NDA for new drugs - FDA inspection of man. |
| Insulin Certification Amendments (1941) | Banting & Best Pat. on Insulin ran out Feds' Mandate Generics have batch assay certification = Standardized Product |
| Durham-Humphrey Amendments (1951) | Amend. to FDCA - New Label "Caution: Fed. Law Prohibits Dispensing w/out Rx" - Two Cat. Non-Rx and Rx Drugs - Restrictions for Refills - Minimal Info for Pharmacist to Include on Label: Name/Add. Pharmacy, Fill Date, Doc & Pt. Name, SIG, & LEGEND |
| Thalidomide Lessons (1962) | OTC in Europe, Prohibited by Chief Med. Officer of FDA to US, - Adverse Birth Defects - Babies w/Phocomelia (no limbs) - Today Rx in US with strict guidelines |
| Kefauver-Harris Act (1962) | "Drug Efficacy Amendments" - Req. Man. to Provide Pt. Inserts, Prove Safety & Efficacy, Required Informed Consent of Human Testing |
| Drug Efficacy Study Implementation, DESI (1966) | FDA Contracted NAS/NRC to study drugs from 1938 - 1962 for efficacy - 4,000 drugs and 1,100 Ineffective |
| Controlled Substance Act (1970) | Creation of Scheduled Drugs |
| Poison Prevention Act (1970) | Consumer Prod. Safety Comm (CPSC) to Prevent poisoning of children, Child Safety Caps, Extended to Household Products |
| OTC Drug Review (1972) | Analyze 300K OTC's - 3 Catagories: 1) Safe/effective 2) Not Safe/Ineffective/Misbranded 3) Insufficient Data for Classification |
| Medical Device Amendments (1976) | Premarket Approval & Good Man. Practice (GMP) standards for Medical devices such as Needles... |
| Federal Anti-Tampering Act (1982) | Mandates Tamper Resistant Packaging for OTC's - Enacted after Tylenol Tampering resulting in Deaths |
| Orphan Drug Act (1983) | Provides Incentives to Manufactures for drugs of Rare Diseases - Example: Thalidomide |
| Price Competition & Patent Restoratio Act (1984) | Title I: FDA Abbrev. New Drug App (ANDA) for Generics post-1962 - Title II: Patent Extension Life up to 5 yrs for "review period" Pat. Life 20 yrs but Marketing Life 14 yrs |
| Prescription Drug Marketing Act (PDMA) - (1986) | Lic. of Wholesale Dist. - Bans sale of Samples - Prohibits Resale of Rx drugs by Institutions - Req. Requests for Samples be in Writing & mandates Records Kept |
| Omnibus Budget Reconciliation Act 1990 (OBRA 90) | AKA Medicaid Prudent Pharm Purchasing Act - Allows Fed Gov. Agencies to purchase at Disc. Prices "Best Price" to HCFA in form of Rebate to Medicaid |
| Pharmacy Req under OBRA 90 | Report to State Medicaid Agencies the NDC numbers for all Rx's dispensed for recipients - Counsel Medicaid Pt. on all new Rx's |
| Prescription Drug User Fee Act (PDUFA) 1992 | FDA to charge Manufactures fees for New Drug Applications - Shortens wait time from 30+ mos to 13 mos for approval of a new drug |
| Health Insurance Portability & Accountability Act (HIPPAA) 1996 | Can not be denied Health Insurance - Exclusionary periods limited to one year - No Exclusionary Period for Prev. Insured Individuals (No Break Coverage) - Insurers cannot cancel prev. available ins. plans to holders |
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MCPHS
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