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Federal Anti-Tampering - Asset Managment - Lecture Slides, Slides of Management Fundamentals

Mizoram University Management Fundamentals

Asset Management is an important subject in Economics. In these Lecture Slides, following concepts are discussed : Federal Anti-Tampering, Intentional Cyanide, Contamination, Drugstore Shelves, Drug Products, Tamper-Proof Indicator, Opened, Package, Tampered, Barrier

Typology: Slides

2012/2013

Uploaded on 07/26/2013

devnarayan 🇮🇳

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Federal Anti-Tampering Act of 1982

Not part of FDCA

Somewhat related to, but independent of PPPA

Enacted after intentional cyanide contamination of

OTC products on drugstore shelves

Tylenol (TYMURS), Chicago

Most ORAL OTC drug products and many dietary

supplements must have tamper-proof indicator or

barrier that shows if package has been opened or

tampered with

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Federal Anti-Tampering Act of 1982 ^ Not part of FDCA ^ Somewhat related to, but independent of PPPA ^ Enacted after intentional cyanide contamination ofOTC products on drugstore shelves^ Tylenol (TYMURS), Chicago ^ Most ORAL OTC drug products and many dietarysupplements must have tamper-proof indicator orbarrier that shows if package has been opened ortampered with

Medical Device Act of 1976 Pre-Market Approval GMP manufacturing standards Performance Standards Classified according to intended Use Records and Reporting Requirements Not a major focus of exam

Drug Price Competition and PatentTerm Restoration Act of 1984  a/k/a “Hatch-Waxman Act”  Established Standards for marketing of ‘generic’drugs without necessity of NDA process  Replaced with Abbreviated New DrugApplication/Approval (ANDA)  Generics have to be ‘therapeutically equivalent’ topioneer drugs  Generally, adds about 5 years of exclusivity (patent)rights to pioneer (innovator) company

Hatch-Waxman Act  FDA published “Orange Book” “Approved Drug Products with Therapeutic EquivalenceEvaluations.”  Is Guideline Only Some States Require Following it • Positive Formularies • Negative Formularies Michigan is NOT and Orange Book State • If generic is chemically/pharmaceutically equivalent to Brand nameprescribed generic interchange is permitted • DO NOT use term ‘generic substitution’ for DPS – Substitution is illegal in Michigan» Means to dispense a drug other than the drug prescribed» i.e., a different chemical entity» erythromycin vs. erythromycin ethylsuccinate» E-Par vs. EES

Robinson-Patman Act of 1936  NOT an amendment to FDCA  Is part of the Antitrust Laws  a/k/a/ ‘Anti-Price Discrimination Act’  Prohibits institutions (hospitals) that buy drugs atfavorable discounted rates from selling drugs at costto others—primarily community pharmacies  “Own Use” Doctrine  ‘Bone fide emergency’ exception  http://uwacadweb.uwyo.edu/PHARMACYNOTES/Casey%20Wood/unit%205%20core%20ctw.pdf

OBRA ‘90 Applied originally only to Medicaidprescriptions Most states enacted regulations making OBRAstandards applicable to all prescriptions Drug Utilization Review Necessary and Appropriate Offer to Counsel Counseling only by RPh or intern Record-keeping

FDA Modernization Act of 1997 Established ‘fast track’ NDA process for drugsintended to treat life-threatening diseases Established guidelines to allow pharmacycompounding of drugs without adhering toGMPs or NDAs Changed ‘prescription-legend’ to ‘Rx only’ Eliminated Habit-forming warning labeling Provides incentives for SNDAs Mandates pediatric testing of pediatric drugs

Medicare Prescription DrugImprovement and ModernizationAct of 2003  NOT part of FDCA  Medicare Modernization Act

or^ MMA ) produced the largest overhaul of Medicare in the public healthprogram's 38-year history

Medicare Part D^ Its most touted change is the introduction of an entitlement benefit forprescription drugs, through tax breaks and subsidies.^ In the years since Medicare's creation in 1965, the role of prescriptiondrugs in U.S. patient care has significantly increased. As new andexpensive drugs have come into use, patients, particularly seniorcitizens for whom Medicare was designed, have found prescriptionsharder to afford. The MMA, is meant to address this problem.