NY MPJE Study Guide With Absolute Solution

NY MPJE Study Guide With Absolute Solution CSA - Controlled Substances Act (enforced by the DEA) Poison Prevention Packaging Act - Sets child-resistant drug packaging requirements, under US Consumer Product Safety Commission HIPAA - set by the department of health and human services CMEA - Control Methamphetamine Epidemic Act (CMEA)- pseudoephedrine containing product requirements Hatch-Waxman Act - included the ANDA approval process for generic drugs includes review of product's chemistry, manufacturing controls, labeling (does not include pre-clinical animal studies and clinical studies with human subjects; uses bioequivalency analysis instead of bioavailability data) FDC Act - Food Drugs and Cosmetics Act (1938) The Orange Book - FDA's Approved Drug Products with Therapeutic Equivalence Evaluations contains approved drugs ONLY (unapproved drugs will have NDC but will not be listed) Prescription Drug advertising - monitored by the FDA OTC Drug advertising - monitored by the COnsumer PRoduct Safety Commission (under the e FDA AD minimum requirements - - min. one approved use - generic name - brief summary, major statement, or 'adequate provision' of drug risks Sherman Antitrust act of 1890 - outlawed monopolies Pure Food and Drug Act of 1906 - Also known as the Wiley Act - mandated accurate labeling -ingredients must meet standards of strength, quality, and purity in the USP And NF - must list dangerous ingredients - no adulterated or misbranded drugs could be sent through interstate commerce Food Drug and Cosmetic act 1938 - enacted due to the sulfanilamide incident - required the manufacturer prove safety - allows FDA to conduct inspections (manufacturer and distributor) - established penalties for mislabeling - all ingredients must be listed on the label Public Health Service Act of 1944 - PHS Act defined biological products (biologics)-- approved under BLA (biologics license application) requires that biologics be approved for purity, potency and safety Durham-Humphrey Amendment of 1951 - first time to have a clear distinction between OTC and prescription drugs RX drugs: - habit-forming - considered unsafe for use except under expert supervision due to toxicity concerns - limited to Rx use only under a manufacturer's new drug application - required 'legend' stating "Caution: Federal law prohibits dispensing without a prescription" (now: Rx only) - OTC drugs require Drug Facts Label - Unit dose labeling requirements established Drug Facts Label Requirements for OTCs - safety in pregnancy and breast feeding, calcium, sodium, magnesium, potassium content, and US contact information to report ADR Kefauver-Harris Amendments of 1962 - Required manufacturer to prove safety AND efficacy for claims in the product's labeling. Required manufacturers to maintain records of adverse events associated with drugs and report them to the FDA Created the NDA and supplemental sNDA IRB was established for INDs; Studies can only begin after IND is reviewed by FDA and local IRB cGMP requirements - - manufacturers must be registered with the FDA, inspected every 2 years - all drugs must come from factory registered with FDA (or considered misbranded) - if standards of strength, quality, or purity are lacking, the drug is considered adulterated Controlled Substance Act of 1970 - every DEA registrant must follow all aspects of controlled substances PPPA - Poison Prevention and Packaging Act of 1970 Enforced by the Consumer Product Safety Commission Requires child-resistant packaging for some substances Drug Listing Act of 1972 - Amended the FDCA to require registering all drugs with the FDA-- hence NDC number (NDC 3 parts: labeler code, product code, package code) Federal Anti-Tampering Act of 1982 - Federal crime to tamper with OTC products Products require tamper-resistant features on OTC medications (exempt: skin, insulin, lozenges, tooth cleaning powder-dentrifrice) Federal False Claims Act of 1982 - false billing of Medicare and Medicaid whistleblowers receive 25% of recovered damages Orphan Drug Act 1983 - authorized incentives to manufacturers tax credit of 50% of clinical testing costs 7 year period of exclusivity diseases 200,000 people or for products with no reasonable expectation that the cost of research and development will be recovered by the sales revenue Hatch-Waxman Act 1984 - Price Competition and Patent Act expedited and streamlined generic drug approvals streamlined patent litigation involving generic drugs generally shortened the approval process for generic drugs ANDA or 505(b)(2) -- paper NDA Prescription Drug Marketing Act of 1987 - - prohibits re-importation except by the manufacturer - sale of drug samples and coupons prohibited - Patients cannot buy drugs and bring into US except if it is 90 d/s for the patient OR if an effective treatment is not available in the US, the condition is serious, and the drug being ipmortant has no unreasonable risk. - requires wholesalers to be state-licensed and meet uniform standards - placed limits on drugs that hospitals can resell-- sales to other hospitals is only permitted under shortage OBRA 1990 - Omnibus Budget Reconciliation Act (OBRA)- originally mandated counseling for medicaid beneficiaries Also requires DUR program (both prospective and retrospective); Retrospective is done by the state. Prospective is done by the dispensing pharmacist. DSHEA 1994 - Dietary Supplement Health and Education Act- allowed dietary supplement to be classified under food products adulteration and misbranding is prohibited still, but does not require FDA approval regulates identity, purity, quality, strength, and composition. If there are possible safety concerns, manufacturer will be held liable. Problems are reported through the SRP (Safety Reporting Portal)-- NOT MEDWATCH EREA 1996 - FDA Export Reform and Enhancement Act of 1996 - FDA approved drugs can be exported if they meet other country's standards - unapproved drugs can be exported for clinical drug trials only - API can be imported from a foreign manufacturer if being used for an FDA drug application, or for use in compounding. The API cannot be imported for manufacturing FDAMA 1997 - FDA Modernization Act of 1997 requried establishment of a registry for clinical trials approved labeling changes for food/drugs allowed manufacturers to discuss OFF LABEL uses when requested extended PDUFA Exemption for compounding pharmacists as long as products do not have to be manufactured Updated fast-track approvals with 4 programs: fast track, breakthrough, accelerated approval, priority review DATA 2000 - Drug Addiction Treatment Act of 2000 Prior to DATA, primary was methadone now permits practitioners to prescribe and dispense in typical patient care settings FDAAA 2007 - FDA Amendments Act of 2007 Developed REMS program ACA 2010 - Affordable Care Act 2010 CMS Innovation Centers Essential Health Benefits Medical Loss Ratio Integrated Care Models Transitional Care Models Improvements to Med D MTM Biologics Price Competition and Innovation act of 2010 - established an approval process for biosimilars (first biosimilar approved in 2015) part of ACA created abbreviated licensure pathway for biosimilars to become interchangeable with licensed product DQSA 2013 - Drug Quality and Security Act of 2013 Resulted from the new england compounding center