Ch 2, pharm tech
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| Pure Food and Drug Act of 1906 | show 🗑
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| show | enacted in 1914 parallel with international treaties to curb the recreational use of opium; could no longer be purchased without a prescription; restricted the importation, sale, and distribution of opium, coca leaves, and any derivative products
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| Food, Drug, and Cosmetic Act of 1938 (FDCA 1938) | show 🗑
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| adulteration | show 🗑
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| show | labeling of a product that is false or misleading; label information must include directions for use; safe and/or unsafe dosages; manufacturer, packer, or distributor; quantity; and weight
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| FDCA 1938 | show 🗑
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| Durham-Humphrey Act of 1951 | show 🗑
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| show | drug that requires a prescription for dispensing and must carry the federal legend "Caution: Federal law prohibits dispensing without a prescription"
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| Over-the-Counter (OTC) | show 🗑
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| show | requires all medications in the US to be pure, safe, and effective; established procedures for both drug applications and investigational drugs; manufacturers required to be responsible for Good Manufacturing Practice (GMP); also required drug-related adverse events be reported to FDA
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| show | also known as the Controlled Substance Act; formed the Drug Enforcement Agency (DEA); placed controlled substances in one of five schedules based on potential for abuse and accepted medical use
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| show | placed under the supervision of the Department of Justice; primary role is to enforce the nation's federal drug laws; issues licenses to practitioners, pharmacies, and manufacturers of controlled substances
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| show | enacted to reduce potential poisoning in children; requires most OTC and legend drugs to be packaged with childproof caps or packaging
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| child-resistant container | show 🗑
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| CPSC | show 🗑
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| show | physician requests for non-childproof caps for their patients, certain legend medications such as sublingual nitroglycerin, customer requests for non-childproof caps, and all medications dispensed in a hospital or nursing home setting do not require childproof packaging
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| show | established NDC number for each drug; unique 10 or 11 digit number divided into three segments identifying the labeler, product, and trade package size
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| show | National Drug Code; 10 or 11 digit number divided into three segments identifying the labeler, product, and trade package size
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| labeler code | show 🗑
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| product code | show 🗑
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| show | last set of numbers in the NDC consisting of one or two numbers that identifies the specifics of the package size and type; set by drug company
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| two asterisks at the end of the NDC | show 🗑
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| Occupational Safety and Health Act of 1970 | show 🗑
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| SDS | show 🗑
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| show | consists of 16 user friendly sections such as safe handling, storage, and first aid measures
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| OSHA requires | show 🗑
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| show | encourage drug companies through tax incentives and exclusive licensing to develop and market orphan drugs
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| orphan drugs | show 🗑
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| Hatch-Waxman Act of 1984 (Drug Price Competition and Patent Term Restoration) | show 🗑
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| Prescription Drug Marketing Act of 1987 | show 🗑
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| Prescription Drug Marketing Act of 1987 provision for animals | show 🗑
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| show | also known as the Nursing Home Reform Act of 1987; established resident rights and quality standards for long term care facilities such as nursing homes
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| show | enacted harsher penalties for the abuse of anabolic steroids and their misuse by athletes
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| show | act states that a pharmacist must offer to counsel (at the time of purchase) all Medicaid patients who receive new prescriptions; also requires DUE to evaluate drug for appropriateness, interactions, etc; pharmacies must maintain patient profiles; educational programming to improve prescribing and dispensing practices
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| DUE | show 🗑
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| Health Insurance Portability and Accountability Act of 1996 | show 🗑
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| show | DATA 2000; permits physicians to prescribe controlled substances (approved by the DEA) in schedules III, IV, or V to individuals suffering from opioid addiction for the purpose of maintenance or detoxification treatments
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| show | provided a drug discount card to beneficiaries with low incomes who require pharmacy company assistance for obtaining medications; administered under the Medicare Advantage Program
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| 2005 Combat Methamphetamine Act | show 🗑
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| pseudoephedrine storage | show 🗑
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| maximum amount of PSE sold | show 🗑
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| required to purchase PSE | show 🗑
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| show | done electronically or by log book to be kept for at least two years
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| Patient Protection and Affordable Care Act of 2010 (PPACA) | show 🗑
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| show | gives the FDA greater oversight of bulk pharmaceutical compounding and enhances the agency's ability to track drugs through the distribution process; compounding safety and tracking system using barcodes by manufacturers (track and trace pedigree system)
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