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drug laws
Ch 2, pharm tech
| Question | Answer |
|---|---|
| Pure Food and Drug Act of 1906 | also known as the Wiley Act; prohibits the interstate transportation or sale of adulterated and misbranded food or drugs |
| 1914 Harrison Narcotics Act | 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 |
| Food, Drug, and Cosmetic Act of 1938 (FDCA 1938) | this act provided the legal status for the FDA; also describes the exact labeling for products and defined misbranding and adulteration as illegal; requires package inserts and directions to the consumer for safe use |
| adulteration | deals with the preparation and/or storage of a medication; the mishandling of medication that can lead to contamination or impurity, falsification of contents, or loss of drug quality or potency. Adulteration may cause illness or injury to the consumer |
| misbranding | 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 |
| FDCA 1938 | also required all addictive substances to be labeled "Warning: May be habit forming" |
| Durham-Humphrey Act of 1951 | required the labeling "Caution: Federal law prohibits dispensing without a prescription"; makes the distinction between legend drugs and OTC medications |
| legend drugs | drug that requires a prescription for dispensing and must carry the federal legend "Caution: Federal law prohibits dispensing without a prescription" |
| Over-the-Counter (OTC) | describes a medication that can be purchased without a prescription; nonlegend medications |
| Kefauver-Harris Amendment of 1962 | 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 |
| Comprehensive Drug Abuse Prevention and Control Act of 1970 | 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 |
| DEA | 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 |
| Poison Prevention Packaging Act of 1970 | enacted to reduce potential poisoning in children; requires most OTC and legend drugs to be packaged with childproof caps or packaging |
| child-resistant container | cannot be opened by 80% of children younger than 5 years but can be opened by 90% of adults |
| CPSC | Consumer Product Safety Commission; oversees the Poison Prevention Packaging Act of 1970 |
| some exceptions for child-resistant containers | 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 |
| Drug Listing Act of 1972 | established NDC number for each drug; unique 10 or 11 digit number divided into three segments identifying the labeler, product, and trade package size |
| NDC | National Drug Code; 10 or 11 digit number divided into three segments identifying the labeler, product, and trade package size |
| labeler code | first set of numbers in the NDC consisting of four or five digits assigned by the FDA identifying the manufacturer |
| product code | second set of numbers in the NDC consisting of up to 4 digits that identifies the strength, dosage form, and formulation for a particular drug ; set by drug company |
| package code | 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 |
| two asterisks at the end of the NDC | identifies the product as bulk, raw, or nonformulated controlled susbstance |
| Occupational Safety and Health Act of 1970 | created Occupational Safety and Health Administration (OSHA) to ensure a safe and healthful workplace for all employees; requires a reporting system for job-related injuries and illnesses; requires use of SDS |
| SDS | safety data sheets; chemical manufacturers, distributors, or importers of hazardous chemicals are required to supply the purchaser with SDS |
| format of SDS | consists of 16 user friendly sections such as safe handling, storage, and first aid measures |
| OSHA requires | all employers have SDS on file in a SDS binder (normally bright yellow or black) or available electronically through a database; required by law |
| Orphan Drug Act of 1983 (ODA) | encourage drug companies through tax incentives and exclusive licensing to develop and market orphan drugs |
| orphan drugs | medications for treatment of diseases or conditions in which there are fewer than 200,000 cases worldwide |
| Hatch-Waxman Act of 1984 (Drug Price Competition and Patent Term Restoration) | encouraged the creation of both generic and new medications by streamlining the process for generic drug approval and by extending patent licenses |
| Prescription Drug Marketing Act of 1987 | helps prevent counterfeit drugs and ingredients in the supply chain and limits the diversion of pharmaceutical samples and prescription drugs; prohibits the importation of a drug into the US by anyone other than the manufacturer |
| Prescription Drug Marketing Act of 1987 provision for animals | requires the following label to appear on all medications to be administered to animals: "Caution: Federal law restricts this drug to use by or on an order of a licensed veterinarian" |
| Omnibus Reconciliation Act of 1987 | 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 |
| Anabolic Steroid Control Act of 1990 | enacted harsher penalties for the abuse of anabolic steroids and their misuse by athletes |
| Omnibus Budget Reconciliation Act of 1990 | 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 |
| DUE | drug utilization evaluation; an authorized, structured, ongoing review of health care provider prescribing, pharmacist dispensing, and patient use of medication |
| Health Insurance Portability and Accountability Act of 1996 | purpose was to improve portability and continuity of health coverage in the group and individual markets; promote use of medical savings accounts; established principle of protected health information (PHI) |
| 2000 Drug Addiction Treatment Act | 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 |
| 2003 Medicare Modernization Act (MMA) | provided a drug discount card to beneficiaries with low incomes who require pharmacy company assistance for obtaining medications; administered under the Medicare Advantage Program |
| 2005 Combat Methamphetamine Act | this bill addressed all areas of the manufacturing, law enforcement, regulations and sale of pseudoephedrine (PSE) |
| pseudoephedrine storage | behind the counter (BTC) or locked in a cabinet; only a licensed pharmacist or technician may dispense, sell, or distribute this drug |
| maximum amount of PSE sold | may not exceed 3.6 g in a calendar day or 9 g per 30 days retail, or 7.5 g per 30 days via mail order |
| required to purchase PSE | purchaser's identification must be provided along with drug name, strength, amount, date/time of sale, customer's name, customer's address, and signature |
| documentation of PSE sale | done electronically or by log book to be kept for at least two years |
| Patient Protection and Affordable Care Act of 2010 (PPACA) | comprehensive health care reform requiring health insurance companies to cover preexisting conditions, etc; includes electronic health record (EHR) incentives and e-prescribing; Medication Therapy Management (MTM); Accountable care organizations (ACOs) |
| 2013 Drug Quality and Security Act (DQSA) | 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) |
Created by:
DbaileyC
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