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drug laws

Ch 2, pharm tech

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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