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Pharmacy Laws
| Term | Definition |
|---|---|
| 1906 Pure Food and Drug Act | Address problems with use of dangerous ingredients, false marketing claims, and inaccurate labeling Prohibit sale or interstate transportation of adulterated or misbranded food & drugs |
| 1914 Harrison Narcotics Act | Enacted to curb recreational use of opium - No longer available without a prescription - Records required for prescriptions - Importation and distribution were restricted |
| 1938 Food, Drug, and Cosmetic Act | Required drug companies to include direction to the consumer regarding use of a drug and package inserts All addictive substances had to be labeled: "Warning : May be habit forming" Manufacturers were required to file a new drug application (NDA) |
| 1938 Food, Drug, and Cosmetic Act (continued) | Clarified the definitions of adulterated and misbranded drugs Provided the legal status for the Food and Drug Administration (FDA) Manufacturers must obtain approval before releasing any new drug |
| 1951 Durham-Humphrey Amendment | Required label on prescription drugs: "Caution: Federal law prohibits dispensing without a prescription." Distinction between legend drugs (prescription) and patent (OTC) drugs Pharmacists can take refill prescriptions over the phone |
| 1962 Kefauver-Harris Amendments | Clinical trials had to prove that drugs were safe and effective for humans Passed in response to the birth of thousands of infants (mostly in Europe) with severe abnormalities resulting from mothers who had taken a new tranquilizer called thalidomide |
| 1970 Comprehensive Drug Abuse Prevention and Control Act | Established the Drug Enforcement Administration (DEA) to enforce the laws covering controlled substances and their distribution Classified drugs with potential for abuse as controlled substances 5 levels of restrictions, or schedules |
| 1970 Comprehensive Drug Abuse Prevention and Control Act (continued) | DEA issues physician DEA license number DEA also issues licenses to pharmacies enabling them to order controlled substances from a wholesaler - if record keeping for controlled substances is not up to date, the DEA is charged with enforcement |
| 1970 Poison Prevention Packaging Act | Required all medications to be placed in containers with childproof caps or packaging EXCEPTIONS: - physician request - Certain legend medications - Emergency medications - Patient request |
| 1972 Drug listing Act: National Drug Code (NDC) | 10-digit number composed of 3 segments - First segment: labeler code - Second segment: product code (identifies specific strength, dosage form, and formulation) - Third segment: Package code (identifies package sizes and types |
| 1983 Orphan Drug Act | Ease restrictions (and thus costs) for development of new drugs for those with a rare disease (affecting 1 in 200,000 people) Provides manufacturers tax incentives and grants them longer periods to have the exclusive licenses to market these drugs |
| 1987 Prescription Drug Marketing Act | Helps prevent counterfeit drugs and ingredients from entering the supply chain Required all drug wholesalers be licensed by the states Prohibited sale, trading, or distribution of drug samples to persons other than those licensed to prescribe them |
| 1990 Omnibus Budget Reconciliation Act (OBRA '90) | Enacted because of reimbursement regulations for people who are covered by Medicaid or Medicare Requires pharmacists to counsel (at time of purchase) all patients who receive new prescriptions - Pharmacy Technicians cannot counsel |
| OBR '90 continued | Drug Utilization Evaluation/Review (DUR) - Can include, but not limited to review of possible drug interactions, appropriateness of dosage and duration of therapy, and contraindications - Most pharmacies now offer counseling for all patients |
| 1996 Health Insurance Portability and Accountability Act (HIPPA) | Protects patients privacy - Family member is not considered a HIPAA covered entity Pharmacists and technicians have direct knowledge of a patient's medical information; the patient must sign a consent form to grant others access to this information |
| 2000 Drug Addiction Treatment Act (DATA 2000) | Physicians can prescribe controlled substances to persons suffering from opioid addiction - Only for maintenance or detoxification treatments - First letter in the DEA number begins with X |
| 2003 Medicare Modernization Act | Government insurance for seniors and for those with long-term disabilities under the age of 65 (ex: dialysis patients) Provides voluntary prescription drug coverage to Medicare beneficiaries. Created preventative medical benefits for senior citizens. |
| 2005 Combat Meth Act | Restricted the sale of OTC drugs used in the manufacturer of amphetamines like pseudoephedrine, ephedrine, and phenylpropanolamine |
| Combat Meth Act Guidelines | 3.6 g per calendar day 9 g per 30 days from a retailer 7.5 g per 30 days by mail order Kept behind the pharmacy counter or in a locked cabinet 18 yrs or older with a valid photo ID to purchase |
| 2010 Affordable Care Act (ACA) | electronic health records (EHR) Required states to provide health insurance options to those who were not covered (federal funding assistance to those who needed it) and to offer catastrophic insurance coverage for individuals with high-cost illnesses |
| 2013 Drug Quality and Security Act (DQSA) | FDA tracking system for bulk compounding supplies aka Compounding Quality Act Better protect patients from drugs contaminated in the compounding process and sold in a different state, as well as to provide protection from counterfeit or stolen drugs |
| 1984 Drug Price Competition and Patent Term Restoration Act aka Hatch-Waxman Amendments | established approval pathway for generic drug products under which applicants can submit an abbreviated new drug application streamlined the process to approve equally effective drugs with non-proprietary names or generic names |
| 1994 Dietary Supplement Health and Education Act | Provides definitions and guidelines on dietary supplements, including vitamins, minerals, herbs, and nutritional supplements Supplement manufacturers are not required to provide proof of efficacy or standardization to the FDA |
| 1990 Anabolic Steroid Control Act | Increased penalties for abuse of anabolic steroids (includes use by athletes) Designated anabolic steroids as a Schedule II class of drugs |
| 2004 Anabolic Steroid Control Act (updated) | eliminated the need to prove muscle growth Ensures proper registration, security, labeling, packaging, inventory, record maintenance, disposal, import & export, and criminal liability in connection with anabolic steroids |
| 2009 Biologics Price and Competition and Innovation Act | Provided an abbreviated approval pathway for biological therapeutic products shown to be biosimilar to an FDA-approved biological reference product |
| 1906 Pure Food and Drug Act (continued) | labels could no longer legally contain false information about the strength or purity of the drugs |
| 2003 Medicare Prescription Drug, Improvement, and Modernization Act | Updated the Medicare system and initiated the option of a prescription drug insurance program called Medicare Part D Launched Medicare Part C program, or the Medicare Advantage program, a comprehensive healthcare insurance program option |
| 1997 Food and Drug Administration Modernization Act | Update the drug approval process, streamlining them to accelerate the time until the release of newly patented and manufactured drugs FDA regulate medical devices and required that biological drug products go through similar new drug approval process |
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rach6774
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