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Pharmacy Law
Law CW101-unit 2
| Question | Answer | |
|---|---|---|
| 1906 Pure Food and Drug Act | enacted to stop the sale of inaccurately labeled drugs. | Manufacturers were required to: Provide truthful information on the label before a drug was sold. Prove the drug’s effectiveness. |
| 1914 Harrison Narcotic 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 | Defined the exact labeling for products and defined misbranding and adulteration as illegal. | Requires the following: • Mandatory food labeling • Standards of identity • Information on imitation foods • Nutritional information for special dietary foods Provided the legal status for the Food and Drug Administration (FDA). |
| 1951 Durham Humphrey Amendment | Required label on prescription drugs: “Caution: Federal law prohibits dispensing without a prescription.” Required a doctor’s order and supervision for certain drugs. | Made the initial distinction between legend drugs (by prescription only) and OTC medications that do not require a doctor's order (non-prescription drugs). |
| 1962 Kefauver Harris Amendment | Enacted in an attempt to ensure the safety and effectiveness of all new drugs on the market. | Burden put on manufacturers to ensure “good manufacturing practice” (GMP). |
| 1970 Comprehensive Drug Abuse Prevention and Control Act | Established the Drug Enforcement Administration (DEA) to enforce the laws covering controlled substances and their distribution. | Created stair-step categories of controlled substances (Schedules I-V). The DEA issues physicians a DEA license number enabling them to write Rx for controlled substances. The DEA also issues licenses to pharmacies enabling them to order controlled subs |
| 1970 Poison Prevention Packaging Act | Required all medications to be placed in containers with childproof caps or packaging - includes both OTC and legend drugs. | Exceptions include: • Physician request for non-childproof cap • Certain legend medications • Emergency medications such as sublingual nitroglycerin • Patient or physician’s request • Hospitalized patients or patient request |
| 1970 Occuptational Safety and Health Act | Created OSHA, safe and healthful workplace, attempts to reduce hazards in the workplace, requires use of SDS. | |
| 1972 Drug Listing Act | A 10-digit number composed of 3 segments that is completely unique in identifying the label, product, and package size/type. | National Drug Code (NDC) |
| 1983 Orphan Drug Act | Eased restrictions (and thus costs) for development of new drugs for those with a rare disease (affecting 1 in 200,000 people). | |
| 1984 Drug Price Competition and Patent-Term Restoration Act (Hatch-Waxmman Amendment) | Encouraged the creation of both generic and new medications. | |
| 1987 Prescription Drug Marketing Act | Helps prevent counterfeit drugs and ingredients from entering the supply chain. Limits diversion of pharmaceutical samples and prescription drugs. | |
| 1990 Anabolic Steroid Control Act (updated in 2004) | designates anabolic steroids as a CIII and allows the fda to enforce the law for legal drugs as well as illegal imports | |
| 1990 Omnibus Budget Reconciliation Act (OBRA | Deals specifically with practicing pharmacists. Enacted because of reimbursement regulations for people who are covered by Medicaid or Medicare. | Requires pharmacists to counsel (at the time of purchase) all patients who receive new prescriptions; a patient can refuse counseling: • A Pharmacy Technician cannot counsel. • Most individual states have set higher standards than those in OBRA 90. |
| 1994 Dietary Supplement Health and Education Act (DSHEA) | provided definitions and guidelines on dietary supplements including vitamins, minerals, herbs, and nutritional supplements | |
| 1996 Health Insurance Portability and Accountability Act (HIPAA) | protects patients health information | a family member is not considered to be a covered entity |
| 2000 Drug Addiction Treatment Act | Physicians can prescribe controlled substances to persons suffering from opioid addiction only for maintenance or detoxification treatments. | The first letter in the DEA number begins with X. |
| 2003 Medicare Prescription Drug Improvement Modernization Act | better known as medicare part d. provides prescription drug coverage to patients eligible for medicare benefits | |
| 2005 Combat Methamphetamine Epidemic Act | reclassified all products containing pseudoephedrine and restricted the amount that can be purchased at one time and in a 30 day period. also required all of these products be stored behind the counter at the pharmacy | Limits of: 3.6g per calendar day 9g per 30 days from a retailer 7.5g per 30 days by mail order |
| 2009 Biologics Price Competition and Innovation (BPCI) Act | amends the Public Health Services Act to create an abbreviated approval pathway for biological products shown to be biosimilar to, or interchangeable with, an FDA licensed reference biological product | |
| 2010 Affordable Care Act (ACA) | provides consumers with subsides to lower the cost of health insurance; expanded the medicaid program | includes two important technician-related components: • Electronic health records (EHR) • Medication therapy management (MTM |
| 2013 Drug Quality and Security Act (DQSA) | the FDA enforces guidelines for manufacturers to ensure safety and effectiveness of medications: | Prevents illegal distribution and misuse of controlled substances. |
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Pharm tech 506
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