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Stack #3419499
| Pharmacy Law | Definition |
|---|---|
| 1906 Pure Food and Drug Act | One of the first laws enacted to stop the sale of inaccurately labeled drugs. |
| 1914 Harrison Narcotic Act | Required practitioner registration, documentation regarding prescriptions and dispensing, and implementation of restrictions regarding the importation, sale, and distribution of opium, coca leaves, and any derivative products. |
| 1938 Food, Drug, and Cosmetic Act | Important concepts of this act were adulteration, misbranding, and providing the legal status for the FDA. |
| 1951 Durham Humphrey Amendment | Added more instructions for drug companies, required the labeling "Caution: Federal law prohibits dispensing without a prescription," and made the initial distinction between legend drugs and OTC medications that do not require a physician's order. |
| 1962 Kefauver Harris Amendment | Ensures the safety and effectiveness of all new drugs on the US market. |
| 1970 Comprehensive Drug Abuse Prevention and Control Act | Formed the DEA to enforce the laws concerning controlled substances and their distribution and introduced a stair-step schedule of controlled substances. |
| 1970 Poison Prevention Packaging Act | Requires manufacturers and pharmacies to place all medications in containers with childproof caps or packaging, including both over-the-counter and legend drugs. |
| 1970 Occuptational Safety and Health Act | To assure so far as possible every working man and woman in the nation safe and healthful working conditions and to preserve our human resources. |
| 1972 Drug Listing Act | Provides the FDA with an accurate list of all drugs manufactured, prepared, propagated, compounded, or processed by a drug establishment regulated under the FDA and amends the Federal Food, Drug, and Cosmetic Act and prevents unfair packaging and labeling |
| 1983 Orphan Drug Act | Encourages drug companies to develop drugs for rare diseases by providing research assistance, grants, and cost incentives to manufacturers. |
| 1984 Drug Price Competition and Patent-Term Restoration Act (Hatch-Waxman Amendment) | Established the approval pathway for generic drug products, under which applicants can submit an abbreviated new drug application. |
| 1987 Prescription Drug Marketing Act | Helps to avoid counterfeit drugs and ingredients in the supply chain and also helps limit diversion of pharmaceutical samples and prescription drugs. |
| 1990 Anabolic Steroid Control Act (updated in 2004) | Helps enforce regulations on the abuse of anabolic steroids. |
| 1990 Omnibus Budget Reconciliation Act (OBRA | Congressional act that changed reimbursement limits and mandated drug utilization evaluation, pharmacy patient consultation, and educational outreach programs. |
| 1994 Dietary Supplement Health and Education Act (DSHEA) | Better defines the term dietary supplements to include herbs such as ginseng, garlic, fish oil, psyllium, enzymes, glandulars, and mixtures of these. |
| 1996 Health Insurance Portability and Accountability Act (HIPAA) | Federal act for protecting patients' rights, establishing national standards for electronic health care communication, and ensuring the security and privacy of health data. |
| 2000 Drug Addiction Treatment Act | Permits physicians to prescribe controlled substances (preapproved by the DEA) in schedules C-III, C-IV, or C-V to persons suffering from opioid addiction, for the purpose of maintenance or detoxification treatments. |
| 2003 Medicare Prescription Drug Improvement Modernization Act | Provides a drug discount card to beneficiaries with low income who require pharmacy company assistance for obtaining medications. |
| 2005 Combat Methamphetamine Epidemic Act | Addresses all areas related to manufacture of, enforcement of laws pertaining to, and sale of pseudoephedrine, which can be used to create methamphetamine. |
| 2009 Biologics Pride Competition and Innovation (BPCI) Act | Amends the Public Health Service Act (PHS 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) | Makes preventative care more accessible and affordable for many Americans. |
| 2013 Drug Quality and Security Act (DQSA) | Gives greater oversight of bulk pharmaceutical compounding and enhances the agency's ability to track drugs through the distribution process. |
| FDA | Is under the direction of the Department of Health and Human Services and is important to pharmacy. Enforces guidelines to manufacturers to ensure safety and effectiveness of medications. |
| MedWatch | FDA program that allows consumers and healthcare professionals to report any discrepancies, drug errors and adverse reactions to medications. |
| Class 1 (recalled drug) | Products that could cause serious harm or prove fatal. |
| Class 2 (recalled drug) | Products found to cause a temporary health problem or pose a slight threat of serious harm. |
| Class 3 (recalled drug) | Products that may have a minor defect or other condition that would not harm the patient. |
| C - I | Strongest potential for abuse; no medicinal use in the United States (for example, LSD, heroin) |
| C - II | Must be locked up because of high potential abuse. |
| REMS | Risk Evaluation and mitigation strategy |
| Form 224 | Needed by pharmacy to dispense controlled substances. |
| Form 225 | To manufacture or distribute controlled substances. |
| Form 363 | To run a narcotic treatment program or compound substances. |
| Form 222 | Used for the purchasing and returning of outdated C-II drugs (three part copies to it) and there are ten lines on each order form; only one item may be entered per line. Must be filled out in pen, typewriter, or indelible pencil. |
| Form 41 | Returns to reverse distributor damaged, outdated or unwanted controlled substances. |
| Refilling controlled substances | Drugs rated C-II through C-V can be refilled a maximum of five times or within 6 months of the original order, whichever comes first. |
| Ordering controlled substances | Copy 1 and 2 : sent to the supplier. Copy 3 (second carbon copy; blue) stay with the Pharmacist (the purchaser) |
| Controlled Substance inventory | Controlled substance inventory performed every 2 years. |
| Drug diversion | intentional misuse of a drug intended for medical purposes or recreational use of a prescription or a scheduled drug. |
| Boxed warning | also called Black Box Warning |
| Category X | Not to be used during pregnancy highest degree of teratogenicity. |
| Category A | No evidence of harm based on studies. |
| Category B-D | Various levels of risk |
| DEA verification | First two characters will be the letter: A,B, F, or M followed by the first letter of the prescriber's last name. |
| iPledge Program | to control the use which is basically a consent form. |
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