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Pharmacy Laws
Unit 1
| Term | Definition |
|---|---|
| 1906 Pure Food and Drug Act | 1st federal law regulating drugs. Enacted to stop the sale of inaccurately labeled drugs. |
| 1914 Harrison Narcotic Act | Enacted because of the excessive number of opium addicts in the United States. People could no longer obtain opium without a prescription. |
| 1938 Food, Drug, and Cosmetic Act | Basis for pharmacy law today. New Drug Application required by FDA. Narcotics labeled “Warning: May be habit-forming”. Required adequate directions for use (package inserts). Defined exact labeling: misbranding and adulteration as being illegal. |
| 1951 Durham-Humphrey Amendment | Initial distinction between legend drugs (prescription) and non-prescription (over the counter). Required legend drugs be labeled “Caution: federal law prohibits dispensing without a prescription”. Must be prescribed by licensed practitioner. |
| 1962 Kefauver-Harris Amendment | Safety and effectiveness of all new drugs (legend and OTC) Burden on companies to have GMP. FDA inspections & Drug testing and approval required. Prevented sale of thalidomide in the U.S. bc children were born with birth defects after use in pregnancy. |
| 1970 Comprehensive Drug Abuse Prevention and Control Act | DEA was formed to enforce laws concerning narcotics and distribution. Created controlled substance schedule I-V. Closed system allowing distribution of controlled substances to only those registered with DEA Established strict recordkeeping guidelines. |
| 1970 Poison Prevention Packaging Act (PPPA) | Reduce accidental poisoning in children. Requires most OTC and legend drugs be packaged in child-resistant containers. (80% under 5yrs cannot open and 90% adults can open) Except specific request of physician or written consent of elderly patients. |
| Occupational Safety and Health Act of 1970 (OSHA) | Safe + healthy workplace. Reporting system for job-related injuries and illness. Reduce hazards in workplace and conduct audits Est. universal precautions. Addresses air cont, flame/combust liquids, eye/skin prot, and hazard comm standards Use of SDS |
| 1972 Drug Listing Act: National Drug Code | Implemented under the authority of the FDA Every drug has a unique 10-digit number divided into three segments |
| Orphan Drug Act of 1983 | Bypass the long time requirements of testing a new drug and cost to provide a med to people w/ rare disease(s) (1/200,000). Covers diseases that affect >200,000 if proved that the cost of developing + testing drug can't be recovered by the sales. |
| 1987 Prescription Drug Marketing Act | Legal supply channels from mfg. to distrib. & salers Prohibits sale of samples to anyone other than prescriber Controlled drug use in animals. Required Label “Caution: Federal law restricts this drug to use by or in order of a licensed Veterinarian” |
| 1990 Omnibus Budget Reconciliation Act (OBRA 90) | Limits on Medicare & Medicaid payment for meds Meds prescribed would be reviewed Pharmacist must counsel patients who receive new pres. Patients must be given info on drug: name, when+how long to take it, side effects Created need for pharmacy techs |
| Resource Conservation and Recovery Act (RCRA) | Waste management guideline program envisioned by Congress. Hazardous waste – waste can harm health or environ. (2) Listed wastes: EPA regs: F-list, P- list, K- list, and U- list Characteristic wastes: ignitability, corrosivity, reactivity, and toxicity |
| Health Insurance Portability and Accountability Act of 1996 (HIPAA) | Patient’s right to continue health insurance when changing employers Confidentiality: patients sign consent form to grant access to medical inform. Includes: info created or received by the pharmacy, relating to patients health, may identify a patient |
| 2000 Drug Addiction Treatment Act (DATA 2000) | Permits physicians to prescribe controlled substances (pre-approved by the DEA) in schedules C-III, C-IV, C-V to individuals suffering from opioid addiction for the purpose of maintenance or detoxification treatments. |
| 2003 Medicare Prescription and Modernization Act | Medicare is a govt-managed insurance program that provides to people older than age 65 Younger than 65 w/ disabilities + individuals with end-stage renal failure Provides drug discount card to beneficiaries with low incomes |
| Isotretinoin Safety and Risk Management Act of 2004 | Regulates use of Accutane Can cause severe birth defects & depression/suicide Mandatory regist. & edu for physicians, pharmacist, patients No internet, mail order, phone pres. Female patient required monthly pregnancy test before pres. refilled |
| 2004 Anabolic Steroid Control Act | Placed anabolic steroids on Schedule III Harsher penalties for the abuse of anabolic steroids and their misuse by athletes Amended in 2004 (stricter) |
| 2005 Combat Meth Act | All areas of manu., law enf., and sale of ephedrine & pseudoephedrine, ing in the prep of methamphetamine Licensed pharmacist/tech may dispense/sell/distrib. Daily sales limit of 3.6 grams / 9 g per 30 days Customer identification/recordkeeping |
| Biologics Price Competition and Innovation (BPCI) Act of 2009 | Lowers cost and provides patient access to crucial biological therapies that they need. Permits the FDA to approve a biosimilar product with a designation that is interchangeable with the FDA-licensed reference biologic. |
| Drug Supply Chain Security Act (DSCSA) | Outlines critical steps to build an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed in the United States. |
| 2010 Patient Protection and Affordable Care Act | Preventive care more accessible and affordable Requires insurance companies to cover applicants with new standards ACA involve pharmacy professionals, such as: EHR incentives and e-prescribing, MTM, ACO, The Home Demonstration Project |
| 2013 Drug Quality and Security Act | Gives FDA greater oversight of bulk pharmaceutical compounding and enhances the agency’s ability to track drugs through the distribution process Comprises two separate acts Compounding Quality Act Drug Supply Chain Security Act |
| Compounding Quality Act | Creates a new class of compounding manufacturers that voluntarily register with the FDA as an “outsourcing facility” |
| Drug Supply Chain Security Act | Requires the FDA to create and implement a national tracking system to be used by manufacturers |
Created by:
huynhleslie0914
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