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Pharmacy Law
| Law | Purpose | Year | More information |
|---|---|---|---|
| Pure Food & Drug Act, 1906, June 30th | Congress passed this law to provide for federal inspection of meat products & forbade the manufacture, sale or transport of adulterated food products or poisonous patient medicine | 1906, June 30th | |
| Sherley Amendment, 1912 | Prohibits labeling medicines with false therapeutic claims intended to defraud the cunsumers | 1912 | |
| Food Drug and Cosmetic Act (FDCA) 1938 | Limits interstate commerce to those that are safe and effective. Manufacturers required to prove safety & all must have warnings & adequate directions for use. New drugs must be tested. Regulates diagnostic agents, therapeutic devices & cosmetics | 1938 (FDCA) | |
| Sulfanilamide Disaster 1937 | 107 people died from a mixture of sulfanilamide and diethylene glycol (Antifreeze) marketed as a remedy for sore throats | 1937 | |
| Durham-Humphrey Amendment (Prescription Drug Amendment) 1951 | Requires prescription drugs to bear the legend "Caution: Federal law prohibits dispensing without a prescription" | 1951 | |
| Kefauver-Harris Amendment (Drug Efficacy Amendment)1962 | Manufacturers accountability ... Good manufacturing standards (GMP) established. Prior to marketing... required to supply proof of effectiveness and safety. Advertising RX drugs under the supervision of FDA. Procedures - NDAs & investigational established | 1962 | |
| Comprehensive Drug Abuse Prevention & Control Act (Controlled Substance Act or CSA) 1970 | Combined all federal laws about narcotics, stimulants, depressants & designer drugs. Established the DEA, agency within the Dept. of Justice | 1970 | Established the 5 classes of drugs called schedules |
| Poison Prevention Packaging Act 1970 | (PPPA) All legend & controlled drugs must be dispensed in child proof containers with some exceptions. Patients must sign a written request for non-child proof caps & it must be kept on file. | 1970 | Exceptions include sublingual nitroglycerin, contraceptives, drugs dispensed to patients in hospitals & certain emergency medications |
| Occupational Safety & Health Act (OSHA) 1970 | Established standards for workplace health & safety. (also created NIOSH a research institution | 1970 | |
| Drug Listing Act 1972 | Amended the FDCA to require drug establishments to register products & list all of their commercially market drug products with the FDA | 1972 | Each Drug is assigned a unique number (NDC) National Drug Code |
| Medical Device Amendment 1976 | Required that the safety & effectiveness of life-sustaining & life-supporting devices have premarket approval from the FDA | 1976 | |
| Orphan Drug Act 1983 | Enacted to stimulate the development of drugs for rare diseases (affect 200,000 or fewer) | 1983 | 3 Incentives.. 7 year market exclusivity, Tax credit of 50% of the cost of conducting human trials, Federal research grants for clinical testing of new therapies to treat &/or diagnose rare diseases |
| Drug Price Competition & Patent Term Restoration Act (Hatch-Waxman Act) 1984 | Established the system for Generic drugs. Manufacturers can file Abbreviated New Drug Applications (ANDA) to seek FDA approval for generic version of drugs for which patent is about to expire. | 1984 | |
| Prescription Drug Marketing Act 1987 | Enacted to address certain prescription drug marketing practices that have contributed to diversion of large quantiets of drugs | 1987 | Practices like...distribution of free samples, use of coupons redeemable for drugs at no cost or low cost, sale of deeply discounted to hospitals and health care entities |
| Anabolic Steroid Control Act 1990 | Placed anabolic steroids in C-III class. | 1990 | Anabolic steroids are any drug or hormonal substance chemically & pharmacologically related to testosterone (other than estrogens, progestin, & corticosteroids) that promote muscle growth |
| Omnibus Budget Reconciliation Act 1990 | (OBRA) Focused on Federal funding of Medicare & Medicaid programs. Mandated Drug Utilization Reviews and offer counseling to patients | 1990 | **Created an increased need for pharmacy techs. |
| Dietary Supplement Health & Education Act 1994 | Establishes guidelines for safety, ingredient & nutritional labeling, for literature and nutritional support claims. FDA established GMP regulations. | 1994 | Established an executive level Commission on Dietary Supplement Labels & Office of Dietary Supplements within the National Institute of Health |
| Health Insurance Portability & Privacy Act | Enacted to ensure patient confidentiality & privacy, Gave patients rights to review med. records and requires patient consent for transfer of any type of med. records. Patient consent needed to fill an RX | 1996 | HIPPA is any info created or received by the pharmacy, information relating to patient health-mental or physical, past, present or future & any info that could ID a patient. |
| Food & Drug Administration Modernization Act 1997 | Simplifies various FDA regulations & procedures. Greater speed in FDA approval of new drugs, grants access to investigational drugs. Federal law abbreviated to "RX Only" | 1997 | |
| Drug Addiction Treatment Act 2000 | Established to permit DRs, trained & registered with the DEA, to prescribe C-III, C-IV & C-V meds as a means of maintenance & detox of opioid addiction in patients. | 2000 | |
| Medicare Modernization Act 2003 | Medicare beneficiaries able to enroll in Medicare Advantage of Medicare Part D (Voluntary RX Plan for Seniors) | 2003 | Prior to this Medicare patients had RX coverage only when hospitalized (Pt. A) or through nursing homes or DR offices (PT. B) |
| USP Chapter <797> 2004, went into affect 2007 | US Pharmacopoeia established the 1st enforceable standards for sterile compounding in Chapter <797>, applicable in all settings in which sterile preparations are compounded | 2004 and went into affect 2007 | |
| Combat Methamphetamine Epidemic Act 2005 | (CMEA) Regulates retail OTC sales of pseudoephedrine & phenylpropanolamine. | 2005 | Includes daily sales limits and 30 day purchase limit. placement of product out of direct customer access, sale logs, ID verification & employee training. |
| Medicaid Tamper-Resistant Prescription Pad Law 2008 | All RX must be written on tamper resistant prescription pads. | 2008 | RX must have at least one of these deterrents...1) Industry recognized features designed to prevent copying of a blank or written RX. 2) Features to prevent erasure. 3) Features designed to prevent counterfeiting. |
| Affordable Care Act (Obama Care) 2010 | (ACA) Designed to ensure US citizens to access to insurance coverage through an open market exchange. | 2010 | All individuals are required to have health care insurance or face a penalty. (2018 penalty no longer used) |
| Federal Hazardous Substance Labeling Act (FHSA) 1960 | Authorized the FDA to regulate hazardous substances, including those that are toxic, corrosive, irritants, strong sensitizers, flammable, or pressure generated. Must bear labels that caution consumers to these potential hazards. | 1960 | |
| Schedule I drugs (established in 1970) | High abuse potential. No current acceptable medical use. | est. 1970 | Illegal |
| Schedule II drugs (established in 1970) | Currently acceptable medical use. High potential for abuse or severe dependence. | Controlled, no refills allowed | |
| Schedule III drugs (established in 1970) | Currently acceptable medical use. Moderate physical dependence or high psychological dependence. | Refills limited to 5. RX good for 6 months from the date written. | |
| Schedule IV drugs (established in 1970) | Currently acceptable medical use. Low potential for abuse, may lead to limited dependence | Refills limited to 5. RX good for 6 months from the date written | |
| Schedule V drugs (established in 1970) | Currently acceptable medical use. Low potential for abuse, may lead to limited dependence | RX good for 1 year from date first written, Refills limited to 1 year. | |
| DEA Registration (established in 1970 by (CSA) | These activities require registration with the DEA... Manufacturing, Distributing, Dispensing , Researching, Teaching Activities, Treatment Programs, Chemical analysis, Importing or Exporting, Compounding of/ with Controlled Substances | Required Registration Forms ...363 to compound or conduct a narcotic treatment program, 224 to dispense, 225 to manufacture o distribute |
Created by:
LMSwanson