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Laws and Amendments

Quiz yourself by thinking what should be in each of the black spaces below before clicking on it to display the answer.
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Question
Answer
show FDA-Food, Drug, and Cosmetic Act  
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show NDA- New Drug Application  
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product contains decomposed substance   show
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the label may be false or misleading   show
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The Durham-Humphrey Amendment is also called the   show
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show mis-branding  
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manufacturer name and place of business absent   show
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stock label fails to say "warning-may be habit forming" if med is habit forming   show
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product has been packaged under unsanitary conditions   show
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product has different strength or purity than whats indicated on label   show
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show Kefauver-Harris Amendment  
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show 1. requires manufacturers to register annually 2. be inspected every 2 years 3. report any drug interactions  
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requires all medication on the U.S market to be pure, safe, and effective   show
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PPI's are regulated by the FDA. What are these?   show
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show oral contraceptives estrogen progestin isotetinoin (accutane) intrauterine devices ( IUD's) inhalers  
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show product description indications for use contraindications (when/ and what it interacts with) warnings (extreme side-effects) precautions (less sever side-effects) Dose (how much and how often)  
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The Occupational and Safety Act of 1970 gave rise to   show
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show ensures job safety and an injury reporting system for job related injuries or illnesses  
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show post the number to poison control have a reference guide for toxicities must have Material Safety Data Sheets (MSDS) for any "hazardous materials" in pharmacy  
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The Poison Prevention Packaging Act was enacted to   show
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The Poison Prevention Act requires pharmacies to   show
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show medical emergency meds written requests from DRs or patients  
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show be labeled "package not child resistant" of the package is not child-resistant.  
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Examples of medication exempt from the PPA include:   show
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A Poison Log must include:   show
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show complete name of poison the word "POISON" boldly imprinted on label place of business of the seller proper directions of use  
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What is Syrup of Ipecac and how much should be ingested?   show
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show absorbs and eliminates poison in the body (not to be taking with Syrup of Ipecac as this will either not work or make the person vomit)  
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Who enforces the Controlled Substances Act of 1970? And what do they do?   show
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Every pharmacy must make a complete inventory of controlled substances every ___ years and kept on record for ___ years.   show
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show Two letters, seven numbers  
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show start with A, B or M for residents 2nd letter is Drs initial to last name  
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show Do math and answer.  
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Can CII medications be refilled?   show
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CIII and CIV scripts cannot be filled more than ___ times in a ____ month period.   show
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CII and CIV scripts can be filled verbally with what exception?   show
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show be recorded in the CV log.  
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show not accepted for medical use in the U.S lack of accepted safety use under medical supervision, and a high potential for abuse  
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Some examples of CI meds include:   show
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Schedule II medications   show
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show hydromorphone methadone meperidone oxycodone fentanyl morphine opium codeine hydrocodone  
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Schedule III medications   show
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Some examples of CIII meds include:   show
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Schedule IV medications   show
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show Xanax, Klonopin, Valium, Ativan, Restoril  
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show have a low potential for abuse, contain limited quantities of certain narcotics  
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show Robitussin AC Phenergan w/ codeine Ezogabine cough preparations containing note more than 200 mg of codeine per 100 ml or per 100 grams  
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Limitations of Pharmacy Technician duties:   show
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Drugs are recalled if   show
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Class I drug recall:   show
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Class II drug recall:   show
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show not likely to cause health hazards  
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show Omnibus Reconciliation Act of 1990  
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show directed toward pharmacists but require technician assistance improves quality of drug therapy and saves healthcare costs (requires pharmacists to give consultations)  
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OBRA requires counseling that must include:   show
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Created by: braswell1994
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