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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| Which law made label requirements for OTC products? | show 🗑
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| When a drug is in the process of being made or discovered, this application must be filed with the FDA to prove efficacy and safety before becoming commercially available. | show 🗑
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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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| show | mis-branding
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| stock label fails to say "warning-may be habit forming" if med is habit forming | show 🗑
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| show | adulterated
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| show | adulterated
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| What is the amendment that requires manufacturers to dispense medications with labels to the patient? | show 🗑
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| What are requirements for manufacturers as outlined by the Kefauver-Harris Amendment? | show 🗑
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| show | Kefauver-Harris Amendment
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| PPI's are regulated by the FDA. What are these? | show 🗑
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| PPI's MUST be supplied to patients receiving what medications? | show 🗑
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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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| OSHA requires the pharmacy to | show 🗑
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| show | reduce accidental poisonings in children
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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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| According to the PPA, OTC meds must | show 🗑
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| show | nitroglycerin sublingual (for chest pain)
betamethasone, mebendazole, methylprednisolone (<85 mg), oral contraceptives, pancrelipase, cholestyramine
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| show | date of sale
name and address of purchaser
name and quantity of poison dispensed
full name of dispenser
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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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| show | used in the emergency treatment of certain kinds of poisoning
15ml or 1 tablespoon
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| What does activated Charcoal do? | show 🗑
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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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| DEA letters usually | show 🗑
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| show | Do math and answer.
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| show | No, new prescription is required with every fill
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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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| CV meds can be dispensed without script is state allows but this must | show 🗑
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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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| show | has a potential for abuse, less than CI and CII. May lead to moderate or low physical dependence or high psychological dependence.
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| show | products containing not more than 90 milligrams of codeine per dosage unit --Tylenol 3 & 4, Suboxone
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| show | low potential for abuse
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| show | Xanax, Klonopin, Valium, Ativan, Restoril
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| Schedule V medications | show 🗑
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| Some examples of CV meds include: | show 🗑
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| show | -varies by state
cannot take verbal scripts
cannot give consultations
cannot take or transfer prescriptions
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| show | it was improperly made or labeled and causes severe adverse reactions
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| Class I drug recall: | show 🗑
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| Class II drug recall: | show 🗑
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| Class III drug recall: | show 🗑
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| OBRA is also known as the | show 🗑
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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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