Term
| Pure food and drug act of 1906 |
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Definition
| Prohibited adulteration and misbranding of food and drugs |
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Term
| 1912 amendment to Pure food and drug act |
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Definition
| prohibit false and fraudulent efficacy claims |
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Term
| Federal Food Drug and Cosmetic Act of 1938 |
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Definition
| New drugs mus be proven to be safe. |
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Term
| Durham-Humphrey Amendments 1951 |
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Definition
established legend and OTC class
Authorized oral rx and refills |
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Term
| Kefauver-Harris Amendments 1962 |
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Definition
Drugs must be proven to be effective
established good manufacture practices (GMP)
required informed consent of subjects in clinical trials |
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Term
| FDA modernization Act 1997 |
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Definition
| prescription labels must contain "RX only" |
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Term
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Definition
| Use for indications other then approved by the FDA |
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Term
| Can manufacturers promote off label uses of their drugs |
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Definition
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Term
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Definition
-filthy,putrid or decomposed
-prepared, packaged or held under unsanitary conditions
-container composed of poisonous or deleterious substance
-unsafe color additive
-quality or strength reduced by addition or substitution |
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Term
|
Definition
-label is false or misleading
-label is inadequate
-fails to have required statements prominently displayed |
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Term
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Definition
1. articles recognized in USP
2. articles intended for use in the diagnosis cur mitigation treatment or prevention of disease |
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Term
| What are possible punishments for FDCA infractions? |
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Definition
-injunctions
-criminal proceedings
-drug seizure |
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Term
| Rx label must contain (7) |
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Definition
1.name and address of pharmacy
2.rx number
3.date of fill
4. prescriber
5.pt name
6.sig
7.cautionary statements (warning labels) |
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Term
| What must be given to patients with high-risk drugs? |
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Definition
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Term
| How many drugs are required to have MedGuide Handouts? |
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Definition
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Term
| Who regulates compounding? |
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Definition
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Term
| Is a compounding pharmacy exempt from Good Manufacture Practices (GMP)? |
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Definition
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Term
| Prescriptions from other states are usually _______, whereas foreign prescriptions are not. |
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Definition
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Term
|
Definition
| Serious adverse effects or death |
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Term
|
Definition
| temporary adverse effects |
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Term
|
Definition
not likely to cause adverse effects
example-label problem |
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Term
| Purpose of Controlled Substance Act |
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Definition
| control distribution of drugs with potential for addiction or abuse |
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Term
| The Controlled Substance Act is enforced by? |
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Definition
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Term
| What are the schedules of controlled substances? |
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Definition
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Term
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Definition
High potential for abuse
no accepted medical us in United States |
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Term
| In 1937 marijuana was classified as a ______ under the Federal Controlled Substance Act. |
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Definition
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Term
| Can pharmacies in Colorado dispense Medical Marijuana? |
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Definition
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Term
| In Colorado, what are accepted conditions for recommendation of medical marijuana? |
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Definition
| Cancer, glaucoma, HIV/AIDS, severe pain or nausea, seizures, and multiple sclerosis |
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Term
| Can a doctor be employed by a medical marijuana dispensory? |
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Definition
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Term
|
Definition
High potential for abuse
accepted medical us in United States
SEVERE physical or psychological dependence potential |
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Term
|
Definition
| Moderate physical or HIGH psychological dependence potential |
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Term
|
Definition
| Low or limited physical or psychological dependence potential |
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Term
|
Definition
| extremely low physical or psychological dependence potential |
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Term
| What cannot be changed by a pharmacist on a schedule II prescription? |
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Definition
product prescribed (except generic sub)
Patient name
signature of prescriber |
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Term
| How many refills are allowed for schedule II drugs? |
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Definition
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Term
| What is maximum quantity of a schedule II drug that can be dispensed? |
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Definition
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Term
| Who must have a DEA number to dispense controlled substances, the pharmacy or each pharmacist? |
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Definition
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Term
| How long is pharmacy registration for dispensing controlled substances good for? |
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Definition
|
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Term
| what are the record keeping requirements for controlled substances (3) |
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Definition
1.Inventory
2.Receipt
3.Dispensing |
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Term
| How long must controlled substance records be maintained? |
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Definition
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|
Term
| How often are controlled substance inventories required? |
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Definition
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|
Term
| What is the accepted filling procedure in Colorado? |
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Definition
1 file for CII
1 file for CIII-V
1 file for legend drugs |
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Term
| How many times can schedule III-V drugs be transfered |
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Definition
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Term
| Are refills authorized for schedule III-V drugs, and if so how many times? |
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Definition
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Term
| Are oral schedule II orders valid? |
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Definition
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Term
| According to Colorado Law how long until a pharmacy must have a written prescription for an emergency fill of a schedule II drug? |
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Definition
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Term
| Can a schedule II drug be partial filled? |
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Definition
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Term
| What is the time frame that the remainder of a partial fill of a CII must be picked up within? |
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Definition
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Term
| When must drug theft or loss be reported when dealing with controlled substances? |
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Definition
| Immediately upon discovery |
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Term
| How much of pharmacy total sales can legally be attributed to the casual sale of controlled substances? |
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Definition
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Term
| How much pseudoephedrine can one person purchase in Colorado in one 24 hour period? |
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Definition
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|
Term
| In Colorado can schedule V drugs be sold over the counter? |
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Definition
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Term
| How many refills are allowed for schedule V drugs in Colorado? |
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Definition
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