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21 Cards in this Set
- Front
- Back
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Which act created teh NDC (National Drug Code) number
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Drug listing act of 1972
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What do the digits stand for on the NDC number
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first 5 digits - manufacturer
next 4 digits - drug product final 2 - package size and packaging |
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What is the Pure Food and Drug Act of 1906?
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Prohibits interstate transportation or sale of adulterated misbranded food or drugs
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What was FOOD.DRUG,AND COSMETIC ACT OF 1938 (FDCA 1938) created for?
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(FDA) created under FDCA 1938 requires all new drug applications be filed with the FDA. Defines adulteration/misbranding of drugs and food products
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What is the DURHAM-HUMPHREY ACT OF 1951?
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Amendment to FDCA 1938 requires direction for use unless contains "Caution Federal law prohibits dispensing without RX
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Under Durham-Humphrey Act what are the two drug categories?
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Legend and nonlegend (over the counter) OTC. Legend requires an RX, supervision of Dr, allows verbal over the phone, allows refills to be called in from Dr's office
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What is the KEFAUVER-HARRIS AMENDMENT OF 1962?
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It requires all medications in the United States to be pure, safe, and effective.
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What is the COMPREHENSIVE DRUG ABUSE PREVENTION AND CONTROL ACT OF 1970?
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Drug Enforcement Agency (DEA) created under the supervision of the Dept. of Justice - 5 schedules (categories) based on a potential for abuse and accepted medical use in the USA
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What is the Schedule 1 category?
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No accepted medical use in the U.S. and possesses an extremely high potential for abuse. Examples; crack, heroin, Marijuana
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What is the Schedule 2 category?
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Has a medical use, high abuse potential with severe psychological or physical dependency
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What is the Schedule 3 category?
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Has accepted medical use, abuse potential less than with Schedule 1 and 2 drugs
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What is Schedule IV?
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Abuse potential is less than with Schedule III drugs, but administration may lead to limited physical or psychological dependence,
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What is Schedule V?
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Abuse potential is less than with Schedule IV drugs;schedule includes exempt narcotics.
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What form is used for the Drug Enforcement Agency Registration?
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DEA Form 224. Facility that dispenses controlled substances must be registered with DEA. The pharmacy must renew this registration every 3 years.
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What form is used for ordering and receipt of Schedule II medications?and who must sign for them?
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DEA Form 222 .The person whose name the DEA registration is listed. Form valid for 60 days. 1 item per line, max of 10 different items.Total on bottom of form. Typed, pen, or indelible pencil.
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Where are unused DEA 222 forms kept?
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Secure location in pharmacy.On receipt of meds, # of pkgs , form dated, signed by pharmacist.Invoice or pkg slip and DEA form 222 must be retained in pharmacy for minimum of 2 years
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Retention of Drug Enforcement Agency Records are kept for how long and stamped with what?
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Minimum of 2 yrs.kept separately from other invoices. readily retrievable or marked with asterisk, a red line. A red C must be stamped on Schedule III to V records if they are filed with other invoices. 72 hrs if requested by DEA representative
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Defective forms are incomplete,illegible, shows signs of alteration, erasure, or change. Must be kept for how long?
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Defective forms must be kept for a minimum of 2 years and be readily retrievable
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What is Initial inventory?
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A complete accurate inventory of all controlled substances before the opening of the first day of business for a pharmacy.
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What is Biennial Inventory?
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Inventory taken every 2 years after initial inventory is taken.Exact count for Schedule II and an estimated count for Schedule III to V drugs. Records kept minimum of 2 years
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What is Perpetual Inventory?
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Shows controlled substances received by facility, supplied to other locations, returned to pharmacy and dispensed to patients.It will show actual # of units of a drug at a particular moment in time
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