Flashcard Set Preview
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| 1 |
1906 - Federal Food and Drug Act
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This act prohibits the sale of adulterated or mislabeled food, drinksand drugs
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1914 - Harrison Narcotic Act
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This act limits the transport of opium. In order to purchase opium, a prescription is required.
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1938 - Food Drug and Cosmetic Act
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This act made the food and Drug Act more comprehensive to include cosmetics. The act also defines...
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1951 - Durham Humphrey Amendment
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This act distinguishes legend drugs(prescription) from the over the counter drugs (OTC). This...
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1962 - Kefauver-Harris Amendment
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All drugs made from 1938 forward must be proven save and effective. Also the FTC now handles...
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1970 - Comprehensive Drug Abuse Prevention and Control Act (Controlled substance Act - CSA)
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Drug enforcement agency (DEA) was formed. Also controlled substanced were placed in schedules...
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1970 - Poison Prevention packaging act
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This act required childproof packaging on most drugs dispensed in a pharmacy. Drugs that are...
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1983 - Orphan Drug Act
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This act enables the FDA to promote the research and marketing of drugs needed for the treatment...
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1984 - Drug price Competition and Patent-term restoration Act( Hatch-Waxman Amendment)
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This act streamlines the process for granting approval of generic drugs. It also give manufacturers...
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1988 - Food and Drug Administration Act
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This act established the FDA as an agency of the Department of Health and Human Services. Any...
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1988 - Prescription Drug Marketing Act
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This act banned the sale, trade, or purchase of drug samples
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1990 - Omnibus Budget Reconciliation Act (OBRA)
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This act requires a pharmacist to attempt or offer counsel to patients on all new prescriptions....
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1996 - Health Insurance Portability and Accountability Act (HIPAA)
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This act created rules regarding the privacy/security of patient health information. This act...
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2006 - Combat Methamphetamine Epidemic Act (CMEA)
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This act limits the purchase of pseudophedrine(pse) products to 3.6g of pse per dat or 9g per...
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Class I Recall
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An attempt must be made to notify the patient that the drug he/she may be taking could cause...
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Class II recall
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The probability of serious harm is not likely and the effects may be temporary or reversable....
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Class III recall
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Not likely to cause any serious adverse effects and does not go to the customer level
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| 18 |
OTC labeling must contain:
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Product Name, manufacturer address, net contents, all ingredients(active or inactive), habit-forming...
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| 19 |
Food, Drug, and cosmetic act requires precription drugs to contain:
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Name/address/phone# of dispensing pharmacy, patient and doctor's name, prescription number...
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| 20 |
Package inserts must contain:
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Description of the drug, Clinical pharmacology, indications and usage, contraindications/precautions/warnings/adverse...
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| 21 |
Package inserts must be distributed with the following drug classes:
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Oral contraceptives, estrogen-containing and progestational drugs, intrauterine contraceptive...
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| 22 |
National Drug Code (NDC)
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Each drug produced by a manufacturer is identified with a specific NDC number. THe NDC number...
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NDC first set (five numbers) indicate what?
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Manufacturer
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NDC second set/middle set (four numbers) indicates what?
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Specific drug - each drug has its own number
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NDC last two numbers indicate what?
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Package size - (100 tablets may be 01, 500 tablets may be 05)
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Schedule I drugs
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These drugs have NO accepted medical use in the united states. These drugs have the highest...
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Schedule II drugs
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These drugs may NOT be refilled. The ordering of these drugs requires a DEA 222 form....
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Schedule III drugs
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These drugs may be refilled 5 times in a six month period. These drugs have less potential...
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Schedule IV drugs
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These drugs may be refilled 5 times in a 6 month period. These drugs have less potential...
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Schedule V drugs
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These drugs have less potential for abuse than schedule II, III, and IV drugs.
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| 31 |
Heroin
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Schedule I
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Peyote
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Schedule I
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LSD
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Schedule I
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Marijuana
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Schedule I
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Mescaline
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Schedule I
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Cocaine
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Schedule II
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Morphine
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Schedule II
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Amphetamines
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Schedule II
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Codeine
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Schedule II
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Opium
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Schedule II
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Methadone
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Schedule II
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Oxycodone
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Schedule II
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Hydromorphone
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Schedule II
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Fentanyl
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Schedule II
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Meperidine
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Schedule II
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Methylphenidate
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Schedule II
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Secobarbital
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Schedule II
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Codeine w/ acetaminophen (tylenol No. 3)
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Schedule III
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Hydrocodone w/ acetaminophen (vicodin, lorcet, lortab, norco)
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Schedule III
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Drobabinol (Marinol)
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Schedule III
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Anabolic steroids(testosterone)
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Schedule III
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Cough syrups containing hydrocodone
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Schedule III
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Benzodiazepines(diazepam, alprazolam, lorazepam)
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Schedule IV
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Phentermine
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Schedule IV
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Pentazocine
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Schedule IV
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Phenobarbitol
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Schedule IV
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Diethylpropion
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Schedule IV
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Antitussives w/codeine
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Schedule V
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Antidiarrhealsw/opioid
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Schedule V
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| 60 |
Controlled substance inventory must be done how often?
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Every two years
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| 61 |
Two file Prescription filing system #1:
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One file for CDS-CII and CDS-CIII-CV(marked with a red "C" one inch high at thebottome right...
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Two file prescription filing system #2:
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One file for CDS-CII only. Another file for CDS CIII-CV and all other drugs (CDS-CIII must...
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Three file prescription filing system:
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One file for CDS-CII, one file for CDS- CIII-CV and one file for all other prescriptions
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| 64 |
DEA 222
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Used for purchsing and returning of outdated CII drugs (blue copy:purchaser keeps for 2 years,...
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DEA 106
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Used to report lost or stolen controlled substances. (required when 5% of yearly product sold...
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DEA 41
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Used to document the destruction of controlled substances
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DEA 224
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needed for a pharmacy to dispense controlled substances
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DEA 363
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needed to operate a controlled substance treatment program or compound controlled substances
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DEA 225
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needed to manufacture or distribute controlled substances
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A doctor that precribes medications must have this?
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DEA Number
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| 71 |
Valid DEA Number
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2 letters followed by 7 numbers. First letter is an A or B. Second letter is first letter of...
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| 72 |
Orange Book(approved drug products w/therapeutic equivalence evaluations)
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Compares therapeutic equivalence using an alphabetic rating system. A rated products can be...
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USP/NF US pharmacopoeia/National Formulary
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Contains monographs and chemical characteristics of drugs
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| 74 |
USPDI US pharmacopoeia dispensing information
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Volume I:Drug info for healthcare provider
Volume II: Drug info for patients
Volume III:...
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| 75 |
US Pharmacopoeia general chapter 797:
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States the procedures and requirements for pharmaceutical compounding of sterile preparations
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| 76 |
Drug facts and comparisons
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Contains a comprehensive listing of drugs and comparative drugs. These drugs are organized...
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Drug Topics Red Book
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Gives a listing of drugs by pricing, strengths, sizes, manufacturers, brands, and generics
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| 78 |
Handbook on injectable drugs
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Lists injectable drug information such as compatability, storage and dosages
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| 79 |
Physician's Desk Reference(PDR)
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Contains packet insert drug information intended for physicians and is published annually....
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Mosby's Complete Drug Reference
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Lists generic drugs in alphabetical order. Contains additional drug information
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| 81 |
American Drug Index
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Drugs are listed alphabetically and provide brand,generic and the chemical names of the drugs....
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| 82 |
Handbook of injectable drugs
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Used to determine the compatibility of medications that will be used in an IV bag. Shows the...
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| 83 |
Material Safety Data Sheets
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MSDS provides information on hazardous materials that may be in the pharmacy and also provides...
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| 84 |
When ordering a CIII medication what document is required for proof of receipt?
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Commercial invoice
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| 85 |
Because federal and state record keeping requirements can vary in each state, which law should...
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The most stringent law
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| 86 |
For general laws concerning pharmacy rules and regulations, which law should be followed?
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The most stringent law
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| 87 |
To whom are drug recalls, drug reactions, and outcomes reported?
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FDA
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| 88 |
When drug manufacturers notify a pharmacy of a drug recall , how are the affected drugs identified?
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Lot number and expiration date
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| 89 |
What do the first five, middle four, and last two digits of an NDC number represent?
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Manufacturer, drug, package size
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| 90 |
A list of drug package inserts could be located in which book?
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Physicians desk reference
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| 91 |
What is the maximum amount of refills for CIII-CV prescriptions in a six-,month period?
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5 refills
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| 92 |
Who may initiate the ordering of an investigational drug?
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Physician
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| 93 |
Who may order controlled substance schedule CI drugs?
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No one
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| 94 |
The expiration date on a bottle of Naproxen is 8/08. When will this drug expire?
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The last day of august
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| 95 |
Which drug recall must go to the customer level?
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Class I
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| 96 |
Which form is used to report lost or stolen drugs?
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DEA 106
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| 97 |
Which schedule has no medicinal use?
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Schedule I
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| 98 |
Which form is used when ordering CII drugs?
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DEA 222
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| 99 |
A prescription for alprazolam may be refilled how many times?
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5 times
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| 100 |
If a doctor indicates 2 refills on a prescription for perco
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ho
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