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Pharmacy Technician Certification (PTCB) Review - Federal
Pharmacy Law Questions And Answers 100% Correct
1. 1906 - Federal Food and Drug Act
ANS This act prohibits the sale of adulterated or mislabeled food, drinksand drugs
2. 1914 - Harrison Narcotic Act
ANS This act limits the transport of opium. In order to purchase opium, a prescription is required.
3. 1938 - Food Drug and Cosmetic Act
ANS This act made the food and Drug Act more comprehensive to include cosmetics. The act also defines misbranding or adulteration of drugs to be illegal, This act requires drug companies to provide package inserts,requires that habit-forming drugs be labeled "may be habit form- ing" , requires that a new drug has to be proven safe under FDA guidelines before marketing
4. 1951 - Durham Humphrey Amendment
ANS This act distinguishes legend drugs(prescription) from the over the counter drugs (OTC). This act requires companies to label legend drugs "Caution ANSFederal law prohibits dispensing without a prescrition", requires physician supervision for the purchase of legend drugs. Also, over the counter drugs without medical supervision are required to have on the label ANS Product Name, Name and Address of manufacturer, Active ingredients, quantities of all other ingredients whether active or not
5. 1962 - Kefauver-Harris Amendment
ANS All drugs made from 1938 forward must be proven save and effective. Also the FTC now handles drug advertisement. Stricter requirements for drug approval. Manufacturersmust now register annually, be inspected ever 2 years, and report adverse effects of drugs.
6. 1970 - Comprehensive Drug Abuse Prevention and Control Act (Controlled
substance Act - CSA) ANS Drug enforcement agency (DEA) was formed. Also con- trolled substanced were placed in schedules I-V based on abuse potential.Sched- ule I drugs have the highest abuse potential and schedule V drugs have the lowest abuse potential.
7. 1970 - Poison Prevention packaging act
ANS This act required childproof packag- ing on most drugs dispensed in a pharmacy. Drugs that are exempt from this act are drugs used in emergency situations, such as dispensing nitroglycerin, or if a drug is packaged in such a small quantity it would not hard a child under 5 years old.
8. 1983 - Orphan Drug Act
ANS This act enables the FDA to promote the research and marketing of drugs needed for the treatment of rare diseases.
9. 1984 - Drug price Competition and Patent-term restoration Act( Hatch-Wax- man
Amendment) ANS This act streamlines the process for granting approval of generic drugs. It also give manufacturers incentives to develop new drugs by giving patent extensions. This act allows generic drug companies the ability to rely on safety and efficacy findings of an innovator's drug after the expiration of the patent.
10. 1988 - Food and Drug Administration Act
ANS This act established the FDA as an agency of the Department of Health and Human Services. Any adverse drug reactions and outcomes should be reported to the FDA
11. 1988 - Prescription Drug Marketing Act
ANS This act banned the sale, trade, or purchase of drug samples
12. 1990 - Omnibus Budget Reconciliation Act (OBRA)
ANS This act requires a pharmacist to attempt or offer counsel to patients on all new prescriptions. Pharma- cist must provide anem and description of drug, how much should be taken, side effects, contraindications, interactions, adverse effects, storage,
- Name/address/phone# of dispensing pharmacy, patient and doctor's name, pre- scription number and the date filled, drug name/strength/quantity/directions for use, name/initials of dispensing pharmacist or technician, patient address, ex-
piration date, refill information, precautions, the statement "federal law prohibits dispensing without a prescription", package insert on selected drugs.
20. Package inserts must contain
ANS
Description of the drug, Clinical pharma- cology, indications and usage, contraindications/precautions/warnings/adverse re- actions, drug abuse/dependance/overdosage information, dosage/administration information, the date of the most recent label revision
21. Package inserts must be distributed with the following drug classes
ANS
Oral contraceptives, estrogen-containing and progestational drugs, intrauterine contra- ceptive devices, diethylstilbestrol products, accutane, metered-dose inhalers
22. National Drug Code (NDC)
ANS Each drug produced by a manufacturer is identi- fied with a specific NDC number. THe NDC number is composed of three sets of numbers, which identifies the manufacturer, drug, and pack size.
23. NDC first set (five numbers) indicate what?
ANS Manufacturer
24. NDC second set/middle set (four numbers) indicates what?
ANS Specific drug
- each drug has its own number
25. NDC last two numbers indicate what?
ANS Package size - (100 tablets may be 01, 500 tablets may be 05)
26. Schedule I drugs
ANS These drugs have NO accepted medical use in the united states. These drugs have the highest abuse potential
27. Schedule II drugs
35. Mescaline
ANS Schedule I
36. Cocaine
ANS Schedule II
37. Morphine
ANS Schedule II
38. Amphetamines
ANS Schedule II
39. Codeine
ANS Schedule II
40. Opium
ANS Schedule II
41. Methadone
ANS Schedule II
42. Oxycodone
ANS Schedule II
43. Hydromorphone
ANS Schedule II
44. Fentanyl
ANS Schedule II
45. Meperidine
ANS Schedule II
46. Methylphenidate
ANS Schedule II
47. Secobarbital
ANS Schedule II
48. Codeine w/ acetaminophen (tylenol No. 3)
ANS Schedule III
49. Hydrocodone w/ acetaminophen (vicodin, lorcet, lortab, norco)
ANS Schedule III
50. Drobabinol (Marinol)
ANS Schedule III
51. Anabolic steroids(testosterone)
ANS Schedule III
52. Cough syrups containing hydrocodone
ANS Schedule III
53. Benzodiazepines(diazepam, alprazolam, lorazepam)
ANS Schedule IV
54. Phentermine
ANS Schedule IV
55. Pentazocine
ANS Schedule IV
56. Phenobarbitol
ANS Schedule IV
57. Diethylpropion
ANS Schedule IV
58. Antitussives w/codeine
ANS Schedule V
59. Antidiarrhealsw/opioid
ANS Schedule V
60. Controlled substance inventory must be done how often?
ANS Every two years
62. Two file prescription filing system
ANS
One file for CDS-CII only. Another file for CDS CIII-CV and all other drugs (CDS-CIII must be marked with a one inch high red "C" on the bottom right corner)
63. Three file prescription filing system
ANS
ANS One file for CDS-CII, one file for CDS- CIII-CV and one file for all other prescriptions
64. DEA 222
ANS Used for purchsing and returning of outdated CII drugs (blue copy purchaser keeps for 2 years, green copy seller sends to local DEA, brown copy seller keeps on file)
65. DEA 106
ANS Used to report lost or stolen controlled substances. (required when 5% of yearly product sold is missing - ie 50 tablets from a 1000 yearly supply)
66. DEA 41
ANS Used to document the destruction of controlled substances
67. DEA 224
ANS needed for a pharmacy to dispense controlled substances
68. DEA 363
ANS needed to operate a controlled substance treatment program or compound controlled substances
69. DEA 225
ANS needed to manufacture or distribute controlled substances
70. A doctor that precribes medications must have this?
ANS DEA Number
71. Valid DEA Number
ANS 2 letters followed by 7 numbers. First letter is an A or B. Second letter is first letter of last name. The last number of the sum of odd numbers
- (sum of even number) * 2 should equal the last number
72. Orange Book(approved drug products w/therapeutic equivalence evalu-
ations) ANS Compares therapeutic equivalence using an alphabetic rating system. A rated products can be substituted and B rated products cannot because they are not bioequivalent. This is published yearly.
73. USP/NF US pharmacopoeia/National Formulary
ANS Contains monographs and chemical characteristics of drugs
74. USPDI US pharmacopoeia dispensing information
ANS Volume I Drug info for healthcare provider Volume II Drug info for patients Volume III Therapeutic equiv- alency information and pharmacy law
75. US Pharmacopoeia general chapter 797
ANS
States the procedures and re- quirements for pharmaceutical compounding of sterile preparations
76. Drug facts and comparisons
ANS Contains a comprehensive listing of drugs and comparative drugs. These drugs are organized by therapeutic class and provide general information with a list of monographs. Also contains listing of drug manufacturers, addresses and phone numbers. Updated monthly
ANS The most stringent law
86. For general laws concerning pharmacy rules and regulations, which law
should be followed? ANS The most stringent law
87. To whom are drug recalls, drug reactions, and outcomes reported?
ANS FDA
88. When drug manufacturers notify a pharmacy of a drug recall , how are the
affected drugs identified? ANS Lot number and expiration date
89. What do the first five, middle four, and last two digits of an NDC number
represent? ANS Manufacturer, drug, package size
90. A list of drug package inserts could be located in which book?
ANS Physicians desk reference
91. What is the maximum amount of refills for CIII-CV prescriptions in a
six-,month period? ANS 5 refills
92. Who may initiate the ordering of an investigational drug?
ANS Physician
93. Who may order controlled substance schedule CI drugs?
ANS No one
94. The expiration date on a bottle of Naproxen is 8/08. When will this drug
expire? ANS The last day of august
95. Which drug recall must go to the customer level?
ANS Class I
96. Which form is used to report lost or stolen drugs?
ANS DEA 106
97. Which schedule has no medicinal use?
ANS Schedule I
98. Which form is used when ordering CII drugs?
ANS DEA 222
99. A prescription for alprazolam may be refilled how many times?
ANS 5 times
100. If a doctor indicates 2 refills on a prescription for perco
ANS ho
