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Pharmacy Technician Certification (PTCB) Review - Federal Pharmacy Law Questions & Answers, Exams of Pharmacy

Pharmacy Technician Certification (PTCB) Review - Federal Pharmacy Law Questions And Answers 100% Correct 1. PTCB federal pharmacy law practice questions with answers 2. 100% correct PTCB federal law study guide 3. Pharmacy technician certification federal law exam prep 4. Best PTCB federal pharmacy law review materials 5. Free federal pharmacy law questions for PTCB exam 6. PTCB federal law study tips and tricks 7. Comprehensive federal pharmacy law review for PTCB 8. PTCB federal law exam pass rate strategies 9. Federal pharmacy regulations study guide for PTCB 10. PTCB federal law question bank with explanations 11. How to ace PTCB federal pharmacy law section 12. PTCB federal law mock exam with answers 13. Federal pharmacy law flashcards for PTCB certification 14. PTCB federal law exam common mistakes to avoid 15. Latest updates on federal pharmacy laws for PTCB exam 16. PTCB federal law review course online 17. Federal pharmacy law mnemonics for PTCB exam 18. PTCB federal law

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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.
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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