PTCB Grand FINAL UPDATED ACTUAL EXAM
QUESTIONS AND CORRECT ANSWERS
Question 1.
What is the 1938 Federal Food, Drug and Cosmetic Act?
ANSWER
Misbranding and mislabeling
Question 2.
What is the 1951 Durham-Humphrey Amendment?
ANSWER
Distinction between legend drugs and otc drugs
Question 3.
What is the 1970 Poison Prevention Packaging Act?
ANSWER
Made sure all manufacturers and pharmacies to place medications with childproof caps and
packaging
Question 4.
What is the 1983 Orphan Drug Act?
ANSWER
Encourages companies to develop drugs for rare diseases by providing research assistance,
grants and cost incentives
Question 5.
What is 1990 Omnibus Budget Reconciliation Act (OBRA)?
ANSWER
Pharmacist must offer to counsel a patient
,Question 6.
What is the
1996 Health Insurance Portability and Accountability Act (HIPAA)?
ANSWER
To protect patients health information
Question 7.
What is the maximum amount for pseudoephedrine to be sold ?
ANSWER
i. 3.6 g in a day
ii. 9 g per 30 days retail
iii. 7.5 g per 30 days by mail order
Question 8.
How is pseudoephedrine stored ?
ANSWER
Behind the counter and locked in a cabinet
Question 9.
Pseudoephedrine documentation is kept in ? And if used what identification must be provided?
ANSWER
Kept in a log book and must provide:
Records of all information must be kept for at least 2 years.
Drug name
Drug strength
Drug amount
Date/time of sale
Customer's name
Customer's address
Customer's signature
,Question 10.
Define what the FDA does ?
ANSWER
enforce the guidelines for manufacturers to Ensures all medications are pure, safe and
effective.
Question 11.
What does the DEA enforce?
ANSWER
Controlled Substances Act investigates and prosecutes violators of controlled substance laws.
Question 12.
How many refills are permitted on class 2 substances ?
ANSWER
Zero need a new prescription every time
Question 13.
Class III-V can be refilled how many times ?
ANSWER
Maximum of times or within 6 months from the original
Question 14.
Class 5 can be refilled how many times?
ANSWER
As often as prescribed
Question 15.
Scheduled 3-5 can be refilled how many times ?
ANSWER
One time basis
, Question 16.
What scheduled drug must be locked away or refrigerated?
ANSWER
Schedule 2
Question 17.
What is the name
of the program on which patients can return unused controlled substances?
ANSWER
Take back program
Question 18.
Define form 106
ANSWER
Report of theft
Question 19.
Define form 41
ANSWER
Destruction due to damage
Question 20.
Define define form 222
ANSWER
Order scheduled 2 drugs
Question 21.
What is a boxed warning?
ANSWER
Type of warning on medications that carry high risks
QUESTIONS AND CORRECT ANSWERS
Question 1.
What is the 1938 Federal Food, Drug and Cosmetic Act?
ANSWER
Misbranding and mislabeling
Question 2.
What is the 1951 Durham-Humphrey Amendment?
ANSWER
Distinction between legend drugs and otc drugs
Question 3.
What is the 1970 Poison Prevention Packaging Act?
ANSWER
Made sure all manufacturers and pharmacies to place medications with childproof caps and
packaging
Question 4.
What is the 1983 Orphan Drug Act?
ANSWER
Encourages companies to develop drugs for rare diseases by providing research assistance,
grants and cost incentives
Question 5.
What is 1990 Omnibus Budget Reconciliation Act (OBRA)?
ANSWER
Pharmacist must offer to counsel a patient
,Question 6.
What is the
1996 Health Insurance Portability and Accountability Act (HIPAA)?
ANSWER
To protect patients health information
Question 7.
What is the maximum amount for pseudoephedrine to be sold ?
ANSWER
i. 3.6 g in a day
ii. 9 g per 30 days retail
iii. 7.5 g per 30 days by mail order
Question 8.
How is pseudoephedrine stored ?
ANSWER
Behind the counter and locked in a cabinet
Question 9.
Pseudoephedrine documentation is kept in ? And if used what identification must be provided?
ANSWER
Kept in a log book and must provide:
Records of all information must be kept for at least 2 years.
Drug name
Drug strength
Drug amount
Date/time of sale
Customer's name
Customer's address
Customer's signature
,Question 10.
Define what the FDA does ?
ANSWER
enforce the guidelines for manufacturers to Ensures all medications are pure, safe and
effective.
Question 11.
What does the DEA enforce?
ANSWER
Controlled Substances Act investigates and prosecutes violators of controlled substance laws.
Question 12.
How many refills are permitted on class 2 substances ?
ANSWER
Zero need a new prescription every time
Question 13.
Class III-V can be refilled how many times ?
ANSWER
Maximum of times or within 6 months from the original
Question 14.
Class 5 can be refilled how many times?
ANSWER
As often as prescribed
Question 15.
Scheduled 3-5 can be refilled how many times ?
ANSWER
One time basis
, Question 16.
What scheduled drug must be locked away or refrigerated?
ANSWER
Schedule 2
Question 17.
What is the name
of the program on which patients can return unused controlled substances?
ANSWER
Take back program
Question 18.
Define form 106
ANSWER
Report of theft
Question 19.
Define form 41
ANSWER
Destruction due to damage
Question 20.
Define define form 222
ANSWER
Order scheduled 2 drugs
Question 21.
What is a boxed warning?
ANSWER
Type of warning on medications that carry high risks
