PTCB FINAL EXAM QUESTIONS AND
ANSWERS WITH COMPLETE SOLUTION
What is the 1938 Federal Food, Drug and Cosmetic Act? ~Correct Answer
~Misbranding and mislabeling of foods, drugs, medical devices, tobacco products, and
cosmetics.
What is the 1951 Durham-Humphrey Amendment? ~Correct Answer ~Distinction
between legend drugs and otc drugs
What is the 1970 Poison Prevention Packaging Act? ~Correct Answer ~Made sure all
manufacturers and pharmacies to place medications with childproof caps and
packaging
What is the 1983 Orphan Drug Act? ~Correct Answer ~Encourages companies to
develop drugs for rare diseases by providing research assistance, grants and cost
incentives
What is 1990 Omnibus Budget Reconciliation Act (OBRA)? ~Correct Answer
~Pharmacist must offer to counsel a patient
What is the 1996 Health Insurance Portability and Accountability Act (HIPAA)?
~Correct Answer ~To protect patients health information
What is the maximum amount for pseudoephedrine to be sold ? ~Correct Answer ~3.6
g in a day
9 g per 30 days retail
,7.5 g per 30 days by mail order
How is pseudoephedrine stored ? ~Correct Answer ~Behind the counter and locked in
a cabinet
Pseudoephedrine documentation is kept in ? And if used what identification must be
provided? ~Correct 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
Define what the FDA does ? ~Correct Answer ~enforce the guidelines for
manufacturers to Ensures all medications are pure, safe and effective.
What does the DEA enforce? ~Correct Answer ~Controlled Substances Act investigates
and prosecutes violators of controlled substance laws.
How many refills are permitted on class 2 substances ? ~Correct Answer ~Zero need a
new prescription every time
, Class III-V can be refilled how many times ? ~Correct Answer ~Maximum of times or
within 6 months from the original
Class 5 can be refilled how many times? ~Correct Answer ~As often as prescribed
Scheduled 3-5 can be refilled how many times ? ~Correct Answer ~One time basis
What scheduled drug must be locked away or refrigerated? ~Correct Answer
~Schedule 2
What is the name of the program on which patients can return unused controlled
substances? ~Correct Answer ~Take back program
Define form 106 ~Correct Answer ~Report of theft
Define form 41 ~Correct Answer ~Destruction due to damage
Define define form 222 ~Correct Answer ~Order scheduled 2 drugs
What is a boxed warning? ~Correct Answer ~Type of warning on medications that
carry high risks
What does the Occupational Safety and Health Administration (OSHA) do? ~Correct
Answer ~Ensures a safe workplace for employees
ANSWERS WITH COMPLETE SOLUTION
What is the 1938 Federal Food, Drug and Cosmetic Act? ~Correct Answer
~Misbranding and mislabeling of foods, drugs, medical devices, tobacco products, and
cosmetics.
What is the 1951 Durham-Humphrey Amendment? ~Correct Answer ~Distinction
between legend drugs and otc drugs
What is the 1970 Poison Prevention Packaging Act? ~Correct Answer ~Made sure all
manufacturers and pharmacies to place medications with childproof caps and
packaging
What is the 1983 Orphan Drug Act? ~Correct Answer ~Encourages companies to
develop drugs for rare diseases by providing research assistance, grants and cost
incentives
What is 1990 Omnibus Budget Reconciliation Act (OBRA)? ~Correct Answer
~Pharmacist must offer to counsel a patient
What is the 1996 Health Insurance Portability and Accountability Act (HIPAA)?
~Correct Answer ~To protect patients health information
What is the maximum amount for pseudoephedrine to be sold ? ~Correct Answer ~3.6
g in a day
9 g per 30 days retail
,7.5 g per 30 days by mail order
How is pseudoephedrine stored ? ~Correct Answer ~Behind the counter and locked in
a cabinet
Pseudoephedrine documentation is kept in ? And if used what identification must be
provided? ~Correct 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
Define what the FDA does ? ~Correct Answer ~enforce the guidelines for
manufacturers to Ensures all medications are pure, safe and effective.
What does the DEA enforce? ~Correct Answer ~Controlled Substances Act investigates
and prosecutes violators of controlled substance laws.
How many refills are permitted on class 2 substances ? ~Correct Answer ~Zero need a
new prescription every time
, Class III-V can be refilled how many times ? ~Correct Answer ~Maximum of times or
within 6 months from the original
Class 5 can be refilled how many times? ~Correct Answer ~As often as prescribed
Scheduled 3-5 can be refilled how many times ? ~Correct Answer ~One time basis
What scheduled drug must be locked away or refrigerated? ~Correct Answer
~Schedule 2
What is the name of the program on which patients can return unused controlled
substances? ~Correct Answer ~Take back program
Define form 106 ~Correct Answer ~Report of theft
Define form 41 ~Correct Answer ~Destruction due to damage
Define define form 222 ~Correct Answer ~Order scheduled 2 drugs
What is a boxed warning? ~Correct Answer ~Type of warning on medications that
carry high risks
What does the Occupational Safety and Health Administration (OSHA) do? ~Correct
Answer ~Ensures a safe workplace for employees
