Federal Requirements Practice Test for the PTCB Exam

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Which of these recalls would be issued by the Food and Drug Administration (FDA) for a medication that was deemed to cause temporary adverse health effects for patients that used that medication?

Class II Recall

Which piece of legislation was enacted to ensure drug products are both safe and effective?

The Kefauver-Harris Amendment of 1962

What is the appropriate form to use when ordering schedule II controlled substances from a pharmacy supplier?

DEA 222 Form

Which of these DEA numbers is valid?

CG2467896

Which piece of legislation was enacted to minimize adulterated and misbranded food and drugs from entering the market?

Pure Food and Drug Act

According to the Combat Methamphetamine Epidemic Act of 2005 (CMEA), what is the maximum amount of pseudoephedrine a customer can purchase in a 30-day period?

9 grams

Which of these is always true regarding Schedule II controlled substances?

The pharmacist in charge must verify and document the date received on all received CII medications.

What needs to be documented by the receiving pharmacy of a transferred controlled substance (CIII-V) prescription?

The DEA number of the transferring pharmacy.

When purchasing products containing pseudoephedrine, what needs to be documented in the logbook (hand-written or electronic)?

The total amount of pseudoephedrine purchased

Which of these sets the standards for keeping pharmacy employees safe while completing tasks associated with pharmacy practice?

The Occupational Safety and Health Administration (OSHA)

What is the most appropriate source of instructions on the proper way to store and handle a hazardous substance?

Safety Data Sheet (SDS)

Which of these is true regarding the disposal of hazardous drug waste?

It must be stored in a leakproof container.

When a state pharmacy law and federal pharmacy law conflict, which law should be followed?

The more strict Law

Which DEA form is used to report a controlled substance theft or significant loss?

DEA 106

What is the maximum number of refills that is allowed on a Schedule III-V controlled substance prescription?

5

All of the following are common reasons for a medication recall except____?

Expensive cost of Medication

What is the acronym for the online controlled substance ordering platform that has largely replaced the traditional paper format?

CSOS (Controlled Substance Ordering System)

What is the maximum number of refills a prescription for lorazepam can have?

5

The Combat Methamphetamine Epidemic Act of 2005 places restrictions on the sale, storage, and record requirements of all of the following medications, except____?

Phenylephrine

Which of the following controlled substance schedules carries the highest risk of abuse, misuse, and addiction?

Schedule II