Federal Law Test 2

Under the iPLEDGE Risk Evaluation and Mitigation Strategy (REMS) for isotretinoin, what is the maximum number of refills that may be authorized on a prescription?

In which situation would it be illegal for a pharmacy to compound drugs?

What DEA form is necessary to purchase or transfer Schedule II controlled substances?

A patient calls the pharmacy and says they just got home from the hospital after having broken their leg. The patient cannot make it to the pharmacy to pick up their prescription for a Schedule II controlled substance that is ready to pick up. The patient asks if the pharmacy can mail the prescription to the house (mail delivery). How should the pharmacist respond?

Which of the following statements is/are true about narrow therapeutic index (NTI) drugs?

I.    Small differences in the dose or blood concentration may lead to adverse reactions

II.   They are not permitted to be prescribed

III.  They require careful titration or patient monitoring for safe and effective use

What act set the requirement for child-resistant closures for prescription drugs, non-prescription drugs, and hazardous household products?

For which type of drug recall is there a possibility of temporary or medically reversible adverse effects, but the probability of serious adverse effects is remote?

What types of patients are included in a Phase I clinical trial for drug development?

Re-importation of medications is only legal if performed by the:

I.    Retail pharmacy

II.   Original manufacturer

III.  Wholesale distributor

What law requires drugs to be proven effective (as well as safe) before being marketed?

Which DEA registration form is used for pharmacies to register with the DEA to possess and dispense controlled substances?

What information is required to be included in the transaction report transmitted from a manufacturer to a pharmacy when the pharmacy purchases bulk bottles of a medication?

A pharmacist receives an urgent notification from a manufacturing company for a recall of a specific medication because it may cause serious adverse health issues or death. What type of drug recall is this?

What act requires health care facilities to report death or injuries caused by or suspected to have been caused by a medical device to the FDA or the manufacturer?

An example of a misbranded manufacturer’s container of a drug would be:

Which of the following is true regarding the stocking and dispensing of methadone at retail pharmacies?

According to the FDA, a drug is considered to be an orphan drug if it is for rare diseases or conditions that impact fewer than how many people in the U.S.?

Which of the following ingredients has special labeling requirements if it is included in a product?

In which case(s) is it appropriate to receive a faxed prescription for a Schedule II controlled substance?

I.    Patient is a resident of a long-term care facility (LTCF)

II.   Patient is enrolled in hospice program

III.  Medication is intended for home infusion therapy

What is the acronym of the voluntary reporting system for medication adverse events?

Within how many days must a prescriber deliver a written prescription for a Schedule II controlled substance that was called in orally to be dispensed in an emergency situation?

A pharmacy intern wants to know where to find information on therapeutic equivalence between biologics. Which book contains this information?

In which case(s) must an exact count be taken while performing a controlled substance inventory?

I.    It is a Schedule II controlled substance

II.   The bottle holds more than 1000 tablets or capsules

III.  Containers are sealed or unopened

The scheduling of controlled substances at the federal level is performed by the:

A manufacturer of a prescription-only drug wants to reclassify the drug as an over-the-counter (OTC) drug. What is one of the forms that may be submitted to the FDA when requesting reclassification of a prescription-only drug to an over-the-counter drug?