PPLE - Final Exam Practice Problems Module 4

B (Module 4: Reading)

Today, patient package inserts are required for any drug package intended for patient distribution. Before, this only applied to:

A. Drugs for at-home renal dialysis

B. Estrogen-containing and progestational drugs

C. Blood and blood products

D. Administration products such as syringes

A (Module 4: Reading)

Manufacturers must produce patient package inserts for each package intended for patient distribution. Failure to do so is:

A. Misbranding

B. Adulteration

C. Both Misbranding and Adulteration

D. Neither Misbranding nor Adulteration

C (Module 4: Reading)

In which situation is a MedGuide NOT required?

A. The first time a drug is dispensed in an outpatient setting of any kind

B. Drug is dispensed in an outpatient setting where the patient is not under direct supervision from a healthcare professional

C. Drug is dispensed to a healthcare professional to be administered to a patient in an inpatient setting

D. Patient or patient's agent requests one

A (Module 4: Reading)

Which of the following can be found on Drug Info Rounds?

A. Training videos of important drug information to help patients make good medication decisions

B. Monographs of discontinued drugs

C. A log of the approval timeline for a prescription drug on the market

D. Research data on the safe and effective usage of dietary supplements

A (Module 4: Reading)

Electronic prescribing for medicinal drugs shall NOT:

A. interfere with a patient's freedom to choose a pharmacy

B. require the signature of the prescribing practitioner, since the e-prescription is encrypted

C. be used for controlled substance prescriptions, since counterfeit-proof prescription pads are required

D. show information regarding a payor's formulary

C (Module 4: Reading)

In Florida, who may accept an oral prescription?

A. only a licensed pharmacist

B. only a licensed pharmacist, registered pharmacy intern, or registered pharmacy technician

C. only a licensed pharmacist or registered pharmacy intern under the supervision of a pharmacist

D. only a licensed pharmacist or a registered pharmacy intern under the supervision of the pharmacist in charge (PIC)

A (Module 4: Reading)

In Florida, any pharmacy or any pharmacist engaged in sterile compounding shall not exceed a ratio of _____ registered technicians to licensed pharmacist(s).

A. 3:1

B. 4:1

C. 6:1

D. 1:1

A (Module 4: Reading)

An applicant for a pharmacy permit must submit the fingerprints of all owners of over 5% of the company or for company with over 100,000,000 of taxable assets in Florida, the prescription department manager or consultant pharmacist. These fingerprints will be submitted by the Florida Department of Health to:

A. The FBI and the Florida Department of Law Enforcement

B. The Florida Department of Law Enforcement

C. The DEA

D. The FBI

B (Module 4: Reading)

A non-resident pharmacy must, for at least 6 days per week and a minimum of 40 hours per week, do which of the following?

A. keep the pharmacy department open for patients needing prescription drugs

B. provide toll-free telephone access to a pharmacist, with the toll-free number on the label

C. make patient records available for inspection

D. provide online internet access to a pharmacist, with the pharmacy's url on the label of the drug

D (Module 4: Reading)

Which of the following best describes the difference between a Class I institutional pharmacy and a Class II institutional pharmacy?

A. In Class I institutional pharmacies, most drugs are administered from individual prescription containers to the individual patient, whereas in Class II institutional pharmacies the pharmacist is allowed to dispense prescription drugs to patients only upon discharge for outpatient use

B. In Class I institutional pharmacies, all medicinal drugs are dispensed in individual containers to individual patients on the premises, whereas Class II institutional pharmacies may dispense medicinal drugs to outpatients upon discharge from that institution

C. Class I institutional pharmacies are those in short-term, primary care treatment centers in which the pharmacist in charge may dispense medicinal drugs only to outpatients of that primary care treatment center, whereas Class II institutional pharmacies may only dispense medicinal drugs for patients on the premises

D. In Class I institutional pharmacies, no medicinal drugs may be dispensed, whereas in Class II institutional pharmacies, drugs may be dispensed, but only for patients of that institution on the premises, except in emergencies declared by the Governor

A (Module 4: Lecture)

An entity in Florida with which of the following permits is exempt from certain establishment, security, and storage requirements otherwise required in Florida?

A. Prescription manufacturer (virtual) permit

B. Retail pharmacy drug wholesale distributor permit

C. Restricted prescription drug distributor permit

D. Prescription drug wholesale distributor permit

D (Module 4: Lecture)

Which of the following permits is required for any person or entity in Florida who engages in the receipt or distribution of a prescription drug in this state for the purpose of processing its return or its destruction (other than the person initiating the return, the wholesale supplier, or the manufacturer)?

A. Prescription drug wholesale distributor-broker permit

B. Retail pharmacy drug wholesale distributor permit

C. Prescription manufacturer (virtual) permit

D. Restricted prescription drug distributor permit

D (Module 4: Lecture)

Which of the following permits is required in Florida for any entity whose wholesale distribution activity does not exceed 30% of the total annual purchase of prescription drugs?

A. Prescription manufacturer (virtual) permit

B. Prescription drug wholesale distributor-broker permit

C. Restricted prescription drug distributor permit

D. Retail pharmacy drug wholesale distributor permit

A (Module 4: Lecture)

Which of the following permits is required in Florida for an entity who engages in the wholesale distribution of prescription drugs and does not take physical possession of any prescription drugs?

A. Prescription drug wholesale distributor-broker permit

B. Retail pharmacy drug wholesale distributor permit

C. Prescription manufacturer (virtual) permit

D. Restricted prescription drug distributor permit

C (Module 4: Lecture)

Which of the following is required for Rx drug manufacturers outside of Florida or the US that distributes prescription drugs in Florida?

A. Out-of-state Rx Drug Wholesale Distributor Permit

B. Nonresident Prescription Drug Repackager Permit

C. Nonresident Rx Drug Manufacturer Permit

D. Prescription Drug Manufacturer Permit

A (Module 4: Lecture)

Which of the following is required for any wholesale distributor of Rx drugs in Florida?

A. Prescription Drug Wholesale Distributor Permit

B. Prescription Drug Wholesale Distributor Broker-Permit

C. Retail Pharmacy Drug Wholesale Distributor Permit

D. Restricted Prescription Drug Distributor Permit

D (Module 4: Lecture)

Restricted Prescription Drug Distributor Permit:

A. Required for any person who distributes a Rx drug, not considered "wholesale distribution."

B. Required for blood establishments that distribute blood components that is licensed as a closed pharmacy

C. Not required between pharmacies who have active permits, common ownership, or operating a freestanding end-stage renal dialysis clinic

D. All of the above

C (Module 4: Lecture)

Under a restricted prescription drug distributor permit, which of the following can a blood establishment NOT do?

A. distribute blood derivatives

B. distribute drugs deemed medically necessary

C. distribute maintenance Rx drugs such as antihypertensives

D. distribute blood-collection containers approved under the federal act

B (Module 4: Reading)

A veterinary prescription wholesale distributor that also distributes prescription drugs subject to the FDCA, which it did not manufacture, could obtain ______ in lieu of the veterinary prescription wholesale distributor permit.

A. Prescription Drug Wholesale Distributor Permit

B. Limited Prescription Drug Veterinary Wholesale Distributor Permit

C. An out-of-state Rx drug wholesale distributor permit

D. A freight forwarder permit

B (Module 4: Lecture)

A person distributing veterinary Rx drugs for an institution lawfully instructing veterinary medicine or for use in research (non-clinical) requires:

A. Prescription Drug Wholesale Distributor Permit

B. Limited Prescription Drug Veterinary Wholesale Distributor Permit

C. An out-of-state Rx drug wholesale distributor permit

D. A freight forwarder permit

C (Module 4: Lecture)

An over-the-counter drug manufacture permit is required for anyone that engages in the _____ of an OTC drug.

A. manufacture

B. repackaging

C. manufacture or repackaging

D. manufacture, repackaging, or distribution

D (Module 4: Lecture)

A device manufacture permit is required for anyone that engages in the ______ of a medical device.

A. manufacture

B. repackaging

C. manufacture or repackaging

D. manufacture, repackaging, or assembly

C (Module 4: Lecture)

A cosmetic manufacture permit is required for anyone that engages in the ______ of cosmetics in the state of Florida.

A. manufacture

B. repackaging

C. manufacture or repackaging

D. manufacture, repackaging, or distribution

C (Module 4: Lecture)

Which type of permit is required for the purchase of a prescription drug by a place of business at a single physical location or by a Florida licensed health care practitioner/veterinarian?

A. Third Party Logistics Provider Permit

B. Complimentary Drug Distributor Permit

C. Health Care Clinic Establishment Permit

D. Retail Pharmacy Drug Wholesale Distributor Permit