Federal Pharmacy Law Practice Exam - Uniform MPJE

1. Question

Sally has reason to believe that her health insurance company is not adhering to HIPAA guidelines on February 28, 2026. Which of the following is an appropriate action for Sally to take?

File a complaint to the Department of Justice within 30 days

Correct Incorrect Correct answer

Report the incident to the DEA

Correct Incorrect Correct answer

Report the incident to the local police

Correct Incorrect Correct answer

File a complaint to the Secretary of Health and Human Services within 180 days

Correct Incorrect Correct answer

File a complaint to the Secretary of Health and Human Services within 30 days

Correct Incorrect Correct answer

2. Question

What color bin should Dr. Brown place his outer gloves and gown after preparing a solution containing cisplatin for infusion?

Blue

Correct Incorrect Correct answer

Black

Correct Incorrect Correct answer

Red

Correct Incorrect Correct answer

Orange

Correct Incorrect Correct answer

Yellow

Correct Incorrect Correct answer

3. Question

What action should a pharmacist take when they discover that a medication refrigerator has been outside the recommended temperature range for 10 hours?

Dispense affected products until guidance is obtained

Correct Incorrect Correct answer

Quarantine affected products and assess stability

Correct Incorrect Correct answer

Automatically destroy all products

Correct Incorrect Correct answer

Reduce expiration dates by half

Correct Incorrect Correct answer

Transfer products to another pharmacy

Correct Incorrect Correct answer

4. Question

A multi-dose vial of labetalol was first punctured on September 30^th, 2026. According to USP 797, when is the last day this multiple-dose vial can be used before it must be properly discarded?

October 1st, 2026

Correct Incorrect Correct answer

October 27th, 2026

Correct Incorrect Correct answer

March 30th, 2027

Correct Incorrect Correct answer

September 30th, 2027

Correct Incorrect Correct answer

This vial must be immediately discarded and can only be used once

Correct Incorrect Correct answer

5. Question

The “minimum necessary standard” is important because it requires covered entities to do which of the following?

Share all patient health information when requested to ensure the requestor has all the information they may need

Correct Incorrect Correct answer

Discuss a patient’s information with them in a crowded waiting room so the patient receives their information in a timely manner

Correct Incorrect Correct answer

Refuse to share any patient health information to the patient’s healthcare provider when it pertains to the patient’s treatment

Correct Incorrect Correct answer

Withhold some of the patient’s information with them because there is a limited amount of information that can be shared with the patient at each encounter

Correct Incorrect Correct answer

Share the least amount of information needed for another covered entity to complete their task

Correct Incorrect Correct answer

6. Question

Based on the new USP 797 rules, what is the maximum beyond-use-date for a Category 1 compound stored in the refrigerator?

No more than 72 hours

Correct Incorrect Correct answer

No more than 60 hours

Correct Incorrect Correct answer

No more than 48 hours

Correct Incorrect Correct answer

No more than 30 hours

Correct Incorrect Correct answer

No more than 24 hours

Correct Incorrect Correct answer

7. Question

Which of the following would NOT be a privacy violation under HIPAA?

I. Leaving an extensive message regarding a script with the patient’s spouse

II. Allowing a pharmaceutical sales rep to review the script files if only the patients who use the firm’s products

III. Mailing a script reminder to a patient in a sealed envelope

I only

Correct Incorrect Correct answer

III only

Correct Incorrect Correct answer

I & II only

Correct Incorrect Correct answer

II & III only

Correct Incorrect Correct answer

I, II, & III

Correct Incorrect Correct answer

8. Question

Which of the following is/are TRUE about preparing allergen extracts as compounded sterile preparations?

I. All allergen extracts as CSPs shall contain appropriate substances in effective concentrations to prevent the growth of microorganisms

II. Before beginning compounding activities, personnel perform a thorough hand-cleansing procedure by removing debris from under fingernails using a nail cleaner under running warm water followed by a vigorous hand and arm washing to the elbows for at least 30 seconds with either non-antimicrobial or antimicrobial soap and water

III. Compounding personnel don hair covers, facial hair covers, gowns, and face masks

I only

Correct Incorrect Correct answer

I & II only

Correct Incorrect Correct answer

II & III only

Correct Incorrect Correct answer

III only

Correct Incorrect Correct answer

I, II, & III

Correct Incorrect Correct answer

9. Question

According to new USP 795 rules, what is the maximum beyond use date for a suspension that has water activity (A_w) greater than 0.6?

180 days at controlled room temperature

Correct Incorrect Correct answer

120 days in the freezer

Correct Incorrect Correct answer

85 days in the refrigerator

Correct Incorrect Correct answer

45 days at controlled room temperature

Correct Incorrect Correct answer

35 days in the refrigerator

Correct Incorrect Correct answer

10. Question

Which of the following references describe drugs approved for veterinary medicine?

Red Book

Correct Incorrect Correct answer

Orange Book

Correct Incorrect Correct answer

Green Book

Correct Incorrect Correct answer

Yellow Book

Correct Incorrect Correct answer

Purple Book

Correct Incorrect Correct answer

11. Question

When disposing of hazardous drugs, what goes into the black bin?

Bulk anti-neoplastic waste

Correct Incorrect Correct answer

Hazardous sharps

Correct Incorrect Correct answer

Trace antineoplastic waste

Correct Incorrect Correct answer

Normal trash

Correct Incorrect Correct answer

Used gloves and masks

Correct Incorrect Correct answer

12. Question

Which of the following is an example of a misbranded OTC product?

I. An acetaminophen 3 mg container that is not child-proof

II. Ibuprofen container that does not contain a toll-free phone number for questions

III. A product that contains X, an unsafe color additive

I

Correct Incorrect Correct answer

I & II

Correct Incorrect Correct answer

I & III

Correct Incorrect Correct answer

II & III

Correct Incorrect Correct answer

I, II, & III

Correct Incorrect Correct answer

13. Question

What should you tell a patient who is requesting a copy of his or her prescription records?

I can only read your list of current medications

Correct Incorrect Correct answer

It is risky to send unencrypted health information via email, but I can provide you with a printout

Correct Incorrect Correct answer

I am not able to share your prescription records. You must get them from the prescriber

Correct Incorrect Correct answer

I have to get authorization from your prescriber before sharing any information from your prescription record

Correct Incorrect Correct answer

I need a signed and dated letter from you requesting a copy of your prescription records

Correct Incorrect Correct answer

14. Question

Which of the following agents used for cleaning after hazardous drug compounding is matched appropriately with the cleaning step?

Water used for decontamination

Correct Incorrect Correct answer

Peroxide used for disinfection

Correct Incorrect Correct answer

Ammonium used for sterilization

Correct Incorrect Correct answer

Isopropyl alcohol used for cleaning

Correct Incorrect Correct answer

Isopropyl alcohol used for deactivation

Correct Incorrect Correct answer

15. Question

Which of the following entities are NOT required to follow HIPAA? Select ALL that apply.

Child Protective Services

Correct Incorrect Correct answer

Veteran Affairs

Correct Incorrect Correct answer

Business Associate

Correct Incorrect Correct answer

Local law enforcement when it involves a minor

Correct Incorrect Correct answer

None of the above

Correct Incorrect Correct answer

16. Question

Brown is a practitioner and not registered as an opioid treatment program provider for detoxification. Which of the following is correct?

Dr. Brown is strictly prohibited from prescribing methadone to her patient for this indication because she is not registered as an OTP

Correct Incorrect Correct answer

Dr. Brown is permitted to administer up to a 3-day supply of the drug for this indication

Correct Incorrect Correct answer

Dr. Brown is strictly prohibited from administering a prescription for this drug to her patient for this indication, for any length of time, because she is not registered as an OTP

Correct Incorrect Correct answer

A & B only

Correct Incorrect Correct answer

A & C only

Correct Incorrect Correct answer

17. Question

A pharmacist practicing under a collaborative practice agreement is asked by a patient to prescribe an antibiotic for symptoms that are not addressed in the collaborative practice agreement. What can the pharmacist legally do in this situation?

Prescribe the antibiotic if the pharmacist believes it is clinically appropriate

Correct Incorrect Correct answer

Prescribe the antibiotic because the pharmacist already has a CPA

Correct Incorrect Correct answer

Decline to prescribe because the requested therapy falls outside the authority granted by the CPA

Correct Incorrect Correct answer

Dispense a limited supply until the physician reviews the patient

Correct Incorrect Correct answer

Issue the prescription and notify the physician later

Correct Incorrect Correct answer

18. Question

If the following DEA number is authentic, MS242651_, which of the following is true about the letter S and the last missing digit?

S is the first letter of the practitioner's last name; 1 is the missing digit

Correct Incorrect Correct answer

S is the practitioner's code; 1 is the missing digit

Correct Incorrect Correct answer

S is the first letter of the practitioner's last name; 0 is the missing digit

Correct Incorrect Correct answer

S is the first letter of the practitioner's first name; 1 is the missing digit

Correct Incorrect Correct answer

S is the first letter of the practitioner's first name; 0 is the missing digit

Correct Incorrect Correct answer

19. Question

A sterile hazardous drug is compounded in an externally vented C-PEC located in an ISO Class 7 buffer room. The C-SEC is externally vented, maintains negative pressure, and completes 18 air changes per hour. Which of these engineering controls does not match the requirements per USP 800?

The C-SEC must be positive pressure, not negative pressure

Correct Incorrect Correct answer

The minimum number of air changes per hour (ACPH) is 30

Correct Incorrect Correct answer

The buffer room must be ISO Class 5

Correct Incorrect Correct answer

The C-PEC cannot be externally vented

Correct Incorrect Correct answer

There are no violations of USP 800 requirements for hazardous sterile compounding in this scenario

Correct Incorrect Correct answer

20. Question

Under what circumstances may PHI be released without an authorization form?

A prospective employer requests it before hiring a candidate for a physically demanding job

Correct Incorrect Correct answer

A parent verbally requests their child's immunization records be sent to school

Correct Incorrect Correct answer

A law enforcement officer asks you for a patient's medication list to determine whether a gang member should possess a firearm

Correct Incorrect Correct answer

A spouse requests a list of their estranged wife's medications to use for a divorce proceeding

Correct Incorrect Correct answer

A health insurance company representative wanting to determine eligibility if they should recommend insurance

Correct Incorrect Correct answer

21. Question

Which of the following reasons are acceptable for non-sterile compounding? Select ALL that apply.

Adding an orange flavor to a child’s medication

Correct Incorrect Correct answer

Commercially available product is too expensive

Correct Incorrect Correct answer

Dose of the medication is not commercially available

Correct Incorrect Correct answer

Patient has an allergy to excipients in the commercially available product

Correct Incorrect Correct answer

Compounded preparation is easy to make

Correct Incorrect Correct answer

22. Question

Which of the following information is/are TRUE about PPE (Personal Protective Equipment) while reconstituting, preparing, or admixing hazardous drugs?

I. Make sure that gloves are labelled as chemotherapy [ASTM 2005] gloves

II. Use double gloving for all activities involving hazardous drugs

III. Use disposable gowns made of polyethylene-non-coated polypropylene

I only

Correct Incorrect Correct answer

I & II only

Correct Incorrect Correct answer

II & III only

Correct Incorrect Correct answer

I & III only

Correct Incorrect Correct answer

I, II, & III

Correct Incorrect Correct answer

23. Question

A drug is found to be weaker than labeled, although it is not used to treat a life-threatening disease. What type of recall will be required?

Class I

Correct Incorrect Correct answer

Class II

Correct Incorrect Correct answer

Class III

Correct Incorrect Correct answer

Class IV

Correct Incorrect Correct answer

No recall is required

Correct Incorrect Correct answer

24. Question

Which one of the following is NOT true about the Pure Food and Drug Act? Select ALL that apply.

This law was passed because of the mistaken use of diethylene glycol that led to the death

Correct Incorrect Correct answer

The law prohibits the commerce of foods, drugs, and cosmetics to be adulterated or misbranded

Correct Incorrect Correct answer

This law was passed by Congress in 1938

Correct Incorrect Correct answer

The law failed to protect the public

Correct Incorrect Correct answer

This law was passed by Congress in 1906

Correct Incorrect Correct answer

25. Question

A patient accidentally receives another patient’s prescription receipt that contains PHI. Once the pharmacist becomes aware of this incident, what would be the most appropriate action to take?

Ignore the incident because the medication was not dispensed incorrectly

Correct Incorrect Correct answer

Document the event and follow privacy breach procedures

Correct Incorrect Correct answer

Notify the DEA

Correct Incorrect Correct answer

Delete the patient's electronic record

Correct Incorrect Correct answer

Notify the state attorney general

Correct Incorrect Correct answer

26. Question

What is important for a pharmacist to know to prevent misbranding and adulteration?

Dispensing a drug stored at room temperature when it is supposed to be refrigerated is considered adulteration

Correct Incorrect Correct answer

You can re-use returned medications as long as it has been less than 24 hours since you dispensed them

Correct Incorrect Correct answer

Manufacturers are responsible for providing MedGuides, not pharmacists

Correct Incorrect Correct answer

Dispensing a light-sensitive drug in a light-resistant container is considered misbranding

Correct Incorrect Correct answer

Dispensing a scent-sensitive drug in a scent-resistant container is considered misbranding

Correct Incorrect Correct answer

27. Question

According to the new USP 795 rules, what is the maximum beyond use date for other nonaqueous dosage forms when stored at controlled room temperature?

365 days

Correct Incorrect Correct answer

180 days

Correct Incorrect Correct answer

90 days

Correct Incorrect Correct answer

30 days

Correct Incorrect Correct answer

14 days

Correct Incorrect Correct answer

28. Question

A pharmacy technician is compounding a hydromorphone PCA pump and wants to review the instructions for compounding this product. Which document should the pharmacy technician refer to for this information?

USP 800 Guidelines

Correct Incorrect Correct answer

Material Safety Data Sheet

Correct Incorrect Correct answer

Compounding Record

Correct Incorrect Correct answer

Master Formulation Record

Correct Incorrect Correct answer

Hydromorphone package insert

Correct Incorrect Correct answer

29. Question

Which of the following describes an incidence that is NOT considered misbranding?

The active drug is not identified on the label

Correct Incorrect Correct answer

The original bottle of 40 contains only 35 tablets

Correct Incorrect Correct answer

The names of inactive ingredients are not on the label

Correct Incorrect Correct answer

The level of the drug in the product is 10% V/V but the label states 15% V/V

Correct Incorrect Correct answer

The pharmacist dispenses a drug without the prescription

Correct Incorrect Correct answer

30. Question

Which of the follow are true regarding aqueous preparations when compounding? Select all that apply.

The water activity (Aw) is ≥ 0.6

Correct Incorrect Correct answer

Creams are considered aqueous preparations

Correct Incorrect Correct answer

Suspensions are considered aqueous preparations

Correct Incorrect Correct answer

Troches are considered aqueous preparations

Correct Incorrect Correct answer

Suppositories are considered aqueous preparations

Correct Incorrect Correct answer

31. Question

A pharmacist is compounding a preparation that requires terminal sterilization of a Category 3 sterile drug. Based on the new USP 797 rules, what is the beyond use date for this preparation when refrigerated?

180 days

Correct Incorrect Correct answer

120 days

Correct Incorrect Correct answer

90 days

Correct Incorrect Correct answer

60 days

Correct Incorrect Correct answer

30 days

Correct Incorrect Correct answer

32. Question

Which is NOT an exempt situation from the minimum necessary rule?

An employer requesting a copy of a patient's medication records for a disability claim

Correct Incorrect Correct answer

A payer requesting a patient's diagnosis for a medication prior authorization

Correct Incorrect Correct answer

A patient permits to provide pharmacy records to a relative

Correct Incorrect Correct answer

Accessing your personal health information

Correct Incorrect Correct answer

Accessing your parent’s personal health information

Correct Incorrect Correct answer

33. Question

Which of the following are requirements the containment secondary engineering control (C-SEC) must have when being used for sterile and nonsterile compounding? Select all that apply.

I. Be physically separated

II. Be internally vented

III. Be externally vented

IV. Be calibrated

V. Have appropriate air exchange

II & V

Correct Incorrect Correct answer

I, II & III

Correct Incorrect Correct answer

III, IV, & V

Correct Incorrect Correct answer

IV & V

Correct Incorrect Correct answer

I, III, & V

Correct Incorrect Correct answer

34. Question

How often must a healthcare entity review the National Institute for Occupational Safety and Health (NIOSH) list of hazardous drugs?

Any time a new drug is added

Correct Incorrect Correct answer

Every 6 months

Correct Incorrect Correct answer

Every 12 months

Correct Incorrect Correct answer

Every 5 years

Correct Incorrect Correct answer

Any time a new pharmacist is employed

Correct Incorrect Correct answer

35. Question

If a patient’s spouse asks whether the patient recently filled a prescription for an antidepressant and the name of the prescriber on file, how should a pharmacist respond to follow patient privacy laws?

Provide the information because spouses automatically have access

Correct Incorrect Correct answer

Provide the information only if the spouse is paying for the medication

Correct Incorrect Correct answer

Only provide the prescription number with no other information

Correct Incorrect Correct answer

Provide the information because the spouse is not requesting PHI

Correct Incorrect Correct answer

Follow applicable privacy requirements before disclosing information

Correct Incorrect Correct answer

36. Question

A patient asks why the pharmacy cannot simply relabel a clonazepam bottle that has passed its expiration date. Which response is most appropriate?

Expiration dates are suggestions only

Correct Incorrect Correct answer

Federal law permits relabeling if approved by the pharmacist

Correct Incorrect Correct answer

Expired products should not remain available for dispensing

Correct Incorrect Correct answer

Relabeling is only allowed for non-controlled substances

Correct Incorrect Correct answer

Expiration dates apply only to sterile products

Correct Incorrect Correct answer

37. Question

Which would be considered a marketing activity according to HIPAA? Select ALL that apply.

Sending refill reminders on prescriptions patients are currently taking

Correct Incorrect Correct answer

Sending all diabetes patients, a manufacturer's promotional pamphlets on a new insulin

Correct Incorrect Correct answer

Providing patients with information about formulary restrictions on brand name drugs for a patient’s drug plan

Correct Incorrect Correct answer

Providing obese patients with information about how to eat healthily and control weight

Correct Incorrect Correct answer

Providing patients promotional gifts of nominal value

Correct Incorrect Correct answer

38. Question

A pharmacist discovers that an intern has been documenting final prescription verification under the pharmacist’s login credentials. What is the most appropriate action for the pharmacist to take?

Allow the practice if prescriptions are checked later

Correct Incorrect Correct answer

Continue if the intern is licensed

Correct Incorrect Correct answer

Stop the practice and address the compliance issue immediately

Correct Incorrect Correct answer

Allow it during staffing shortages

Correct Incorrect Correct answer

Permit it for noncontrolled substances only

Correct Incorrect Correct answer

39. Question

Which of the following recalls is implemented when there is reasonable probability that the product will cause serious adverse health consequences?

Class I Recall

Correct Incorrect Correct answer

Class II Recall

Correct Incorrect Correct answer

Class III Recall

Correct Incorrect Correct answer

Class IV Recall

Correct Incorrect Correct answer

Class V Recall

Correct Incorrect Correct answer

40. Question

How many times does the area and equipment used for handling hazardous drugs (HDs) need to be sanitized?

Twice daily, start and end of the day

Correct Incorrect Correct answer

Once daily

Correct Incorrect Correct answer

Periodically

Correct Incorrect Correct answer

Three times daily

Correct Incorrect Correct answer

Occasionally

Correct Incorrect Correct answer

41. Question

Jenny, a pharmacist at a local retail pharmacy, was recently informed that metformin 500 mg tablets from MM manufacturing were being recalled because they possibly came onto contact with a fatal contaminant. Which class of drug recall would this be?

Class I

Correct Incorrect Correct answer

Class II

Correct Incorrect Correct answer

Class III

Correct Incorrect Correct answer

Class IV

Correct Incorrect Correct answer

Class V

Correct Incorrect Correct answer

42. Question

A medication that was recently released for a rare disease was recalled because it was found to contain high levels of zinc. Which agency would the FDA work along with to file an injunction for this drug recall?

Food and Drug Administration

Correct Incorrect Correct answer

CDER

Correct Incorrect Correct answer

Department of Justice

Correct Incorrect Correct answer

Centers for Disease Control

Correct Incorrect Correct answer

Supreme Court

Correct Incorrect Correct answer

43. Question

A pharmacist practicing under a collaborative practice agreement orders a lithium drug level for a patient to monitor medication therapy. This activity is characterized as:

Practicing outside pharmacy scope

Correct Incorrect Correct answer

Delegated authority permitted under applicable law

Correct Incorrect Correct answer

Manufacturing

Correct Incorrect Correct answer

Independent medical practice

Correct Incorrect Correct answer

Drug dispensing

Correct Incorrect Correct answer

44. Question

Which of the following accurately depicts the difference between 503A pharmacies and 503B pharmacies? Select all that apply.

503A pharmacies are regulated by the FDA, while 503B pharmacies are regulated by the respective state’s Board of Pharmacy

Correct Incorrect Correct answer

503A pharmacies compound for specific prescriptions; 503B pharmacies may or may not compound for prescriptions

Correct Incorrect Correct answer

503A pharmacies are considered “outsourcing facilities”; 503B pharmacies are not considered “outsourcing facilities”

Correct Incorrect Correct answer

503A pharmacies do not have to follow USP 795 and 797 standards; 503B pharmacies do have to follow USP 795 and 797 standards

Correct Incorrect Correct answer

503A pharmacies are not required to report adverse events to the FDA; 503B pharmacies must report adverse events to the FDA

Correct Incorrect Correct answer

45. Question

When prescribing Suboxone® via telemedicine, a DEA-registered practitioner may initially prescribe up to how many months’ supply?

1

Correct Incorrect Correct answer

3

Correct Incorrect Correct answer

4

Correct Incorrect Correct answer

6

Correct Incorrect Correct answer

12

Correct Incorrect Correct answer

46. Question

Which statement about refilling and transferring of Schedules III through V controlled substances is correct?

Transfers can only be performed once if the pharmacies do not share a real-time online database

Correct Incorrect Correct answer

All refills may be transferred electronically if the pharmacies share a real-time online database

Correct Incorrect Correct answer

Transferring pharmacist must write “VOID” on the face of the transferred prescription

Correct Incorrect Correct answer

The transfer must occur between two pharmacists

Correct Incorrect Correct answer

All the above

Correct Incorrect Correct answer

47. Question

Which is an accurate limit on precursor sales imposed by the CMEA?

You cannot sell more than 3.6 g of pseudoephedrine sulfate to a customer per day

Correct Incorrect Correct answer

You cannot sell more than 9 g of pseudoephedrine sulfate to a customer in 90 days

Correct Incorrect Correct answer

You cannot sell more than 146 tablets of pseudoephedrine HCL 30 mg in a single day to the same customer

Correct Incorrect Correct answer

Non-liquid dosage forms of methamphetamine precursors sold as loose capsules or tablets

Correct Incorrect Correct answer

You cannot sell more than 9 g of pseudoephedrine chloride to a customer in 90 days

Correct Incorrect Correct answer

48. Question

The prescriber issues the following prescriptions for Percocet®. What is wrong with the prescriptions?

#1: Percocet® 325/5 mg, 1 tablet PO daily #90, issue date 7/30/2020

#2: Percocet® 325/5 mg, 1 tablet PO daily #90, issue date 7/30/2020, do not fill until 10/30/2020

#3: Percocet® 325/5 mg, 1 tablet PO daily #90, issue date 7/30/2020, do not fill until 1/30/2021

The “do not fill date” is incorrect

Correct Incorrect Correct answer

The days’ supply exceeds the legal limit

Correct Incorrect Correct answer

Multiple prescriptions for Percocet® drug are not allowed

Correct Incorrect Correct answer

Nothing is wrong with the prescriptions, fill as written

Correct Incorrect Correct answer

The total quantity exceeds the legal limit

Correct Incorrect Correct answer

49. Question

Which of the following is a Schedule I Controlled Substance considered by the DEA to have no accepted medical use in treatment in the United States? Select ALL that apply.

Lysergic acid diethylamide (LSD)

Correct Incorrect Correct answer

Marijuana (cannabis)

Correct Incorrect Correct answer

3, 4 –methylenedioxymethamphetamine (MDMA)

Correct Incorrect Correct answer

Cocaine

Correct Incorrect Correct answer

Methylphenidate

Correct Incorrect Correct answer

50. Question

Which of the following acts require child-resistant safety containers for oral prescription medication?

Poison Prevention Packaging Act of 1970

Correct Incorrect Correct answer

Federal Anti-Tempering Act

Correct Incorrect Correct answer

Durham-Humphrey Amendment

Correct Incorrect Correct answer

Omnibus Budget Reconciliation Act

Correct Incorrect Correct answer

Combat Methamphetamine Epidemic Act

Correct Incorrect Correct answer

51. Question

WG is completely out of his buprenorphine and would like to meet with his provider via telemedicine for a refill. The first time he met with his provider who original prescribed the medication was in-person. Which of the following statements are true concerning JB’s eligibility for a telemedicine appointment so that he can obtain his refills?

He is eligible because his initial visit with his provider was in-person.

Correct Incorrect Correct answer

He is eligible because he already has a medication history with this medication, and has been using it appropriately.

Correct Incorrect Correct answer

He is ineligible because his first medical evaluation with his provider was in person, so further evaluations must also be in person.

Correct Incorrect Correct answer

He is ineligible because Schedule III to V controlled substances cannot be prescribed via telemedicine.

Correct Incorrect Correct answer

None of the above.

Correct Incorrect Correct answer

52. Question

A pharmacist may partially dispense prescriptions for Schedule II controlled substances for an individual residing in a LTCF who has been diagnosed with a terminal illness. How many days are the prescriptions valid for unless terminated earlier by the discontinuance of the medication?

7

Correct Incorrect Correct answer

30

Correct Incorrect Correct answer

60

Correct Incorrect Correct answer

180

Correct Incorrect Correct answer

365

Correct Incorrect Correct answer

53. Question

OTC acetaminophen must have which warning on the label?

Warning of stomach bleeding

Correct Incorrect Correct answer

Warning of liver toxicity

Correct Incorrect Correct answer

Warning of an allergic reaction

Correct Incorrect Correct answer

Warning of difficulty breathing

Correct Incorrect Correct answer

Warning of foul taste

Correct Incorrect Correct answer

54. Question

What federal regulatory body approves patient package inserts after they are developed by the drug manufacturer?

The Drug Enforcement Administration

Correct Incorrect Correct answer

The National Institute of Health

Correct Incorrect Correct answer

The Agency for Healthcare Research and Quality

Correct Incorrect Correct answer

The Food and Drug Administration

Correct Incorrect Correct answer

MedWatch

Correct Incorrect Correct answer

55. Question

The formulary of a pharmacy providing services under MMA (Medicare Modernization Act) may be limited to which of the following?

Top 200 drugs

Correct Incorrect Correct answer

Generic drugs

Correct Incorrect Correct answer

At least one drug from each of all therapeutic categories developed by the USP

Correct Incorrect Correct answer

Top 100 drugs

Correct Incorrect Correct answer

Single-sourced drugs

Correct Incorrect Correct answer

56. Question

When transferring a prescription for acetaminophen with codeine (a C-III substance), the pharmacy must do which of the following?

I. Write “VOID” on the face of the invalidated prescription if the physical script or include information that the prescription was transferred on the prescription record if the electronic script

II. Record information about the pharmacy to which the prescription was transferred including the DEA registration number of that pharmacy on the reverse of the physical script (or on the prescription record if electronic)

III. Record date of transfer and name of a pharmacist who transferred the prescription

I

Correct Incorrect Correct answer

I & II

Correct Incorrect Correct answer

II & III

Correct Incorrect Correct answer

I & III

Correct Incorrect Correct answer

I, II, & III

Correct Incorrect Correct answer

57. Question

Colestipol powder in packages of what size or less is exempt from the Poison Prevention Packaging Act of 1970?

2 grams

Correct Incorrect Correct answer

4 grams

Correct Incorrect Correct answer

5 grams

Correct Incorrect Correct answer

6 grams

Correct Incorrect Correct answer

8 grams

Correct Incorrect Correct answer

58. Question

Sally is upset that her pain medications are not working. She would like to return her controlled substance prescription medication to the pharmacy. What can you do?

Accept the return of unused or unwanted controlled substance medication as long as you are DEA-authorized

Correct Incorrect Correct answer

Give them to your pharmacy owner and fill out DEA Form 363

Correct Incorrect Correct answer

Instruct Sally to dispose of her medications with DEA approval

Correct Incorrect Correct answer

Only return if Sally’s medication has a known recall

Correct Incorrect Correct answer

If you made a dispensing error, you must accept Sally’s medication return and refund her money

Correct Incorrect Correct answer

59. Question

What is the name of the safety reporting program in which health professionals, patients, and consumers can report adverse events for FDA regulated products?

VAERS

Correct Incorrect Correct answer

ADR

Correct Incorrect Correct answer

MedWatch

Correct Incorrect Correct answer

REMS

Correct Incorrect Correct answer

NIOSH

Correct Incorrect Correct answer

60. Question

What does federal law mandate for multiple prescriptions for Schedule II controlled substances? Select ALL that apply.

There is a limit of 3 prescriptions that can be written on the same day for the same Schedule II controlled substance for a single patient

Correct Incorrect Correct answer

The date on the prescription should be the same day that they are written and cannot be post-dated

Correct Incorrect Correct answer

They can total no more than a 90-day supply

Correct Incorrect Correct answer

They can total no more than a 120-day supply

Correct Incorrect Correct answer

They must all be filled on the same day they are dropped off at the pharmacy

Correct Incorrect Correct answer

61. Question

Which of the following are labeling requirements for Sublimaze? Select all that apply.

Name of prescriber

Correct Incorrect Correct answer

“CAUTION: Federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed”

Correct Incorrect Correct answer

Pharmacy email address

Correct Incorrect Correct answer

Filling date

Correct Incorrect Correct answer

Name of pharmacist

Correct Incorrect Correct answer

62. Question

Which drug is correctly assigned to its schedule?

Schedule III – 1.5 g of codeine/100 mL

Correct Incorrect Correct answer

Schedule III – 350 mg of ethyl morphine/100 mL

Correct Incorrect Correct answer

Schedule IV – 300 mg of ethyl morphine/100 mL

Correct Incorrect Correct answer

Schedule IV – 150 mg of dihydrocodeine/100 mL

Correct Incorrect Correct answer

Schedule III – 350 mg of dihydrocodeine/100 mL

Correct Incorrect Correct answer

63. Question

What controlled substance schedule is heroin listed in?

I

Correct Incorrect Correct answer

II

Correct Incorrect Correct answer

III

Correct Incorrect Correct answer

IV

Correct Incorrect Correct answer

V

Correct Incorrect Correct answer

64. Question

You have a formulation of Phenergan with Codeine that contains 10 mg of codeine per 5 mL of syrup. Per the DEA’s scheduling protocol what schedule is this substance?

Schedule II Controlled Substance

Correct Incorrect Correct answer

Schedule III Controlled Substance

Correct Incorrect Correct answer

Schedule IV Controlled Substance

Correct Incorrect Correct answer

Schedule V Controlled Substance

Correct Incorrect Correct answer

Non-Controlled Substance

Correct Incorrect Correct answer

65. Question

What could you share with a colleague regarding partial fills of Schedule II controlled substances according to federal law?

You are not required to notify the prescriber if you fill the remaining quantity on a partially filled prescription within 7 days

Correct Incorrect Correct answer

They are allowed only for patients in long-term care facilities

Correct Incorrect Correct answer

You do not need to document the amount dispensed when you are planning on dispensing the remainder within 72 hours

Correct Incorrect Correct answer

If you do not dispense the remaining quantity within 72 hours, it will be voided

Correct Incorrect Correct answer

If you do not dispense the remaining quantity within 24 hours, it will be voided

Correct Incorrect Correct answer

66. Question

What is the period in which a 17-year-old becomes eligible for narcotic maintenance treatment after two documented attempts of detoxification?

1 month

Correct Incorrect Correct answer

3 months

Correct Incorrect Correct answer

6 months

Correct Incorrect Correct answer

12 months

Correct Incorrect Correct answer

18 months

Correct Incorrect Correct answer

67. Question

Which of the following is required under the Methamphetamine Production Prevention Act of 2008?

The seller must require all purchasers of PSE to sign the sales logbook, either manually or electronically

Correct Incorrect Correct answer

The seller must maintain each entry in the sales logbook for a minimum of 2 years

Correct Incorrect Correct answer

All purchasers of PSE must present government-issued photographic identification

Correct Incorrect Correct answer

If the seller uses a bound paper sales logbook, he/she must affix a printed sticker next to the signature line that displays the product name, quantity, name of purchaser, date & address, or a unique identification that can be linked to that information

Correct Incorrect Correct answer

All the above are required under MAPA

Correct Incorrect Correct answer

68. Question

Which of the following statements apply to prescriptions sent by mail? Select all that apply.

I. Prescriptions sent by USPS must be in a package with no markings that indicate contents

II. Controlled substances may be mailed to other DEA registrants

III. Controlled substances may be mailed by a common carrier (FedEx, UPS)

I

Correct Incorrect Correct answer

I & II

Correct Incorrect Correct answer

I & III

Correct Incorrect Correct answer

II & III

Correct Incorrect Correct answer

I, II, & III

Correct Incorrect Correct answer

69. Question

Why can’t you fill a prescription for Effexor XR® capsules with venlafaxine extended-release tablets?

The tablets are less effective than capsules

Correct Incorrect Correct answer

The tablets are not as safe as the capsules

Correct Incorrect Correct answer

The tablets are dosed differently than the capsules

Correct Incorrect Correct answer

The tablets are not AB-rated to the capsules

Correct Incorrect Correct answer

The capsules are less effective than tablets

Correct Incorrect Correct answer

70. Question

What are the two essential records that must be maintained for each compounded product?

Prescription record and medication administration record

Correct Incorrect Correct answer

Master formulation and compounding record

Correct Incorrect Correct answer

Compounding record and ingredient list

Correct Incorrect Correct answer

BUD and active ingredients

Correct Incorrect Correct answer

Master formulation and compounder’s signature

Correct Incorrect Correct answer

71. Question

For the pregnancy labeling requirements, which section would have information regarding the drug’s pregnancy exposure registry?

Pregnancy

Correct Incorrect Correct answer

Lactation

Correct Incorrect Correct answer

Category C

Correct Incorrect Correct answer

Females and Males of Reproductive Potential

Correct Incorrect Correct answer

Category X

Correct Incorrect Correct answer

72. Question

Which product requires an allergy warning on the label?

Ipecac syrup

Correct Incorrect Correct answer

Sulfites

Correct Incorrect Correct answer

Isoproterenol inhalation

Correct Incorrect Correct answer

Potassium salts

Correct Incorrect Correct answer

None of the above

Correct Incorrect Correct answer

73. Question

Which is an acceptable Schedule II prescription according to federal law?

A faxed prescription for fentanyl patch 100 mg, one every 3 days, #10, for a patient in a hospice

Correct Incorrect Correct answer

A written script for morphine 10 mg, one every 8 hours PRN pain, #60, with 1 refill

Correct Incorrect Correct answer

A written prescription filled out and signed by a registered nurse for morphine 60 mg, once daily, #30

Correct Incorrect Correct answer

A phoned-in prescription for oxycodone 20 mg, one BID, #60, to be delivered to a homebound patient

Correct Incorrect Correct answer

A faxed prescription for fentanyl patch 100 mg, one every 3 days, #5

Correct Incorrect Correct answer

74. Question

Which of the following statements is considered FALSE for scheduled listed chemical products (SLCP) for pseudoephedrine?

A maximum of 3.6 g per day or 9 g per month of pseudoephedrine can be sold

Correct Incorrect Correct answer

The product must be sold from behind the counter

Correct Incorrect Correct answer

The pseudoephedrine must be stored in a locked cabinet only

Correct Incorrect Correct answer

Pseudoephedrine can be sold to individuals 21 years and older with a valid ID

Correct Incorrect Correct answer

None of the above

Correct Incorrect Correct answer

75. Question

OTC nonsteroidal anti-inflammatory drugs (NSAIDs) must have which warning on the label?

Warning of stomach bleeding

Correct Incorrect Correct answer

Warning of liver toxicity

Correct Incorrect Correct answer

Warning of an allergic reaction

Correct Incorrect Correct answer

Warning of difficulty breathing

Correct Incorrect Correct answer

Warning of foul taste

Correct Incorrect Correct answer

76. Question

Which of the following are labeling requirements for Lyrica? Select all that apply.

Name of prescriber

Correct Incorrect Correct answer

"CAUTION: Federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed”

Correct Incorrect Correct answer

Pharmacy email address

Correct Incorrect Correct answer

Filling date

Correct Incorrect Correct answer

Name of pharmacist

Correct Incorrect Correct answer

77. Question

Which statement about ordering and/or transferring Schedule II medications is correct?

I. A pharmacy may transfer a bottle of a C-II medication to another pharmacy, provided that the pharmacy transferring the drug properly executes a DEA Form 222

II. A pharmacy may purchase a bottle of a C-II medication from a wholesale distributor, provided that the distributor properly executes a DEA Form 222

III. A pharmacy may order a bottle of a C-II medication electronically from a supplier, provided that the pharmacy signs a DEA Form 222 order form using a DEA-issued digital signature

III only

Correct Incorrect Correct answer

I & II only

Correct Incorrect Correct answer

I & III only

Correct Incorrect Correct answer

II only

Correct Incorrect Correct answer

I, II, & III

Correct Incorrect Correct answer

78. Question

What is the maximum number of tablets a container of OTC pediatric aspirin can have?

28 tablets

Correct Incorrect Correct answer

30 tablets

Correct Incorrect Correct answer

32 tablets

Correct Incorrect Correct answer

36 tablets

Correct Incorrect Correct answer

48 tablets

Correct Incorrect Correct answer

79. Question

What action must a facility take if they want to ship sterile compounded preparations nationwide?

Register as a 503A facility through the FDA

Correct Incorrect Correct answer

Register as a 503B facility through the FDA

Correct Incorrect Correct answer

Create policies and procedures compliant with USP 795 standards

Correct Incorrect Correct answer

Register with the DEA using DEA Form 224

Correct Incorrect Correct answer

Obtain a license from the state Board of Pharmacy in which the facility is located

Correct Incorrect Correct answer

80. Question

Which of the following statements is FALSE for transfers in Schedule III-V medication prescriptions according to Federal law?

A pharmacy can transfer up to once per prescription to another pharmacy

Correct Incorrect Correct answer

The date of the transfer and the name of the transferring pharmacist must be recorded

Correct Incorrect Correct answer

Pharmacies that share a database are only required to transfer the maximum refills allowed by law only

Correct Incorrect Correct answer

The word, “void” must be written on the face of the invalidated prescription

Correct Incorrect Correct answer

For written or oral prescriptions, the word “transferred” must be written on the transferred prescription

Correct Incorrect Correct answer

81. Question

Drug products of the same strength and same dosage form may be interchangeable if they are in which of the following classes? Select ALL that apply.

A

Correct Incorrect Correct answer

BC

Correct Incorrect Correct answer

B

Correct Incorrect Correct answer

BS

Correct Incorrect Correct answer

AB

Correct Incorrect Correct answer

82. Question

Which of the following is an Element to Assure Safe Use (ETASU)?

A Dear Healthcare Provider Letter

Correct Incorrect Correct answer

A REMS advertisement in a major journal

Correct Incorrect Correct answer

A MedGuide

Correct Incorrect Correct answer

A Patient Registry

Correct Incorrect Correct answer

A Drug Guide

Correct Incorrect Correct answer

83. Question

Acetophenetidin products must include a warning regarding damage to which organ?

Liver

Correct Incorrect Correct answer

Kidney

Correct Incorrect Correct answer

Bladder

Correct Incorrect Correct answer

Heart

Correct Incorrect Correct answer

Brain

Correct Incorrect Correct answer

84. Question

When can the FDA require REMS for a specific drug?

At any time, pre-or post-approval

Correct Incorrect Correct answer

Only before marketing

Correct Incorrect Correct answer

Only after marketing

Correct Incorrect Correct answer

Only after marketing based on post-marketing surveillance

Correct Incorrect Correct answer

If there is a large number of minor side effects

Correct Incorrect Correct answer

85. Question

How many partial fills can a pharmacist complete with a Schedule II medication according to Federal law?

0

Correct Incorrect Correct answer

1

Correct Incorrect Correct answer

5

Correct Incorrect Correct answer

7

Correct Incorrect Correct answer

There is no limit

Correct Incorrect Correct answer

86. Question

The CMEA requires a pharmacy to undergo a self-certification how often?

Monthly

Correct Incorrect Correct answer

Every 6 months

Correct Incorrect Correct answer

Annually

Correct Incorrect Correct answer

Biennially

Correct Incorrect Correct answer

Every 3 months

Correct Incorrect Correct answer

87. Question

Which of the following is exempt from the Poison Prevention Packaging Act of 1970?

Methylprednisolone tablets in a package containing 105 mg

Correct Incorrect Correct answer

Sublingual nitroglycerin

Correct Incorrect Correct answer

Prednisone tablets in a package containing 125 mg

Correct Incorrect Correct answer

Betamethasone tablets in a package containing 16.8 mg

Correct Incorrect Correct answer

None of the above

Correct Incorrect Correct answer

88. Question

According to federal labeling requirements, mineral oil should only be taken at what time of day?

Right when you wake up

Correct Incorrect Correct answer

With breakfast

Correct Incorrect Correct answer

With lunch

Correct Incorrect Correct answer

Bedtime

Correct Incorrect Correct answer

Any time of the day

Correct Incorrect Correct answer

89. Question

A pharmacist is dispensing the following medications to a patient: lisinopril 40 mg oral tablets, sertraline 200 mg oral tablets, zolpidem 10mg oral tablets, and nitroglycerin 0.3 mg sublingual tablets. Which medication from the patient’s list is exempt from child-resistant packaging according to the Poison Prevention Packaging Act of 1970?

Lisinopril

Correct Incorrect Correct answer

Sertraline

Correct Incorrect Correct answer

Zolpidem

Correct Incorrect Correct answer

Nitroglycerin

Correct Incorrect Correct answer

None of the above

Correct Incorrect Correct answer

90. Question

Which of the following products is classified as a Schedule III controlled substance?

A product containing 90 mg of codeine per dose
A product containing 15 mg of hydrocodone per dose
A product containing 3 mg of diphenoxylate and 25 mcg of atropine sulfate per dose

I only

Correct Incorrect Correct answer

III only

Correct Incorrect Correct answer

I & II only

Correct Incorrect Correct answer

II & III only

Correct Incorrect Correct answer

I, II, & III

Correct Incorrect Correct answer

91. Question

What information must a controlled substance prescription contain?

I. Patient name and address

II. Practitioner’s name, address, and DEA number

III. Drug name and strength

IV. Directions for use

V. Date of issue

All of the above

Correct Incorrect Correct answer

I & II only

Correct Incorrect Correct answer

I, II, & IV only

Correct Incorrect Correct answer

I, II, & V only

Correct Incorrect Correct answer

I, II, IV, & V only

Correct Incorrect Correct answer

92. Question

In regard to specific volume requirements of OTC containers, sodium phosphate products must not exceed more than which of the following?

30 mL

Correct Incorrect Correct answer

60 mL

Correct Incorrect Correct answer

90 mL

Correct Incorrect Correct answer

120 mL

Correct Incorrect Correct answer

150 mL

Correct Incorrect Correct answer

93. Question

What is the quantity limit imposed by the CMEA?

You cannot sell more than 3.6 g per day of pseudoephedrine HCl to a customer

Correct Incorrect Correct answer

You cannot sell a customer more than 9 g of pseudoephedrine base per day

Correct Incorrect Correct answer

You can sell a patient any amount of pseudoephedrine liquid since it is extremely dilute

Correct Incorrect Correct answer

Non-liquid forms of pseudoephedrine must be sold in blister packs or unit-dose packaging

Correct Incorrect Correct answer

You cannot sell a customer more than 7.5 g of pseudoephedrine base per day

Correct Incorrect Correct answer

94. Question

Which of the following describes examples of drugs that can be exempted from child-resistant packaging requirements?

I. No drugs are exempted

II. Acetaminophen effervescent tablets containing 20% of the drug

III. Aspirin effervescent tablets containing 15% of the drug

I only

Correct Incorrect Correct answer

III only

Correct Incorrect Correct answer

I & II only

Correct Incorrect Correct answer

II & III only

Correct Incorrect Correct answer

I, II, & III

Correct Incorrect Correct answer

95. Question

Which of the following drugs is not correctly matched with its schedule classification?

Schedule II – Dilaudid®

Correct Incorrect Correct answer

Schedule III – Tramadol

Correct Incorrect Correct answer

Schedule IV – Diazepam

Correct Incorrect Correct answer

Schedule V – Lyrica®

Correct Incorrect Correct answer

Schedule VI – Losartan

Correct Incorrect Correct answer

96. Question

Partial refilling of which of the following prescriptions of controlled substances may be granted upon request of the patient?

I. Valium®

II. Concerta®

III. Alfenta®

I only

Correct Incorrect Correct answer

III only

Correct Incorrect Correct answer

I & II only

Correct Incorrect Correct answer

II & III only

Correct Incorrect Correct answer

I, II, & III

Correct Incorrect Correct answer

97. Question

When a drug product contains FD&C Yellow No.5 or FD&C Yellow No.6 ,which of the following specific labels must it contain?

Do not use with alcohol

Correct Incorrect Correct answer

May cause allergic reaction

Correct Incorrect Correct answer

For adults 18 years or older

Correct Incorrect Correct answer

Do not take on an empty stomach

Correct Incorrect Correct answer

All of the above

Correct Incorrect Correct answer

98. Question

Which of the following actions are concerning to a pharmacist in the event of a suspicious prescription? Select ALL that apply.

Cash payments

Correct Incorrect Correct answer

Long distances traveled to the prescriber’s office or the pharmacy

Correct Incorrect Correct answer

Nervous patient demeanor

Correct Incorrect Correct answer

Requests for early refills of prescriptions

Correct Incorrect Correct answer

16 year old boy

Correct Incorrect Correct answer

99. Question

The prescription label for drugs in Schedule(s)_____ must contain the following warning: “CAUTION: Federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed.”

I & II only

Correct Incorrect Correct answer

II only

Correct Incorrect Correct answer

II & III only

Correct Incorrect Correct answer

II, III, & IV only

Correct Incorrect Correct answer

II, III, IV, & V only

Correct Incorrect Correct answer

100. Question

Which of the following correctly describes a CMS requirements for tamper-resistant prescriptions?

I. Prescriptions for outpatient medications covered by Medicaid must use a tamper-resistant feature

II. A tamper-resistant feature for a prescription includes technology that prevents unauthorized duplication of a prescription form

III. If a pharmacy receives a prescription not compliant with tamper-resistant features, it may be filled in the event of an emergency

I

Correct Incorrect Correct answer

I & II

Correct Incorrect Correct answer

I & III

Correct Incorrect Correct answer

II & III

Correct Incorrect Correct answer

I, II, & II

Correct Incorrect Correct answer

101. Question

Which transaction can be completed based on federal precursor drug sales limits?

830 mL of pseudoephedrine HCl 30 mg/5 mL syrup per customer per day

Correct Incorrect Correct answer

30 tablets of pseudoephedrine HCl 120 mg per customer per day

Correct Incorrect Correct answer

155 tablets of pseudoephedrine sulfate 60 mg per customer per day

Correct Incorrect Correct answer

90 tablets of pseudoephedrine sulfate 240 mg to a customer in 30 days

Correct Incorrect Correct answer

120 tablets of pseudoephedrine sulfate 240 mg to a customer in 30 days

Correct Incorrect Correct answer

102. Question

A physician calls in an emergency C-II prescription to a pharmacist for a patient. By what day must the pharmacist receive the original prescription?

5 Days

Correct Incorrect Correct answer

6 Days

Correct Incorrect Correct answer

7 Days

Correct Incorrect Correct answer

8 Days

Correct Incorrect Correct answer

4 Days

Correct Incorrect Correct answer

103. Question

A pharmacist received a prescription for diacetylmorphine written for 1 tablet by mouth twice daily for a quantity of 60 (for a 30-day supply). Unfortunately, the pharmacy is out of supply for that day. How should the pharmacist proceed to dispense the prescription?

Dispense the medication as written

Correct Incorrect Correct answer

Order the medication for the next day to fill

Correct Incorrect Correct answer

Refuse to fill the medication

Correct Incorrect Correct answer

A & B

Correct Incorrect Correct answer

None of the above

Correct Incorrect Correct answer

104. Question

The drug products regulated by the federal Combat Methamphetamine Epidemic Act of 2005 are restricted to the sale of what quantity (per patient) in one day?

1.2g

Correct Incorrect Correct answer

2.4g

Correct Incorrect Correct answer

3.6g

Correct Incorrect Correct answer

4.8g

Correct Incorrect Correct answer

6.0g

Correct Incorrect Correct answer

105. Question

Which is an accurate description of the Orange Book coding system?

The first letter of the Orange Book code determines the dosage form of the drug

Correct Incorrect Correct answer

AB2 codes identify drugs that are not FDA-approved

Correct Incorrect Correct answer

Drug products designated with a “T” code are therapeutically equivalent

Correct Incorrect Correct answer

BD codes represent drug products that are not therapeutic equivalents

Correct Incorrect Correct answer

DB codes represent drug products that are not therapeutic equivalents

Correct Incorrect Correct answer

106. Question

Which of these would be classified as Schedule III controlled substances?

I. Anabolic Steroids

II. Marinol®

III. MS Contin®

I only

Correct Incorrect Correct answer

III only

Correct Incorrect Correct answer

I & II only

Correct Incorrect Correct answer

II & III only

Correct Incorrect Correct answer

I, II, & III

Correct Incorrect Correct answer

107. Question

Which of the following barbiturates is schedule II?

Fiorinal

Correct Incorrect Correct answer

Phenobarbital

Correct Incorrect Correct answer

Seconal tablet

Correct Incorrect Correct answer

Nucynta

Correct Incorrect Correct answer

Butabarbital

Correct Incorrect Correct answer

108. Question

Which of the following nonprescription products must have a child-safety container? Select all that apply.

Diphenhydramine HCl 25 mg tablets

Correct Incorrect Correct answer

Naproxen 220 mg capsules

Correct Incorrect Correct answer

Levocetirizine, originally sold Rx then switched to OTC

Correct Incorrect Correct answer

Ibuprofen 500mg

Correct Incorrect Correct answer

Aspirin 81 mg

Correct Incorrect Correct answer

109. Question

Which portion of the following federal counseling regulations is/are a requirement for each state?

I. Prospective review

II. Meta-analysis review

III. Retrospective review

I only

Correct Incorrect Correct answer

III only

Correct Incorrect Correct answer

I & II only

Correct Incorrect Correct answer

II & III only

Correct Incorrect Correct answer

I, II, & III

Correct Incorrect Correct answer

110. Question

What is the correct order for the 3 segments of the NDC code?

Package Segment, Labeler Code, Product Segment

Correct Incorrect Correct answer

Product Segment, Labeler Code, Package Segment

Correct Incorrect Correct answer

Labeler Code, Package Segment, Product Segment

Correct Incorrect Correct answer

Package Segment, Product Segment, Labeler Code

Correct Incorrect Correct answer

Labeler Code, Product Segment, Package Segment

Correct Incorrect Correct answer

111. Question

For a drug to be considered Pharmaceutically Equivalent, which of the following statements is not true?

Identical amounts of the same active ingredient

Correct Incorrect Correct answer

Identical strength or concentration

Correct Incorrect Correct answer

Same route of administration

Correct Incorrect Correct answer

Same excipients

Correct Incorrect Correct answer

Same dosage form

Correct Incorrect Correct answer

112. Question

Conjugated estrogen tablets in packages containing no more than what amount of the drug are exempt from the Poison Prevention Packaging Act of 1970?

28 mg

Correct Incorrect Correct answer

30 mg

Correct Incorrect Correct answer

32 mg

Correct Incorrect Correct answer

34 mg

Correct Incorrect Correct answer

26 mg

Correct Incorrect Correct answer

113. Question

Abuse of a what class of controlled substance medications may lead to moderate or low physical dependence or high psychological dependence?

Schedule I

Correct Incorrect Correct answer

Schedule II

Correct Incorrect Correct answer

Schedule III

Correct Incorrect Correct answer

Schedule IV

Correct Incorrect Correct answer

Schedule V

Correct Incorrect Correct answer

114. Question

What is required by federal law when logging methamphetamine precursor sales?

You must make sure that the patient’s name and address is entered

Correct Incorrect Correct answer

You must always enter the patient’s phone number

Correct Incorrect Correct answer

You must keep the logbook for at least 7 years

Correct Incorrect Correct answer

You must keep a hardcopy logbook

Correct Incorrect Correct answer

You must keep the logbook for at least 10 years

Correct Incorrect Correct answer

115. Question

On January 1, 2023, a pharmacist partially dispenses Synalgos-DC® with codeine. What is the last date the balance may be filled?

January 4, 2023

Correct Incorrect Correct answer

January 8, 2023

Correct Incorrect Correct answer

June 30, 2023

Correct Incorrect Correct answer

December 31, 2023

Correct Incorrect Correct answer

None of the above because a pharmacist, under federal law, cannot partially dispense drugs in this CSA Schedule

Correct Incorrect Correct answer

116. Question

Which of the following is NOT exempt from the Poison Prevention Packaging Act of 1970?

Pancrelipase tablets

Correct Incorrect Correct answer

Oral contraceptives

Correct Incorrect Correct answer

Isosorbide dinitrate 10 mg chewable tablets

Correct Incorrect Correct answer

Erythromycin ethyl succinate tablets in a package of 16 grams

Correct Incorrect Correct answer

Novolin 70/30 FlexPen

Correct Incorrect Correct answer

117. Question

How can a community pharmacy transmit controlled substance prescription information to a central fill pharmacy?

I. A pharmacist in the community pharmacy may phone in a prescription for a controlled substance in Schedules II-V, provided that the oral order is given only to a pharmacist at the central fill pharmacy

II. A prescription for a controlled substance in Schedules II-V can be transmitted electronically by the community pharmacy to the central fill pharmacy

III. A facsimile of a prescription for a controlled substance in Schedules II-V may be provided by the community pharmacy to the central fill pharmacy

I only

Correct Incorrect Correct answer

II only

Correct Incorrect Correct answer

III only

Correct Incorrect Correct answer

II & III only

Correct Incorrect Correct answer

I, II, & III

Correct Incorrect Correct answer

118. Question

Which of the following components are required to make up a product identifier? Select all that apply.

QR code

Correct Incorrect Correct answer

Serialized Numerical Identifier (SNI)

Correct Incorrect Correct answer

Lot number

Correct Incorrect Correct answer

Expiration date

Correct Incorrect Correct answer

GTIN

Correct Incorrect Correct answer

119. Question

Which of the following FDA resources lists drug products with therapeutic equivalence?

Pink Book

Correct Incorrect Correct answer

Orange Book

Correct Incorrect Correct answer

Green Book

Correct Incorrect Correct answer

Purple Book

Correct Incorrect Correct answer

Red Book

Correct Incorrect Correct answer

120. Question

Dr. Williams is treating ten patients with buprenorphine for opioid use disorder. The following week, Dr. Williams eventually ends up treating five more patients. In this case, what is the best course of action that Dr. Williams should take according to the Consolidated Appropriations Act?

Cap the patients at five; Dr. Williams can only treat up to five patients with opioid use disorder

Correct Incorrect Correct answer

Cap the patients at ten; Dr. Williams can only treat up to ten patients with opioid use disorder

Correct Incorrect Correct answer

Cap the patients at fifteen; Dr. Williams can only treat up to fifteen patients with opioid use disorder

Correct Incorrect Correct answer

Submit a waiver form to the DEA annually to maintain unlimited prescriptive authority of buprenorphine for treating patients with opioid use disorder

Correct Incorrect Correct answer

None of the above; there are no limits or caps in treating patients with buprenorphine for opioid use disorder

Correct Incorrect Correct answer

121. Question

Pharmacist Joe receives a prescription for Norco®10-325mg as needed for pain for a quantity of #120 tablets. The patient received a partial fill on July 10, 2022, and came to the pharmacy for the remainder on July 16, 2022. What should the pharmacist do?

Dispense the remainder of the prescription as it is within 7 days

Correct Incorrect Correct answer

Dispense the remainder of the prescription as it is within 14 days

Correct Incorrect Correct answer

Dispense the remainder of the prescription as there is no time limit on partial fills for schedule II drugs

Correct Incorrect Correct answer

Refuse to fill the remainder and notify the prescriber that a new prescription is needed as it is beyond 72 hours

Correct Incorrect Correct answer

Refuse to fill the remainder and notify the prescriber that a new prescription is needed as it is beyond 5 days

Correct Incorrect Correct answer

122. Question

What can happen if CMEA rules are violated?

Financial penalties for failing to comply with CMEA requirements can be up to $500

Correct Incorrect Correct answer

Imprisonment up to 1 year if the violation is committed unknowingly

Correct Incorrect Correct answer

You can be imprisoned for up to 10 years for knowingly violating CMEA

Correct Incorrect Correct answer

Your pharmacy may no longer be able to sell precursor drugs

Correct Incorrect Correct answer

Imprisonment up to 2 years if the violation is committed unknowingly

Correct Incorrect Correct answer

123. Question

Which of the following best describes examples of labeling? Select all that apply.

A magazine article for Linzess®

Correct Incorrect Correct answer

A television commercial for Ozempic®

Correct Incorrect Correct answer

A radio commercial for Chantix®

Correct Incorrect Correct answer

A slide deck describing Benlysta®

Correct Incorrect Correct answer

A brochure for Rybelsus® at an ASHP conference tabling event

Correct Incorrect Correct answer

124. Question

Which statement regarding multiple Schedule II prescriptions written on the same day for the same drug and patient is correct?

Each prescription must be issued for a valid medical indication

Correct Incorrect Correct answer

The prescriber must specifically indicate on each prescription the earliest date on which each prescription may be dispensed

Correct Incorrect Correct answer

The total quantity prescribed cannot exceed a 90-day supply

Correct Incorrect Correct answer

All the above

Correct Incorrect Correct answer

A & C only

Correct Incorrect Correct answer

125. Question

Under which of the following conditions may practitioners of “Traditional Chinese Medicine” sell ephedra-containing products?

The level of ephedra is less than 2 mg per dose

Correct Incorrect Correct answer

Only a 5-day supply of the product is sold

Correct Incorrect Correct answer

The label does not indicate that the product is a dietary supplement

Correct Incorrect Correct answer

A prescription is issued for the product

Correct Incorrect Correct answer

Sales are illegal

Correct Incorrect Correct answer

126. Question

Which of the following statements is not true regarding controlled substance inventory?

A 120-count bottle of a CII substance can be estimated

Correct Incorrect Correct answer

A 1500-count bottle of a CIII substance must have an exact count

Correct Incorrect Correct answer

A 120-count bottle of a CIV substance can be estimated

Correct Incorrect Correct answer

A 90-count bottle of a CII substance must have an exact count

Correct Incorrect Correct answer

A 30-count bottle of a CIII substance can be estimated

Correct Incorrect Correct answer

127. Question

Which of the following must be ordered using DEA Form 222?

I. Secobarbital Suppository

II. Pentobarbital Injection

III. Amobarbital Capsule

I only

Correct Incorrect Correct answer

III only

Correct Incorrect Correct answer

I & II only

Correct Incorrect Correct answer

II & III only

Correct Incorrect Correct answer

I, II, & III

Correct Incorrect Correct answer

128. Question

What should you do to comply with DEA 106 procedures?

You must notify the DEA of any theft of controlled substances within one business day of discovery

Correct Incorrect Correct answer

Your pharmacy is responsible for notifying the DEA of the loss of controlled substances if your receipt from your distributor does not match what you received from them

Correct Incorrect Correct answer

A significant loss is when you lose more than 40% of the total amount of any single controlled substance

Correct Incorrect Correct answer

A significant loss is when you lose more than 20% of the total amount of any single controlled substance

Correct Incorrect Correct answer

You need to complete DEA Form 106 right away when you discover missing controlled substances

Correct Incorrect Correct answer

129. Question

A new over-the-counter product called SleepAway just came to the market that claims that it can “help you go to sleep faster.” Under what regulating authority would this product fall?

Food and Drug Administration

Correct Incorrect Correct answer

Department of Health

Correct Incorrect Correct answer

Federal Trade Commission

Correct Incorrect Correct answer

All of the above

Correct Incorrect Correct answer

None of the above

Correct Incorrect Correct answer

130. Question

What are the federal inventory requirements for controlled substances CII-CV after the initial inventory?

Annual inventory

Correct Incorrect Correct answer

Biennial inventory

Correct Incorrect Correct answer

Monthly inventory

Correct Incorrect Correct answer

Daily inventory

Correct Incorrect Correct answer

No specific federal inventory requirements

Correct Incorrect Correct answer

131. Question

What federal law established the distinction between prescription and over the counter drugs?

Food, Drug, and Cosmetic Act

Correct Incorrect Correct answer

Poison Prevention Packaging Act

Correct Incorrect Correct answer

Kefauver-Harris Amendments

Correct Incorrect Correct answer

Durham-Humphrey Amendment

Correct Incorrect Correct answer

Public Health Service Act

Correct Incorrect Correct answer

132. Question

What must be placed on the face of the paper prescription for the filling of controlled substances for marked identification?

A number indicated what type of drug schedule it is

Correct Incorrect Correct answer

An orange “2”

Correct Incorrect Correct answer

A black “S”

Correct Incorrect Correct answer

A signature from the pharmacist dispensing

Correct Incorrect Correct answer

A red “C”

Correct Incorrect Correct answer

133. Question

Copy 3 of DEA Form 222 stays in the custody of which entity? Select ALL that apply.

Supplier of the drug

Correct Incorrect Correct answer

Pharmacy

Correct Incorrect Correct answer

DEA

Correct Incorrect Correct answer

Wholesale distributor

Correct Incorrect Correct answer

Recipient of the drug

Correct Incorrect Correct answer

134. Question

A supplier fulfills a pharmacy’s order for CII substances. What step must the supplier take by the 15^th day of the month in the quarter following the quarter the order was fulfilled?

File a distribution transaction report via ARCOS

Correct Incorrect Correct answer

File a distribution transaction report via CSOS

Correct Incorrect Correct answer

Send the original DEA Form 222 to the DEA

Correct Incorrect Correct answer

Send copy 3 of DEA Form 222 to the DEA

Correct Incorrect Correct answer

Request a copy of DEA Form 222 from the DEA

Correct Incorrect Correct answer

135. Question

A pharmacy technician at Brownstone Pharmacy discovers that several bottles of a Schedule III controlled substance are missing from the inventory. The pharmacist-in-charge investigates and confirms that the loss is unaccounted for and potentially a theft. What is the appropriate next steps the pharmacy must take? Select all that apply.

I. Report the loss to the local authorities

II. Notify the DEA by submitting DEA Form 106

III. Record the loss in the pharmacy logbook, and discuss with staff after the pharmacy closes

IV. Wait until the end of the month to assess if additional inventory is missing before reporting

V. Take no further action

II

Correct Incorrect Correct answer

III & V

Correct Incorrect Correct answer

I & II

Correct Incorrect Correct answer

I & III

Correct Incorrect Correct answer

II, III & IV

Correct Incorrect Correct answer

136. Question

Facsimiles may serve as original prescriptions for Schedule IIs for which of the following? Select ALL that apply.

Any Schedule II substance for a hospice patient

Correct Incorrect Correct answer

Schedule II narcotic substances compounded by a pharmacy for direct IV administration to a patient undergoing home infusion

Correct Incorrect Correct answer

Any Schedule II medication for a patient residing in a long-term care facility

Correct Incorrect Correct answer

Any Schedule II medication for patients of a community pharmacy

Correct Incorrect Correct answer

Any Schedule II medication for patients of a community pharmacy in emergencies

Correct Incorrect Correct answer

137. Question

Someone broke into your pharmacy, but no medications were stolen. What form do you need to file when you discover that no controlled substance drugs have been stolen?

DEA Form 41

Correct Incorrect Correct answer

DEA Form 106

Correct Incorrect Correct answer

DEA Form 222

Correct Incorrect Correct answer

DEA Form 224

Correct Incorrect Correct answer

No form will need to be filled

Correct Incorrect Correct answer

138. Question

Weiss is planning to conduct a clinical trial of drug X to treat breast cancer. Which phase of a clinical trial is she going to perform if the primary goal of this study is to determine the dosing requirements?

Phase I

Correct Incorrect Correct answer

Pre-clinical study

Correct Incorrect Correct answer

Phase IIa

Correct Incorrect Correct answer

Phase IIb

Correct Incorrect Correct answer

Phase III

Correct Incorrect Correct answer

139. Question

Pharmacist Jenny comes into the pharmacy one day to find out that some medications including pseudoephedrine-containing products were stolen overnight. While only focusing on the pseudoephedrine products, how long does the pharmacist have to file a written report of losses?

2 days

Correct Incorrect Correct answer

6 days

Correct Incorrect Correct answer

7 days

Correct Incorrect Correct answer

14 days

Correct Incorrect Correct answer

15 days

Correct Incorrect Correct answer

140. Question

Which of the following entities do NOT need to complete either a DEA Form 224, DEA Form 225, DEA Form 363, or DEA Form 501?

MediAnalysis, a research company that chemically analyzes controlled and non-controlled substances

Correct Incorrect Correct answer

Reliably Delivered, a shipping company that delivers controlled and non-controlled substances

Correct Incorrect Correct answer

Recovering Hearts, a narcotic treatment program that utilizes methadone for medication-assisted treatment

Correct Incorrect Correct answer

LotusRx, a mail-order pharmacy that dispenses controlled and non-controlled substances

Correct Incorrect Correct answer

Manufactured Meds, a company that manufactures controlled and non-controlled substances

Correct Incorrect Correct answer

141. Question

How should sales of drug products covered by the Combat Methamphetamine Epidemic Act be recorded? Select ALL that apply.

Electronic logbook

Correct Incorrect Correct answer

Doctor's prescription

Correct Incorrect Correct answer

Bound logbook

Correct Incorrect Correct answer

Photocopy of purchaser's ID

Correct Incorrect Correct answer

No record is required

Correct Incorrect Correct answer

142. Question

What information needs to be recorded in a logbook when a pharmacist sells a non-prescription schedule V controlled substance, such as a liquid with less than 200 mg of codeine per 100 mL? Select all that apply.

Name of the buyer

Correct Incorrect Correct answer

Age of the buyer

Correct Incorrect Correct answer

Name of the medication purchased

Correct Incorrect Correct answer

Quantity of the medication purchased

Correct Incorrect Correct answer

Name of the pharmacist that dispensed the product

Correct Incorrect Correct answer

143. Question

Which of the following was not a provision of the Federal Food, Drug, and Cosmetic Act passed by Congress in 1938?

It eliminated the Sherley Amendment

Correct Incorrect Correct answer

It extended control to cosmetics

Correct Incorrect Correct answer

It required new drug products be proven safe before marketing

Correct Incorrect Correct answer

It required manufacturers to establish safety of food additives

Correct Incorrect Correct answer

It extended control to therapeutic devices

Correct Incorrect Correct answer

144. Question

Which of the following entities does not need a DEA registration to prescribe controlled substances?

PAs

Correct Incorrect Correct answer

Midwives

Correct Incorrect Correct answer

VA physician

Correct Incorrect Correct answer

Narcotic treatment program

Correct Incorrect Correct answer

Hospital pharmacy

Correct Incorrect Correct answer

145. Question

Which of the following items must be ordered from a wholesaler on DEA order Form 222?

I. Morphine Sulfate extended-release tablet, 100 mg

II. Meperidine HCL injection, 50 mg/mL

III. Diazepam tablet, 5 mg

I only

Correct Incorrect Correct answer

III only

Correct Incorrect Correct answer

I & II only

Correct Incorrect Correct answer

II & III only

Correct Incorrect Correct answer

I, II, & III

Correct Incorrect Correct answer

146. Question

What information can you share with a new employee about a triplicate DEA Form 222?

It is the form to use when ordering Schedule III controlled substances

Correct Incorrect Correct answer

If erasure is made while filling out the form, it will not be accepted by the supplier

Correct Incorrect Correct answer

Any person employed by the pharmacy can sign Form 222

Correct Incorrect Correct answer

Your wholesaler must provide the exact package size you specify on Form 222

Correct Incorrect Correct answer

Your supplier must provide the exact package size you specify on Form 222

Correct Incorrect Correct answer

147. Question

The FDA has how many days to decide whether to file an NDA for review?

10 Days

Correct Incorrect Correct answer

30 Days

Correct Incorrect Correct answer

60 Days

Correct Incorrect Correct answer

90 Days

Correct Incorrect Correct answer

180 Days

Correct Incorrect Correct answer

148. Question

Which of the following is not true regarding a single DEA Form 222?

Contains 10 lines

Correct Incorrect Correct answer

Contains 20 lines

Correct Incorrect Correct answer

Purchaser will keep a copy of the original DEA Form 222

Correct Incorrect Correct answer

Supplier must fill out information on the original DEA Form 222

Correct Incorrect Correct answer

Purchaser must record information of products received on a copy of DEA Form 222

Correct Incorrect Correct answer

149. Question

Which schedule of controlled substance medications must a community pharmacy keep in a locked cabinet?

Schedule I only

Correct Incorrect Correct answer

Schedule II only

Correct Incorrect Correct answer

Schedule I & Schedule II drugs only

Correct Incorrect Correct answer

Schedule II – Schedule V drugs

Correct Incorrect Correct answer

None of the above, as federal law does not require controlled substances to be kept in locked cabinets

Correct Incorrect Correct answer

150. Question

How can controlled substance prescription records at a community pharmacy without an electronic order processing system be stored?

I. 2 Files: One file for all controlled substances & one file for all non-controlled drugs

II. 3 Files: One file for all Schedule II controlled substances, one file for Schedule III-V controlled substances, and one file for all non-controlled drugs

III. 2 Files: One file for all Schedule II controlled substances & one file for all other drugs (non-controlled & Schedule III-V)

I only

Correct Incorrect Correct answer

II only

Correct Incorrect Correct answer

III only

Correct Incorrect Correct answer

II & III only

Correct Incorrect Correct answer

I, II, & III

Correct Incorrect Correct answer

151. Question

What form does a permitted pharmacy complete to destroy damaged, outdated, or otherwise unwanted controlled substances?

DEA Form 41

Correct Incorrect Correct answer

DEA Form 106

Correct Incorrect Correct answer

DEA Form 222

Correct Incorrect Correct answer

DEA Form 224

Correct Incorrect Correct answer

No form will need to be completed

Correct Incorrect Correct answer

152. Question

Pharmacy RxCoV is a new store and completed the DEA registration. Which of the following is/are appropriate actions relevant to DEA Form 222 when the pharmacist of the RxCoV pharmacy orders schedule-II controlled substances? Select ALL that apply.

Fill out the triplicate DEA Form 222

Correct Incorrect Correct answer

Fill out the single sheet DEA Form 222

Correct Incorrect Correct answer

The pharmacy must make a copy of the original DEA Form 222 for its records

Correct Incorrect Correct answer

The pharmacy must send the original DEA Form 222 to the supplier

Correct Incorrect Correct answer

The supplier must send the original DEA Form 222 to the pharmacy

Correct Incorrect Correct answer

153. Question

When a controlled substance inventory is conducted, which of the following must be included?

I. Drugs returned by a customer

II. Drugs ordered by a customer but not yet paid for

III. All controlled substances dispensed over the past month

I only

Correct Incorrect Correct answer

III only

Correct Incorrect Correct answer

I & II only

Correct Incorrect Correct answer

II & III only

Correct Incorrect Correct answer

I, II, & III

Correct Incorrect Correct answer

154. Question

On April 4^th, 2026 , Pharmacy A submits a DEA Form 106 when an entire bottle of hydrocodone/acetaminophen 5/325 mg is found missing. What is the first date the pharmacy is allowed to no longer keep a copy of this report per federal law?

April 5th, 2027

Correct Incorrect Correct answer

April 5th, 2028

Correct Incorrect Correct answer

October 5th, 2028

Correct Incorrect Correct answer

April 5th, 2029

Correct Incorrect Correct answer

April 5th, 2030

Correct Incorrect Correct answer

155. Question

Which of the following clinical trial phases is paired correctly with their purpose?

Preclinical- study humans

Correct Incorrect Correct answer

Phase I- primary purpose is effectiveness

Correct Incorrect Correct answer

Phase II- primary purpose is safety

Correct Incorrect Correct answer

Phase III- test metabolism of the drug

Correct Incorrect Correct answer

Phase IV- report post-marketing effects

Correct Incorrect Correct answer

156. Question

Which of the following are possible reasons a supplemental NDA (sNDA) may need to be filed by the manufacturer? Select all that apply.

Changes to an approved product’s indications

Correct Incorrect Correct answer

Changes to an approved product’s active ingredients

Correct Incorrect Correct answer

Changes to an approved product’s labeling

Correct Incorrect Correct answer

Changes to an approved product’s advertising

Correct Incorrect Correct answer

Changes to an approved product’s price

Correct Incorrect Correct answer

157. Question

What is the main purpose of a Phase 3 clinical trial for a new drug?

To evaluate the drug’s safety in animals

Correct Incorrect Correct answer

To determine adverse effects and dosage

Correct Incorrect Correct answer

To determine the drug’s effectiveness versus the effectiveness of the gold standard

Correct Incorrect Correct answer

To determine whether the drug can be safely given to humans

Correct Incorrect Correct answer

To assess the marketability of the drug

Correct Incorrect Correct answer

158. Question

Frank, the pharmacist, wants to hire Tom, another pharmacist who was just released from prison for a felony regarding controlled substances. Tom regrets his past ways and demonstrates this to the Board of Pharmacy, and gets his license reinstated. Under federal law, can Frank hire Tom if Tom has access to controlled substances in this position?

No, any person who has been convicted of a felony relating to controlled substances may not be employed in such a position in any circumstance

Correct Incorrect Correct answer

No, any person who has had their pharmacy license revoked may not be employed in such a position, even if it has been reinstated

Correct Incorrect Correct answer

Yes, but only after Frank gets a waiver approved by the DEA allowing Tom to be employed in such a position

Correct Incorrect Correct answer

Yes, Tom has a valid license to practice pharmacy, his past is irrelevant

Correct Incorrect Correct answer

None of the above

Correct Incorrect Correct answer

159. Question

How many years of market exclusivity are given to the first applicant to get market approval for an orphan drug?

5 years

Correct Incorrect Correct answer

7 years

Correct Incorrect Correct answer

10 years

Correct Incorrect Correct answer

15 years

Correct Incorrect Correct answer

20 years

Correct Incorrect Correct answer

160. Question

In accordance with the Prescription Drug User Fee Act (PDUFA), the FDA expect to review what percent of the standard drug NDAs no later than 10 months after receiving the applications?

100%

Correct Incorrect Correct answer

90%

Correct Incorrect Correct answer

80%

Correct Incorrect Correct answer

75%

Correct Incorrect Correct answer

70%

Correct Incorrect Correct answer

161. Question

Dr. Lee, a university researcher, is developing a new medication to treat a rare neurological disorder. Before clinical trials in humans, she needs to submit an Investigational New Drug (IND) application to the FDA. Which of the following entities can act as a sponsor for Dr. Lee’s IND application?

Only a pharmaceutical company

Correct Incorrect Correct answer

Only a government agency

Correct Incorrect Correct answer

Only an accredited academic institution

Correct Incorrect Correct answer

Any individual or organization, including a nonprofit or academic institution

Correct Incorrect Correct answer

Only licensed physicians

Correct Incorrect Correct answer

162. Question

The DEA registration Form 363 is required from which of the following entities? Select ALL that apply.

Narcotic Treatment Programs

Correct Incorrect Correct answer

Researchers

Correct Incorrect Correct answer

Pharmacies

Correct Incorrect Correct answer

Medical center

Correct Incorrect Correct answer

Manufacturers

Correct Incorrect Correct answer

163. Question

What is the main provision of the Lowest Price Act of 2018, which went into effect on January 1, 2020?

It requires pharmacies to offer discount on all prescription medications

Correct Incorrect Correct answer

It prohibits Medicare Part D plans from preventing pharmacies from informing customers if a drug would be cheaper without using insurances

Correct Incorrect Correct answer

It mandates that all pharmacies accept Medicare Part B

Correct Incorrect Correct answer

It mandates that all pharmacies must accept prescription saving cards like GoodRx

Correct Incorrect Correct answer

It allows insurance companies to set the price for the prescription drugs

Correct Incorrect Correct answer

164. Question

Frank, the pharmacist, wishes to start his pharmacy. If Frank wants to be able to dispense controlled substances at his new pharmacy, which form should be complete?

DEA Form 222

Correct Incorrect Correct answer

DEA Form 224

Correct Incorrect Correct answer

DEA Form 41

Correct Incorrect Correct answer

DEA Form 106

Correct Incorrect Correct answer

DEA Form 106a

Correct Incorrect Correct answer

165. Question

To be approved for marketing, a generic drug must meet ALL of which criteria?

The same rate and extent of absorption

Correct Incorrect Correct answer

The same strength or concentration, route of administration, and dosage form

Correct Incorrect Correct answer

The same rate and extent of absorption, the same strength, route of administration, and dosage form

Correct Incorrect Correct answer

The same strength, route of administration, dosage form, and inactive ingredients

Correct Incorrect Correct answer

None

Correct Incorrect Correct answer

166. Question

How long must a sponsor or sponsor-investigator wait to commence clinical trials after submitting an investigational new drug (IND) application?

30 days

Correct Incorrect Correct answer

90 days

Correct Incorrect Correct answer

9 months

Correct Incorrect Correct answer

1 year

Correct Incorrect Correct answer

2 years

Correct Incorrect Correct answer

167. Question

You are working in a pharmacy inside a grocery store. The store has just been audited due to recalled and expired canned foods that were found on the shelf. The front store manager asks you what sort of legal action might be taken against the store. Which is the most appropriate response to this question?

The Division of Biologics Control is responsible for these kinds of matters

Correct Incorrect Correct answer

This is an issue outlined in an amendment made in 1970

Correct Incorrect Correct answer

This is an issue outlined in the Sherley Amendment, but he should be fine because it was eliminated

Correct Incorrect Correct answer

Inform the manager that this is covered in the Food, Drug, and Cosmetic (FDC) Act of 1938

Correct Incorrect Correct answer

This is an issue outlined in an amendment made in 1930

Correct Incorrect Correct answer

168. Question

How often must a pharmacy renew their registration with the DEA using DEA Form 224a?

Every year

Correct Incorrect Correct answer

Every even year

Correct Incorrect Correct answer

Every odd year

Correct Incorrect Correct answer

Every three years

Correct Incorrect Correct answer

Every four years

Correct Incorrect Correct answer

169. Question

What is the term for a pharmaceutical agent that has been developed specifically to treat a rare medical condition?

Orphan Drug

Correct Incorrect Correct answer

Targeted Drug

Correct Incorrect Correct answer

Type 3 drug

Correct Incorrect Correct answer

Type N drug

Correct Incorrect Correct answer

Subsidized drug

Correct Incorrect Correct answer

170. Question

If a pharmacy opts to print out a daily controlled substances refill record, how long must this record be maintained by the pharmacy?

6 months

Correct Incorrect Correct answer

1 year

Correct Incorrect Correct answer

2 years

Correct Incorrect Correct answer

3 years

Correct Incorrect Correct answer

4 years

Correct Incorrect Correct answer

171. Question

Which of the following does not accurately describe a requirement of a 503B pharmacy?

Can apply to be exempt from track-and-trace requirements

Correct Incorrect Correct answer

May not apply to be exempt from following adequate directions for use requirements

Correct Incorrect Correct answer

Must be inspected by the FDA on a set schedule

Correct Incorrect Correct answer

May not compound medications that are essentially copies of approved drug products

Correct Incorrect Correct answer

Demonstrate that comparable controls will be used prior to compounding a REMS

Correct Incorrect Correct answer

172. Question

Which of the following can be a biologic?

Vaccines

Correct Incorrect Correct answer

Serums

Correct Incorrect Correct answer

Blood products

Correct Incorrect Correct answer

Antithrombin III

Correct Incorrect Correct answer

All of the above

Correct Incorrect Correct answer

173. Question

What application must be submitted to the FDA before beginning human clinical trials?

New Drug Application

Correct Incorrect Correct answer

Abbreviated New Drug Application

Correct Incorrect Correct answer

Biologics License Application

Correct Incorrect Correct answer

Investigational New Drug Application

Correct Incorrect Correct answer

Clinical Trial Application

Correct Incorrect Correct answer

174. Question

The DEA registration form 225 is required from which of the following entities? Select all that apply.

Manufacturers

Correct Incorrect Correct answer

Medical center

Correct Incorrect Correct answer

Pharmacies

Correct Incorrect Correct answer

Researchers

Correct Incorrect Correct answer

Narcotic Treatment Programs

Correct Incorrect Correct answer

175. Question

What does federal law say about e-prescribing controlled substances?

Partial fills of e-prescriptions for Schedule II controlled substances are NOT allowed

Correct Incorrect Correct answer

An office manager can act as a proxy and electronically sign e-prescriptions for a prescriber

Correct Incorrect Correct answer

E-prescriptions must be maintained electronically for five years

Correct Incorrect Correct answer

Refills are not allowed for Schedule III controlled substance e-prescriptions

Correct Incorrect Correct answer

E-prescriptions must be maintained electronically for two years

Correct Incorrect Correct answer

176. Question

Orphan drug status can be applied to drugs and biologics for the treatment and prevention of rare diseases or conditions if it affects how many people in the United States?

Less than 500,000

Correct Incorrect Correct answer

Less than 400,000

Correct Incorrect Correct answer

Less than 300,000

Correct Incorrect Correct answer

Less than 200,000

Correct Incorrect Correct answer

Less than 100,000

Correct Incorrect Correct answer

177. Question

Which of the following are true statements regarding the Consolidated Appropriations Act of 2023? Select ALL that apply.

Providers or practitioners do not need a DATA waiver to treat patients with buprenorphine for opioid use disorder

Correct Incorrect Correct answer

Providers or practitioners who are DEA-registered do not need to undergo new training requirements

Correct Incorrect Correct answer

Buprenorphine prescriptions require an “X” in the DEA registration number

Correct Incorrect Correct answer

Methadone prescriptions to treat opioid use disorder are not affected by the Consolidated Appropriations Act of 2023

Correct Incorrect Correct answer

The Consolidated Appropriations Act of 2023 overrides state laws and regulations

Correct Incorrect Correct answer

178. Question

Who has jurisdiction over prescription drug advertising and promotion?

The Food and Drug Administration

Correct Incorrect Correct answer

The Centers for Disease Control and Prevention

Correct Incorrect Correct answer

The National Institute of Health

Correct Incorrect Correct answer

The Healthcare Financing Administration

Correct Incorrect Correct answer

The Centers for Medicare and Medicaid Services

Correct Incorrect Correct answer

179. Question

What year was the act that established purity of biological serums passed?

1966

Correct Incorrect Correct answer

1902

Correct Incorrect Correct answer

1927

Correct Incorrect Correct answer

1914

Correct Incorrect Correct answer

1994

Correct Incorrect Correct answer

180. Question

Which of the following acts requires drug manufacturers to prove the effectiveness of their products to the FDA before marketing them?

Durham-Humphrey Amendments

Correct Incorrect Correct answer

Food, Drug, and Cosmetic Act

Correct Incorrect Correct answer

Drug Supply Chain Act

Correct Incorrect Correct answer

Kefauver-Harris Amendments

Correct Incorrect Correct answer

Poison Prevention Packaging Act

Correct Incorrect Correct answer

181. Question

How long does a drug patent in the United States last?

5 years

Correct Incorrect Correct answer

10 years

Correct Incorrect Correct answer

15 years

Correct Incorrect Correct answer

20 years

Correct Incorrect Correct answer

3 years

Correct Incorrect Correct answer

182. Question

A DEA registrant plans to transfer its business to another registrant. The DEA should be notified within how many days?

5 days before the transfer

Correct Incorrect Correct answer

7 days before the transfer

Correct Incorrect Correct answer

10 days before the transfer

Correct Incorrect Correct answer

14 days before the transfer

Correct Incorrect Correct answer

30 days before the transfer

Correct Incorrect Correct answer

183. Question

Which of the following describes an entity that distributes a drug to a person other than a consumer or patient?

Manufacturer

Correct Incorrect Correct answer

Repackager

Correct Incorrect Correct answer

Logistics provider

Correct Incorrect Correct answer

Wholesale Distributor

Correct Incorrect Correct answer

Dispenser

Correct Incorrect Correct answer

184. Question

Who can sign the DEA Form 222 and CSOS? Select ALL that apply.

Lead technician

Correct Incorrect Correct answer

All pharmacists

Correct Incorrect Correct answer

The person granted power of attorney

Correct Incorrect Correct answer

The person who signed the DEA Form 224

Correct Incorrect Correct answer

Pharmacy store manager

Correct Incorrect Correct answer

Federal Pharmacy Law Practice Exam – Uniform MPJE

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