Federal Pharmacy Law Practice Exam

Question 1 of 150

What is the time period in which an 18-year-old becomes eligible for narcotic maintenance treatment after two documented attempts of detoxification?

1 month
3 months
6 months
12 months
18 months

Question 2 of 150

Which act or amendment granted the FDA the authority to inspect factories?

Pure Food and Drug Act
Food, Drug, and Cosmetic Act
Durham-Humphrey Act
Food, Drug, and Insecticide Administration

Question 3 of 150

Which of the following acts or amendments was the first to regulate the transportation of adulterated or misbranded drugs in interstate commerce?

Pure Food and Drug Act
Food, Drug, and Cosmetic Act
Food, Drug, and Insecticide Administration
Drug Abuse Control
Drug Importation Act

Question 4 of 150

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

I. Secobarbital Suppository

II. Pentobarbital Injection

III. Amobarbital Capsule

I. only
III. only
I. & II. only
II. & III. only
I., II., & III.

Question 5 of 150

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
III. only
I. & II. only
II. & III. only
I., II., & III.

Question 6 of 150

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

I. A product containing 90 mg of codeine per dose

II. A product containing 15 mg of hydrocodone per dose

III. A product that contains 3 mg of diphenoxylate and 25 mcg of atropine sulfate per dose

I. only
III. only
I. & II. only
II. & III. only
I., II., & III.

Question 7 of 150

All of the following incidences would be considered misbranding EXCEPT:

The active drug is not identified on the label
The original bottle of 40 contains only 35 tablets
The names of inactive ingredients are not on the label
The level of the drug in the product is 10% V/V but the label states 15% V/V
The pharmacist dispenses a drug without the prescription

Question 8 of 150

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
III. only
I. & II. only
II. & III. only
I., II., & III.

Question 9 of 150

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

Top 200 drugs
Generic drugs
At least one drug from each
Top 100 drugs
Single-sourced drugs

Question 10 of 150

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

I. Prospective review

II. Meta-analysis review

III. Retrospective review

I only
III only
I & II only
II & III only
I, II, & III

Question 11 of 150

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
III only
I & II only
II & III only
I, II, & III

Question 12 of 150

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
BC
B
BS
AB

Question 13 of 150

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
S is the practitioner's code; 1 the missing digit
S is the first letter of the practitioner's last name; 0 is the missing digit
S is the first letter of the practitioner's first name; 1 is the missing digit
S is the first letter of the pracitioner's first name; 0 is the missing digit

Question 14 of 150

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 death
The law prohibits the commerce of foods, drugs, and cosmetics to be adultered or misbranded
This law was passed by the Congress in 1938
The law failed to protect the public
This law was passed by the Congress in 1906

Question 15 of 150

Which drug is correctly assigned to its schedule?

Schedule III – 1.5 g of codeine/ 100 mL
Schedule III – 350 mg of ethyl morphine/ 100 mL
Schedule IV – 300 mg of ethyl morphine/ 100 mL
Schedule IV – 150 mg of dihydrocodeine/ 100 mL
Schedule III – 350 mg of dihydrocodeine/ 100 mL

Question 16 of 150

Health professionals self-prescribing is acceptable:

I. In most states

II. Nationwide

III. It is not acceptable at all

I only
III only
I & II only
II & III only
I, II, & III

Question 17 of 150

Examples of drugs that can be exempted from child-resistant packaging requirements are:

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
III only
I & II only
II & III only
I, II, III

Question 18 of 150

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
Only a 5-day supply of the product is sold
The label does not indicate that the product is a dietary supplement
A prescription is issued for the product
Sales are illegal

Question 19 of 150

How should sales of drug products covered by the Combat Methamphetamine Epidemic Act be recorded?

Electronic tracking
Doctor's prescription
Bound logbook
Photocopy of purchaser's ID
No record is required

Question 20 of 150

The DEA registration form 363 is required from which of the following entities?

Narcotic Treatment Programs
Researchers
Pharmacies
Medical center
Manufacturers

Question 21 of 150

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

To evaluate the drug's safety on animals
To determine adverse effects and dosage
To determine the drug's effectiveness versus the effectiveness of the gold standard
To determine whether the drug can be safely given to humans
To assess the marketability of the drug

Question 22 of 150

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

Orphan drug
Targeted drug
Type 3 drug
Type N drug
Subsidized drug

Question 23 of 150

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

Package Segment, Labeler Code, Product Segment
Product Segment, Labeler Code, Package Segment
Labeler Code, Package Segment, Product Segment
Package Segment, Product Segment, Labeler Code
Labeler Code, Product Segment, Package Segment

Question 24 of 150

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
Class II
Class III
Class IV
No recall is required

Question 25 of 150

For a drug to be considered Pharmaceutically Equivalent, all of the following must be true EXCEPT:

Identical amounts of the same active ingredient
Identical strength or concentration
Same route of administration
Same excipients
Same dosage form

Question 26 of 150

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

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

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

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

I only
III only
I & II only
II & III only
I, II, & III

Question 27 of 150

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

Pregnancy
Lactation
Category C
Females and Males of Reproductive Potential
Category X

Question 28 of 150

What controlled substance schedule is heroin listed in?

I
II
III
IV
V

Question 29 of 150

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

I. Anabolic Steroids

II. Marinol

III. MS Contin

I
III only
I & II only
II & III only
I, II, & III

Question 30 of 150

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

DEA Form 41
DEA Form 106
DEA Form 222
DEA Form 224
No form will need to be completed

Question 31 of 150

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
DEA Form 106
DEA Form 222
DEA Form 224
No form will need to be filled

Question 32 of 150

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
7 days before the transfer
10 days before the transfer
14 days before the transfer
30 days before the transfer

Question 33 of 150

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

Schedule I only
Schedule II only
Schedule I & Schedule II drugs only
Schedule II – Schedule V drugs
None of the above, as federal law does not require controlled substances to be kept in locked cabinets

Question 34 of 150

How can controlled substances 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, & 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
II only
III only
II & III only
I & III only

Question 35 of 150

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

Supplier of the drug
Pharmacy
DEA
Wholesale distributor
Recipient of the drug

Question 36 of 150

In states where nurse practitioners may prescribe controlled substances as mid-level practitioners, what letter will that number begin with?

A
B
M
N
P

Question 37 of 150

Facsimiles may serve as original prescriptions for Schedule II’s for which of the following? Select all that apply.

Any Schedule II substance for a hospice patient
Schedule II narcotic substances compounded by a pharmacy for direct IV administration to a patient undergoing home infusion
Any Schedule II medication for a patient residing in a long-term care facility
Any Schedule II medication for patients of a community pharmacy
Any Schedule II medication for patients of a community pharmacy in emergency situations

Question 38 of 150

The prescription 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
II only
II & III only
II, III, & IV only
II, III, IV, & V only

Question 39 of 150

A pharmacist may partially dispense prescriptions for Schedule II controlled substances for an individual residing in an 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
30
60
180
365

Question 40 of 150

On January 1, 2018, a pharmacist partially dispenses Synalgos-DC® with codeine. What is/was the last date the balance to be filled?

January 4, 2018
January 8, 2018
June 30, 2018
December 31, 2018
None of the above because a pharmacist, under federal law, cannot partially dispense drugs in the CSA Schedule

Question 41 of 150

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
II only
III only
II & III only
I, II, & III

Question 42 of 150

Dr. 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
Dr. Brown is permitted to administer up to a day’s supply of the drug for this indication for up to 72 hours
Dr. Brown is strictly prohibited from administering the drug to her patient for this indication, for any length of time, because she is not registered as an OTP
A & B only
A & C only

Question 43 of 150

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

Schedule I
Schedule II
Schedule III
Schedule IV
Schedule V

Question 44 of 150

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

I. A pharmacy may transfer a bottle of a CII 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 CII medication from a wholesale distributor, provided that the distributor properly executes a DEA form 222

III. A pharmacy may order a bottle of a CII medication electronically, provided that the pharmacy signs an order form using a DEA-issued digital signature

III only
I & II only
I & III only
II only
I, II, & III

Question 45 of 150

Which if the following is required under the Methamphetamine Production Prevention Act of 2005?

Seller must require all purchasers of PSE to sign the sales logbook, either manually or electronically
Seller must maintain each entry in the sales logbook for a minimum of 5 years
All purchasers of PSE must present government issued photographic identification
If the seller uses a bound paper sales logbook, he/she must affix a printed sticker next to the signature line that displays product name, quantity, name of purchaser, date & address, or a unique identification that can be linked to that information
All the above are required under MAPA

Question 46 of 150

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?

1.2 g
2.4 g
3.6 g
4.8 g
6.0 g

Question 47 of 150

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

Each prescription must be dated on the day the prescription is to be dispensed.
The prescriber must specifically indicate on each RX the earliest date on which each prescription may be dispensed.
The total quantity prescribed cannot exceed a 90-day supply.
All the above
A & C only

Question 48 of 150

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
All refills may be transferred electronically if the pharmacies share a real-time online database
Transferring pharmacist must write “VOID” on the face of the transferred prescription
Transfer must occur between two pharmacists
All the above

Question 49 of 150

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
1 year
2 years
3 years
4 years

Question 50 of 150

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

I, II, III, IV, & V
I & II only
I, II, & IV only
I, II, & V only
I, II, IV, & V only

Question 51 of 150

Which of the following recalls is implemented in instances when a product is not likely to cause adverse health consequences?

Class I
Class II
Class III
Class IV
Class V

Question 52 of 150

The term “label” refers to which of the following when it is accompanying an article of drug and is not upon the immediate container of drug?

Written matter only
Written or printed matter only
Printed or graphic matter only
Written or graphic matter only
None of the above

Question 53 of 150

How many refills may a practitioner authorize on a Schedule II controlled substance prescription?

1
2
5
0

Question 54 of 150

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

Partial fills of e-prescriptions for Schedule II controlled substances are NOT allowed
An office manager can act as a proxy and electronically sign e-prescriptions for a prescriber
E-prescriptions must be maintained electronically for five years
Refills are not allowed for Schedule III controlled substance e-prescriptions
E-prescriptions must be maintained electronically for two years

Question 55 of 150

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 hospice
A written prescription for morphine 10 mg, one every 8 hours PRN pain, #60 with 1 refill
A written prescription filled out and signed by a registered nurse for morphine 60 mg, one daily, #30
A phoned in prescription for oxycodone 20 mg, one BID, #60 to be delivered to a homebound patient
A faxed prescription for fentanyl patch 100 mg, one every 3 days, #5

Question 56 of 150

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
The date on the prescription should be the same day that they are written and cannot be post-dated
They can total no more than a 90-day supply
They can total no more than a 120-day supply
They must all be filled on the same day they are dropped off at the pharmacy

Question 57 of 150

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
They are allowed only for patients in long-term care facilities
You do not need to document the amount dispensed when you are planning on dispensing the remainder within 72 hours
If you do not dispense the remaining quantity within 72 hours, it will be voided
If you do not dispense the remaining quantity within 24 hours, it will be voided

Question 58 of 150

What is a requirement for filling prescriptions for methadone or buprenorphine according to federal law?

A valid prescription for buprenorphine for treating pain requires a valid DEA number only
Naloxone can only be dispensed by a retail pharmacy for the treatment of opioid dependence
Prescribers must obtain a waiver to use buprenorphine for the treatment of pain
Methadone can only be dispensed by a retail pharmacy for the treatment of opioid dependence
When methadone is used for opioid dependence the prescription only needs to include a DEA number

Question 59 of 150

Which is a federal rule regarding inventory requirements for Schedule II through V drugs?

You need to get an exact count of the number of units of each Schedule III and IV drug in your facility
A full inventory of Schedule II through V drugs must be performed at least every year
Inventory forms can be kept outside the pharmacy if they are readily retrievable
A drug changing from Schedule III to II can be inventoried per its new schedule when the next inventory is due
A full inventory of Schedule II through V drugs must be performed at least every six months

Question 60 of 150

According to FEDERAL law, which is an acceptable form of ID for an adult over 18 years old purchasing a pseudoephedrine product without a prescription?

Social Security card
Birth certificate
U.S. military card
Credit card
ATM Debit card

Question 61 of 150

What is a quantity limit imposed by the CMEA?

You cannot sell more than 3.6 g per day of pseudoephedrine HCl to a customer
You cannot sell a customer more than 9 g of pseudoephedrine base per day
You can sell a patient any amount of pseudoephedrine liquid since it is extremely dilute
Non-liquid forms of pseudoephedrine must be sold in blister packs or unit-dose packaging
You cannot sell a customer more than 7.5 g of pseudoephedrine base per day

Question 62 of 150

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

It is the form to use when ordering Schedule III controlled substances
If an erasure is made while filling out the form, it will not be accepted by the supplier
Any person employed by the pharmacy can sign Form 222
Your wholesaler must provide the exact package size you specify on Form 222
Your supplier must provide the exact package size you specify on Form 222

Question 63 of 150

What should you do in order to comply with DEA 106 procedures?

You must notify the DEA of any theft of controlled substances within one business day of discovery
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
A significant loss is when you lose more than 40% of the total amount of any single controlled substance
A significant loss is when you lose more than 20% of the total amount of any single controlled substance
You need to complete DEA Form 106 right away when you discover missing controlled substances

Question 64 of 150

What can you tell a colleague about exclusivity rights?

They give the brand-name drug company property rights to the new drug
Pediatric exclusivity adds an extra 6 months to the life of a patent
Orphan drug exclusivity gives 5-years market exclusivity
Pediatric exclusivity adds an extra 12 months to the life of a patent
They give the brand-name drug manufacturer marketing rights for an unlimited time

Question 65 of 150

What does the first manufacturer to successfully bring a generic drug to market gain?

Nothing more than other manufacturers
Significant market share
30-day generic exclusivity
180-day generic drug exclusivity
240-day generic drug exclusivity

Question 66 of 150

In order to be approved for marketing, a generic drug must meet ALL of which criteria?

The same rate and extent of absorption
The same strength or concentration, route of administration, and dosage form
The same rate and extent of absorption AND the same strength, route of administration, and dosage form
The same strength, route of administration, and dosage form, AND inactive ingredients
None

Question 67 of 150

How much variability in drug levels does FDA allow between brand name products and their generic counterparts?

The same as the variability between different batches of the brand-name drug
12.5%
25%
45%
23%

Question 68 of 150

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
AB2 codes identify drugs that are not FDA-approved
Drug products designated with a “T” code are therapeutically equivalent
BD codes represent drug products that are not therapeutic equivalents
DB codes represent drug products that are not therapeutic equivalents

Question 69 of 150

Which is an accurate description of biosimilars?

Biosimilars are true generics to a parent biological product
It is possible for biosimilar products to also be classified as interchangeable
Biosimilar products are listed in FDA’s Orange Book
Biosimilar products are listed in FDA’s Green Book
Differences in clinically inactive components are not allowable in biosimilar products

Question 70 of 150

When can the FDA require REMS for a specific drug?

At any time, pre- or post-approval
Only prior to marketing
Only after marketing
Only after marketing based on post-marketing surveillance
If there is a large number of minor side effects

Question 71 of 150

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

A Dear Healthcare Provider Letter
A REMS advertisement in a major journal
A MedGuide
A Patient Registry
A DrugGuide

Question 72 of 150

Which of the following is a part of the long-acting and extended-release opioid REMS?

A mandatory education program for pharmacists
A volunteer education program for prescribers
An implementation system
A volunteer education program for pharmacists
A mandatory education program for prescribers

Question 73 of 150

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

You must make sure that the patient name matches their identification
You always have to enter the patient’s name and address
You must keep the logbook for at least 7 years
You have to keep a hardcopy logbook
You must keep the logbook for at least 10 years

Question 74 of 150

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
You cannot sell more than 9 g of pseudoephedrine sulfate to a customer in a 90-day period
You cannot sell more than 146 tablets of pseudoephedrine HCL 30 mg in a single day to the same customer
Non-liquid dosage forms of methamphetamine precursors can be sold as loose capsules or tablets
You cannot sell more than 9 g of pseudoephedrine chloride to a customer in a 90-day period

Question 75 of 150

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
30 tablets of pseudoephedrine HCl 120 mg per customer per day
155 tablets of pseudoephedrine sulfate 60 mg per customer per day
90 tablets of pseudoephedrine sulfate 240 mg to a customer in 30 days
120 tablets of pseudoephedrine sulfate 240 mg to a customer in 30 days

Question 76 of 150

What can happen if CMEA rules are violated?

Financial penalties for failing to comply with CMEA requirements can be up to $500
Imprisonment up to 1 year if the violation is committed unknowingly
You can be imprisoned for up to 10 years for knowingly violating CMEA
Your pharmacy may no longer be able to sell precursor drugs
Imprisonment up to 2 years if the violation is committed unknowingly

Question 77 of 150

What is important to know about the Drug Quality and Security Act?

Large-scale compounding (“outsourcing”) is regulated by the FDA
All compounding is regulated by the FDA
Only sterile compounding is regulated by the FDA
Only non-sterile compounding is regulated by the FDA
Small scale compounding (“insourcing”) is regulated by the FDA

Question 78 of 150

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

The tablets are less effective than capsules
The tablets are not as safe as the capsules
The tablets are dosed differently than the capsules
The tablets are not AB-rated to the capsules
The capsules are less effective than tablets

Question 79 of 150

What is important to know about the DEA requirements for suspected theft of controlled substances?

You only need to report this if more than five tablets are stolen
You have to report this in writing to the DEA within one business day
DEA Form 106 must be submitted the very same day of discovery
You have to complete a DEA Form 106 EVEN IF the investigation reveals no actual loss or theft
You only need to report this if more than ten tablets are stolen

Question 80 of 150

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
You can re-use returned medications as long as it is been less than 24 hours since you dispensed them
Manufacturers are responsible for providing MedGuides, not pharmacists
Dispensing a light-sensitive drug in a light-resistant container is considered misbranding
Dispensing a scent-sensitive drug in a scent-resistant container is considered misbranding

Question 81 of 150

If receiving multiple schedule II prescriptions, what is the maximum day limit for the prescriptions?

30 days
60 days
90 days
120 days
160 days

Question 82 of 150

The DEA registration form 363 is required from which of the following entities?

Manufacturers
Medical Center
Pharmacies
Researchers
Narcotic Treatment Programs

Question 83 of 150

Whenever a prescription department of any community pharmacy establishment is closed, who is permitted to enter or remain in the prescription department?
I. A pharmacy intern
II. A pharmacy owner
III. A pharmacist

I only
III only
I, II, & III
II and III
None of the above

Question 84 of 150

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
Give them to your pharmacy owner and fill out DEA form 363
Instruct Sally to dispose of her medications with DEA approval
Only return if Sally’s medication has a known recall
If you made a dispensing error, you must accept Sally’s medication return and refund her money

Question 85 of 150

Which of the following references is/are useful for the safe handling of antineoplastic and hazardous drugs?
I. OSHA Technical Manual—Section VI
II. NIOSH Alert
III. MSDSs

I only
I and II only
II and III only
All of the above
None of the above

Question 86 of 150

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 performs a thorough hand-cleansing procedure by removing debris from under fingernails using a nail cleaner under running warm water followed by 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
I and II only
II and III only
All of the above
None of the above

Question 87 of 150

Section 503B of the Federal Food, Drug, and Cosmetic Act addresses which of the following?

Traditional Compounders
Outsourcing Facilities
Compounding pharmacies
Compounding nuclear pharmacies
None of the above

Question 88 of 150

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

IV. Make sure that gloves are labeled as chemotherapy [ASTM 2005] gloves
V. Use double gloving for all activities involving hazardous drugs
VI. Use disposable gowns made of polyethylene-non-coated polypropylene

I only
I and II only
II and III only
All of the above
None of the above

Question 89 of 150

In order to receive FDA approval of a generic drug, which of the following must be met? Select all that apply.

Contain the same active ingredient
Be the same strength
Be the same dosage form (tablet, capsule, etc)
Have the same route of administration (oral, injectable, etc) as the brand name drug
Only be pharmaceutically equivalent

Question 90 of 150

Which of the following is a required caution message placed on patient drug containers for controlled substances?

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

Question 91 of 150

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
6 days
7 days
8 days
4 days

Question 92 of 150

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
A payer requesting a patient's diagnosis for a medication prior authorization
A patient gives permission to provide pharmacy records to a relative
Accessing your own personal health information
Accessing your parent’s personal health information

Question 93 of 150

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

A prospective employer requests it prior to hiring a candidate for a physically demanding job
A parent verbally requests their child's immunization records be sent to school
A law enforcement officer asks you for a patient's medication list to determine whether a gang member should possess a firearm
A spouse requests a list of their estranged wife's medications to use for a divorce proceeding
A health insurance company representative wanting to determine eligibility if they should recommend insurance

Question 94 of 150

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

Sending refill reminders on prescriptions patients are currently taking
Sending all diabetes patients, a manufacturer's promotional pamphlets on a new insulin
Providing patients with information about formulary restrictions on brand name drugs for a patient’s drug plan
Providing obese patients with information about how to eat healthy and control weight
Providing patients promotional gifts of nominal value

Question 95 of 150

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

I can only read you your list of current medications
It is risky to send unencrypted health information via email, but I can provide you with a printout
I am not able to share your prescription records. You must get them from the prescriber
I have to get authorization from your prescriber before sharing any information from your prescription record
I need a signed and dated letter from you requesting a copy of your prescription records

Question 96 of 150

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 under?

Food and Drug Administration
Department of Health
Federal Trade Commission
All of the above
None of the above

Question 97 of 150

A new medication is in the process of development. Which of the following would comprise of the definition of a “new drug”?

I. Been recognized as safe and effective from the manufacturer

II. A product that is in existence in another country but not approved in the United States

III. A drug with a new therapeutic indication

I and II
II and III
I and III
I, II, and III
III only

Question 98 of 150

Which of the following is true regarding the investigational new drug application?

Clinical phase to gather evidence on safety
There is no way that a sponsor-investigator can get an exemption
The clinical trial testing can occur as soon as the application is submitted
Clinical trial can start if appropriate if the sponsor-investigator reports emergency use appropriately
The sponsor-investigator does not need to go through institutional review board for approval

Question 99 of 150

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

Preclinical-study humans
Phase I-primary purpose is effectiveness
Phase II- primary purpose is safety
Phase III- test metabolism of the drug
Phase IV- report post-marketing effects

Question 100 of 150

The FDA is required to review the New Drug Application within how many days of filing?

5 days
10 days
30 days
90 days
180 days

Question 101 of 150

Which of the following is true about biologics?

New biologics get approved via a New Drug Application
It does not follow as rigorous regulatory and clinical testing as medicinal drugs
The Center Biologics Evaluation and Research is unable to work together with Center for Drug Evaluation and Research
All of the above
None of the above

Question 102 of 150

Which of the following laws allowed Tylenol to be an over the counter drug?

Orphan Drug Act of 1983
Durham-Humphrey Amendment
Generic Drug User Fee Amendments
Kefauver-Harris Amendments
Pure Food and Drug Act

Question 103 of 150

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 the supply for that day. How should the pharmacist proceed to dispense the prescription?

Dispense the medication as written
Order the medication for the next day to fill
Refuse to fill the medication
A & B
None of the above

Question 104 of 150

Pharmacist Joe receives a written prescription for Norco®10-325mg as needed for pain for a quantity for #120 tablets. The prescription was written 13 months ago and the patient wants to have it filled. What is wrong with this scenario according to Federal law alone? Select all that apply.

Quantity of tablets
The prescription is older than 12 months
The dose is too high to fill
"Non-Acute Pain" was not specifically written on the prescription pad
There is nothing wrong with the prescription

Question 105 of 150

Pharmacist technician Jessica is about to sterile compound her first IV Medication within the IV Room. However, she has already forgotten the order to properly garment for aseptic compounding. She has already put on her booties, placed a head cover over ears and jewelry, put on a face mask, and washed her hands up to her elbows for 30 seconds with soap and water. What did she do wrong? Select all that apply.

She did not wash her hands for at least 1 minute
She did not wash her hands before putting on the booties
She did not remove all her jewelry before putting on her booties
She did not put on her non-shedding gown before her face mask
None of the above

Question 106 of 150

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

Child Protective Services
Veteran Affairs
Business Associate
Local law enforcement when it involves a minor
None of the above

Question 107 of 150

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

0
1
5
7
There is no limit

Question 108 of 150

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

A maximum of 3.6g per day or 9g per month of pseudoephedrine can be sold
The product must be sold from behind the counter
The pseudoephedrine must be stored in a locked cabinet only
Pseudoephedrine can be sold to individuals 21 years and older with a valid ID
None of the above

Question 109 of 150

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
The date of the transfer and the name of the transferring pharmacist must be recorded
Pharmacies that share a database are only required to transfer the maximum refills allowed by law only
The word, “void” must be written on the face of the invalidated prescription
For written or oral prescriptions, the word “transferred” must be written on the transferred prescription

Question 110 of 150

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

2 days
6 days
7 days
14 days
15 days

Question 111 of 150

Which legislative act allows the FDA to collect fees from sponsor companies?

NDA
PDUFA
FDAMA
FDCA
FEMA

Question 112 of 150

Which word best describes the following definition: a substance derived from or made with the aid of living organisms.

Pure substances
Food
Biologics
New drug
New entity

Question 113 of 150

True or False: The Orphan ACT of 1983 created a series of financial penalties for manufacturers who did not develop drugs to treat rare diseases, defined as any disease that affects fewer than 200,000 persons in the United States.

True
False

Question 114 of 150

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

5 years
10 years
15 years
20 years
3 years

Question 115 of 150

Which of the following drug applications allows a company to market a copy of an expired drug’s patent?

NDA
sNDA
ANDA
BLA
IND

Question 116 of 150

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

Pink Book
Orange Book
Green Book
Purple Book
Red Book

Question 117 of 150

Which of the following prescribers and respective DEA numbers may write a prescription for buprenorphine for the purpose of treating opioid abuse disorder.

Dr. Jones- DEA XJ0012312
Dr. Williams- DEA AW1110222
Dr. Smith- DEA BS21101234
Dr. Evans- DEA ME0077665
Dr. Johnson- DEA MJ8658941

Question 118 of 150

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 physical script or include information that the prescription was transferred on the prescription record if 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 pharmacist who transferred the prescription

I
I & II
II & III
I & III
I, II, & III

Question 119 of 150

Which of the following DEA numbers belongs to a mid-level practitioner?

XJ0012312
AW1110222
BS2101234
ME0077665
AJ5698745

Question 120 of 150

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)
Marijuana (cannabis)
3, 4 – methylenedioxymethamphetamine (MDMA)
Cocaine
Mar

Question 121 of 150

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, this is a:

Schedule II Controlled Substance
Schedule III Controlled Substance
Schedule IV Controlled Substance
Schedule V Controlled Substance
Non-Controlled Substance

Question 122 of 150

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

DEA Form 222
DEA Form 224
DEA Form 41
DEA Form 106
DEA Form 106a

Question 123 of 150

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 demonstrated this to the Board of Pharmacy, and got his license reinstated. Under federal law, can Frank hire Tom if Tom will have 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.
No, any person who has had their pharmacy revoked may not be employed in such a position, even if it has been reinstated.
Yes, but only after if Frank gets a waiver approved by the FDA allowing Tom to be employed in such a position.
Yes, Tom has a valid license to practice pharmacy, his past is irrelevant.
None of the above

Question 124 of 150

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

Monthly
Every 6 months
Annually
Biennially
Every 3 months

Question 125 of 150

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

Methylprednisolone tablets in a package containing 105 mg
Sublingual nitroglycerin
Prednisone tablets in a package containing 125 mg
Betamethasone tablets in a package containing 16.8 mg
None of the above

Question 126 of 150

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

Pancrelipase tablets
Oral contraceptives
Isosorbide dinitrate 10 mg chewable tablets
Erythromycin ethyl succinate tablets in a package of 16 grams
Novolin 70/30 FlexPen

Question 127 of 150

Colestipol powder in packages of _____ or less is exempt from the Poison Prevention Packaging Act of 1970.

2 grams
4 grams
5 grams
6 grams
8 grams

Question 128 of 150

Hormone replacement therapy products are not exempt from the Poison Prevention Packaging Act of 1970, however oral contraceptives are exempt.

True
False

Question 129 of 150

Conjugated estrogen tablets in packages containing no more than ______ of the drug is exempt from the Poison Prevention Packaging Act of 1970.

28 mg
30 mg
32 mg
34 mg
26 mg

Question 130 of 150

If a 5 year old child accidently drinks liquid detergent, the parent should immediately give the child ipecac syrup.

True
False

Question 131 of 150

Any drug containing more than ____ wintergreen oil may be dangerous if used other than directed.

2.5%
5%
10%
15%
8%

Question 132 of 150

Ipecac syrup may be sold in ____ container.

15 ml
15 oz
30 ml
30 oz
5 ml

Question 133 of 150

Mineral oil should only be taken at ______.

Right when you wake up
With breakfast
With lunch
Bedtime
Any time of the day

Question 134 of 150

Which product requires a label warning of allergic reactions?

FD&C Yellow No. 1
FD&C Yellow No. 2
FD&C Yellow No. 4
FD&C Yellow No. 5
FD&C Yellow No. 3

Question 135 of 150

Which product requires an allergy warning on the label?

Ipecac syrup
Sulfites
Isoproterenol inhalation
Potassium salts
None of the above

Question 136 of 150

OTC nonsteroidal anti-inflammatory drugs (NSAIDs) must have _____on the label.

Warning of stomach bleeding
Warning of liver toxicity
Warning of allergic reaction
Warning of difficulty breathing
Warning of foul taste

Question 137 of 150

OTC acetaminophen must have ____on the label.

Warning of stomach bleeding
Warning of liver toxicity
Warning of allergic reaction
Warning of difficulty breathing
Warning of foul taste

Question 138 of 150

What is the grain size of OTC pediatric aspirin?

1 grain
1 1/4 grain
1 1/2 grain
1 3/4 grain
2 grain

Question 139 of 150

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

28 tablets
30 tablets
32 tablets
36 tablets
48 tablets

Question 140 of 150

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

Liver
Kidney
Pancreas
Bladder
Heart

Question 141 of 150

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

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

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

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

The “do not fill date” is incorrect
The days’ supply exceeds the legal limit
Multiple prescriptions for Percocet® drug are not allowed
Nothing is wrong with the prescriptions, fill as written
The total quantity exceeds the legal limit

Question 142 of 150

Which of the following barbiturates is schedule II?

Fiorinal
Phenobarbital
Seconal tablet
Nucynta
Butabarbital

Question 143 of 150

Pharmacy RxCoV is a new store and completed the DEA registration. Which of the following is/are appropriate actions relevant to copies of 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
The pharmacist keeps copy 1 and sends copies 2 and 3 to the supplier
The supplier keeps copy 1 and sends copy 2 to DEA
The pharmacist keeps copy 3 and sends copies 1 and 2 to the supplier
The supplier keeps copy 2 and sends copy 3 to DEA

Question 144 of 150

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

Lead technician
All pharmacists
The person granted power of attorney
The person who signed the DEA Form 224
Pharmacy store manager

Question 145 of 150

True/False: A pharmacy send controlled substances (including schedule II) to a reverse distributor to destroy the damaged and expired medications. The pharmacy also sends copies 2 and 3 of DEA Form 222 and a copy of DEA Form 41.

True
False

Question 146 of 150

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

Poison Prevention Packaging Act of 1970
Federal Anti-Tempering Act
Durham-Humphrey Amendment
Omnibus Budget Reconciliation Act
Combat Methamphetamine Epidemic Act

Question 147 of 150

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

Phase I
Pre-clinical study
Phase IIa
Phase IIb
Phase III

Question 148 of 150

A drug M is suspected to have off-color (supposed to be lilac but it looks like light pink). Which class of this recall will be?

Class I
Class II
Class III
Class IV
None of the above because it does not cause harmful consequences.

Question 149 of 150

Based on the UPS 797 (2019), to evaluate gloving and garbing technique, glove fingertip test and media-fill test must be done initially, thereafter when must they be tested?

Quarterly
6 months
12 months for glove fngertip test and 6 months for media-fill test
12 months
Monthly

Question 150 of 150

Which of following actions are concerned to a pharmacist as a prescription seems suspicious? (Select ALL that apply)

Cash payments
Long distances traveled from the patient’s home to the prescriber’s office or to the pharmacy
Nervous patient demeanor
Requests for early refills of prescriptions
16 years old boy

Average score
Your score

Federal Pharmacy Law Practice Exam

Federal Pharmacy Law Practice Exam

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