Federal Law

Question 1

How many days does the FDA have to file an NDA for review?

Answer 1

60 Days

Question 2

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

Answer 2

90 mL

Question 3

Schedule 2 Barbituates

Answer 3

Seconal (Secobarbital), Pentobarbital, Amnobarbital

Question 4

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

Answer 4

Green Book

Question 5

If a patient requests a copy of their personal information from a pharmacy, how many days does the pharmacy have to fulfill this request (according to HIPAA)?

Answer 5

30 days

Question 6

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

Answer 6

Schedule III

Question 7

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?

Answer 7

90 Days

Question 8

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?

Answer 8

180 days

Question 9

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

Answer 9

Every 3 years

Question 10

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

Answer 10

30 days

Question 11

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

Answer 11

every 12 months

Question 12

The proper order for cleaning sterile hazardous medications?

Answer 12

The proper order for cleaning sterile hazardous medications is to deactivate, decontaminate, clean, and disinfect

Question 13

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

Answer 13

A person under 18 years of age is required to have had two documented unsuccessful attempts at short-term medical withdrawal (detoxification) or drug-free treatment within 12 months to be eligible for methadone maintenance treatment

Question 14

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

I. Secobarbital Suppository

II. Pentobarbital Injection

III. Amobarbital Capsule

Answer 14

II & III only (While secobarbital capsule is C-II, secobarbital suppository is C-III)

Question 15

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

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

Answer 15

IV:The level of the drug in the product is 10% V/V but the label states 15% V/VAdulteration is reducing the purity of a drug/product by adding a foreign or inferior substance to it or even removing a valuable ingredient. So, this could be a difference in strength, quality, or purity from what it was supposed to be or

contains harmful or dirty/decomposed substances. Examples include making a drug in a place that results in adulteration, container system (bottle) could cause adulteration (if the bottle is opened), strength/quality differs from claim on the label, etc.

Misbranding– Presence or absence of information on the label of a product that is false, deceptive, or misleading. Examples of this would be filling for Crestor but putting Lipitor in the bottle. Lots of examples of this pertains to the label itself (false claims of where the product came from or where it was made, size of type is not according to standards, the wrong name of the drug, lack of directions or warnings, MedGuide wasn’t provided when it was supposed to, etc).

Question 16

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

Answer 16

III Only III, Retrospective review for federal law

Question 17

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

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

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

C. This law was passed by Congress in 1938

D. The law failed to protect the public

E. This law was passed by Congress in 1906

Answer 17

The correct answers are A, B, and C. The pure food and drug act was enacted in 1906 (not 1938), thus C is incorrect. Its main purpose was to ban foreign and interstate traffic in adulterated or mislabeled food and drug products and required that active ingredients be placed on the label of a drug’s packaging and that drugs could not fall below purity levels established by the USP or the National Formulary. B is incorrect as it includes “cosmetics”, but this act was limited to food and drugs. Choice A is incorrect as the diethylene glycol (or sulfanilamide) deaths led to the passing of the 1938 Food, Drug, and Cosmetic Act as the 1906 act failed to protect the public, so it was largely replaced by the 1938 act.

Question 18

Codeine CIII Schedule Requirements

Answer 18

C-III controlled substance: “Not more than 1.8 grams of codeine per 100 milliliters or not more than 90 milligrams per dosage unit, with an equal or greater quantity of an isoquinoline alkaloid of opium”

Question 19

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

A. Identical amounts of the same active ingredient
B. Identical strength or concentration
C. Same route of administration
D. Same excipients
E. Same dosage form

Answer 19

The correct answer is D. Pharmaceutical Equivalents. Drug products are considered pharmaceutical equivalents if they contain the same active ingredient(s), are of the same dosage form, route of administration, and are identical in strength or concentration (e.g., chlordiazepoxide hydrochloride, 5mg capsules).

Pharmaceutically equivalent drug products are formulated to contain the same amount of active ingredient in the same dosage form and to meet the same or compendial or other applicable standards (i.e., strength, quality, purity, and identity), but they may differ in characteristics such as shape, scoring configuration, release mechanisms, packaging, excipients (including colors, flavors, preservatives), expiration time, and, within certain limits, labeling.

Question 20

What are examples of Schedule III Controlled Substances?

Answer 20

Schedule III drug abuse potential is less than Schedule I and Schedule II drugs but more than Schedule IV. Some examples of Schedule III drugs are: Products containing less than 90 milligrams of codeine per dosage unit (Tylenol with codeine), Marinol (dronabinol), ketamine, anabolic steroids, testosterone

Question 21

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

Answer 21

Transfer of Business: A pharmacy registrant that transfers its business operations to another pharmacy registrant must submit in person or by registered or certified mail, return receipt requested, to the Special Agent in Charge in his/her area, at least 14 days in advance of the date of the proposed transfer (unless the Special Agent in Charge waives this time limit in individual instances), the following information:

The name, address, registration number, and authorized business activity of the registrant discontinuing the business (registrant-transferor)
The name, address, registration number, and authorized business activity of the person acquiring the business (registrant-transferee)
Whether the business activities will be continued at the location registered by the person discontinuing business or moved to another location (if the latter, the address of the new location should be listed)

Question 22

Facsimiles may serve as original prescriptions for Schedule IIs for which of the following?

Answer 22

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

Question 23

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

Answer 23

II & III
Community pharmacies are permitted to transmit prescription information to a central fill pharmacy in two ways.

First, a facsimile of a prescription for a controlled substance in Schedule II-V may be provided by the community pharmacy to the central fill pharmacy. The community pharmacy must maintain the original hard copy of the prescription and the central fill pharmacy must maintain the facsimile of the prescription.

Question 24

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

A. Dr. Brown is strictly prohibited from prescribing methadone to her patient for this indication because she is not registered as an OTP
B. Dr. Brown is permitted to administer up to a 3-day supply of the drug for this indication
C. 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
D. A & B only
E. A & C only

Answer 24

The correct answer is D. A practitioner who wants to use Schedule II narcotic drugs for maintenance and/or detoxification must obtain separate registration from DEA as a narcotic treatment program according to the Narcotic Addict Treatment Act of 1974.

An exception to the registration requirement, known as the “three-day rule” (Title 21, Code of Federal Regulations, Part 1306.07(b)), allows a practitioner who is not separately registered as a narcotic treatment program, to administer (but not prescribe) narcotic drugs to a patient to relieve acute withdrawal symptoms while arranging for the patient’s referral for treatment, under the following conditions:

Not more than one day’s medication may be administered or given to a patient at one time
This treatment may not be carried out for more than 72 hours
These 72 hours cannot be renewed or extended.

Question 25

Which of the following are true statements regarding the Consolidated Appropriations Act of 2023? Select ALL that apply. A. Providers or practitioners do not need a DATA waiver to treat patients with buprenorphine for opioid use disorder B. Providers or practitioners who are DEA-registered do not need to undergo new training requirements C. Buprenorphine prescriptions require an “X” in the DEA registration number D. Methadone prescriptions to treat opioid use disorder are not affected by the Consolidated Appropriations Act of 2023 E. The Consolidated Appropriations Act of 2023 overrides state laws and regulations

Answer 25

The correct answers are A and D. The passing of the Consolidated Appropriations Act, 2023 removed the federal obligation for providers and practitioners to apply for a DATA waiver to treat patients with buprenorphine for opioid use disorder. Moreover, the designation of an “X” for buprenorphine prescriptions is no longer applicable as all that is required is a standard DEA registration number. The Consolidated Appropriations Act does not impact the treatment of methadone for opioid use disorder. Lastly, all DEA-registered practitioners must undergo new training requirements on or after June 27, 2023.

Question 26

What should you do to comply with DEA 106 procedures?

Answer 26

The correct answer is A. It is suggested that initial reports be required within one business day and that DEA Form 106 must be filed within 30 days.

Question 27

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

Answer 27

The same as the variability between different batches of the brand-name drug

Question 28

Marketing of OTC drugs is regulated by?

Answer 28

Federal Trade Commission

Question 29

Correct Order of Garbing Per USP 797

Answer 29

Remove jewelry, cosmetics, and outer garments such as hats and jackets Booties/shoe covers Hair and beard covers Face mask Wash hands with soap and warm water up to elbows for a minimum of 30 seconds Dry with a lint-free disposable towel Non-shedding gown Scrub bare hands with waterless alcohol-based hand antiseptic; allow to dry thoroughly Sterile powder-free gloves: may be donned in the clean-room Disinfect gloves with 70% IPA”

Question 30

CMEA Requirements

Answer 30

Requirement of regulated sellers to place the products behind the counter or in locked cabinets. Requirement of regulated sellers to check the identity of purchasers and maintain a log of each sale that includes the purchaser’s name and address, the signature of the purchaser, a product sold, quantity sold, date, and time. Requirement of regulated sellers to maintain the logbook for at least two years. Requirement of regulated sellers to train employees in the requirements of the law and certify to DEA that the training has occurred. Places a quantity limit of each of the chemicals that may be sold to an individual in a day to 3.6 grams of the chemical (base) without regard to the number of transactions. For nonliquids, product packaging is limited to blister packs containing no more than 2 dosage units per blister. Where blister packs are not technically feasible, the product must be packaged in unit dose packets or pouches. For individuals, purchases in 30 days are limited to 9 grams, of which not more than 7.5 grams may be imported using a common or contract carrier or the U.S. Postal Service.”

Question 31

Who can sign the DEA Form 222 and CSOS?

Answer 31

Based on the §1305.05 Power of attorney, the registrant who signed the DEA Form 224 and anyone granted power of attorney by the registrant can sign DEA Form 222 and CSOS to order schedule-II controlled substances

Question 32

What are examples of "labeling" under the law?

Answer 32

Labeling, or promotional labeling, of drug products include: Brochures Booklets Lectures Slide kits Magazine articles Letters to physicians Commericials (TV or radio) are not considered labeling

Question 33

Which of the following components are required to make up a product identifier?

Answer 33

only components that are required to be a product identifier are SNI, lot number, and expiration date

Question 34

Different Classes of Recalls

Answer 34

Class I – A reasonable probability exists that use of the product will cause or lead to serious adverse health events or death. An example of a product that could fall into this category is a label mix-up on a lifesaving drug. Class II – The probability exists that use of the product will cause adverse health events that are temporary or medically reversible. One example is a drug that is understrength but that is not used to treat life-threatening situations. Class III – The use of this product will probably not cause an adverse health event. Examples might be a container defect, off taste, or color in a liquid.

Question 35

"CAUTION: Federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed” is required on labels for which schedules?

Answer 35

II-IV (not V)

Question 36

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

Answer 36

Drug studies in humans can begin only after an IND is reviewed by the FDA and a local institutional review board (IRB). They must show the FDA results of preclinical testing in laboratory animals and what they propose to do for human testing. At this stage, the FDA decides whether it is reasonably safe for the company to move forward with testing the drug in humans.

Question 37

What is discarded in Hazardous Waste Yellow Containers?

Answer 37

All PPE worn when handling HDs, such as the outer chemotherapy gloves, the chemotherapy gown, and outer shoe cover, are considered contaminated with trace amounts. They will be trashed in yellow containers. Also, trace anti-neoplastic waste (i.e., empty vials, empty syringes, etc.) is usually thrown away in yellow containers.

Question 38

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

Answer 38

Bulk anti-neoplastic waste

Question 39

Which of the following are possible reasons a supplemental NDA (sNDA) may need to be filed by the manufacturer

Answer 39

Any changes to the approved product’s indications, active ingredients, manufacture or labeling require the manufacturer to submit a sNDA for approval.

Question 40

What are considered aqueous preparations when compounding?

Answer 40

Aqueous preparations have a water activity ≥ 0.6 and include emulsions, gels, creams, solutions, sprays, or suspensions. Nonaqueous preparations have a water activity < 0.6 and include ointments, capsules, tablets, granules, powders, nonaqueous topicals, suppositories, and troches.

Question 41

Phase 1 clinical trials

Answer 41

small group of healthy individuals is given the drug. Primary purpose of this phase is to assess toxicology, PK, SAFETY

Question 42

Phase 2 clinical trials

Answer 42

Larger group that have the disease are given drug- purpose is to assess EFFECTIVENESS, adequate dosing, side effects

Question 43

Phase 3 clinical trials

Answer 43

large groups in several geographic areas, purpose is to assess effectiveness vs placebo

Question 44

Journey from IND to NDA

Answer 44

Data collected from IND clinical trials is submitted to FDA in NDA. If FDA is satisfied, they will approve the NDA. At this point, the manufacturer can market the drug.

Question 45

Abbreviated New Drug Application

Answer 45

Once the patient expires on a drug, other companies can submit ANDA to sell generic versions. Will include pharmacokinetic properties, bioavailability, clinical activity,

Question 46

Supplemental New Drug Application

Answer 46

Would be required for an existing product to: -Add a new dosage form -tablet strength -new therapeutic use for the original drug

Question 47

Dispensing a prescription drug without a prescription or dispensing a medication that doesn't have a refill are examples of...

Answer 47

Misbranding

Question 48

Ipecac Syrup Quantity limit

Answer 48

30 mL

Question 49

Prescription Drug Marketing Act 1987

Answer 49

-Companies cannot ship drugs in between states without first being registered in the state from which they are being shipped -Prohibits drugs from being reimported into the United States except by manufacturer of said drugs -Requires state licensing of drug wholesalers -Retail pharmacies cannot have drug samples -

Question 50

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

Answer 50

Transaction information, transaction history, transaction statement

Question 51

Which ingredients have special labeling requirements if included in a product?

Answer 51

FD&C yellow No.5, aspartame, wintergreen oil, mineral oil, salicylates, sulfites, ipecac syrup, alcohol

Question 52

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

Answer 52

FAERS- FDA Adverse event reporting system

Question 53

What is the purple book used for?

Answer 53

Contains information about biological products and how to interchange biologics

Question 54

Pink Book

Answer 54

Vaccines, vaccine preventable illnesses

Question 55

In which cases must an exact count be taken when performing a controlled substance inventory?

Answer 55

An exact count must be made on: -Schedule I or 2 controlled substances -any schedule of controlled substance where the bottle holds more than 1000 tablets -and if the containers are sealed/unopened

Question 56

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

Answer 56

The US Attorney General

Question 57

A manufacturer of a prescription-only drug wants to re-classify the drug as an OTC drug. What form must be submitted to FDA?

Answer 57

-A full NDA must be submitted to the FDA to re-classify the drug as OTC

Question 58

Manufacturer's containers of OTC medications are required to have:

Answer 58

-Active ingredient -Inactive ingredient -purpose -uses -warnings -directions -storage information (they are not required to have poison control phone #)

Question 59

Patient Package Inserts must be provided to patients in acute care hospitals or long term care facilities...

Answer 59

Prior to the first administration and every 30 days thereafter

Question 60

How long are DEA registrations good for?

Answer 60

36 months, will receive renewal notice 60 days before

Question 61

What types of OTC products are not required to be in tamper resistant packaging?

Answer 61

-Dermatological, dentrifice, insulin or lozenges

Question 62

If a patient requests a copy of pharmacy records, how many days should it take for records to be supplied?

Answer 62

30 days

Question 63

Differences between patients and providers requesting easy open containers

Answer 63

-Patients can sign a blanket easy open waiver to have all rx's with easy open caps -Providers can request easy open caps but only 1 medication

Question 64

When would the FDA require medication guides to be dispensed?

Answer 64

-Drug has serious risks relative to benefits -Patient adherence is crucial to the benefit of the drug -When there is a serious known side effect -providing information can prevent serious adverse events

Question 65

What drugs are exempt from child-resistant packaging requirement?

Answer 65

-SL nitroglycerin tablets -Methylprednisolone tablets containing no more than 84 mg per package -preparations in aerosol containers for inhalation -Effervescent aspirin or acetaminophen (non-effervescent are not exempt) -Packages of prednisone are exempt if they contain less than 105 mg of prednisone

Question 66

HIPAA Breach notification rule requires patients to be notified of a HIPAA breach within:

Answer 66

60 days

Question 67

Reporting requirements for HIPAA breaches involving 500 or more patients

Answer 67

-Must be reported to Secretary of the US Dept of Health & Human Services -notification must be made to prominent media outlets

Question 68

How often must a pharmacist conduct a drug regimen review for long term care patients to comply with CMS?

Answer 68

At least once per month