FedPharmLaw OTC Flashcards
Above what quantity of sodium will the labeling of a nonprescription drug need the warning statement “Ask a doctor before use if you have a sodium-restricted diet”?
A. 5 mg
B. 35 mg
C. 140 mg
D. 600 mg
E. 975 mg
C. 140 mg
Which of the following does NOT need to be on the Drug Facts panel of a nonprescription drug?
A. Active ingredient
B. Uses
C. Warnings
D. Quantity of dosage units within the container
E. Manufacturer’s contact information
D. Quantity of dosage units within the container
What are examples of drug paraphernalia? (Select ALL that apply.)
A. Small glass pipes
B. A syringe used to inject insulin
C. Rolling papers
D. Kits for injection or free basing drugs
E. A bong or other inhalation device that could be used for marijuana
A. Small glass pipes
C. Rolling papers
D. Kits for injection or free basing drugs
E. A bong or other inhalation device that could be used for marijuana
What is the maximum number of pseudoephedrine HCl 60 mg tablets that can be sold OTC within 30 days from a mail-order pharmacy, per federal restrictions?
A. 15
B. 30
C. 60
D. 152
E. 125
D. 152
The maximum amount of pseudoephedrine that can be purchased in one month from a mail-order pharmacy is 7,500 mg (base). Each 60 mg pseudoephedrine HCl tablet contains 49.2 mg of base.
Calculation:
7,500 mg ÷ 49.2 mg ≈ 152.4 tablets → Rounded down to 152 tablets.
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Above what quantity of calcium will the labeling of a nonprescription drug need the following warning statement:
Ask a doctor before use if you have:
* Kidney stones
* A calcium-restricted diet
A. 25 mg
B. 140 mg
C. 600 mg
D. 975 mg
E. 3.2 g
E. 3.2 g
The labeling on nonprescription drugs are written for:
A. Patients with medical background
B. Patients with no medical training
C. Pharmacists
D. Physicians
E. Nurses
B. Patients with no medical training
Which emergency contraception requires a prescription in order to be dispensed?
A. Plan B One-Step
B. Take Action
C. New Day
D. Ella
E. My Way
D. Ella
Which of the following are valid forms of identification for purchasing pseudoephedrine? (Select ALL that apply.)
A. State-issued driver’s license
B. Social security card
C. State-issued identification card
D. Birth certificate
E. Federally-issued passport
A. State-issued driver’s license
C. State-issued identification card
E. Federally-issued passport
Which of the following statements must be on the label of a nonprescription drug, when appropriate? (Select ALL that apply.)
A. “If pregnant or breast-feeding, ask a health professional before use”
B. “Nonprescription drug”
C. “Keep out of reach of children”
D. “For external use only” for topical drug products not intended for ingestion
E. “OTC only”
A. “If pregnant or breast-feeding, ask a health professional before use”
C. “Keep out of reach of children”
D. “For external use only” for topical drug products not intended for ingestion
Above what quantity of potassium will the labeling of a nonprescription drug need the following warning statement:
Ask a doctor before use if you have:
* Kidney stones
* A potassium-restricted diet
A. 25 mg
B. 140 mg
C. 600 mg
D. 975 mg
E. 3.2 g
D. 975 mg
Which of the following is NOT required on the label of an over-the-counter (OTC) drug?
A. Adequate directions for use
B. Established name of the drug
C. Pharmacological category of the drug
D. Warnings
E. National Drug Code
E. National Drug Code
What is required on the label of a nonprescription drug? (Select ALL that apply.)
A. Principal display panel
B. Established name of the drug
C. Quantity
D. NDC number
E. Adequate directions for use
A. Principal display panel
B. Established name of the drug
C. Quantity
E. Adequate directions for use
What is the maximum number of Sudafed 30 mg tablets that can be purchased OTC in one day from a pharmacy, per federal restrictions?
A. 120
B. 30
C. 60
D. 146
E. 240
D. 146
The maximum amount of pseudoephedrine that can be purchased in one day (i.e., 3,600 mg) is based on the base amount of drug. Pseudoephedrine hydrochloride (Sudafed) 30 mg contains 24.6 mg of base. 3,600 mg max base per day / 24.6 mg base per tablet = 146 tablets.
A male stops by the pharmacy and would like to purchase over-the-counter Plan B One-Step. What should the pharmacist do?
A. Dispense if the customer shows proof that he is at least 17 years old
B. Do not dispense, Plan B One-Step can only be sold to females
C. Do not dispense, Plan B One-Step is only available with a prescription
D. Dispense to the patient without proof of age or identification
E. Dispense if the customer shows proof that he is at least 21 years old
D. Dispense to the patient without proof of age or identification
Plan B One-Step and other brands of levonorgestrel emergency contraception (EC) may be sold over-the-counter to anyone, regardless of age or gender. A valid prescription is only required if the patient wants the medication processed by insurance, but the prescription must be written for the female partner.
Which of the following statements is correct regarding the storage of pseudoephedrine (PSE) per federal law?
A. PSE combination products may be placed anywhere in the store.
B. All products containing PSE must be stored in a locked cabinet.
C. It is acceptable to keep the PSE products in the photo department behind the counter.
D. All products containing PSE must be stored in the pharmacy department behind the counter.
E. All products containing PSE must be stored in a location that is easily accessible to customers.
C. It is acceptable to keep the PSE products in the photo department behind the counter.
Pseudoephedrine-containing products cannot be kept in a location where customers can access them without assistance from a store employee. While they are often stored behind the pharmacy counter, this is not a federal requirement.
Which pseudoephedrine sale does not require documentation in a logbook?
A. Two tablets of 30 mg
B. Two tablets of 60 mg
C. Single tablet of 120 mg
D. Mail order purchase
E. Purchase by a patient over 21 years of age
A. Two tablets of 30 mg
A single dose package can be purchased without signing the logbook. A single dose is defined as one to two 30 mg tablets.
What is the maximum number of pseudoephedrine hydrochloride 30 mg tablets that can be purchased OTC within 30 days from a pharmacy, per federal restrictions?
Answer Choices:
A. 60
B. 120
C. 250
D. 365
E. 300
D. 365
The maximum amount of pseudoephedrine that can be purchased OTC in one month (i.e., 9,000 mg) is determined by the base amount of drug. Pseudoephedrine hydrochloride 30 mg contains 24.6 mg of base. 9,000 mg max base per month / 24.6 mg base per tablet = 365.85 tablets (round down to 365 tablets).
Which of the following is true of warning statements on electrolyte labels?
A. A label can only contain a warning statement for one electrolyte.
B. Warning statements can be combined for multiple electrolytes if they are listed in order of highest to lowest potency of electrolyte.
C. A label must contain a separate warning statement for each electrolyte ingredient; the warning statements cannot be combined.
D. Warning statements can be combined for multiple electrolytes if they are listed in alphabetical order.
E. Warning statements are only required on the label if the product contains potassium.
D. Warning statements can be combined for multiple electrolytes if they are listed in alphabetical order.
A 23-year-old female patient comes into the clinic asking for emergency contraception. It has been 92 hours since she had unprotected sex. Which of the following is the best emergency contraception for this patient?
A. Take Action
B. Plan B One-Step
C. Ella
D. New Day
E. My Way
C. Ella
Plan B One-Step and similar products are FDA-approved for administration up to 72 hours after unprotected intercourse. Ulipristal (Ella) can be taken up to 120 hours after intercourse.
Which of the following statements is true regarding FDA regulations that require “adequate directions for use”?
A. The directions must be written clearly so that a healthcare provider can instruct a patient on how to use the OTC drug safely and for appropriate purposes.
B. The directions must be written clearly so that a layperson can use the OTC drug safely and for appropriate purposes.
C. The instructions must be written at an eighth grade level.
D. If the product is commonly used, it is optional for the manufacturer to include dosing, preparation, frequency, duration, time and route of administration.
E. These are required for prescription drugs only and not required for OTC products.
B. The directions must be written clearly so that a layperson can use the OTC drug safely and for appropriate purposes.
OTC drugs must contain adequate directions for use for a layperson to understand, including (when applicable) the dosing, preparation, frequency, duration, time and route of administration.
Above what quantity of magnesium will the labeling of a nonprescription drug need the following warning statement:
Ask a doctor before use if you have:
* Kidney stones
* A magnesium-restricted diet
A. 25 mg
B. 140 mg
C. 600 mg
D. 975 mg
E. 3.2 g
C. 600 mg
