Prepare for the pharmacy law section of your PTCB exam with these practice questions and answers. This guide covers controlled substances, FDA regulations, adulteration, misbranding, and state pharmacy laws.
Q: What was the purpose of the FDCA?
Answer: Focuses on regulating MANUFACTURERS of food, drugs & cosmetics
Q: How are pharmacies impactetd by the FDCA?
Answer: 1. When pharmacy’s compounding activities cross the line and are viewed as manufacturing a new drug2. When pharmacy violates the FDCA prohibtion of marketing/selling a drug product that is MISBRANDED or ADULTERATED
Q: When is a pharmacy exempt from registering with the FDA?
Answer: As long as it operates in conformance with the state law and regularly engaged in DISPENSING prescription prescribed.- DO NOT manufacture, prepare, propagate, compound or process drugs or devices for resale other than in the regular course of business of dispensing or selling at retail
Q: What is the definition of a drug?
Answer: A substance which is:-recognized in USP/NF or Homeopathic pharmacopoeia-Intended for diagnosis, cure, mitigation, treatment or prevention of disease- Non-food article intended to affect structure/function of body- Intended use as component of an item falling within these categories
Q: T or F, the FDCA distinguishes between RX and OTC.
Answer: False
Q: What is the key element of the FDCA?
Answer: The INTENT of the manufacturer or distributor
Q: Can a substance be both a cosmetic and a drug?
Answer: Yes. Classifications are not mutually exclusive.
Q: What category do dietary supplements fall under?
Answer: Food products. They can make “structure function” claims not “drug” claims.
Q: It is ok for a supplement to say “Regular use of this product will help prevent heart disease”?
Answer: FALSE, it can say “regular use of this product will help maintain healthy cholesterol levels
Q: What disclaimer do all supplements have to have on their label?
Answer: “Claims made on the label have not been evaluated or approved by the FDA”
Q: What must all drugs have?
Answer: Labeling in layman’s terms how to use the drug safely and effectively.
Q: What if a drug cannot be made safe by adding warnings or directions to the label?
Answer: The drug is then a PRESCRIPTION or LEGEND drug
Q: What makes a drug a prescription?
Answer: 1. Cannot be made safe by including adequate directions for use2. Medical experts agree that adequate directions for consumer self-medication can’t be provided3. It is habit forming, toxic, potential to harm or NDA limits use to under MD supervision
Q: What are the requirements of OTC?
Answer: – Recognized by experts to be safe & effective- Not considered to be misbranded if manufactured in accordance with GMPs and labeled with layman’s instructions for safe & effective use
Q: What are the violations to the FDCA?
Answer: Misbranding and Adulteration
Q: What is a drug that is sold, dispensed or distributed in violation of the FDCA labeling requirements?
Answer: Misbranded
Q: If a drug’s labeling is false or misleading in any way.
Answer: Misbranded
Q: T or F, if a drug packaging fails to identify the name & address of the manufacturer, packager or distributor it is considered Misbranded.
Answer: True
Q: A drug packaging does not indicate the quantity of drug, is it misbranded?
Answer: Yes
Q: What phrase must be on habit forming medication labels so as to not be considered Misbranded?
Answer: “Warning- may be habit forming”
Q: A drug contains a habit forming substance and the label doesn’t indicate the NAME & PROPORTION of the substance.
Answer: Misbranded
Q: A drug is misbranded IF the established name or each active ingredient for multi-ingredient products, is not identified on the label.
Answer: True
Q: A drug does not need adequate directions for use and adequate warnings, it is not considered misbranded.
Answer: False
Q: Drugs have to be packaged & labeled in acccordance with USP/NP specifications in order to not be misbranded.
Answer: True
Q: If a drug is liable to deterioration and there is no warning on the label, it is misbranded
Answer: True
Q: It a drug has a misleading container it is misbranded.
Answer: True
Q: It is ok for a drug to imitate another drug or be sold under another name.
Answer: False- Misbranding
Q: If the dosage, frequency, duration or route of admin suggested in the labeling is dangerous it is misbranded.
Answer: True
Q: Failure of a drug or device to satisfy FDA purity standards is ________
Answer: Adulterated
Q: A drug consists of any filthy, putrid or decomposed substance.
Answer: Adulterated
Q: If a drug has been prepared, packed or held under unsanitary conditions whereby it may have become contaminated with filth or rendered dangerous to health it is adulterated.
Answer: True
Q: If a drug is manufactured in a facility in violation of GMP it is considered adulterated.
Answer: True
Q: If a drug is packaged in a facility in violation of GMP it is NOT considered adulterated.
Answer: False
Q: A drug consists of a poisonous or deleterious substance that is dangerous to health, what is this known as.
Answer: Adulterated
Q: It is ok for a drug to have unsafe color additives if it’s sole use is for coloring.
Answer: False, this is Adulterated
Q: If a drug’s strength differs from the official compendium or quality or purity falls below compendium standards, is this adulterated or misbranded?
Answer: Adulterated
Q: If a drug is NOT listed in the official compendium and its strength differs from or quality & purity falls below what is on the label is this adulterated or misbranded?
Answer: Adulterated
Q: It is ok to mix a drug with a substance to reduce the drug’s strength.
Answer: No-adulterated
Q: If a substance has been substituted for the drug this is misbranding.
Answer: False adulterated
Q: A pharmacist drops a tablet on the floor but proceeds to put the drug in a vial to dispense to a patient, is this adulterated or misbranded
Answer: Adulterated- the drug may be contaminated
Q: There is a fire in the front end of CVS and smoke fills the entire store. Fire trucks arrive to put out the fire. There is heat and humidity throughout the store. When the fire is put out you see the pharmacy was never touched, are the drugs adulterated?
Answer: Yes