Texas MPJE Pharmacy Law FDCA,
PPPA, & Federal Laws: Dr. C's Review
Chapter 1 Questions and Answers |
Latest Version | 2025/2026 | Correct &
Verified
What does FDCA stand for?
✔✔Federal Food, Drug, and Cosmetic Act.
What is the main purpose of the FDCA?
✔✔To ensure drugs, foods, and cosmetics are safe, effective, and properly labeled.
Which agency enforces the FDCA?
✔✔The U.S. Food and Drug Administration (FDA).
Under the FDCA, what must all prescription drugs have?
✔✔An FDA-approved label and directions for use.
What is the definition of a “new drug” under the FDCA?
✔✔A drug not generally recognized as safe and effective for its labeled use.
What does the FDCA require for drug recalls?
✔✔Notification of the FDA and removal from the market when necessary.
1
,What is the main goal of the Poison Prevention Packaging Act (PPPA)?
✔✔To protect children from accidental ingestion of hazardous household substances and drugs.
Which organization enforces the PPPA?
✔✔The Consumer Product Safety Commission (CPSC).
What type of packaging does the PPPA require for most prescription drugs?
✔✔Child-resistant containers.
Are there exemptions to the PPPA requirements for certain patients?
✔✔Yes, patients or prescribers may request non-child-resistant packaging.
Under federal law, who can request non-child-resistant prescription containers?
✔✔The patient or prescriber.
What is a key requirement for OTC drug labeling under the FDCA?
✔✔Must include active ingredients, dosage instructions, warnings, and purpose.
What does FDA approval of a drug indicate?
✔✔The drug is safe and effective for its intended use when used as directed.
2
,What type of drugs are considered adulterated under the FDCA?
✔✔Drugs contaminated, impure, or manufactured under unsanitary conditions.
What type of drugs are considered misbranded under the FDCA?
✔✔Drugs with false or misleading labeling or missing required information.
What is the role of the FDA in clinical trials?
✔✔To review Investigational New Drug (IND) applications and monitor trial safety.
Under federal law, what is required for dietary supplements labeling?
✔✔Statement of identity, ingredients, net quantity, and manufacturer information.
What does the FDCA require for drug manufacturers regarding adverse events?
✔✔Report serious adverse events to the FDA.
What is a black box warning?
✔✔A strict warning on drug labeling indicating serious or life-threatening risks.
Under the FDCA, what is required for generic drugs?
✔✔They must be bioequivalent to the brand-name drug.
What does the FDCA require for drug advertisements?
3
, ✔✔Must be truthful, not misleading, and include risks and benefits.
Which federal law regulates interstate shipment of drugs?
✔✔The FDCA.
What is required under the FDCA for compounded drugs?
✔✔Compounding must comply with USP standards and avoid mass production.
Under the PPPA, which household items are commonly regulated?
✔✔Prescription drugs, OTC medications, and certain household chemicals.
What is required for a prescription container to be considered child-resistant?
✔✔Difficult for children under five to open but not difficult for adults.
Can repackaged drugs for institutional use be exempt from PPPA?
✔✔Yes, in certain hospitals or institutional settings.
What is the maximum allowed deviation for drug potency under FDCA standards?
✔✔Typically ±10% of labeled strength.
What is a key requirement for drug marketing to healthcare professionals?
✔✔Provide fair balance of risks and benefits.
4
PPPA, & Federal Laws: Dr. C's Review
Chapter 1 Questions and Answers |
Latest Version | 2025/2026 | Correct &
Verified
What does FDCA stand for?
✔✔Federal Food, Drug, and Cosmetic Act.
What is the main purpose of the FDCA?
✔✔To ensure drugs, foods, and cosmetics are safe, effective, and properly labeled.
Which agency enforces the FDCA?
✔✔The U.S. Food and Drug Administration (FDA).
Under the FDCA, what must all prescription drugs have?
✔✔An FDA-approved label and directions for use.
What is the definition of a “new drug” under the FDCA?
✔✔A drug not generally recognized as safe and effective for its labeled use.
What does the FDCA require for drug recalls?
✔✔Notification of the FDA and removal from the market when necessary.
1
,What is the main goal of the Poison Prevention Packaging Act (PPPA)?
✔✔To protect children from accidental ingestion of hazardous household substances and drugs.
Which organization enforces the PPPA?
✔✔The Consumer Product Safety Commission (CPSC).
What type of packaging does the PPPA require for most prescription drugs?
✔✔Child-resistant containers.
Are there exemptions to the PPPA requirements for certain patients?
✔✔Yes, patients or prescribers may request non-child-resistant packaging.
Under federal law, who can request non-child-resistant prescription containers?
✔✔The patient or prescriber.
What is a key requirement for OTC drug labeling under the FDCA?
✔✔Must include active ingredients, dosage instructions, warnings, and purpose.
What does FDA approval of a drug indicate?
✔✔The drug is safe and effective for its intended use when used as directed.
2
,What type of drugs are considered adulterated under the FDCA?
✔✔Drugs contaminated, impure, or manufactured under unsanitary conditions.
What type of drugs are considered misbranded under the FDCA?
✔✔Drugs with false or misleading labeling or missing required information.
What is the role of the FDA in clinical trials?
✔✔To review Investigational New Drug (IND) applications and monitor trial safety.
Under federal law, what is required for dietary supplements labeling?
✔✔Statement of identity, ingredients, net quantity, and manufacturer information.
What does the FDCA require for drug manufacturers regarding adverse events?
✔✔Report serious adverse events to the FDA.
What is a black box warning?
✔✔A strict warning on drug labeling indicating serious or life-threatening risks.
Under the FDCA, what is required for generic drugs?
✔✔They must be bioequivalent to the brand-name drug.
What does the FDCA require for drug advertisements?
3
, ✔✔Must be truthful, not misleading, and include risks and benefits.
Which federal law regulates interstate shipment of drugs?
✔✔The FDCA.
What is required under the FDCA for compounded drugs?
✔✔Compounding must comply with USP standards and avoid mass production.
Under the PPPA, which household items are commonly regulated?
✔✔Prescription drugs, OTC medications, and certain household chemicals.
What is required for a prescription container to be considered child-resistant?
✔✔Difficult for children under five to open but not difficult for adults.
Can repackaged drugs for institutional use be exempt from PPPA?
✔✔Yes, in certain hospitals or institutional settings.
What is the maximum allowed deviation for drug potency under FDCA standards?
✔✔Typically ±10% of labeled strength.
What is a key requirement for drug marketing to healthcare professionals?
✔✔Provide fair balance of risks and benefits.
4
