Bachelor of Pharmacy (B.Pharm.) Pharmaceutical Jurisprudence Flashcards
7 cards from real B.Pharm. Bachelor of Pharmacy practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 7 Bachelor of Pharmacy (B.Pharm.) Pharmaceutical Jurisprudence flashcards as text
Which FDA program allows patients with serious conditions to access investigational drugs outside of clinical trials?
Answer: Expanded Access (Compassionate Use)
Expanded Access (also called Compassionate Use) allows patients with serious conditions access to investigational drugs outside of clinical trials when no comparable alternatives exist.
A pharmacist who dispenses a medication that was removed from market due to safety concerns may face which type of liability?
Answer: Both civil and criminal liability
Dispensing a recalled drug can result in both civil liability for patient harm and criminal liability for violating federal regulations.
The Ryan Haight Online Pharmacy Consumer Protection Act of 2008 requires that prescriptions for controlled substances dispensed via the internet must be based on:
Answer: An in-person medical evaluation by a DEA-registered practitioner
The Ryan Haight Act requires that controlled substances dispensed via online pharmacies be based on a valid prescription from a practitioner who has conducted at least one in-person evaluation.
Which organization accredits hospital pharmacy programs and sets standards for medication management in healthcare organizations?
Answer: The Joint Commission (TJC)
The Joint Commission accredits healthcare organizations and sets medication management standards that hospital pharmacies must meet for accreditation.
Under the Poison Prevention Packaging Act, which product is specifically exempt from child-resistant packaging requirements?
Answer: Both A and B
Both oral contraceptives in dispenser packages and sublingual nitroglycerin are specifically exempt from child-resistant packaging requirements under the PPPA.
A pharmacy sells a controlled substance to a known drug dealer. The pharmacist may be charged under federal law with:
Answer: Drug trafficking and distribution of controlled substances
Knowingly selling controlled substances to a drug dealer constitutes illegal drug trafficking and distribution, a serious federal criminal offense under the CSA.
Which record-keeping requirement applies to Schedule II controlled substances at the pharmacy level?
Answer: Must be maintained for at least 2 years and kept separate from other records
Federal regulations require Schedule II records to be maintained for at least 2 years and kept in a separate file from other controlled substance records.