B.Pharm. Bachelor of Pharmacy Bachelor of Pharmacy (B.Pharm.) Pharmaceutical Jurisprudence 2 — Questions and Answers
Question 1: Under the Controlled Substances Act, which schedule contains drugs with high abuse potential and no currently accepted medical use in the US?
- Schedule II
- Schedule I (Correct answer)
- Schedule III
- Schedule V
Correct answer: Schedule I
Schedule I substances have a high potential for abuse, no accepted medical use, and lack accepted safety for use under medical supervision.
Question 2: Which federal agency is primarily responsible for enforcing the Controlled Substances Act?
- FDA
- DEA (Correct answer)
- CDC
- CMS
Correct answer: DEA
The Drug Enforcement Administration (DEA) is the primary federal agency responsible for enforcing the Controlled Substances Act.
Question 3: A pharmacist receives a prescription for a Schedule II drug signed by a practitioner but undated. What is the appropriate action?
- Fill it immediately
- Contact the prescriber to obtain the date before dispensing (Correct answer)
- Refuse and discard the prescription
- Fill it and note the date received
Correct answer: Contact the prescriber to obtain the date before dispensing
A Schedule II prescription must be complete and signed; a missing date requires contacting the prescriber for clarification before dispensing.
Question 4: Which of the following is true regarding electronic prescriptions for controlled substances (EPCS) in the US?
- EPCS is prohibited by federal law
- EPCS requires DEA-compliant software and two-factor authentication (Correct answer)
- Only Schedule V drugs can be sent via EPCS
- EPCS does not require prescriber identity proofing
Correct answer: EPCS requires DEA-compliant software and two-factor authentication
DEA regulations require that EPCS systems use DEA-compliant software and two-factor authentication to verify prescriber identity.
Question 5: The Durham-Humphrey Amendment of 1951 established which key distinction?
- Over-the-counter versus prescription-only drugs (Correct answer)
- Federal versus state pharmacy jurisdiction
- Brand versus generic drug approval
- Hospital versus community pharmacy requirements
Correct answer: Over-the-counter versus prescription-only drugs
The Durham-Humphrey Amendment defined the categories of legend (prescription-only) drugs and over-the-counter drugs.
Question 6: Under HIPAA, which entity is NOT considered a covered entity?
- Health plan
- Healthcare clearinghouse
- Healthcare provider transmitting PHI electronically
- Pharmaceutical manufacturer (Correct answer)
Correct answer: Pharmaceutical manufacturer
Pharmaceutical manufacturers are not covered entities under HIPAA unless they also function as healthcare providers or clearinghouses.
Question 7: A drug recalled due to a serious health hazard that may cause adverse health consequences or death is classified as which class of recall?
- Class I (Correct answer)
- Class II
- Class III
- Class IV
Correct answer: Class I
Class I recalls involve situations where there is reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
B.Pharm. Bachelor of Pharmacy Bachelor of Pharmacy (B.Pharm.) Pharmaceutical Jurisprudence 2
Under the Controlled Substances Act, which schedule contains drugs with high abuse potential and no currently accepted medical use in the US?