Pennsylvania MPJE Pharmacy Jurisprudence

Under the Controlled Substances Act (CSA), which DEA schedule includes drugs with the highest potential for abuse and no currently accepted medical use?

• ASchedule I
• BSchedule II
• CSchedule III
• DSchedule IV

A DEA Form 222 is required for the transfer of which schedule of controlled substances between registrants?

• ASchedule II only
• BSchedules II and III
• CSchedules III through V
• DAll controlled substances

Under federal law, what is the maximum number of refills allowed for a Schedule III controlled substance prescription?

• ANo refills allowed
• BUp to 3 refills within 6 months
• CUp to 5 refills within 6 months
• DUp to 5 refills within 1 year

The Durham-Humphrey Amendment of 1951 established which key distinction in drug classification?

• AGeneric vs. brand-name drugs
• BPrescription (legend) vs. over-the-counter drugs
• CControlled vs. non-controlled substances
• DBiological vs. chemical drugs

Under the Poison Prevention Packaging Act (PPPA), which of the following medications is EXEMPT from child-resistant packaging requirements?

• AAcetaminophen tablets
• BSublingual nitroglycerin tablets
• CAmoxicillin suspension
• DHydrocodone/acetaminophen tablets

What is the primary purpose of the FDA's Risk Evaluation and Mitigation Strategies (REMS) program?

• ATo reduce drug manufacturing costs
• BTo ensure the benefits of a drug outweigh its risks
• CTo speed up the drug approval process
• DTo establish drug pricing guidelines

Under the Combat Methamphetamine Epidemic Act (CMEA), what is the maximum amount of pseudoephedrine a customer can purchase in a 30-day period?

• A3.6 grams
• B7.5 grams
• C9 grams
• D15 grams

A pharmacist receives a prescription for a Schedule II controlled substance dated 45 days ago. Under federal law, this prescription:

• AMust be filled within 30 days
• BMay be filled as there is no federal time limit
• CCannot be filled because it has expired
• DMay only be partially filled

Under the Health Insurance Portability and Accountability Act (HIPAA), which of the following is NOT considered protected health information (PHI)?

• AA patient's prescription history
• BA patient's date of birth
• CDe-identified aggregate prescription data
• DA patient's home address

Under the Drug Supply Chain Security Act (DSCSA), what must be included with each transaction of a prescription drug between trading partners?

• AOnly the drug name and NDC number
• BTransaction information and a transaction statement
• CDEA Form 222 and invoice
• DCertificate of analysis and lot number only

What is the DEA registration renewal period for a pharmacy?

• AEvery year
• BEvery 2 years
• CEvery 3 years
• DEvery 5 years

Under the Omnibus Budget Reconciliation Act of 1990 (OBRA '90), pharmacists are required to perform which of the following for Medicaid patients?

• APrior authorization for all prescriptions
• BDrug utilization review (DUR) and patient counseling
• CGeneric substitution for all brand-name drugs
• DMandatory mail-order dispensing

A prescriber calls in a prescription for 30 tablets of oxycodone 10mg. Under federal law, this oral Schedule II prescription:

• AIs valid and may be filled immediately
• BMust be followed by a written prescription within 7 days
• CIs never permitted under any circumstances
• DIs only permitted in emergency situations

Under the Dietary Supplement Health and Education Act (DSHEA) of 1994, dietary supplements:

• AMust receive FDA pre-market approval
• BAre regulated as drugs by the FDA
• CDo not require FDA pre-market approval for safety and efficacy
• DMust carry the same warnings as OTC drugs

What is the maximum amount of codeine per dosage unit that qualifies a cough preparation for Schedule V classification?

• A100 mg per dosage unit
• B200 mg per dosage unit
• C300 mg per dosage unit
• D500 mg per dosage unit

According to federal law, how long must a pharmacy maintain records for Schedule II controlled substance prescriptions?

• A1 year
• B2 years
• C3 years
• D5 years

Under the FDA Amendments Act, the Sentinel System was established to:

• ATrack counterfeit drug distribution
• BMonitor post-market drug safety using electronic health data
• CApprove new drug applications faster
• DRegulate pharmacy compounding standards