CCP Federal and State Regulations 2 — Questions and Answers
Question 1: Under the Combat Methamphetamine Epidemic Act (CMEA), what is the daily sales limit for pseudoephedrine products per purchaser?
- 3.6 grams (Correct answer)
- 7.5 grams
- 9 grams
- 12 grams
Correct answer: 3.6 grams
CMEA limits pseudoephedrine sales to 3.6 grams per day per purchaser, with a 30-day limit of 9 grams.
Question 2: Which DEA form must be completed when a pharmacy discovers a significant theft or loss of controlled substances?
- DEA Form 41
- DEA Form 106 (Correct answer)
- DEA Form 222
- DEA Form 363
Correct answer: DEA Form 106
DEA Form 106 (Report of Theft or Significant Loss of Controlled Substances) must be filed when significant theft or loss occurs.
Question 3: A long-term care pharmacy receives an order for a Schedule II controlled substance via fax. Under federal law, what must happen before the drug can be dispensed?
- The pharmacist may dispense based on the fax alone
- The original written prescription must be presented before dispensing (Correct answer)
- A verbal confirmation from the prescriber is sufficient
- A DEA Form 222 must accompany the fax
Correct answer: The original written prescription must be presented before dispensing
Schedule II prescriptions transmitted by fax to LTC pharmacies serve only as the original written Rx; the original must be presented before dispensing.
Question 4: Which federal agency is responsible for enforcing the Omnibus Budget Reconciliation Act (OBRA '90) prospective drug utilization review requirements?
- DEA
- FDA
- CMS (Centers for Medicare & Medicaid Services) (Correct answer)
- FTC
Correct answer: CMS (Centers for Medicare & Medicaid Services)
CMS oversees OBRA '90 compliance for Medicaid programs, including prospective DUR requirements.
Question 5: A pharmacist working in a long-term care setting must perform a Medication Regimen Review (MRR) for each resident at minimum:
- Every 30 days (Correct answer)
- Every 60 days
- Every 90 days (quarterly)
- Every 6 months
Correct answer: Every 30 days
Federal regulations (42 CFR 483.45) require a consultant pharmacist to conduct an MRR for each LTC resident at least monthly.
Question 6: Under HIPAA, a pharmacy may share protected health information (PHI) with a patient's family member without explicit patient authorization when:
- The family member provides photo identification
- The patient is present and does not object (Correct answer)
- The family member is listed in the pharmacy's records
- Any family member requests it in writing
Correct answer: The patient is present and does not object
HIPAA allows disclosure to a family member involved in the patient's care when the patient is present and has the opportunity to agree or object and does not object.
Question 7: Which provision of the Medicare Modernization Act (MMA) of 2003 specifically created requirements for Medication Therapy Management (MTM) services?
- Section 101 — Part A hospice expansion
- Section 1860D-4(c) — Part D MTM programs (Correct answer)
- Section 501 — generic drug substitution
- Section 301 — long-term care facility standards
Correct answer: Section 1860D-4(c) — Part D MTM programs
Section 1860D-4(c) of the MMA mandated that Part D prescription drug plans offer MTM programs to targeted beneficiaries.
CCP Federal and State Regulations 2
Under the Combat Methamphetamine Epidemic Act (CMEA), what is the daily sales limit for pseudoephedrine products per purchaser?