ExCPT Test Pharmacy Law and Regulations 1 — Questions and Answers
Question 1: Which DEA form is required when a pharmacy orders Schedule II controlled substances from a DEA-registered distributor?
- DEA Form 41
- DEA Form 106
- DEA Form 222 (Correct answer)
- DEA Form 363
Correct answer: DEA Form 222
DEA Form 222 (or its electronic equivalent, CSOS) is the official order form mandated by the DEA for purchasing or transferring Schedule II controlled substances. It must be kept on file for at least 2 years.
Question 2: Under the Combat Methamphetamine Epidemic Act (CMEA), what is the maximum amount of pseudoephedrine-containing products a customer may purchase per day?
- 1.8 grams
- 3.6 grams (Correct answer)
- 7.5 grams
- 9 grams
Correct answer: 3.6 grams
CMEA limits pseudoephedrine sales to 3.6 grams per day and 9 grams per 30-day period per customer. Sales must be logged and purchasers must show valid photo ID.
Question 3: The Durham-Humphrey Amendment of 1951 primarily established which of the following in U.S. pharmacy law?
- Mandatory proof of drug efficacy before FDA approval
- The legal distinction between prescription-only and over-the-counter drugs (Correct answer)
- Child-resistant packaging requirements for dispensed medications
- Pharmacist counseling requirements for all new prescriptions
Correct answer: The legal distinction between prescription-only and over-the-counter drugs
The Durham-Humphrey Amendment defined which drugs require a practitioner's prescription (bearing the Rx legend) versus those that can be sold OTC, creating the legal framework still used today.
Question 4: Under HIPAA, which of the following is a right that patients have regarding their Protected Health Information (PHI)?
- The right to have all pharmacy records destroyed after each transaction
- The right to request an amendment to their health record if they believe it is inaccurate (Correct answer)
- The right to prohibit all pharmacy staff members from ever viewing their records
- The right to receive a printed copy of every prescription within 24 hours of dispensing
Correct answer: The right to request an amendment to their health record if they believe it is inaccurate
HIPAA grants patients the right to request amendments or corrections to their health records. Pharmacies must act on such requests within 60 days and may only deny them under specific circumstances.
Question 5: The Poison Prevention Packaging Act (PPPA) requires child-resistant containers for most dispensed medications. Which product is specifically EXEMPT from this requirement by federal regulation?
- Liquid antibiotics dispensed for pediatric patients
- Sublingual nitroglycerin tablets (Correct answer)
- Schedule II opioid medications
- Medications dispensed in amber vials with screw-top caps
Correct answer: Sublingual nitroglycerin tablets
Sublingual nitroglycerin is specifically exempt from PPPA child-resistant packaging because instant access is critical during a cardiac emergency. Other exemptions include oral contraceptives in mnemonic packaging and unit-dose hospital medications.
Question 6: A pharmacy discovers that a quantity of controlled substances is missing and suspects theft. Which DEA form must be submitted to report this event?
- DEA Form 41
- DEA Form 106 (Correct answer)
- DEA Form 224
- DEA Form 363
Correct answer: DEA Form 106
DEA Form 106 (Report of Theft or Significant Loss of Controlled Substances) must be filed promptly when a pharmacy discovers theft or significant unexplained loss. DEA Form 41 is used for destruction of controlled substances, and Form 224 is the pharmacy registration application.
ExCPT Test Pharmacy Law and Regulations 1
Which DEA form is required when a pharmacy orders Schedule II controlled substances from a DEA-registered distributor?