ExCPT Test Pharmacy Law and Regulations 2 — Questions and Answers
Question 1: Under the Controlled Substances Act (CSA), which schedule includes drugs with the highest potential for abuse and no currently accepted medical use in the U.S.?
- Schedule II
- Schedule III
- Schedule IV
- Schedule I (Correct answer)
Correct answer: Schedule I
Schedule I substances (e.g., heroin, LSD, marijuana federally) have the highest abuse potential and no accepted medical use under federal law.
The Controlled Substances Act (CSA), enacted in 1970, classifies controlled substances into five schedules based on medical use, abuse potential, and potential for dependence. Schedule I drugs have the highest abuse potential, no currently accepted medical use in the U.S., and a lack of accepted safety for use under medical supervision. Examples include heroin, LSD, ecstasy (MDMA), peyote, and marijuana at the federal level (though many states have legalized it for medical or recreational use, creating a federal-state legal conflict).
Question 2: The Omnibus Budget Reconciliation Act of 1990 (OBRA '90) requires pharmacists to do which of the following for Medicaid patients?
- Offer generic substitution
- Offer counseling to patients (Correct answer)
- Maintain a paper filing system
- Require physician authorization for refills
Correct answer: Offer counseling to patients
OBRA '90 mandated that pharmacists offer counseling to Medicaid patients about their medications to improve therapeutic outcomes.
OBRA '90 (Omnibus Budget Reconciliation Act of 1990) required state Medicaid programs to implement drug utilization review (DUR) programs. As part of this, pharmacists must offer counseling to Medicaid patients on new prescriptions, covering purpose, dosage, side effects, storage, interactions, and what to do if they miss a dose. While technically required only for Medicaid patients, most states and pharmacies extended this practice to all patients as the standard of care.
Question 3: What is the maximum number of refills allowed for a Schedule III or IV controlled substance?
- No refills permitted
- 3 refills within 6 months
- 5 refills within 6 months (Correct answer)
- Unlimited refills within 1 year
Correct answer: 5 refills within 6 months
Schedule III and IV controlled substances may be refilled up to 5 times within 6 months of the original date of issue.
Under federal DEA regulations, Schedule III and IV controlled substance prescriptions may be refilled up to five times within six months from the original date the prescription was issued. After 6 months or 5 refills (whichever comes first), a new prescription is required. Schedule II drugs have no refills permitted. Schedule V drugs can be refilled as authorized by the practitioner with no specific federal limit (though state laws may vary). Pharmacies must document all refills.
Question 4: A pharmacy receives an oral (telephone) prescription for a Schedule II controlled substance. Under federal law, how may this be handled?
- Accepted only in emergencies; pharmacist must get a written Rx within 7 days (Correct answer)
- Never accepted under any circumstances
- Accepted for up to a 30-day supply without emergency designation
- Accepted if the prescriber faxes the Rx within 24 hours
Correct answer: Accepted only in emergencies; pharmacist must get a written Rx within 7 days
Under the CSA, oral prescriptions for Schedule II drugs are only permitted in genuine emergencies (limited to the amount needed for the emergency period), and the prescriber must provide a signed written prescription within 7 days.
Federal DEA regulations (21 CFR 1306.11) permit Schedule II prescriptions to be telephoned in only in emergency situations. The quantity dispensed must be limited to the amount adequate for the emergency period. The pharmacist must obtain a written and signed prescription from the practitioner within 7 days of authorizing an emergency oral prescription. The pharmacist must note 'Authorization for Emergency Dispensing' on the prescription and notify the DEA if the written Rx is not received within 7 days.
Question 5: Which federal law first required the child-resistant packaging for most OTC and prescription medications?
- Pure Food and Drug Act of 1906
- Durham-Humphrey Amendment of 1951
- Poison Prevention Packaging Act of 1970 (Correct answer)
- Drug Listing Act of 1972
Correct answer: Poison Prevention Packaging Act of 1970
The Poison Prevention Packaging Act (PPPA) of 1970 required child-resistant packaging for most prescription and OTC drugs to reduce accidental pediatric poisonings.
The Poison Prevention Packaging Act (PPPA) of 1970, administered by the Consumer Product Safety Commission (CPSC), required special packaging — commonly called child-resistant (CR) packaging — for most prescription and over-the-counter medications to protect children under 5 years from accidental ingestion. Exemptions exist for certain drugs (e.g., nitroglycerin sublingual tablets, selected oral contraceptives). Patients may also request non-CR packaging in writing, which pharmacies must accommodate.
Question 6: What does the DEA Form 222 allow a pharmacy to do?
- Transfer Schedule II drugs between pharmacies for patient pickup
- Order Schedule I and II controlled substances from a DEA-registered supplier (Correct answer)
- Dispose of expired Schedule III-V substances
- Report suspicious prescribing patterns to the DEA
Correct answer: Order Schedule I and II controlled substances from a DEA-registered supplier
DEA Form 222 (or the electronic equivalent CSOS) is the official ordering document used by DEA-registered practitioners and pharmacies to purchase Schedule I and II controlled substances.
DEA Form 222 is a preprinted, serialized official order form required for purchasing or transferring Schedule I and II controlled substances. Pharmacies registered with the DEA receive these forms and must use them when ordering from DEA-registered distributors. The form comes in triplicate: Copy 1 (supplier keeps), Copy 2 (sent to DEA), Copy 3 (pharmacy keeps for 2 years). Electronic ordering via the Controlled Substance Ordering System (CSOS) is an accepted alternative. Errors on Form 222 void the form — it cannot be corrected.
ExCPT Test Pharmacy Law and Regulations 2
Under the Controlled Substances Act (CSA), which schedule includes drugs with the highest potential for abuse and no currently accepted medical use in the U.S.?