1. A pharmacy technician is preparing to process a prescription for a Schedule II controlled substance. The physician has indicated 'PRN Pain' on the prescription without specifying a maximum daily dose or duration. According to federal regulations, what action should the technician take?
Federal Requirements
A.Contact the prescriber to obtain a specific maximum daily dose and/or duration.
B.Fill the prescription as written, as 'PRN Pain' is a valid indication.
C.Refuse to fill the prescription as it is incomplete and invalid.
D.Clarify with the pharmacist if the prescription can be filled without a specific dose/duration.
Show answerAnswer
A. Contact the prescriber to obtain a specific maximum daily dose and/or duration.
While 'PRN Pain' is a valid indication, for Schedule II controlled substances, federal regulations (and often state laws) require a specific maximum daily dose and/or duration to ensure appropriate use and prevent diversion. The prescriber must be contacted to provide this missing information.
2. A pharmacy technician receives a prescription for fentanyl transdermal patches. The prescriber has indicated 'PRN pain' on the prescription. What federal requirement makes this prescription problematic for dispensing?
Federal Requirements
A.Federal law requires a specific diagnosis to be written on all Schedule II prescriptions.
B.The DEA requires a specific dosage regimen for all Schedule II controlled substances, including frequency and duration.
C.Fentanyl is a Schedule II drug and cannot be prescribed for 'PRN' use.
D.The quantity of fentanyl patches must be explicitly stated, not implied by 'PRN'.
Show answerAnswer
B. The DEA requires a specific dosage regimen for all Schedule II controlled substances, including frequency and duration.
Federal regulations, specifically related to Schedule II controlled substances, mandate that prescriptions include a specific dosage regimen, which means a defined frequency and duration, not just 'PRN' (as needed) without further clarification.
3. A pharmacy technician is reviewing a prescription for a Schedule II controlled substance that was written by a physician. Which of the following elements, if missing, would NOT automatically invalidate the prescription, provided it can be readily obtained from the prescriber?
Federal Requirements
A.Quantity prescribed (numerical and written)
B.Drug name, strength, and dosage form
C.Patient's full name and address
D.Patient's date of birth
Show answerAnswer
D. Patient's date of birth
While a patient's date of birth is important for proper patient identification and billing, it is not a federally mandated element that, if missing, would automatically invalidate a Schedule II prescription. Other critical elements like patient name, drug details, and quantity must be present or the prescription is invalid.
4. A pharmacy technician is stocking non-prescription medications. They come across a product containing pseudoephedrine. Under federal law, what is the maximum amount of pseudoephedrine a customer can purchase in a single day?
Federal Requirements
A.3.6 grams
B.7.5 grams
C.9 grams
D.12 grams
Show answerAnswer
A. 3.6 grams
The Combat Methamphetamine Epidemic Act of 2005 (CMEA) limits the daily purchase of pseudoephedrine to 3.6 grams per customer.
5. A pharmacy technician is assisting a patient who is requesting a medication for severe heartburn. The patient states they have been taking omeprazole for several months without relief and asks for something stronger. Which of the following classifications of medications would require a prescription due to federal regulations?
Federal Requirements
A.H2 Blockers
B.Antacids
C.Proton Pump Inhibitors (PPIs)
D.Bismuth Subsalicylate
Show answerAnswer
C. Proton Pump Inhibitors (PPIs)
While many PPIs are available over-the-counter, some higher-dose or specific formulations still require a prescription, differentiating them from common OTC antacids, H2 blockers, and bismuth subsalicylate.
6. A patient approaches the pharmacy counter asking for an antihistamine to treat their seasonal allergies. They explicitly state they do not have a prescription. Which of the following is an example of an over-the-counter (OTC) antihistamine that can be directly purchased without a prescription?
Federal Requirements
A.Loratadine
B.Fexofenadine with pseudoephedrine (Rx strength)
C.Promethazine
D.Hydroxyzine
Show answerAnswer
A. Loratadine
Loratadine (e.g., Claritin) is a common second-generation antihistamine available over-the-counter for allergy relief.
7. A pharmacy receives an electronic prescription for Adderall XR (amphetamine/dextroamphetamine extended-release), a Schedule II controlled substance. The electronic prescription system flags the order because the prescriber's DEA number is missing. According to federal law, which of the following is REQUIRED information on a prescription for a Schedule II controlled substance?
Federal Requirements
A.The reason for the prescription (diagnosis code).
B.Patient's date of birth and phone number.
C.The pharmacy's NPI number.
D.Prescriber's DEA registration number.
Show answerAnswer
D. Prescriber's DEA registration number.
Federal law mandates that all prescriptions for controlled substances, especially Schedule II drugs, must include the prescriber's DEA registration number. This is a critical identifier for legitimate prescribing.
8. A patient approaches the pharmacy counter with a prescription for phenobarbital 30 mg, to be taken once daily. The prescription is dated 3 months ago. What is the maximum federal validity period for this prescription, and how many refills are allowed?
Federal Requirements
A.1 year, no refills
B.1 year, 5 refills
C.6 months, 5 refills
D.6 months, no refills
Show answerAnswer
C. 6 months, 5 refills
Phenobarbital is a Schedule IV controlled substance. Federal law dictates that Schedule III, IV, and V prescriptions are valid for 6 months from the date of issue and may be refilled up to 5 times within that 6-month period.
9. A pharmacy technician is preparing to return several expired Schedule IV controlled substances to a reverse distributor. What federal DEA form must be used by the pharmacy to document the transfer of these expired medications?
Federal Requirements
A.No specific DEA form is required for returns to a reverse distributor.
B.DEA Form 222
C.DEA Form 106
D.DEA Form 41
Show answerAnswer
D. DEA Form 41
DEA Form 41 is used to document the destruction of controlled substances. When returning expired controlled substances to a reverse distributor for destruction, the reverse distributor typically issues a DEA Form 41 to the pharmacy, documenting the transfer for destruction. If a pharmacy destroys them on-site, they would complete Form 41.
10. A patient calls the pharmacy asking about the difference between over-the-counter (OTC) medications and prescription (Rx) medications. Which federal act primarily established the distinction between these two categories of drugs?
Federal Requirements
A.Controlled Substances Act (CSA) of 1970
B.Durham-Humphrey Amendment of 1951
C.Federal Food, Drug, and Cosmetic Act (FDCA) of 1938
D.Kefauver-Harris Amendment of 1962
Show answerAnswer
B. Durham-Humphrey Amendment of 1951
The Durham-Humphrey Amendment of 1951 specifically established the criteria for distinguishing prescription drugs from over-the-counter (OTC) drugs, making it illegal to dispense prescription drugs without a prescription.
11. A pharmacy technician is helping a patient who is requesting to purchase Children's Tylenol (acetaminophen liquid). The patient is unable to read the drug facts label due to poor eyesight and asks the technician to explain the appropriate dosing for their 3-year-old child who weighs 33 lbs. What federal act specifically requires OTC medications to have clear and adequate directions for use on their labels?
Federal Requirements
A.Federal Food, Drug, and Cosmetic Act of 1938
B.Poison Prevention Packaging Act of 1970
C.Durham-Humphrey Amendment of 1951
D.Kefauver-Harris Amendment of 1962
Show answerAnswer
A. Federal Food, Drug, and Cosmetic Act of 1938
The Federal Food, Drug, and Cosmetic Act (FDCA) of 1938 established the requirement for drug products to be safe and appropriately labeled, including adequate directions for use for OTC medications. The Durham-Humphrey Amendment further clarified the distinction between prescription and OTC drugs.
12. A patient calls the pharmacy asking if they can get an early refill on their Adderall XR (C-II) prescription because they are going on a two-week vacation. The patient states they only have a few days' supply left. According to federal law, what is the maximum number of days' supply a prescriber can provide for a Schedule II controlled substance through multiple prescriptions issued on the same day?
Federal Requirements
A.60 days
B.90 days
C.120 days
D.30 days
Show answerAnswer
B. 90 days
Federal law allows a prescriber to issue multiple prescriptions for a Schedule II controlled substance on the same day, provided each prescription indicates a 'do not fill before' date, and the total quantity does not exceed a 90-day supply.
13. A pharmacy technician is receiving a delivery of various medications. The order includes a box of Promethazine with Codeine cough syrup, a Schedule V controlled substance. What specific documentation is required by federal law for the receipt of this medication?
Federal Requirements
A.The invoice must be signed and dated by the receiving pharmacist or authorized employee.
B.The medication must be immediately entered into a perpetual inventory system.
C.The delivery manifest must be immediately forwarded to the DEA.
D.A completed DEA Form 222 must be signed and dated by the pharmacist.
Show answerAnswer
A. The invoice must be signed and dated by the receiving pharmacist or authorized employee.
For Schedule III, IV, and V controlled substances, federal law requires that the pharmacy maintain a record of receipt, which typically involves signing and dating the invoice from the supplier upon receipt. DEA Form 222 is only for Schedule I and II drugs.
14. A pharmacy technician receives a prescription for clobazam, a Schedule IV controlled substance. The patient is requesting a transfer to another pharmacy. According to federal regulations, how many times can a prescription for clobazam be transferred between pharmacies?
Federal Requirements
A.One time
B.As many times as there are refills remaining
C.Unlimited times within the validity period
D.Zero times
Show answerAnswer
A. One time
Federal law dictates that prescriptions for Schedule III, IV, and V controlled substances may be transferred only one time between pharmacies for refill purposes. If pharmacies share a common electronic database, they may transfer up to the maximum number of refills permitted by law and the prescriber.
15. A pharmacy technician is reviewing a prescription for a controlled substance that was faxed from a prescriber's office. Which of the following Schedule II medications may be accepted as a faxed prescription that serves as the original written prescription?
Federal Requirements
A.Methylphenidate extended-release capsules for a child with ADHD.
B.Fentanyl transdermal patches for a patient with cancer-related pain.
C.Oxycodone tablets for an adult patient with chronic back pain.
D.Hydromorphone for a patient in a long-term care facility (LTCF).
Show answerAnswer
B. Fentanyl transdermal patches for a patient with cancer-related pain.
Federal regulations allow faxed Schedule II prescriptions to serve as the original written prescription in three specific circumstances: for compounded parenteral C-IIs, for C-IIs for residents of a Long-Term Care Facility (LTCF), and for C-II narcotic substances for patients enrolled in a hospice care program. Fentanyl patches for cancer-related pain would fall under the hospice exception if the patient is in hospice.
16. A pharmacy technician is assisting with the annual inventory of controlled substances. The pharmacy maintains a perpetual inventory system for Schedule II medications. According to federal regulations, what is the required accuracy for the count of all Schedule II controlled substances?
Federal Requirements
A.Count within a 5% margin of error.
B.Estimated count for all Schedule II medications.
C.Estimated count if the container holds more than 1,000 units.
D.Exact count (100% accurate).
Show answerAnswer
D. Exact count (100% accurate).
Federal regulations require an exact count for all Schedule II controlled substances during inventory. There is no allowance for estimation or a margin of error for these highly controlled medications, regardless of container size.
17. A pharmacy technician is tasked with preparing an order for a Schedule III controlled substance. The order includes a request for 100 tablets of Tylenol with Codeine #3. What is the maximum quantity of this medication that can be ordered on a single DEA Form 222?
Federal Requirements
A.There is no limit to the quantity on a DEA Form 222, only on the number of line items.
B.DEA Form 222 is only used for Schedule II controlled substances.
C.A maximum of 10 line items, with each item limited to a 90-day supply.
D.A maximum of 5 line items, with each item limited to a 30-day supply.
Show answerAnswer
B. DEA Form 222 is only used for Schedule II controlled substances.
DEA Form 222 is exclusively used for ordering Schedule I and II controlled substances. Schedule III, IV, and V controlled substances are ordered through normal distribution channels using standard purchase orders and invoices.
18. A pharmacy technician is assisting a patient who is requesting a refill for their prescription of a Schedule IV controlled substance. The patient states they are moving to another state and asks if the pharmacy can transfer the remaining refills to a pharmacy in their new location. According to federal regulations, how many times can a Schedule IV prescription with authorized refills be transferred between pharmacies?
Federal Requirements
A.As many times as there are refills, up to the prescription's expiration.
B.Multiple times, as long as it's within the same chain of pharmacies.
C.Zero transfers, as controlled substance prescriptions cannot be transferred.
D.One time, between two DEA-registered pharmacies.
Show answerAnswer
D. One time, between two DEA-registered pharmacies.
Federal law permits a one-time transfer of Schedule III, IV, or V controlled substance prescriptions with refills between two DEA-registered pharmacies. If the pharmacies share a common electronic database, they may transfer up to the maximum number of refills permitted by law.
19. A pharmacy processes a large volume of prescriptions daily, including many controlled substances. To ensure compliance with federal record-keeping requirements for Schedule III, IV, and V prescriptions, how must these records be filed?
Federal Requirements
A.Together with non-controlled prescriptions, but only if the pharmacy uses an electronic system.
B.Separately from all other prescriptions, in their own dedicated file.
C.Together with Schedule II prescriptions, but distinctly marked with a red 'C'.
D.Either separately from non-controlled prescriptions, or with non-controlled prescriptions if readily retrievable and marked with a red 'C'.
Show answerAnswer
D. Either separately from non-controlled prescriptions, or with non-controlled prescriptions if readily retrievable and marked with a red 'C'.
Federal law allows Schedule III, IV, and V prescriptions to be filed in one of two ways: either in a separate file from all other records, or with non-controlled prescriptions, provided they are readily retrievable and marked with a red 'C' (at least one inch high) in the lower right corner.
20. A pharmacy receives a prescription for Adderall XR (amphetamine/dextroamphetamine) for a 12-year-old patient. The prescription is for a 90-day supply and indicates 'do not fill until' specific future dates for each 30-day increment. What is the maximum total day supply of Adderall XR that a prescriber can issue using multiple prescriptions for this Schedule II medication?
Federal Requirements
A.90-day supply
B.60-day supply
C.120-day supply
D.30-day supply
Show answerAnswer
A. 90-day supply
Federal law allows prescribers to issue multiple prescriptions for a Schedule II controlled substance, written on the same day, for a total of up to a 90-day supply. Each prescription must indicate 'do not fill until' a specific date.
21. A pharmacy technician is reviewing a prescription for a Schedule III controlled substance that was written 6 months ago. The prescription indicates 5 refills. According to federal regulations, how many of these refills are still valid?
Federal Requirements
A.5 refills
B.0 refills
C.2 refills
D.3 refills
Show answerAnswer
B. 0 refills
Federal regulations dictate that Schedule III and IV controlled substance prescriptions are valid for 6 months from the date they were written, and refills cannot be dispensed after this period.
22. A pharmacy technician is preparing to return several expired Schedule III controlled substances to a reverse distributor. Which DEA form is primarily used by the pharmacy to document the destruction or return of controlled substances?
Federal Requirements
A.DEA Form 106
B.DEA Form 222
C.DEA Form 41
D.DEA Form 224
Show answerAnswer
C. DEA Form 41
DEA Form 41 is specifically used by registrants to document the destruction of controlled substances. When returning to a reverse distributor, the reverse distributor typically issues a DEA Form 41 for the destruction process.
23. A pharmacy technician is assisting a patient who is picking up a prescription for isotretinoin. The technician knows this medication requires specific monitoring and dispensing restrictions due to severe potential side effects, particularly concerning pregnancy. Which federal program is designed to manage such risks?
Federal Requirements
A.MedWatch Program
B.National Drug Code (NDC) System
C.Drug Utilization Review (DUR) Program
D.Risk Evaluation and Mitigation Strategy (REMS)
Show answerAnswer
D. Risk Evaluation and Mitigation Strategy (REMS)
REMS programs are mandated by the FDA for certain medications with serious safety concerns to ensure that the benefits of the drug outweigh its risks.
24. A pharmacy technician is assisting the pharmacist with an inventory of all controlled substances. According to federal regulations, how frequently must a complete inventory of all controlled substances be performed?
Federal Requirements
A.Biennially (every 2 years)
B.Every 6 months
C.Annually
D.Upon change of the pharmacist-in-charge
Show answerAnswer
A. Biennially (every 2 years)
Federal regulations require a complete inventory of all controlled substances to be performed at least every two years (biennially). State laws may require more frequent inventories.
25. A pharmacy technician is processing a prescription for a Schedule II controlled substance for a patient in a long-term care facility (LTCF). The prescription was faxed to the pharmacy. According to federal regulations, what is the federal requirement for dispensing a faxed Schedule II prescription to an LTCF patient?
Federal Requirements
A.The prescriber must verbally confirm the faxed prescription with the pharmacist.
B.A hard copy of the prescription must be received by the pharmacy before dispensing.
C.The faxed prescription can serve as the original for dispensing.
D.The faxed prescription is only valid for a 72-hour emergency supply.
Show answerAnswer
C. The faxed prescription can serve as the original for dispensing.
Federal regulations permit a faxed Schedule II prescription to serve as the original written prescription for patients residing in a Long-Term Care Facility (LTCF) or for a patient enrolled in a hospice care program. This exception is made to facilitate timely access to medication for these vulnerable populations.
Federal regulations require specific and clear directions for use on Schedule II controlled substance prescriptions, including a maximum daily dose and/or duration when 'PRN' is indicated, to prevent misuse and ensure appropriate therapy.
The classification of a drug as prescription-only (Rx) or over-the-counter (OTC) is determined by federal regulations based on safety, potential for misuse, and necessity of medical supervision.
Rx drugs require a healthcare professional's authorization.
OTC drugs can be purchased without a prescription.
Some drug classes have both Rx and OTC formulations (e.g., lower vs. higher doses).
Medications that can be purchased without a prescription, generally considered safe and effective for use by the general public when directions are followed.
Do not require a doctor's order.
Available directly from pharmacy shelves or other retail stores.
Examples include many pain relievers, cold remedies, and allergy medications.
Federal law limits Schedule III, IV, and V controlled substance prescriptions to be valid for 6 months from the date of issue and allows a maximum of 5 refills within that period.
DEA Form 41, 'Registrants Inventory of Drugs Surrendered', is used to document the destruction of controlled substances by a DEA registrant, or to document the transfer of controlled substances to a reverse distributor for destruction.
Documents destruction/transfer for destruction.
Used for all schedules of controlled substances.
Reverse distributor typically completes it when taking drugs.
The Durham-Humphrey Amendment of 1951 is a federal law that established the distinction between prescription (legend) drugs and over-the-counter (OTC) drugs, requiring a prescription for drugs that are habit-forming, unsafe for self-medication, or new drugs not yet proven safe for OTC use.
The FDCA of 1938 is the foundational law establishing federal oversight of drug safety and requiring drugs to be adequately labeled, including directions for use for non-prescription products.
Mandated drug safety prior to marketing.
Required 'adequate directions for use' on labels.
Established the FDA's authority to regulate drugs and cosmetics.
Federal regulations require pharmacies to maintain records of all controlled substances received. For Schedule III, IV, and V drugs, this typically involves signing and dating the commercial invoice or packing slip upon receipt.
Federal law allows prescriptions for Schedule III, IV, and V controlled substances to be transferred once between pharmacies, unless they share a common electronic database, in which case they can be transferred up to the number of refills authorized.
C-IIs cannot be transferred.
CIII-V can be transferred once to another pharmacy.
If pharmacies share a common electronic database, multiple transfers are allowed up to the number of refills.
Federal law generally requires a hard copy or e-prescription for Schedule II substances, but allows faxed prescriptions to serve as the original for compounded parenteral C-IIs, C-IIs for LTCF residents, and C-II narcotics for hospice patients.
Compounded parenteral C-IIs.
C-IIs for Long-Term Care Facility (LTCF) residents.
Federal regulations dictate the required accuracy of counting controlled substances during inventory, varying by schedule.
Schedule II substances require an exact count (100% accuracy).
Schedule III, IV, and V substances require an exact count if the container holds 1,000 units or less.
Schedule III, IV, and V substances can be estimated if the container holds more than 1,000 units, but an exact count is often preferred for best practice.
Controlled Substance Rx Transfer (Schedules III-V)
Flip card
Federal law allows a one-time transfer of original prescription information for Schedule III, IV, and V controlled substances for refill purposes between two DEA-registered pharmacies. If pharmacies share a common, real-time electronic database, they can transfer up to the maximum number of refills permitted by law.
Applies to Schedules III, IV, V.
Generally, 'one-time' transfer rule.
Exception: shared electronic databases allow more transfers.
Federal regulations provide specific options for how pharmacies must file controlled substance prescriptions to ensure accountability and accessibility.
Schedule II: Must be filed separately from all other prescriptions.
Schedule III, IV, V (Option 1): Filed separately from all non-controlled and Schedule II prescriptions.
Schedule III, IV, V (Option 2): Filed with non-controlled prescriptions, provided they are readily retrievable and marked with a red 'C' (at least 1 inch high) in the lower right corner.
Prescriptions for Schedule III and IV controlled substances are valid for 6 months from the date they were written, and patients may receive a maximum of 5 refills within this 6-month period.
Risk Evaluation and Mitigation Strategy (REMS) is an FDA-mandated program to ensure that the benefits of certain drugs with serious safety concerns outweigh their risks.
Required for drugs with significant potential for adverse effects (e.g., teratogenicity).
May include elements like patient registries, specific training for prescribers/pharmacies, and patient counseling.
Isotretinoin (for severe acne) is a well-known example.
Federal law allows a faxed prescription for a Schedule II controlled substance to serve as the original written prescription for patients residing in a Long-Term Care Facility (LTCF) or for patients enrolled in a hospice care program.
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