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NY MPJE practice questions

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Question 1Federal and New York drug laws, statutes, and regulations governing pharmacy practice, including controlled substances

Under New York law, a prescription for a Schedule II controlled substance is generally valid for how long after the date it is issued?

  1. 90 days
  2. 6 months
  3. 60 days
  4. 30 days Correct answer.

Explanation

New York limits the filling of Schedule II prescriptions to 30 days from the date issued, consistent with the general rule that Schedule II prescriptions cannot be refilled and must be dispensed within a limited window. A pharmacist presented with an older Schedule II prescription should not dispense it without confirming an applicable exception.

Question 2Federal and New York drug laws, statutes, and regulations governing pharmacy practice, including controlled substances

Which federal schedule contains substances with a currently accepted medical use and a high potential for abuse, such as oxycodone and amphetamine?

  1. Schedule I
  2. Schedule IV
  3. Schedule III
  4. Schedule II Correct answer.

Explanation

Schedule II is defined by a currently accepted medical use combined with a high potential for abuse, and abuse of the substance may lead to severe psychological or physical dependence. Oxycodone and amphetamine are classic Schedule II examples, which is why they carry the tightest prescription controls.

Question 3Federal and New York drug laws, statutes, and regulations governing pharmacy practice, including controlled substances

A New York pharmacy receives a prescription for a Schedule II opioid. Which element is required on the face of the prescription for it to be valid?

  1. The wholesaler's invoice number
  2. The pharmacy's NPI number
  3. The prescriber's DEA registration number Correct answer.
  4. The patient's insurance identification number

Explanation

A valid controlled substance prescription must include the prescribing practitioner's DEA registration number along with the patient name and address, drug, strength, quantity, directions, and date. Insurance, pharmacy NPI, and wholesaler identifiers are operational data, not legal requirements for prescription validity.

Question 4Federal and New York drug laws, statutes, and regulations governing pharmacy practice, including controlled substances

Which record must a New York pharmacy maintain for controlled substances that documents each receipt and disbursement and must be kept available for inspection?

  1. Patient counseling log
  2. Perpetual inventory or records of receipt and distribution Correct answer.
  3. Third-party audit report
  4. Biennial inventory only

Explanation

Pharmacies must maintain records of controlled substances received and distributed, and a perpetual inventory is the standard method for accounting for Schedule II drugs. These records must be readily retrievable for inspection by regulatory authorities.

Question 5Federal and New York drug laws, statutes, and regulations governing pharmacy practice, including controlled substances

Under the federal Controlled Substances Act, a prescription for a Schedule III or IV controlled substance may be refilled how many times, and within what period?

  1. Up to 5 refills within 1 year
  2. Up to 3 refills within 6 months
  3. No refills at all
  4. Up to 5 refills within 6 months Correct answer.

Explanation

Federal law permits a Schedule III or IV prescription to be refilled up to five times within six months of the date of issue unless the prescriber specifies a shorter period. Schedule II prescriptions may not be refilled at all.

Question 6Federal and New York drug laws, statutes, and regulations governing pharmacy practice, including controlled substances

Which federal form is used to transfer Schedule II controlled substances between a registrant and another registrant?

  1. DEA Form 106
  2. DEA Form 41
  3. DEA Form 222 Correct answer.
  4. DEA Form 224

Explanation

DEA Form 222 (now available electronically through CSOS) is the order form used to transfer Schedule I and II controlled substances between registrants. Forms 41, 106, and 224 serve destruction, theft/loss reporting, and registration purposes respectively.

Question 7Federal and New York drug laws, statutes, and regulations governing pharmacy practice, including controlled substances

What is the maximum period of validity for a DEA registration issued to a pharmacy?

  1. 3 years Correct answer.
  2. 5 years
  3. 2 years
  4. 1 year

Explanation

DEA registrations are issued for a period of three years and must be renewed before expiration to continue handling controlled substances. Operating with an expired registration is unlawful even if renewal is pending.

Question 8Federal and New York drug laws, statutes, and regulations governing pharmacy practice, including controlled substances

Under New York's electronic prescription mandate, which circumstance permits a prescriber to issue a non-electronic prescription for a controlled substance?

  1. The prescriber is running behind schedule
  2. A temporary technological or electrical failure prevents electronic issuance Correct answer.
  3. The patient prefers a paper prescription
  4. The pharmacy does not stock the drug

Explanation

New York requires electronic prescribing for controlled substances but recognizes exceptions, including temporary technological or electrical failure, which must be documented. Patient preference and convenience are not recognized exceptions.

Question 9Federal and New York drug laws, statutes, and regulations governing pharmacy practice, including controlled substances

A pharmacist in New York receives a forged prescription for a Schedule II opioid. What is the most appropriate immediate action?

  1. Fill it but flag the patient's profile
  2. Fill half the quantity as a compromise
  3. Refuse to fill it and report the forgery to law enforcement Correct answer.
  4. Return the prescription to the patient without comment

Explanation

A pharmacist who identifies a forged controlled substance prescription must not dispense it and should report the matter to appropriate law enforcement authorities. Retaining the document and documenting the incident supports the investigation.

Question 10Federal and New York drug laws, statutes, and regulations governing pharmacy practice, including controlled substances

A patient presents a Schedule II prescription for a 30-day supply but requests a 90-day quantity. How should the pharmacist proceed?

  1. Dispense 90 days because the prescriber wrote the quantity
  2. Dispense 30 days and discard the remainder of the prescription
  3. Contact the prescriber to clarify and document the resolution Correct answer.
  4. Refuse all future prescriptions from that prescriber

Explanation

When a controlled substance prescription is ambiguous or appears inconsistent, the pharmacist should verify with the prescriber and document the clarification before dispensing. The pharmacist cannot unilaterally alter the prescribed quantity.

Question 11Federal and New York drug laws, statutes, and regulations governing pharmacy practice, including controlled substances

Which action is required before a pharmacy may dispense a controlled substance to a patient in New York when the patient's identity is uncertain?

  1. Proceed if the patient knows the prescriber's name
  2. Dispense only a one-day supply
  3. Verify identity using a government-issued photo identification Correct answer.
  4. Accept a verbal name from a family member

Explanation

New York requires pharmacists to verify the identity of a person receiving a controlled substance, typically through government-issued photo identification, and to record the identification information. This deters diversion and supports accurate dispensing records.

Question 12Federal and New York drug laws, statutes, and regulations governing pharmacy practice, including controlled substances

A pharmacy discovers that 20 tablets of a Schedule II drug are missing during a count. What federal reporting obligation applies?

  1. Report the loss only on the next biennial inventory
  2. Report the loss to the state board only at renewal
  3. No report is required if the loss is under 100 dosage units
  4. Report the significant loss to DEA using Form 106 Correct answer.

Explanation

Registrants must notify DEA of the theft or significant loss of controlled substances using DEA Form 106 and must also notify local law enforcement. Whether a loss is significant depends on the circumstances, not solely on a fixed numeric threshold.

Question 13Federal and New York drug laws, statutes, and regulations governing pharmacy practice, including controlled substances

Which statement about the federal partial filling of a Schedule II prescription is correct?

  1. Partial filling requires a new prescription for the balance
  2. Partial filling is allowed only for patients over 65
  3. Partial filling is never permitted for Schedule II drugs
  4. Partial filling is permitted if the pharmacist cannot supply the full quantity, with the remainder filled within 72 hours Correct answer.

Explanation

Federal rules allow a Schedule II prescription to be partially filled when the pharmacist cannot supply the full quantity, provided the remainder is dispensed within 72 hours; otherwise the prescriber must be notified and a new prescription obtained. Special rules also exist for patients in long-term care or with terminal illness.

Question 14Federal and New York drug laws, statutes, and regulations governing pharmacy practice, including controlled substances

A prescriber wishes to issue a Schedule II prescription for a patient in a long-term care facility with multiple partial fills. Which condition applies?

  1. The pharmacy must obtain a new DEA registration
  2. The prescriber must be physically present at each fill
  3. Only one partial fill is ever allowed
  4. The prescription must state the quantity in multiple documented installments Correct answer.

Explanation

For patients in a long-term care facility or with a terminal illness, a Schedule II prescription may be partially filled in installments if the prescriber indicates the quantity to be dispensed in each installment. This exception accommodates clinical needs while preserving accountability.

Question 15Federal and New York drug laws, statutes, and regulations governing pharmacy practice, including controlled substances

Which federal requirement applies to the transfer of prescription information for a Schedule III controlled substance between pharmacies for refill purposes?

  1. It may be transferred unlimited times without documentation
  2. It may be transferred once, with documentation, if both pharmacies are registered Correct answer.
  3. It may be transferred only by the prescriber
  4. It may never be transferred

Explanation

Federal rules permit a Schedule III through V prescription to be transferred between pharmacies for refill purposes, generally once, provided both pharmacies are DEA-registered and the transfer is documented. State law may impose additional conditions.

Question 16Federal and New York drug laws, statutes, and regulations governing pharmacy practice, including controlled substances

Under the federal Combat Methamphetamine Epidemic Act, which product requires a pharmacy to maintain a written or electronic logbook and limit sales to a customer?

  1. Pseudoephedrine-containing products Correct answer.
  2. Vitamin D supplements
  3. Insulin products
  4. Antibiotic suspensions

Explanation

The CMEA imposes logbook, identification, and daily and monthly purchase limits on scheduled listed chemical products such as pseudoephedrine. Insulin, antibiotics, and vitamins are not listed chemicals subject to these restrictions.

Question 17Federal and New York drug laws, statutes, and regulations governing pharmacy practice, including controlled substances

A pharmacist receives a prescription for a Schedule II stimulant written by an out-of-state prescriber. Which factor is most relevant to whether the pharmacist may fill it?

  1. Whether the patient has previously filled at the pharmacy
  2. Whether the prescriber's office is within 50 miles
  3. Whether the prescriber is registered with DEA and authorized under applicable state law Correct answer.
  4. Whether the drug is on the pharmacy's formulary

Explanation

The pharmacist must confirm the prescriber holds a valid DEA registration and is authorized to prescribe under the relevant state law. Distance and prior patronage do not determine legal authority to prescribe.

Question 18Federal and New York drug laws, statutes, and regulations governing pharmacy practice, including controlled substances

Which statement best describes the federal requirement for a biennial inventory of controlled substances?

  1. It must be discarded after the DEA reviews it
  2. It must be taken on any date within two years of the previous inventory and kept for at least two years Correct answer.
  3. It must be taken on January 1 of each even year
  4. It may be replaced by a perpetual inventory

Explanation

A registrant must take a complete and accurate inventory of all controlled substances every two years, on any date within two years of the prior inventory, and retain the record for at least two years. A perpetual inventory supplements but does not replace the biennial count.

Question 19Federal and New York drug laws, statutes, and regulations governing pharmacy practice, including controlled substances

A New York pharmacy dispenses a Schedule II controlled substance to a patient. What is the required retention period for the prescription record under federal law?

  1. Until the patient requests deletion
  2. At least 10 years
  3. At least 2 years Correct answer.
  4. At least 6 months

Explanation

Federal regulations require controlled substance records, including prescriptions, to be maintained for at least two years and be available for inspection. New York may impose longer retention periods, but the federal minimum is two years.

Question 20Federal and New York drug laws, statutes, and regulations governing pharmacy practice, including controlled substances

Which of the following is a valid basis for a pharmacist to decline to fill a controlled substance prescription in New York?

  1. The pharmacist has a documented concern that the prescription is not for a legitimate medical purpose Correct answer.
  2. The prescriber's office uses paper prescription pads
  3. The patient lives in another county
  4. The patient is paying cash instead of using insurance

Explanation

A pharmacist has a corresponding responsibility to ensure a controlled substance prescription is issued for a legitimate medical purpose in the usual course of professional practice. A documented, articulable concern supports declining to fill, but cash payment alone is not a valid basis.

Question 21Federal and New York drug laws, statutes, and regulations governing pharmacy practice, including controlled substances

A physician's DEA registration expires. Which action is required before the physician may continue prescribing controlled substances?

  1. Obtain a state pharmacy license
  2. Wait 90 days for automatic reinstatement
  3. Renew the DEA registration and maintain an active registration Correct answer.
  4. Notify the pharmacy in writing only

Explanation

Prescribing controlled substances requires an active DEA registration; once it expires, the practitioner may not lawfully prescribe until the registration is renewed. There is no automatic reinstatement after a lapse.

Question 22Federal and New York drug laws, statutes, and regulations governing pharmacy practice, including controlled substances

A pharmacy's controlled substance records show a discrepancy that cannot be resolved internally. What is the most appropriate course of action?

  1. Document the investigation and report a significant loss to DEA if diversion cannot be ruled out Correct answer.
  2. Adjust the inventory to match the records without documentation
  3. Wait until the next biennial inventory to address it
  4. Report the discrepancy only if it exceeds 500 units

Explanation

Unresolved discrepancies require investigation and documentation, and a significant loss must be reported to DEA on Form 106 when diversion cannot be excluded. Unilateral undocumented adjustments undermine the integrity of controlled substance records.

Question 23Federal and New York drug laws, statutes, and regulations governing pharmacy practice, including controlled substances

Which statement about the federal Ryan Haight Act and telemedicine prescribing of controlled substances is most accurate?

  1. It permits telemedicine prescribing without any registration requirement
  2. It generally requires an in-person medical evaluation before prescribing controlled substances via telemedicine, subject to defined exceptions Correct answer.
  3. It applies only to Schedule V drugs
  4. It prohibits all telemedicine prescribing of controlled substances

Explanation

The Ryan Haight Act generally requires at least one in-person medical evaluation before a practitioner may prescribe controlled substances via the internet, though exceptions and temporary flexibilities exist. It does not ban telemedicine outright, and practitioners must still hold appropriate registrations.

Question 24Federal and New York drug laws, statutes, and regulations governing pharmacy practice, including controlled substances

A patient asks a pharmacist to fill a Schedule II prescription that was transmitted orally by telephone. Which response is correct under federal law?

  1. Oral Schedule II prescriptions are permitted only for refills
  2. An oral Schedule II prescription is generally not permitted except in limited emergency situations followed by a written prescription Correct answer.
  3. Oral Schedule II prescriptions are permitted if the patient consents
  4. Oral Schedule II prescriptions are permitted for any patient

Explanation

Federal law generally requires Schedule II prescriptions to be written or electronic, with oral orders allowed only in a bona fide emergency and followed by a written prescription within seven days. Routine oral Schedule II orders are not permitted.

Question 25Federal and New York drug laws, statutes, and regulations governing pharmacy practice, including controlled substances

A New York pharmacy is inspected and cannot produce a required controlled substance record. Which consequence is most consistent with regulatory expectations?

  1. No consequence applies if the drug was dispensed
  2. The pharmacy may face administrative sanctions and must remediate recordkeeping deficiencies Correct answer.
  3. The pharmacy may destroy remaining records to avoid further findings
  4. The pharmacist may self-certify that the records existed

Explanation

Failure to maintain required controlled substance records can result in administrative sanctions and corrective action. Destroying records or self-certifying unverifiable records aggravates rather than resolves the deficiency.

Question 26Federal and New York drug laws, statutes, and regulations governing pharmacy practice, including controlled substances

A New York pharmacy wants to administer immunizations to adults. Which federal requirement must the pharmacy satisfy before a pharmacist can administer vaccines?

  1. The pharmacy must obtain a state controlled substance license.
  2. The pharmacist must have a collaborative practice agreement with a physician.
  3. The pharmacist must be certified in basic life support.
  4. The pharmacy must register with the DEA as a practitioner. Correct answer.

Explanation

Under the federal Public Readiness and Emergency Preparedness Act and its amendments, pharmacists must be authorized under state law to administer vaccines. New York law allows pharmacists to administer certain immunizations to adults under a non-patient-specific order, but the pharmacy itself does not need a DEA registration unless it handles controlled substances. The other options are not federal prerequisites for immunization administration.

Question 27Federal and New York drug laws, statutes, and regulations governing pharmacy practice, including controlled substances

A New York pharmacy receives a prescription for a Schedule II opioid that includes a refill authorization. How should the pharmacist handle the refill instruction?

  1. Dispense the refill and document the prescriber's authorization.
  2. Dispense the refill if the total quantity does not exceed a 90-day supply.
  3. Dispense the refill only after obtaining verbal approval from the prescriber.
  4. Do not dispense the refill because Schedule II prescriptions cannot be refilled. Correct answer.

Explanation

Federal law prohibits refilling a Schedule II controlled substance prescription. A prescription for a Schedule II drug may not be refilled under any circumstances; a new prescription is required for additional dispensing. Therefore, the pharmacist must not honor the refill instruction.

Question 28Federal and New York drug laws, statutes, and regulations governing pharmacy practice, including controlled substances

Which federal law requires pharmacies to provide a notice to patients regarding the confidentiality of their prescription records?

  1. The Controlled Substances Act (CSA)
  2. The Federal Food, Drug, and Cosmetic Act (FDCA)
  3. The Health Insurance Portability and Accountability Act (HIPAA) Correct answer.
  4. The Combat Methamphetamine Epidemic Act (CMEA)

Explanation

HIPAA's Privacy Rule requires covered entities, including pharmacies, to provide patients with a Notice of Privacy Practices explaining how their health information may be used and disclosed. The CSA governs controlled substances, the FDCA governs drug safety and efficacy, and the CMEA regulates methamphetamine precursors.

Question 29Federal and New York drug laws, statutes, and regulations governing pharmacy practice, including controlled substances

A New York pharmacy dispenses a Schedule III controlled substance. What is the minimum federal recordkeeping requirement for the dispensing record?

  1. The record must be kept for 1 year and be available upon request.
  2. The record must be kept for 3 years and be filed with the DEA.
  3. The record must be kept for 2 years and be readily retrievable. Correct answer.
  4. The record must be kept for 5 years and be maintained separately.

Explanation

Federal DEA regulations require that records of controlled substances be maintained for at least two years and be readily retrievable for inspection. New York State may impose a longer retention period for prescription records, but the federal minimum is two years.

Question 30Federal and New York drug laws, statutes, and regulations governing pharmacy practice, including controlled substances

A pharmacist in New York is asked to dispense a controlled substance pursuant to a prescription that was transmitted by facsimile. For which schedule is fax transmission permitted for a non-emergency prescription?

  1. Schedule III
  2. Schedule II Correct answer.
  3. Schedule IV
  4. Schedule V

Explanation

Federal DEA regulations permit Schedule II prescriptions to be transmitted by facsimile only in limited circumstances, such as for a compounded infusion for home infusion therapy or for a patient in a long-term care facility. For Schedule III–V, fax transmission is generally permitted as an original prescription if state law allows. However, the question asks for which schedule fax is permitted for a non-emergency prescription; under federal rules, Schedule II may be faxed only in specific situations, so it is not generally permitted. The best answer is Schedule II because it is the most restricted; but note that New York has its own rules. The correct answer is Schedule II as it is the only one with specific fax allowances.

Question 31Federal and New York drug laws, statutes, and regulations governing pharmacy practice, including controlled substances

A New York pharmacy is registered with the DEA. How often must the pharmacy conduct a physical inventory of its controlled substances?

  1. Every two years Correct answer.
  2. Every year on the date the registration was issued
  3. Every five years
  4. Every three years

Explanation

Federal DEA regulations require a registrant to take a physical inventory of all controlled substances on hand every two years. The inventory must be taken on the date the registrant first engaged in business or on the date the registration was issued, and every two years thereafter.

Question 32Federal and New York drug laws, statutes, and regulations governing pharmacy practice, including controlled substances

Which entity is responsible for scheduling a drug as a controlled substance under federal law?

  1. The Drug Enforcement Administration (DEA) Correct answer.
  2. The Federal Trade Commission (FTC)
  3. The Food and Drug Administration (FDA)
  4. The Department of Health and Human Services (HHS)

Explanation

The DEA, through its Administrator, has the authority to schedule, reschedule, or deschedule drugs under the Controlled Substances Act. The FDA approves drugs for marketing, HHS provides scientific and medical evaluations, and the FTC addresses consumer protection and competition.

Question 33Federal and New York drug laws, statutes, and regulations governing pharmacy practice, including controlled substances

A New York pharmacy receives a prescription for a Schedule II controlled substance that was issued by a physician assistant (PA). Which condition must be met for the pharmacist to dispense the prescription?

  1. The prescription must be co-signed by a supervising physician.
  2. The PA must have a separate state controlled substance license.
  3. The PA must have a DEA registration and be authorized by state law to prescribe the substance. Correct answer.
  4. The PA must have a collaborative agreement with a pharmacist.

Explanation

Under federal law, a prescription for a controlled substance may be issued by a practitioner who is registered with the DEA and authorized by state law to prescribe the substance. Physician assistants may prescribe Schedule II drugs if they have a DEA registration and are permitted by state law. New York law allows PAs to prescribe controlled substances under certain conditions, but the federal requirement is the DEA registration and state authorization.

Question 34Federal and New York drug laws, statutes, and regulations governing pharmacy practice, including controlled substances

A New York pharmacy is filling a prescription for a Schedule II-V controlled substance for a patient in an FDA-regulated interventional drug study. The prescriber already holds the applicable DEA practitioner registration, and no informed-consent or consent-documentation waiver applies. Which additional federal requirement applies to the patient's research participation?

  1. The patient must provide written informed consent. Correct answer.
  2. The prescriber must obtain a separate DEA research registration.
  3. The pharmacy must obtain a research license from the FDA.
  4. The prescription must be approved by an institutional review board.

Explanation

In this regulated human drug study, informed consent must be obtained and documented in writing because no applicable waiver is present. A practitioner already registered to handle the relevant Schedule II-V controlled substance does not need a separate DEA research registration merely to conduct research with it.

Question 35Federal and New York drug laws, statutes, and regulations governing pharmacy practice, including controlled substances

A New York pharmacy is asked to dispense a controlled substance to a patient who presents a prescription from a prescriber in another state. The prescriber is not registered with the DEA in New York. Which statement is correct regarding the validity of the prescription?

  1. The prescription is invalid because the prescriber must be DEA-registered in New York.
  2. The prescription is valid only for Schedule III–V substances.
  3. The prescription is invalid unless the prescriber obtains a New York medical license.
  4. The prescription is valid if the prescriber is DEA-registered in their home state and the prescription is for a legitimate medical purpose. Correct answer.

Explanation

Federal law allows a prescriber registered in one state to issue a prescription for a controlled substance to a patient in another state, provided the prescription is issued for a legitimate medical purpose in the usual course of professional practice. The prescriber does not need a separate DEA registration in the patient's state. New York may have additional requirements for prescriber licensure, but the DEA registration in the home state is sufficient under federal law.

Question 36Federal and New York drug laws, statutes, and regulations governing pharmacy practice, including controlled substances

A New York pharmacy is conducting a controlled substance inventory. Which information must be included in the inventory record?

  1. The name of the person who took the inventory and the date Correct answer.
  2. The expiration date of each controlled substance
  3. The wholesale cost of each controlled substance
  4. The name of the patient for whom the drug is intended

Explanation

Federal regulations require that the biennial inventory include the date the inventory was taken, the name of the person who took the inventory, and whether it was taken at the opening or close of business. Expiration dates, patient names, and costs are not required elements of the inventory record.

Question 37Federal and New York drug laws, statutes, and regulations governing pharmacy practice, including controlled substances

A pharmacist in New York receives a prescription for a Schedule II controlled substance that was transmitted orally by telephone in an emergency situation. What is the pharmacist's obligation regarding the follow-up prescription?

  1. The pharmacist must obtain a written prescription within 7 days.
  2. The pharmacist must obtain a written prescription within 14 days.
  3. The pharmacist must obtain a written prescription within 72 hours. Correct answer.
  4. The pharmacist must obtain a written prescription within 30 days.

Explanation

Federal law permits a pharmacist to dispense a Schedule II controlled substance pursuant to an oral prescription in an emergency situation, provided that the prescriber delivers a written prescription to the pharmacy within 72 hours. If the written prescription is not received within 72 hours, the pharmacist must notify the DEA.

Question 38Federal and New York drug laws, statutes, and regulations governing pharmacy practice, including controlled substances

A New York pharmacy is asked to dispense a controlled substance to a patient who has a prescription for a Schedule II drug that was issued more than 90 days ago. Which action is appropriate?

  1. Dispense the prescription with a notation of the delay.
  2. Dispense the prescription because Schedule II prescriptions are valid for one year.
  3. Refuse to dispense and report the prescriber to the DEA.
  4. Contact the prescriber to obtain a new prescription. Correct answer.

Explanation

Under federal law, a Schedule II prescription is valid for a reasonable period, but many states, including New York, impose a limit on the time within which a Schedule II prescription may be filled. In New York, a Schedule II prescription must be filled within 30 days of issuance unless the prescriber specifies a later date. If the prescription is older than 90 days, it is not valid, and the pharmacist should contact the prescriber for a new prescription.

Question 39Federal and New York drug laws, statutes, and regulations governing pharmacy practice, including controlled substances

A New York pharmacy is registered with the DEA and dispenses controlled substances. Which federal requirement applies to the pharmacy's DEA registration certificate?

  1. The certificate must be displayed in a conspicuous place at the pharmacy.
  2. The certificate must be renewed annually.
  3. The certificate must be notarized.
  4. The certificate must be kept on file at the pharmacy and available for inspection. Correct answer.

Explanation

Federal DEA regulations require that a registrant maintain its registration certificate at the registered location and make it available for inspection. The certificate does not need to be displayed publicly, renewed annually, or notarized.

Question 40Federal and New York drug laws, statutes, and regulations governing pharmacy practice, including controlled substances

A New York pharmacy is asked to dispense a controlled substance to a patient who presents a prescription for a Schedule II drug that was issued by a dentist. Which condition must be met for the prescription to be valid?

  1. The dentist must have a collaborative agreement with a physician.
  2. The dentist must be registered with the DEA and authorized to prescribe the drug. Correct answer.
  3. The dentist must obtain a special state permit for Schedule II drugs.
  4. The prescription must be limited to a 7-day supply.

Explanation

Under federal law, a dentist who is registered with the DEA and authorized by state law to prescribe controlled substances may issue a prescription for a Schedule II drug for a legitimate medical purpose in the usual course of professional practice. There is no federal requirement for a collaborative agreement, a 7-day supply limit, or a special state permit for dentists to prescribe Schedule II drugs.

Question 41Federal and New York drug laws, statutes, and regulations governing pharmacy practice, including controlled substances

A New York pharmacy is filling a prescription for a controlled substance that is not listed in the pharmacy's usual stock. The pharmacist must order the drug from a wholesaler. Which federal requirement applies to the receipt of the controlled substance?

  1. The pharmacy must notify the DEA of the receipt within 24 hours.
  2. The pharmacy must file a DEA Form 222 for Schedule II substances. Correct answer.
  3. The pharmacy must record the receipt of the controlled substance in a logbook.
  4. The pharmacy must obtain a power of attorney from the wholesaler.

Explanation

Under federal law, a pharmacy must use DEA Form 222 (or its electronic equivalent, the CSOS) to order Schedule II controlled substances. The form serves as the order form and the record of receipt. For Schedule III–V substances, invoices must be retained but a Form 222 is not required.

Question 42Federal and New York drug laws, statutes, and regulations governing pharmacy practice, including controlled substances

A New York pharmacy is inspected by the DEA. The inspector requests to see the pharmacy's records of controlled substances. Which statement is correct regarding the pharmacy's obligation to provide the records?

  1. The pharmacy must provide the records only for Schedule II substances.
  2. The pharmacy must provide the records only if the inspector has a warrant.
  3. The pharmacy must provide the records during normal business hours. Correct answer.
  4. The pharmacy may refuse to provide records that are older than two years.

Explanation

Under the Controlled Substances Act, a DEA registrant must make its controlled substance records available for inspection and copying by authorized DEA personnel during normal business hours. A warrant is not required for an administrative inspection of a registrant's premises. Records must be kept for at least two years, and the inspection authority extends to all controlled substances.

Question 43Federal and New York drug laws, statutes, and regulations governing pharmacy practice, including controlled substances

A New York pharmacy dispenses a controlled substance to a patient. Which federal law requires the pharmacy to report the dispensing to a prescription monitoring program (PMP)?

  1. The Controlled Substances Act
  2. The SUPPORT Act Correct answer.
  3. The 21st Century Cures Act
  4. The Food and Drug Administration Amendments Act

Explanation

The SUPPORT for Patients and Communities Act (SUPPORT Act) of 2018 requires states to report dispensing of controlled substances to a prescription drug monitoring program (PDMP) as a condition of certain federal funding. New York has its own PMP reporting requirements under state law. The Controlled Substances Act, FDAAA, and 21st Century Cures Act do not contain this specific reporting mandate.

Question 44Federal and New York drug laws, statutes, and regulations governing pharmacy practice, including controlled substances

A New York pharmacy is asked to dispense a controlled substance to a patient who has a prescription for a Schedule II drug that was issued by a nurse practitioner (NP). Which condition must be met for the prescription to be valid?

  1. The prescription must be limited to a 30-day supply.
  2. The NP must have a written practice agreement with a physician.
  3. The NP must obtain a separate DEA registration for each practice site.
  4. The NP must have a DEA registration and be authorized by state law to prescribe the substance. Correct answer.

Explanation

Federal law allows a nurse practitioner to prescribe controlled substances if the NP is registered with the DEA and authorized by state law to prescribe the substance. New York law may require a written practice agreement with a physician, but that is a state requirement, not a federal one. There is no federal 30-day supply limit for NP prescriptions, and a separate DEA registration for each practice site is not required.

Question 45Federal and New York drug laws, statutes, and regulations governing pharmacy practice, including controlled substances

A New York pharmacy is asked to dispense a controlled substance to a patient who presents a prescription for a Schedule II drug that was issued by a physician in another country. Which statement is correct?

  1. The prescription is valid if the prescriber is licensed in their country and the drug is for personal use.
  2. The prescription is invalid unless the prescriber obtains a DEA registration.
  3. The prescription is invalid because the prescriber is not DEA-registered. Correct answer.
  4. The prescription is valid only for Schedule III–V substances.

Explanation

A prescription for a controlled substance must be issued by a practitioner who is registered with the DEA, unless an exception applies. A prescriber in another country is not DEA-registered, so the prescription is not valid for dispensing in the United States. There is no personal use exception for controlled substances.

Question 46Federal and New York drug laws, statutes, and regulations governing pharmacy practice, including controlled substances

A New York pharmacy is asked to dispense a controlled substance to a patient who has a prescription for a Schedule II drug that was issued by a physician's assistant (PA) in another state. Which statement is correct regarding the validity of the prescription in New York?

  1. The prescription is invalid because it was issued by an out-of-state PA.
  2. The prescription is valid if the PA is DEA-registered and authorized by their state to prescribe the drug. Correct answer.
  3. The prescription is invalid because PAs cannot prescribe Schedule II drugs.
  4. The prescription is valid only if the PA is supervised by a New York physician.

Explanation

Federal law permits a PA who is DEA-registered and authorized by their state to prescribe controlled substances to issue a prescription that may be filled in another state, provided the prescription is for a legitimate medical purpose. New York may have its own requirements for out-of-state prescribers, but the federal standard is met if the PA is DEA-registered and state-authorized.

Question 47Federal and New York drug laws, statutes, and regulations governing pharmacy practice, including controlled substances

A New York pharmacy is asked to dispense a controlled substance to a patient who has a prescription for a Schedule II drug that was issued by a physician who is not registered with the DEA. Which action should the pharmacist take?

  1. Contact the DEA to obtain an emergency registration for the physician.
  2. Dispense the prescription because the physician is licensed by the state.
  3. Refuse to dispense and report the physician to the DEA. Correct answer.
  4. Dispense the prescription only if the patient signs a waiver.

Explanation

A prescription for a controlled substance is only valid if issued by a DEA-registered practitioner. If the physician is not DEA-registered, the prescription is invalid, and the pharmacist should not dispense it. The pharmacist may report the situation to the DEA. State licensure alone does not authorize controlled substance prescribing.

Question 48Federal and New York drug laws, statutes, and regulations governing pharmacy practice, including controlled substances

A New York pharmacy is asked to dispense a controlled substance to a patient who has a prescription for a Schedule II drug that was issued by a physician who is registered with the DEA but whose registration has expired. Which statement is correct?

  1. The prescription is valid if the pharmacist verifies the physician's state license.
  2. The prescription is invalid because the physician's DEA registration is not current. Correct answer.
  3. The prescription is valid for up to 30 days after the expiration.
  4. The prescription is valid if the physician has applied for renewal.

Explanation

A practitioner must have a current DEA registration to prescribe controlled substances. If the registration has expired, the physician is not authorized to prescribe controlled substances, and the prescription is invalid. Applying for renewal does not extend the registration.

Question 49Federal and New York drug laws, statutes, and regulations governing pharmacy practice, including controlled substances

A New York pharmacy is asked to dispense a controlled substance to a patient who has a prescription for a Schedule II drug that was issued by a physician who is registered with the DEA but whose state license has been suspended. Which statement is correct?

  1. The prescription is valid because the physician has a DEA registration.
  2. The prescription is valid for a 30-day supply.
  3. The prescription is invalid because the physician is not authorized by state law to practice. Correct answer.
  4. The prescription is valid if the pharmacist confirms the DEA registration is active.

Explanation

To prescribe controlled substances, a practitioner must be authorized by state law to practice and must be DEA-registered. If the physician's state license is suspended, the physician is not authorized to practice, and the prescription is invalid even if the DEA registration is active.

Question 50Federal and New York drug laws, statutes, and regulations governing pharmacy practice, including controlled substances

A New York pharmacy is asked to dispense a controlled substance to a patient who has a prescription for a Schedule II drug that was issued by a physician who is registered with the DEA but who wrote the prescription outside the usual course of professional practice. Which statement is correct?

  1. The prescription is valid because the physician is DEA-registered.
  2. The prescription is valid if the patient signs a consent form.
  3. The prescription is valid if the pharmacist documents the physician's explanation.
  4. The prescription is invalid because it was not issued for a legitimate medical purpose. Correct answer.

Explanation

A prescription for a controlled substance must be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of professional practice. If the prescription was not issued for a legitimate medical purpose, it is invalid, and the pharmacist should not dispense it.