Controlled Substances Regulations Quiz
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Questions and Answers

How many days in advance must the DEA be notified before establishing central record keeping?

  • 14 days (correct)
  • 10 days
  • 7 days
  • 30 days
  • Which method is NOT acceptable for notifying the DEA of central record keeping?

  • Hand-delivered with confirmation
  • Email (correct)
  • Certified mail with return receipt requested
  • Registered mail
  • What is the maximum time a supplier has to fulfill the balance of an order they couldn't fill completely?

  • 30 days
  • 60 days (correct)
  • 90 days
  • 45 days
  • Which of the following records CANNOT be kept at a central location?

    <p>Prescriptions</p> Signup and view all the answers

    If a mistake is made on a DEA Form 222, what should be done with the form?

    <p>It should be marked 'VOID' and stored with other executed order forms.</p> Signup and view all the answers

    Who can sign a DEA 222 order form?

    <p>Only the registrant or someone given power of attorney.</p> Signup and view all the answers

    What action can the DEA take if a registrant fails to comply with central record-keeping conditions?

    <p>Cancel the central record-keeping authorization without a hearing</p> Signup and view all the answers

    In addition to the DEA, which organization must New Jersey pharmacies make records available to?

    <p>The DCU</p> Signup and view all the answers

    What technology is used by CSOS for secure electronic transmission of controlled substance orders?

    <p>Public Key Infrastructure (PKI)</p> Signup and view all the answers

    Who is responsible for appointing a CSOS coordinator for a registrant?

    <p>The registrant</p> Signup and view all the answers

    Under what condition can a CSOS digital certificate be revoked?

    <p>If the digital certificate used to sign electronic orders has been compromised.</p> Signup and view all the answers

    Which of the following is NOT a reason for an electronic order to be rejected?

    <p>The supplier has an issue with the products available.</p> Signup and view all the answers

    What is required of a purchaser when receiving a controlled substance shipment via CSOS?

    <p>They must create a record of the quantity of each item received and the date received, linked to the original order.</p> Signup and view all the answers

    What happens if an electronic order cannot be filled?

    <p>The supplier must notify the purchaser and provide a statement as to the reason.</p> Signup and view all the answers

    How long is a CSOS digital certificate valid?

    <p>Until the DEA registration expires or the certificate is revoked.</p> Signup and view all the answers

    What is the electronic equivalent of a DEA 222 form, according to the text?

    <p>A digital certificate.</p> Signup and view all the answers

    What action can the Attorney General take against a retailer that violates sales restrictions for scheduled listed chemical products?

    <p>Prohibit the retailer from selling any scheduled listed chemical products.</p> Signup and view all the answers

    What is a permissible measure retail stores can take when screening job applicants regarding scheduled listed chemical products?

    <p>Asking about convictions related to SLCP products or controlled substances.</p> Signup and view all the answers

    What is the current requirement regarding DATA-Waiver registration numbers for buprenorphine prescriptions?

    <p>They are no longer needed for any buprenorphine prescription.</p> Signup and view all the answers

    Given that an individual can purchase 3.6 grams of base per day, what is the maximum amount of 30mg Pseudoephedrine HCl tablets they can purchase?

    <p>146 tablets</p> Signup and view all the answers

    What is the required action regarding a loss or disappearance of scheduled listed chemical products?

    <p>Report to the DEA orally ASAP, followed by a written report within 15 days.</p> Signup and view all the answers

    What was the previous limit on the number of patients a practitioner could treat with buprenorphine in their first year?

    <p>30 patients.</p> Signup and view all the answers

    In New Jersey, in addition to reporting to the DEA, when is it necessary to report a loss of SLCP product to local law enforcement??

    <p>Loss of 30 grams or more of products where the SLCP is the sole active ingredient.</p> Signup and view all the answers

    Which of the following healthcare providers are now eligible to prescribe buprenorphine if authorized by state law, holding a schedule III DEA?

    <p>Physicians, physician assistants, and nurse practitioners.</p> Signup and view all the answers

    What is the new one-time training requirement for all controlled substance prescribers, with some exceptions?

    <p>8 hours of training on treating and managing substance use disorders.</p> Signup and view all the answers

    How many hours of applicable CE were previously required for Physician Assistants (PA) and Nurse Practitioners (NP) to prescribe buprenorphine?

    <p>24 hours.</p> Signup and view all the answers

    Besides continuing education credits, what other way can physicians, physician assistants, and nurse practitioners qualify to prescribe buprenorphine?

    <p>Having 8 hours of education in substance use disorders within 5 years of applying or renewing their DEA registration.</p> Signup and view all the answers

    Subutex and Suboxone are classified under which schedule of controlled substances?

    <p>Schedule III</p> Signup and view all the answers

    Which of the following statements correctly reflects federal or state requirements for storing controlled drugs?

    <p>Controlled drugs must be stored in a way that obstructs theft or diversion.</p> Signup and view all the answers

    When a purchaser discovers that order forms have been stolen or lost, to whom must it be reported immediately?

    <p>The Drug Enforcement Administration (DEA) Special Agent in Charge and the Drug Control Unit (DCU)</p> Signup and view all the answers

    If a supplier cannot provide the serial numbers of stolen or lost original order forms received from purchasers, what information should they report?

    <p>The names of the purchasers and the date(s) of the order forms</p> Signup and view all the answers

    What should a purchaser do if they recover a previously reported stolen or lost order form?

    <p>Immediately notify the DEA Special Agent in Charge and the DCU</p> Signup and view all the answers

    How often do pharmacies need to register with the Attorney General for controlled substance activities?

    <p>Triennially</p> Signup and view all the answers

    Which statement is true regarding a hospital's DEA registration, according to the text?

    <p>Decentralized and satellite pharmacy services within the same physical structure of a registered hospital do not require separate registrations.</p> Signup and view all the answers

    If an entire book of order forms is lost or stolen, what is the reporting requirement if the purchaser doesn't know the serial numbers?

    <p>Report the date or approximate date of issuance of the book.</p> Signup and view all the answers

    Although there is no requirement to use 222 forms sequentially, why does it make sense to do so?

    <p>To help meet the reporting requirements for lost and/or stolen order forms</p> Signup and view all the answers

    Which statement best describes the registration requirements for pharmacies under DEA rules?

    <p>Each pharmacy owned by the same firm requires a separate registration, although individual pharmacists are not required to register</p> Signup and view all the answers

    Which condition must be met for a practitioner to issue multiple prescriptions for a Schedule II controlled substance, allowing up to a 90-day supply?

    <p>The practitioner determines there is no risk of diversion or abuse, and provides written instructions on each prescription.</p> Signup and view all the answers

    What is the key difference in the statutory authority for issuing multiple prescriptions for schedule II controlled substances between physicians and other prescribers in New Jersey?

    <p>Only physicians, but not advance practice nurses or physician assistants, are allowed to issue multiple prescriptions for a 90-day supply.</p> Signup and view all the answers

    In New Jersey, how many multiple prescriptions, for Schedule II controlled substances, are allowed for a 90-day supply, and what are the timeframes associated with filling them?

    <p>A total of 3 prescriptions, with each to be filled within 30 days of their earliest fill date.</p> Signup and view all the answers

    According to the DEA, who is now considered an authorized agent who can transmit a prescription for a controlled substance to a pharmacist?

    <p>A nonemployee agent authorized by the prescriber.</p> Signup and view all the answers

    What is the key condition that limits all prescriptions for controlled substances in New Jersey?

    <p>All prescriptions must be filled within 30 days from the date they are written or the designated fill date.</p> Signup and view all the answers

    Prior to the change in DEA policy, what was the DEA's stance on nurses or employees transmitting physician orders to pharmacies?

    <p>The DEA did <em>not</em> authorize this practice as they weren't considered agents of the physician.</p> Signup and view all the answers

    What specific instruction must be included in each multiple prescription (except for the first one meant to be filled immediately) for a Schedule II controlled substance?

    <p>The earliest date on which the pharmacy may fill the prescription.</p> Signup and view all the answers

    In the context of issuing multiple prescriptions for Schedule II controlled substances, which of the following is NOT a condition that must be met?

    <p>The patient must have previously received a prescription for the same substance from any practitioner.</p> Signup and view all the answers

    Study Notes

    Controlled Substances

    • This section is crucial for the MPJE exam
    • New Jersey law differs from federal law in over 20 areas related to controlled substances
    • Schedules are divided based on dependence and abuse potential

    Schedules

    • Schedule I: No currently accepted medical use.
      • Examples: Methaqualone, Heroin, Mescaline, GHB, THC, LSD, Marijuana, Peyote
    • Schedule II: High potential for abuse and dependence.
      • Examples: Cocaine, Methamphetamine, Pentobarbital (Nembutal), Fentanyl, Amobarbital, Oxycodone, etc.
    • Schedule III: Moderate potential for abuse and dependence. Includes some narcotics.
      • Examples: Alprazolam (Xanax), Butorphanol (Stadol), Chloral Hydrate (Noctec).
    • Schedule IV: Low potential for abuse and dependence.
      • Examples: Chlordiazepoxide (Librium), Clonazepam (Klonopin), Diazepam (Valium), Flurazepam (Dalmane), Lorazepam (Ativan), Oxazepam (Serax).
    • Schedule V: Low potential for abuse and dependence. Primarily used for cough suppressants and anti-diarrheals.
      • Examples: Actifed/Codeine, Lomotil, Novahistine Expectorant.

    Schedule II Combination Products

    • Hydrocodone-combination products changed from Schedule III to Schedule II effective October 6, 2014
    • Schedule II suppositories became Schedule III substances.

    Scheduling Authority

    • The Attorney General has the final say about scheduling, but must get scientific and medical input from HHS
    • The attorney general can bypass HHS if there's an “imminent hazard to public safety” on a drug.

    Emergency Dispensing of Schedule II Drugs

    • Allowed in emergencies when immediate administration is needed, no alternative tx exists, or a 72-hour supply is required.
    • An emergency period is limited to a 72-hour supply.
    • The prescription must be documented (in writing) within 7 days.

    Partial Filling of Schedules II-V

    • Partial fillings are allowed for many schedules, but there are guidelines for specific situations
    • Schedule II partial fills are possible for a limited 60-day supply under certain conditions
    • Special rules exist for terminally ill patients in LTC.

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    Description

    This quiz tests your knowledge on the regulations surrounding controlled substances, specifically focusing on Central Record Keeping and DEA requirements. You will explore various aspects of DEA Form 222, CSOS technology, and notification procedures necessary for compliance. Prepare to apply your understanding to ensure compliance in your practice.

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