Controlled Substances and Pharmacy Regulations
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Questions and Answers

What type of prescription is required to dispense schedule II controlled substances?

  • Official New York State prescription (correct)
  • Electronic prescription delivered within 60 days
  • Fax prescription
  • Out-of-state prescription or an oral prescription (correct)
  • Who can dispense schedule II controlled substances in a registered pharmacy?

  • A pharmacy intern only
  • A licensed, registered pharmacist only
  • A licensed, registered pharmacist or a pharmacy intern (correct)
  • Any authorized practitioner
  • What information must be indelibly typed, printed, or legibly written on the orange label?

  • Only the name of the prescribing practitioner
  • Only the name, address, and telephone number of the pharmacy
  • All the required information, including the directions for use and the legend (correct)
  • Only the name and address of the ultimate user
  • What is the purpose of the orange label on schedule II controlled substances?

    <p>To inhibit removal of the label</p> Signup and view all the answers

    What is required on the prescription for schedule II controlled substances?

    <p>The name of the prescribing practitioner and specific directions for use</p> Signup and view all the answers

    What is the time frame for delivering an electronic prescription for schedule II controlled substances?

    <p>Within 30 days</p> Signup and view all the answers

    What is the purpose of the legend on the orange label?

    <p>To warn of the dangers of the controlled substance</p> Signup and view all the answers

    What information must be recorded in the pharmacy prescription file for schedule II controlled substances?

    <p>The prescription number and date of filling</p> Signup and view all the answers

    What is the timeframe within which a pharmacy must file prescription information with the Bureau of Narcotic Enforcement?

    <p>Within 24 hours of delivery</p> Signup and view all the answers

    What is the purpose of a zero report filed by pharmacies and dispensing practitioners?

    <p>To report the non-dispensing of controlled substances</p> Signup and view all the answers

    What information must be included when filing prescription information with the Bureau of Narcotic Enforcement?

    <p>All of the above, plus other required information</p> Signup and view all the answers

    Under what circumstances may a waiver of filing requirements be issued by the commissioner?

    <p>Upon a showing of economic hardship or technological limitations</p> Signup and view all the answers

    What is the maximum period of time for which a waiver granted by the commissioner shall be valid?

    <p>Two years</p> Signup and view all the answers

    What is the timeframe within which a pharmacy must retain an endorsed prescription?

    <p>5 years</p> Signup and view all the answers

    What must a pharmacy or practitioner who has been granted a waiver do within five business days of a change in circumstances?

    <p>Notify the department in writing</p> Signup and view all the answers

    What is the purpose of requiring patient identification at the time of delivery of a controlled substance?

    <p>To make a good faith effort to verify the patient's identity</p> Signup and view all the answers

    How must an emergency oral prescription be recorded by the pharmacist?

    <p>In a written memoranda or electronic record</p> Signup and view all the answers

    What information must be included on an official New York State prescription?

    <p>All of the above, plus other required information</p> Signup and view all the answers

    What must a pharmacist do to verify an emergency oral prescription?

    <p>Make a good-faith effort to verify the identity of the practitioner and ultimate user</p> Signup and view all the answers

    Under what circumstances may a pharmacy deliver prescriptions by mail or licensed express delivery services?

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

    What is the maximum quantity of controlled substances that can be dispensed in an emergency oral prescription?

    <p>Five-day supply</p> Signup and view all the answers

    What is the timeframe within which a pharmacy must file a zero report with the Bureau of Narcotic Enforcement?

    <p>Within 14 days of the relevant period</p> Signup and view all the answers

    What must a prescribing practitioner do within 72 hours after authorizing an emergency oral prescription?

    <p>Deliver a written prescription to the pharmacist</p> Signup and view all the answers

    What information must be included on the face of the written prescription delivered to the pharmacist within 72 hours?

    <p>The words 'Authorization for emergency dispensing'</p> Signup and view all the answers

    What is the purpose of requiring a licensed, registered pharmacist to endorse a prescription?

    <p>To indicate that the prescription has been filled</p> Signup and view all the answers

    What must a pharmacist do if they fail to receive the original prescription within 72 hours after transmitting a prescription by facsimile?

    <p>Notify the department in writing or electronically</p> Signup and view all the answers

    How must prescriptions transmitted by facsimile be filed by the pharmacist?

    <p>In the same manner as other prescriptions</p> Signup and view all the answers

    What must a pharmacist do with the original prescription received from the prescribing practitioner?

    <p>Attach it to the facsimile prescription</p> Signup and view all the answers

    Under what circumstances can a pharmacist change information on an official New York State prescription or an out-of-state written prescription?

    <p>With oral authorization from the practitioner, but only for the patient's address, sex, or age</p> Signup and view all the answers

    What notation must a pharmacist make when filling an electronic prescription that requires a change in accordance with subdivision (k) or subdivision (l) of this section?

    <p>An electronic annotation in the prescription record</p> Signup and view all the answers

    What must a pharmacist do when receiving a written or oral prescription for a schedule II controlled substance that indicates it was originally transmitted electronically to the pharmacy?

    <p>Conduct a reasonable search of the pharmacy records to ensure the electronic version was not received and the prescription dispensed</p> Signup and view all the answers

    What must a pharmacist do when receiving a written or oral prescription for a schedule II controlled substance that indicates it was originally transmitted electronically to a separate pharmacy?

    <p>Confer with the separate pharmacy to determine if they received the electronic prescription and if they dispensed it</p> Signup and view all the answers

    What is required for a pharmacy computer application to process electronic controlled substance prescriptions?

    <p>Compliance with federal security requirements</p> Signup and view all the answers

    Why must a pharmacist mark a prescription as void when receiving a written or oral prescription for a schedule II controlled substance that indicates it was originally transmitted electronically to the pharmacy?

    <p>Because the electronic version was received and dispensed</p> Signup and view all the answers

    What must a pharmacist do when filling a prescription in a manner that requires a notation on the prescription if it were written?

    <p>Make the same notation electronically when filling an electronic prescription</p> Signup and view all the answers

    What is required for a pharmacist to process electronic controlled substance prescriptions?

    <p>A pharmacy computer application that meets federal security requirements</p> Signup and view all the answers

    Under what circumstances may a waiver be issued to allow a pharmacy to file information electronically with the New York State Department of Health within a longer period of time?

    <p>Upon a showing of exceptional circumstances and technological limitations</p> Signup and view all the answers

    What is required on the prescription when a pharmacist partially fills a prescription for a schedule II controlled substance?

    <p>The quantity supplied, the date of partial filling, and the signature of the dispensing pharmacist</p> Signup and view all the answers

    What is the time frame within which a pharmacist must partially fill a prescription for a schedule II controlled substance under certain circumstances?

    <p>Within 72 hours of the first partial filling</p> Signup and view all the answers

    When may a pharmacist orally receive missing information from a practitioner to complete a prescription?

    <p>When the prescription is incomplete, but not when it is unsigned, undated, or missing required information</p> Signup and view all the answers

    What is the maximum time frame within which a partial filling of a prescription for a schedule II controlled substance may occur for patients residing in a residential healthcare facility?

    <p>60 days from the date the prescription was issued</p> Signup and view all the answers

    What information must be recorded on the prescription when a patient is diagnosed as terminally ill?

    <p>The date of partial filling, the quantity dispensed, and the signature of the dispensing pharmacist</p> Signup and view all the answers

    Under what circumstances may a pharmacist partially fill a prescription for a schedule II controlled substance?

    <p>All of the above</p> Signup and view all the answers

    What is the purpose of recording the date of filling on the prescription?

    <p>All of the above</p> Signup and view all the answers

    What is required when a pharmacist partially fills a prescription for a schedule II controlled substance under certain circumstances?

    <p>The pharmacist must make a notation of the quantity supplied on the prescription</p> Signup and view all the answers

    What is the deadline for submitting information electronically to the New York State Department of Health?

    <p>Within 24 hours of the substance being delivered</p> Signup and view all the answers

    Study Notes

    Pharmacists and Controlled Substances

    • A licensed, registered pharmacist or pharmacy intern can sell and dispense schedule II, III, or IV controlled substances to an ultimate user in a registered pharmacy, provided they are dispensed pursuant to a valid prescription.
    • The prescription must be dispensed within 30 days of the date it was signed by the authorized practitioner.

    Labeling Requirements

    • The substance must be enclosed in a suitable and durable container with an orange label that includes:
      • The name and address of the ultimate user
      • The name, address, and telephone number of the pharmacy
      • Specific directions for use
      • The name of the prescribing practitioner
      • A legend warning that the substance is dangerous unless used as directed
      • The prescription number and date of filling
      • The name of the controlled substance or its code number assigned by the department

    Prescription Filing and Verification

    • The pharmacist must endorse the prescription with their signature, date of filling, and prescription number.
    • The endorsed prescription must be retained by the pharmacy for five years.
    • Prescription information must be filed electronically with the Bureau of Narcotic Enforcement within 24 hours of delivery.
    • The information filed must include patient demographics, prescription details, and dispensing information.

    Emergency Oral Prescriptions

    • Emergency oral prescriptions for schedule II, III, or IV controlled substances can be dispensed in an emergency situation.
    • The pharmacist must contemporaneously reduce the prescription to a written memoranda or electronic record.
    • The prescription must be verified with the prescribing practitioner and the ultimate user.

    Partial Filling of Prescriptions

    • A pharmacist can partially fill a prescription for a schedule II controlled substance under certain circumstances.
    • The partial filling must be recorded on the prescription, and the remaining portion can be filled within 72 hours.

    Prescription Validation and Notification

    • A pharmacist must validate the prescription with the prescribing practitioner before dispensing.
    • If the prescription is incomplete, the practitioner can orally furnish the missing information to the pharmacist.
    • If the prescription is changed, the pharmacist must make a notation on the prescription and initial the change.

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    Description

    This quiz covers the laws and regulations regarding the dispensing of controlled substances, including schedule II, III, and IV substances, by licensed pharmacists and pharmacy interns.

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