Pharmacy Regulations on Controlled Substances
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Questions and Answers

What is required for a pharmacist to dispense schedule II controlled substances?

  • Only an in-person consultation with the patient.
  • An official New York State prescription, an out-of-state prescription, or an electronic prescription. (correct)
  • A prescription accompanied by a recommendation letter from a specialist.
  • A written prescription from any licensed physician.

    • What information must be included on the orange label of a controlled substance package?

  • The name of the prescribing practitioner and specific directions for use. (correct)
  • The storage temperature and relevant safety warnings.
  • The manufacturer details and expiration date.
  • The pharmacy's operating hours and payment instructions.

    • Which of the following components is NOT required on the label of a controlled substance?

  • Name and address of the ultimate user or animal owner.
  • A warning about side effects of the substance. (correct)
  • The date of filling and prescription number.
  • The pharmacy's address and telephone number.

    • How long after a prescription is signed can an electronic prescription for a controlled substance be dispensed?

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

    Who is allowed to dispense controlled substances listed in section 80.67(a)?

    <p>Registered pharmacists and pharmacy interns acting under specific regulations.</p> Signup and view all the answers

    What must be marked prominently on the label of a controlled substance?

    <p>CONTROLLED SUBSTANCE, DANGEROUS UNLESS USED AS DIRECTED.</p> Signup and view all the answers

    For what type of substance is it necessary to include the species of the animal on the label?

    <p>Schedule III and IV substances intended for animal use.</p> Signup and view all the answers

    Which of the following is NOT stipulated as a requirement for dispensing a controlled substance?

    <p>The inclusion of warnings regarding food interactions.</p> Signup and view all the answers

    What must accompany a request for a waiver?

    <p>A sworn statement of facts detailing the circumstances</p> Signup and view all the answers

    What is the maximum duration for which a waiver can be granted?

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

    What is required of a pharmacy or practitioner after being granted a waiver?

    <p>They must comply with all reporting requirements until a subsequent waiver is granted</p> Signup and view all the answers

    What must a pharmacist do when dispensing emergency oral prescriptions for controlled substances?

    <p>Reduce the oral prescription to written memoranda or electronic records</p> Signup and view all the answers

    Within how many hours must a written or electronic prescription be delivered to the pharmacist after an emergency oral prescription is authorized?

    <p>72 hours</p> Signup and view all the answers

    What does the pharmacist need to verify when dispensing an emergency oral prescription?

    <p>The identity of both the practitioner and the ultimate user</p> Signup and view all the answers

    What should be indicated on the written or electronic prescription after an emergency oral prescription is filled?

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

    What is the maximum allowable quantity for an emergency oral prescription of controlled substances?

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

    What happens if the pharmacist fails to receive the written prescription after an emergency dispensing?

    <p>They shall notify the department within 7 days</p> Signup and view all the answers

    What must be attached to a facsimile prescription transmitted to a pharmacist?

    <p>The original official New York State prescription</p> Signup and view all the answers

    What is the maximum filing period for a pharmacy to submit information regarding the delivery of controlled substances without a waiver?

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

    Under what condition can a pharmacist partially fill a prescription for a schedule II controlled substance if they lack sufficient quantity?

    <p>They can fill it with a notation on the prescription.</p> Signup and view all the answers

    How long does a pharmacist have to fill the remaining portion of a partially filled prescription for schedule II controlled substances?

    <p>72 hours</p> Signup and view all the answers

    If the remaining portion of a prescription cannot be filled within the designated time, who must the pharmacist notify?

    <p>The prescribing practitioner</p> Signup and view all the answers

    What is the maximum validity period for a prescription for controlled substances issued by a practitioner?

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

    What must be recorded on a prescription being partially filled for a patient diagnosed as terminally ill?

    <p>Whether the patient is 'terminally ill' and the date of partial filling</p> Signup and view all the answers

    What is required for a pharmacy to obtain a waiver to extend the filing period beyond the normal requirements?

    <p>Demonstrating an economic hardship or exceptional circumstances</p> Signup and view all the answers

    What should a pharmacist do if an official prescription is incomplete?

    <p>Obtain oral authorization to enter the missing information</p> Signup and view all the answers

    What must be done if the remaining portion of a partially filled prescription is not filled within 30 days?

    <p>The prescription must be considered invalid.</p> Signup and view all the answers

    If a prescription for a controlled substance is issued for more than a 30-day supply for specific patients, how long does the pharmacist have to complete partial fillings?

    <p>60 days</p> Signup and view all the answers

    What is required for a pharmacist to enter a patient's address, sex, or age without authorization from the practitioner?

    <p>A good-faith effort to acquire the information</p> Signup and view all the answers

    Which of the following pieces of information cannot be changed by the pharmacist based on oral authorization from a practitioner?

    <p>Drug name</p> Signup and view all the answers

    What must a pharmacist do when they make an annotation on an electronic prescription?

    <p>Make the same notation electronically</p> Signup and view all the answers

    What action should a pharmacist take if they receive both a written and an electronic version of a prescription for controlled substances?

    <p>Mark one version as void if both were received</p> Signup and view all the answers

    What should a pharmacist do if they receive an oral prescription indicating it was originally transmitted electronically to another pharmacy?

    <p>Contact the separate pharmacy before deciding on dispensing</p> Signup and view all the answers

    Which of the following is NOT a requirement for processing electronic controlled substance prescriptions?

    <p>Employing a third-party verification service</p> Signup and view all the answers

    What must be noted by a pharmacist along with the oral authorization on a prescription?

    <p>The date the authorization was received</p> Signup and view all the answers

    What is necessary for a pharmacy application used for electronic controlled substance prescriptions?

    <p>It must meet federal security requirements</p> Signup and view all the answers

    What is the maximum period a pharmacy may wait before filing prescription information with the Bureau of Narcotic Enforcement after a substance is delivered?

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

    Which of the following is NOT required to be included in the information filed with the Bureau of Narcotic Enforcement?

    <p>Pharmacy's operating hours</p> Signup and view all the answers

    How long must a pharmacy retain an endorsed prescription for controlled substances?

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

    What action must a pharmacy take if there are no controlled substances dispensed during a relevant period?

    <p>Submit a zero report</p> Signup and view all the answers

    What is the latest a pharmacist can fill a prescription after it has been issued?

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

    Which piece of information is NOT necessary for a pharmacy's electronic filing?

    <p>Name of pharmacist on duty</p> Signup and view all the answers

    What must the pharmacy do if the person accepting a delivered prescription is unknown to them?

    <p>Require appropriate identification</p> Signup and view all the answers

    Under what conditions might a pharmacy be granted a waiver for filing prescription information beyond the typical time frame?

    <p>Technological limitations not within control</p> Signup and view all the answers

    Which of the following is NOT a reason for filing a zero report?

    <p>The pharmacy is closing temporarily</p> Signup and view all the answers

    What must be displayed on a prescription by the pharmacist when it is filled?

    <p>Date filled and pharmacist's signature</p> Signup and view all the answers

    Study Notes

    Pharmacists and Controlled Substances Dispensing

    • Licensed pharmacists and pharmacy interns can sell and dispense Schedule II, III, or IV controlled substances following a valid New York State prescription, out-of-state prescription, or electronic prescription within 30 days of issuance.
    • All dispensed substances must be enclosed in a suitable container with an orange label detailing:
      • Name and address of the user or animal owner.
      • Pharmacy's contact information.
      • Specific usage directions as per the prescription.
      • Prescribing practitioner's name.
      • Prominent warning: "CONTROLLED SUBSTANCE, DANGEROUS UNLESS USED AS DIRECTED".
      • Prescription number and filling date.
      • Name of the controlled substance or its assigned code number.

    Prescription Verification and Filing

    • Pharmacists must verify the identity of individuals receiving dispensed prescriptions, requiring appropriate identification if they are unknown.
    • Endorsed prescriptions must be retained for five years, and the prescription information filed electronically with the Bureau of Narcotic Enforcement within 24 hours of dispensing.

    Emergency Oral Prescriptions

    • Emergency oral prescriptions can be dispensed for Schedule II, III, or IV substances. Pharmacists must:
      • Record details of the prescription, including practitioner's information and Drug Enforcement Administration (DEA) registration number.
      • Label medications as required for standard prescriptions.
      • Ensure the quantity does not exceed a five-day supply.
    • Practitioners must provide a written or electronic prescription within 72 hours of the oral authorization or notify the Department if not received.

    Partial Filling of Prescriptions

    • Prescriptions for Schedule II controlled substances can be partially filled under specific conditions:
      • If insufficient medication is available, the remaining quantity must be filled within 72 hours, or the practitioner must be notified.
      • Conditions applicable to residents in Residential Health Care Facilities or terminally ill patients allow for specific record-keeping.
    • Prescriptions are valid for 30 days, with extended periods for certain populations like those in hospice care.

    Changes and Corrections to Prescriptions

    • Missing information on prescriptions can be orally provided by practitioners, allowing pharmacists to enter the information and note the authorization date.
    • Practitioners may authorize pharmacists to correct information on prescriptions, except for the practitioner's signature and drug details.
    • Documentation must include recording dates and the pharmacist's signature.

    Handling of Electronic Prescriptions

    • Pharmacists are required to ensure that electronic prescriptions are not duplicated by checking pharmacy records before dispensing.
    • If both oral and electronic prescriptions exist, one must be marked void.
    • Pharmacies must use federally compliant computer applications for electronic prescription processing and register them with the Bureau of Narcotic Enforcement.

    Reporting and Waivers

    • Pharmacies must submit zero reports if no controlled substances are dispensed within specific periods.
    • Waivers allow pharmacies flexibility in filing deadlines based on hardships, but must be formally requested and justified.
    • The administration outlines strict requirements for reporting and managing prescriptions involving controlled substances to prevent misuse and maintain safety.

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    Description

    This quiz covers the key regulations governing pharmacists' responsibilities when dispensing controlled substances, including Schedule II, III, and IV substances. Test your knowledge on the legal requirements and professional practices of pharmacy dispensing as outlined in the relevant laws.

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