NV MPJE study materials
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NV MPJE cheat sheet

NV MPJE · Keep the key ideas within reach.

Quick reference

Federal Pharmacy Law and Regulations

  • Durham-Humphrey Amendment (1951) created the prescription-only legend category: a drug is Rx-only unless its label states it may be dispensed without a prescription.

  • A prescription for a Schedule III–V drug may not be filled or refilled more than 6 months after the date of issue and may not be refilled more than 5 times unless the prescriber renews it in writing.

  • Schedule II prescriptions require a written, electronic, or emergency oral order; emergency oral C-II orders must be followed by a written/electronic prescription within 7 days, and partial fills are limited to 30 days from the date written (72 hours for emergency oral).

  • DEA Form 222 (or CSOS) is required to order Schedule I/II substances; a power of attorney authorizes an agent to sign, and the form is valid for 60 days after execution.

  • The Poison Prevention Packaging Act requires child-resistant containers unless the prescriber or patient requests otherwise; an oral request for non-CR packaging is valid for one prescription only, while a blanket request must be written.

  • Medicare Part D and most third-party plans require the prescriber's NPI on the claim; the NPI is a 10-digit identifier that replaced UPINs in 2007 and contains no embedded intelligence.

  • Under the Combat Methamphetamine Epidemic Act, scheduled listed chemical products (pseudoephedrine, ephedrine, phenylpropanolamine) sold at retail must be kept behind the counter, logged with purchaser ID, and limited to 3.6 g per day and 9 g per 30 days per purchaser.

  • The FDA requires a Medication Guide to be provided with each dispensing for drugs with serious and significant public health concerns (e.g., certain antidepressants, isotretinoin, anticoagulants) when the patient receives less than a full 30-day supply or requests one.

  • Anabolic steroids are Schedule III controlled substances; federal law prohibits refills of Schedule III–V prescriptions beyond the limits above and requires that all controlled substance dispensing records be maintained for at least 2 years.

Quick reference

North Dakota Pharmacy Practice Act and Board Rules

  • The North Dakota State Board of Pharmacy licenses pharmacies, pharmacists, pharmacy technicians, and pharmacy interns; the Board's rules are codified in Title 61 of the North Dakota Administrative Code and the Act in N.D.C.C. Chapter 43-15.

  • A North Dakota pharmacist license must be renewed annually by December 31; continuing education requirements apply and lapses require reinstatement, which may include a fee and additional CE.

  • A North Dakota pharmacy technician must be registered with the Board and work under the direct supervision of a licensed pharmacist; the pharmacist is responsible for the technician's activities and for final verification of dispensed prescriptions.

  • North Dakota requires a pharmacist to counsel patients on new prescriptions and to offer counseling on refills; counseling may be declined by the patient, and the refusal should be documented.

  • Prescription records in North Dakota must be retained for at least 5 years and be readily retrievable; controlled substance records must be kept for the period required by federal and state law and be available for Board inspection.

  • A pharmacist may dispense a prescription drug pursuant to a valid prescription from a practitioner licensed in any state, provided the prescription is for a legitimate medical purpose and the pharmacist verifies authenticity.

  • North Dakota allows a pharmacist to administer immunizations to patients of appropriate age under a protocol or prescription, subject to Board rules and certification requirements.

  • A prescription may be transferred between pharmacies; North Dakota follows the federal rule that Schedule III–V prescriptions may be transferred once (or as allowed by DEA rules), and Schedule II prescriptions generally may not be refilled or transferred.

  • The Board may discipline a licensee for unprofessional conduct, including dispensing without a valid prescription, practicing while impaired, or failing to maintain required records; sanctions range from reprimand to revocation.

Quick reference

Controlled Substances Laws (Federal and State)

  • Schedule I drugs have no accepted medical use and high abuse potential (e.g., heroin, LSD); Schedule II drugs have accepted medical use but high abuse potential (e.g., oxycodone, morphine, amphetamine).

  • A DEA registration is required for each principal place of business; a registrant may not use a registration at a location not covered by it, and registration must be renewed every 3 years for pharmacies.

  • Schedule II prescriptions may be filled only if issued for a legitimate medical purpose by a practitioner acting in the usual course of professional practice; the pharmacist has a corresponding responsibility to resolve red flags.

  • An oral Schedule II prescription may be accepted only in an emergency, must be reduced to writing by the pharmacist, and the prescriber must provide a written or electronic prescription within 7 days.

  • Schedule III–V prescriptions may be refilled up to 5 times within 6 months of the date of issue; the pharmacist must record the date and quantity of each refill.

  • A partial fill of a Schedule II prescription is permitted when the pharmacy cannot supply the full quantity, provided the remainder is dispensed within 72 hours; otherwise the prescriber must be notified and the balance dispensed within 30 days of the date written.

  • The DEA requires a biennial inventory of controlled substances on May 1 of each odd-numbered year (or the next business day), and newly registered pharmacies must take an initial inventory on the date they begin business.

  • North Dakota schedules mirror the federal schedules under N.D.C.C. Chapter 19-03.1; the Board and the state Board of Pharmacy enforce state controlled substance laws, and practitioners must hold a valid DEA registration and state license.

  • Records of controlled substances must be maintained for at least 2 years and kept separate from other records; theft or significant loss must be reported to DEA in writing within one business day of discovery.

Quick reference

Pharmacy Operations, Licensure, and Personnel

  • A pharmacy must have a pharmacist-in-charge (PIC) who is responsible for compliance with laws and rules, and the Board must be notified of a change in PIC within the time specified by Board rule.

  • Pharmacy technicians must be registered with the Board and may perform only tasks delegated by and under the supervision of a pharmacist; the pharmacist retains responsibility for the final check.

  • A prescription must contain the patient's name and address, drug name, strength, dosage form, quantity, directions for use, prescriber's name and address, and date; missing elements must be resolved before dispensing.

  • Pharmacies must maintain a perpetual inventory or equivalent record system for controlled substances and reconcile receipts, dispensing, and returns to detect discrepancies.

  • Automated dispensing systems and pharmacy automation must be validated, have security controls, and be included in the pharmacy's quality assurance program; the PIC is accountable for their use.

  • A pharmacy's quality assurance program should include a system for documenting and reviewing medication errors and near misses, with the goal of continuous improvement rather than blame.

  • Sterile compounding must follow USP <797> standards, including environmental monitoring, personnel training, and beyond-use dating; nonsterile compounding follows USP <795>.

  • The Board may inspect a pharmacy at reasonable times without prior notice; the pharmacy must produce licenses, records, and inventory for inspection.

  • A pharmacist who is absent from the pharmacy must arrange for coverage; a pharmacy may not operate without a pharmacist on duty, and the pharmacy must be secured when closed.

Quick reference

Professional Ethics and Patient Safety

  • The pharmacist's corresponding responsibility means the pharmacist must resolve red flags (e.g., early refills, cash payment, distance from prescriber, pattern of controlled substances) before dispensing a controlled substance.

  • Patient counseling is a professional obligation; the pharmacist should provide information on proper use, storage, and potential adverse effects, and document when counseling is declined.

  • Patient confidentiality is protected by HIPAA and state law; disclosures require patient authorization or a legal exception, and minimum necessary information should be shared.

  • A pharmacist must avoid conflicts of interest and must not accept gifts or inducements that could compromise professional judgment.

  • Medication error reporting should be nonpunitive and focused on system improvement; errors should be disclosed to the patient and documented according to policy.

  • The pharmacist should verify the prescription's legitimacy by contacting the prescriber when there is a question about the dose, drug, or patient, and should not alter a prescription without authorization.

  • Pharmacists must report suspected impaired practitioners or unsafe practice conditions to the appropriate authority, consistent with state law and Board rules.

  • Patient safety includes proper labeling, auxiliary labels, and verification of allergies and drug interactions; the pharmacist should use available clinical information systems to screen for problems.

  • Ethical practice requires maintaining competence through continuing education and staying current with law and clinical standards; the Board may discipline licensees for practicing outside their competence.

Quick reference

Federal Pharmacy Law and Regulations

  • Durham-Humphrey Amendment (1951) created the prescription-only legend category: a drug is Rx-only unless its label states it may be dispensed without a prescription.

  • A prescription for a Schedule III–V drug may not be filled or refilled more than 6 months after the date of issue and may not be refilled more than 5 times unless the prescriber renews it in writing.

  • Schedule II prescriptions require a written, electronic, or emergency oral order; emergency oral C-II orders must be followed by a written/electronic prescription within 7 days, and partial fills are limited to 30 days from the date written (72 hours for emergency oral).

  • DEA Form 222 (or CSOS) is required to order Schedule I/II substances; a power of attorney authorizes an agent to sign, and the form is valid for 60 days after execution.

  • The Poison Prevention Packaging Act requires child-resistant containers unless the prescriber or patient requests otherwise; an oral request for non-CR packaging is valid for one prescription only, while a blanket request must be written.

  • Medicare Part D and most third-party plans require the prescriber's NPI on the claim; the NPI is a 10-digit identifier that replaced UPINs in 2007 and contains no embedded intelligence.

  • Under the Combat Methamphetamine Epidemic Act, scheduled listed chemical products (pseudoephedrine, ephedrine, phenylpropanolamine) sold at retail must be kept behind the counter, logged with purchaser ID, and limited to 3.6 g per day and 9 g per 30 days per purchaser.

  • The FDA requires a Medication Guide to be provided with each dispensing for drugs with serious and significant public health concerns (e.g., certain antidepressants, isotretinoin, anticoagulants) when the patient receives less than a full 30-day supply or requests one.

  • Anabolic steroids are Schedule III controlled substances; federal law prohibits refills of Schedule III–V prescriptions beyond the limits above and requires that all controlled substance dispensing records be maintained for at least 2 years.

Quick reference

North Dakota Pharmacy Practice Act and Board Rules

  • The North Dakota State Board of Pharmacy licenses pharmacies, pharmacists, pharmacy technicians, and pharmacy interns; the Board's rules are codified in Title 61 of the North Dakota Administrative Code and the Act in N.D.C.C. Chapter 43-15.

  • A North Dakota pharmacist license must be renewed annually by December 31; continuing education requirements apply and lapses require reinstatement, which may include a fee and additional CE.

  • A North Dakota pharmacy technician must be registered with the Board and work under the direct supervision of a licensed pharmacist; the pharmacist is responsible for the technician's activities and for final verification of dispensed prescriptions.

  • North Dakota requires a pharmacist to counsel patients on new prescriptions and to offer counseling on refills; counseling may be declined by the patient, and the refusal should be documented.

  • Prescription records in North Dakota must be retained for at least 5 years and be readily retrievable; controlled substance records must be kept for the period required by federal and state law and be available for Board inspection.

  • A pharmacist may dispense a prescription drug pursuant to a valid prescription from a practitioner licensed in any state, provided the prescription is for a legitimate medical purpose and the pharmacist verifies authenticity.

  • North Dakota allows a pharmacist to administer immunizations to patients of appropriate age under a protocol or prescription, subject to Board rules and certification requirements.

  • A prescription may be transferred between pharmacies; North Dakota follows the federal rule that Schedule III–V prescriptions may be transferred once (or as allowed by DEA rules), and Schedule II prescriptions generally may not be refilled or transferred.

  • The Board may discipline a licensee for unprofessional conduct, including dispensing without a valid prescription, practicing while impaired, or failing to maintain required records; sanctions range from reprimand to revocation.

Quick reference

Controlled Substances Laws (Federal and State)

  • Schedule I drugs have no accepted medical use and high abuse potential (e.g., heroin, LSD); Schedule II drugs have accepted medical use but high abuse potential (e.g., oxycodone, morphine, amphetamine).

  • A DEA registration is required for each principal place of business; a registrant may not use a registration at a location not covered by it, and registration must be renewed every 3 years for pharmacies.

  • Schedule II prescriptions may be filled only if issued for a legitimate medical purpose by a practitioner acting in the usual course of professional practice; the pharmacist has a corresponding responsibility to resolve red flags.

  • An oral Schedule II prescription may be accepted only in an emergency, must be reduced to writing by the pharmacist, and the prescriber must provide a written or electronic prescription within 7 days.

  • Schedule III–V prescriptions may be refilled up to 5 times within 6 months of the date of issue; the pharmacist must record the date and quantity of each refill.

  • A partial fill of a Schedule II prescription is permitted when the pharmacy cannot supply the full quantity, provided the remainder is dispensed within 72 hours; otherwise the prescriber must be notified and the balance dispensed within 30 days of the date written.

  • The DEA requires a biennial inventory of controlled substances on May 1 of each odd-numbered year (or the next business day), and newly registered pharmacies must take an initial inventory on the date they begin business.

  • North Dakota schedules mirror the federal schedules under N.D.C.C. Chapter 19-03.1; the Board and the state Board of Pharmacy enforce state controlled substance laws, and practitioners must hold a valid DEA registration and state license.

  • Records of controlled substances must be maintained for at least 2 years and kept separate from other records; theft or significant loss must be reported to DEA in writing within one business day of discovery.

Quick reference

Pharmacy Operations, Licensure, and Personnel

  • A pharmacy must have a pharmacist-in-charge (PIC) who is responsible for compliance with laws and rules, and the Board must be notified of a change in PIC within the time specified by Board rule.

  • Pharmacy technicians must be registered with the Board and may perform only tasks delegated by and under the supervision of a pharmacist; the pharmacist retains responsibility for the final check.

  • A prescription must contain the patient's name and address, drug name, strength, dosage form, quantity, directions for use, prescriber's name and address, and date; missing elements must be resolved before dispensing.

  • Pharmacies must maintain a perpetual inventory or equivalent record system for controlled substances and reconcile receipts, dispensing, and returns to detect discrepancies.

  • Automated dispensing systems and pharmacy automation must be validated, have security controls, and be included in the pharmacy's quality assurance program; the PIC is accountable for their use.

  • A pharmacy's quality assurance program should include a system for documenting and reviewing medication errors and near misses, with the goal of continuous improvement rather than blame.

  • Sterile compounding must follow USP <797> standards, including environmental monitoring, personnel training, and beyond-use dating; nonsterile compounding follows USP <795>.

  • The Board may inspect a pharmacy at reasonable times without prior notice; the pharmacy must produce licenses, records, and inventory for inspection.

  • A pharmacist who is absent from the pharmacy must arrange for coverage; a pharmacy may not operate without a pharmacist on duty, and the pharmacy must be secured when closed.

Quick reference

Professional Ethics and Patient Safety

  • The pharmacist's corresponding responsibility means the pharmacist must resolve red flags (e.g., early refills, cash payment, distance from prescriber, pattern of controlled substances) before dispensing a controlled substance.

  • Patient counseling is a professional obligation; the pharmacist should provide information on proper use, storage, and potential adverse effects, and document when counseling is declined.

  • Patient confidentiality is protected by HIPAA and state law; disclosures require patient authorization or a legal exception, and minimum necessary information should be shared.

  • A pharmacist must avoid conflicts of interest and must not accept gifts or inducements that could compromise professional judgment.

  • Medication error reporting should be nonpunitive and focused on system improvement; errors should be disclosed to the patient and documented according to policy.

  • The pharmacist should verify the prescription's legitimacy by contacting the prescriber when there is a question about the dose, drug, or patient, and should not alter a prescription without authorization.

  • Pharmacists must report suspected impaired practitioners or unsafe practice conditions to the appropriate authority, consistent with state law and Board rules.

  • Patient safety includes proper labeling, auxiliary labels, and verification of allergies and drug interactions; the pharmacist should use available clinical information systems to screen for problems.

  • Ethical practice requires maintaining competence through continuing education and staying current with law and clinical standards; the Board may discipline licensees for practicing outside their competence.