ND MPJE flashcards
ND MPJE · Build recall with a focused review session.
38 cards. Read the term and the definition here. The deck at the top of this page is optional.
- Durham-Humphrey Amendment
- 1951 federal law that created the prescription-only legend drug category and required the federal caution legend on prescription medications.
- Kefauver-Harris Amendment
- 1962 law requiring substantial evidence of drug effectiveness before approval and establishing informed consent and advertising oversight requirements.
- Orphan Drug Act
- 1983 law granting seven years of market exclusivity for drugs treating rare diseases affecting fewer than 200,000 patients in the United States.
- Hatch-Waxman Act
- 1984 law creating the abbreviated new drug application pathway and providing five-year new chemical entity exclusivity and three-year exclusivity for new clinical investigations.
- Poison Prevention Packaging Act
- Requires child-resistant packaging for most prescription drugs, with exemptions for certain drugs and when the prescriber or patient requests non-child-resistant packaging.
- Combat Methamphetamine Epidemic Act
- 2005 law restricting over-the-counter pseudoephedrine sales with behind-the-counter placement, photo identification, logbook recording, and daily and monthly purchase limits.
- Drug Supply Chain Security Act
- 2013 law requiring package-level product tracing, verification of suspect products, and licensure verification of trading partners throughout the pharmaceutical supply chain.
- REMS
- Risk Evaluation and Mitigation Strategies authorized by the FDA Amendments Act of 2007 to manage serious safety concerns through medication guides, communication plans, or restricted distribution.
- North Dakota Board of Pharmacy
- State agency regulating pharmacy practice under Century Code Chapter 43-15 and Board rules, responsible for licensure, inspections, and discipline of pharmacists and pharmacies.
- Continuing education requirement
- North Dakota pharmacists must complete Board-specified continuing education hours each renewal period and document completion before license renewal.
- Conscience clause
- North Dakota law allows pharmacists to decline to dispense a prescription for reasons of conscience or professional judgment, subject to Board rules on referral and notification.
- Immunization authority
- North Dakota pharmacists may administer immunizations and certain medications under protocols authorized by statute and Board rule, with required training and documentation.
- Collaborative practice agreement
- Written protocol between a North Dakota pharmacist and prescriber defining scope of drug therapy management, communication, and documentation requirements.
- Board inspection authority
- The North Dakota Board of Pharmacy conducts inspections and may discipline licensees for violations including unprofessional conduct, dispensing errors, and recordkeeping failures.
- Theft or loss reporting
- North Dakota requires reporting theft or significant loss of controlled substances to the Board and DEA, with completion of the applicable DEA form.
- Technician registration
- North Dakota pharmacy technicians must be registered with the Board where required, and pharmacists are responsible for supervision and verification of technician work.
- DEA registration
- Required for each principal place of business where controlled substances are handled; separate registration per location and renewal every three years.
- Schedule II refill prohibition
- Schedule II prescriptions may not be refilled; emergency oral orders require a written prescription from the prescriber within seven days.
- Schedule III-V refills
- Schedule III through V prescriptions may be refilled up to five times within six months of the issue date unless the prescriber specifies otherwise.
- Power of attorney
- Document authorizing an agent to order Schedule II controlled substances under the registrant's DEA number; must be executed and retained by the registrant.
- DEA Form 222
- Order form, or its electronic equivalent CSOS, used to order Schedule I and II controlled substances; retained and available for inspection.
- DEA Form 106
- Form used to report theft or significant loss of controlled substances to the DEA field office in writing within one business day of discovery.
- State scheduling conflict
- North Dakota scheduling generally mirrors federal schedules, but state law may be stricter; pharmacists must comply with the more restrictive requirement when rules conflict.
- Valid prescription elements
- Requires patient name, drug name strength and quantity, directions, prescriber name and signature, and date; missing elements make it invalid unless corrected per Board rules.
- EPCS
- Electronic prescriptions for controlled substances require DEA-compliant systems with two-factor authentication for prescriber identity verification.
- Prospective DUR
- Pharmacist review covering therapeutic duplication, drug-disease contraindication, drug-drug interaction, incorrect dose, and allergy cross-sensitivity before dispensing.
- Patient counseling
- Must be offered to every patient; if the patient declines, documentation of the refusal is required under many state rules and is good practice everywhere.
- Generic substitution
- Permitted unless the prescriber writes dispense as written or the patient requests brand; the patient must be informed of substitution in most states.
- Labeling requirements
- Labels must include pharmacy name and address, prescription number, date, patient name, directions, prescriber, and quantity, plus auxiliary warning labels as appropriate.
- Prescription transfers
- Allowed when state law permits; transferring and receiving pharmacies must document the transfer, and only remaining refills are transferred.
- Prescription expiration
- Non-controlled prescriptions may be dispensed only within the timeframe allowed by state law, often one year from the date written; expired prescriptions require prescriber authorization.
- Biennial inventory
- Controlled substance inventory required every two years, documenting quantity and schedule of all controlled substances on hand at the registered location.
- Record retention
- Prescription and controlled substance records must be retained for the period required by state and federal law and be readily retrievable for Board inspection.
- Perpetual inventory
- Running record of controlled substance receipts and disbursements; not universally required by federal law but recognized as a best practice and sometimes required by state rule.
- Quality assurance program
- Continuous quality improvement activities including error tracking, staff training records, and documentation supporting patient safety and regulatory defense.
- Policy and procedure manual
- Written manual covering dispensing, compounding, and controlled substance handling, reviewed and updated periodically to reflect current practice.
- DEA recordkeeping
- DEA records including power of attorney files, Form 222 files, inventory records, and destruction records must be kept for at least two years.
- Compliance audit
- Review verifying that licenses are current, staff training is documented, and controlled substance records reconcile with dispensing data.