ND MPJE cheat sheet

Durham-Humphrey Amendment (1951) created the prescription-only legend status and required the federal legend "Caution: Federal law prohibits dispensing without prescription" on Rx drugs.

Kefauver-Harris Amendment (1962) added the requirement for substantial evidence of effectiveness and informed consent, and shifted FDA oversight of prescription drug advertising to the FTC/FDA split still used today.

The Orphan Drug Act (1983) grants 7 years of market exclusivity for drugs treating conditions affecting fewer than 200,000 US patients.

Hatch-Waxman Act (1984) created the ANDA pathway and gives new chemical entities 5 years of NCE exclusivity, with 3 years for new clinical investigations of already-approved drugs.

The Poison Prevention Packaging Act requires child-resistant containers but permits non-CR packaging when the prescriber or the patient (in writing) requests it, or for certain exempted drugs like sublingual nitroglycerin.

Combat Methamphetamine Epidemic Act (2005) restricts OTC sale of pseudoephedrine and ephedrine: behind-the-counter placement, photo ID, logbook, and daily/monthly purchase limits.

The Drug Supply Chain Security Act (2013) requires product tracing at the package level, verification of suspect product, and licensure verification of trading partners; full interoperable tracing with unit-level serialization is phased in.

The FDA's Risk Evaluation and Mitigation Strategies (REMS) authority comes from FDAAA (2007); REMS may include medication guides, communication plans, and elements to assure safe use such as restricted distribution.

The North Dakota State Board of Pharmacy regulates pharmacy practice under the North Dakota Century Code Chapter 43-15 and the corresponding Administrative Code title for Board rules.

North Dakota requires pharmacy licensure for all practice sites; a pharmacist license must be renewed on the Board's renewal cycle, and continuing education hours are required per renewal period as set by the Board.

North Dakota recognizes a pharmacist's right to decline to dispense a prescription for reasons of conscience or professional judgment, but must follow Board rules on referral and patient notification.

Pharmacists in North Dakota may administer immunizations and certain medications under protocols authorized by statute and Board rule, with required training and documentation.

Collaborative practice agreements allow North Dakota pharmacists to manage drug therapy under a written protocol with a prescriber; the agreement must define scope, communication, and documentation.

The Board conducts inspections and may discipline licensees for violations including unprofessional conduct, dispensing errors, and recordkeeping failures; discipline can include reprimand, suspension, or revocation.

North Dakota requires reporting of theft or significant loss of controlled substances to the Board and DEA, with completion of the applicable DEA form.

Pharmacy technicians in North Dakota must be registered with the Board where required, and pharmacists are responsible for supervision and verification of technician work.

DEA schedules: Schedule II has high abuse potential with accepted medical use and may cause severe dependence; Schedule III-IV have decreasing abuse potential; Schedule V has lowest abuse potential.

A DEA registration is required for each principal place of business; a separate registration is required for each location, and registrations renew every 3 years.

Schedule II prescriptions must be written, signed, and may not be refilled; a pharmacist may dispense pursuant to an oral emergency order only if the prescriber provides a written prescription within 7 days.

Schedule III-V prescriptions may be refilled up to 5 times within 6 months of the date of issue unless the prescriber specifies otherwise.

A power of attorney authorizes an agent to order Schedule II drugs under the registrant's DEA number; the POA must be executed and retained by the registrant.

The DEA Form 222 (or its electronic equivalent, CSOS) is used to order Schedule I and II controlled substances; Forms 222 are retained and must be available for inspection.

Theft or significant loss of controlled substances must be reported to the DEA field office in writing within one business day of discovery, using DEA Form 106.

North Dakota scheduling generally mirrors federal schedules; state law may be stricter, and pharmacists must comply with the more restrictive requirement when federal and state rules conflict.

A valid prescription requires the patient name, drug name/strength/quantity, directions, prescriber name and signature, and date; missing required elements makes it invalid unless corrected per Board rules.

Prescriptions may be transmitted orally, in writing, or electronically; electronic prescriptions for controlled substances require DEA-compliant EPCS systems with two-factor authentication.

The pharmacist must perform a prospective drug utilization review covering therapeutic duplication, drug-disease contraindication, drug-drug interaction, incorrect dose, and allergy cross-sensitivity.

Patient counseling must be offered; if the patient declines, documentation of the refusal is required under many state rules and is good practice everywhere.

Substitution of a therapeutic equivalent generic is permitted unless the prescriber writes "dispense as written" or the patient requests brand; the patient must be informed of the substitution in most states.

Labeling must include the pharmacy name and address, prescription number, date, patient name, directions, prescriber, and quantity; auxiliary labels should address specific warnings.

Refills may be transferred between pharmacies when allowed by state law; the transferring and receiving pharmacies must document the transfer, and only remaining refills are transferred.

A prescription may be dispensed only within the timeframe allowed by state law (often one year from the date written for non-controlled drugs); expired prescriptions require prescriber authorization.

Prescription records must be retained for the period required by state and federal law; North Dakota requires records be readily retrievable and available for Board inspection.

Controlled substance records must be maintained separately or be readily retrievable and must include a biennial inventory (every 2 years) and records of receipt and disposition.

A perpetual inventory is not universally required by federal law but is a recognized best practice and may be required by state rule for certain schedules.

Medication error and adverse event reporting should follow Board rules and internal quality assurance programs; documentation supports both patient safety and regulatory defense.

Pharmacies must maintain a written policy and procedure manual covering dispensing, compounding, and controlled substance handling, reviewed and updated periodically.

Quality assurance programs should include continuous quality improvement activities, error tracking, and staff training records.

Recordkeeping for DEA includes a power of attorney file, DEA Form 222 files, inventory records, and records of destruction, all kept for at least 2 years.

Compliance audits should verify that licenses are current, that staff training is documented, and that controlled substance records reconcile with dispensing data.

Food, Drug, and Cosmetic Act (1938) required premarket safety review and created the modern new drug application framework.

The FDA Amendments Act of 2007 expanded FDA authority over drug safety, including REMS and postmarket study requirements.

The Biologics Price Competition and Innovation Act (2010) created the biosimilar pathway with 12-year reference product exclusivity.

The SUPPORT Act (2018) expanded DEA authority to regulate controlled substances and required electronic prescribing for Medicare Part D controlled substances starting 2021.

The 21st Century Cures Act (2016) accelerated drug development and required electronic health record interoperability provisions.

The Board's mission is public protection; its rules address licensure, practice standards, and discipline.

North Dakota allows pharmacy technicians to perform certain tasks under pharmacist supervision, with the pharmacist retaining responsibility for final verification.

Continuing education requirements are set by the Board and must be completed and documented before license renewal.

The Board may require reporting of changes in employment or practice location within a specified timeframe.

North Dakota law addresses prescription drug monitoring program (PDMP) query requirements for controlled substances.

Schedule II drugs include opioids, stimulants, and certain barbiturates; Schedule III includes anabolic steroids and ketamine; Schedule IV includes benzodiazepines and zolpidem; Schedule V includes certain cough preparations.

A DEA registration may be revoked or suspended for violations including improper recordkeeping, diversion, or failure to report theft.

Controlled substance prescriptions must include the prescriber's DEA number, except for certain hospital or institutional settings.

Partial filling of Schedule II prescriptions is allowed under limited circumstances, such as when the pharmacy lacks sufficient stock, with the remainder dispensed within 72 hours.

North Dakota may require PDMP review before dispensing controlled substances and may impose additional documentation requirements.

Prescription verification includes checking prescriber authority, patient identity, drug appropriateness, dose, and directions.

Compounding must follow applicable USP standards and Board rules; compounded preparations require a prescription and appropriate labeling.

Refusals to fill must be documented and communicated to the prescriber when appropriate.

Dispensing errors must be reported per Board rules and internal policies; patients should be informed and corrective action taken.

Prescription transfers must include all required information and be documented by both pharmacies.

Inventory records for controlled substances must be accurate and reconcilable with dispensing and receipt records.

Destruction of controlled substances must follow DEA and Board rules; registrants may use reverse distributors or witnessed destruction.

Staff training on controlled substance handling and recordkeeping should be documented and updated regularly.

Policies should address diversion prevention, including access controls and audit trails for automated dispensing systems.

Compliance with HIPAA privacy and security rules is required for all patient records, including prescription records.