MN MPJE flashcards

32 cards. Read the term and the definition here. The deck at the top of this page is optional.

Federal Controlled Substances Act

21 U.S.C. §801 et seq. and 21 C.F.R. Parts 1300-1321 create the five schedules, registration, recordkeeping, and dispensing rules enforced by DEA; state law may be stricter but not more permissive.

Minnesota Pharmacy Practice Act

Minn. Stat. ch. 151, with rules in Minn. R. ch. 6800, governs pharmacist and pharmacy licensure, dispensing, and discipline through the Minnesota Board of Pharmacy.

Preemption in pharmacy law

Federal drug law sets a minimum standard; a state such as Minnesota may impose stricter requirements, but no state may authorize conduct that federal law prohibits.

Minnesota e-prescribing mandate

Minn. Stat. §62J.497 requires prescriptions to be transmitted electronically, with exceptions for technical failure, certain care settings, and waivers granted to prescribers.

Minnesota Health Records Act

Minn. Stat. §§144.291-.298 governs patient consent, access, and release of health records in Minnesota; where it is stricter than HIPAA, the stricter rule controls.

Schedule II partial fill rule

A Schedule II prescription may be partially filled; the remaining quantity must be dispensed within 30 days of the original prescription date or it becomes void.

Schedule III-V refill limit

Schedule III, IV, and V prescriptions may be refilled up to five times within six months of the date of issue; after that a new prescription is required.

Emergency oral Schedule II order

A pharmacist may dispense a limited emergency quantity of a Schedule II drug on an oral order if the prescriber delivers a written or electronic prescription within seven days.

Minnesota PMP reporting deadline

Under Minn. Stat. §152.126, dispensers must submit each controlled substance dispensing to the Minnesota Prescription Monitoring Program by the next business day after dispensing.

Naloxone under statewide protocol

Minnesota pharmacists may dispense naloxone without a patient-specific prescription under a statewide protocol, and good-faith prescribers, dispensers, and administrators receive civil and criminal immunity.

Required prescription elements

Patient name and address, drug name, strength, dosage form, quantity, directions, date, prescriber identification, and for controlled substances the prescriber's DEA number.

Default refill authorization

If a prescriber does not specify refills, the pharmacist may not refill the prescription; the default authorization is zero refills.

Generic substitution rules

A pharmacist may substitute a therapeutically equivalent generic unless the prescriber writes dispense as written or the patient refuses; the patient must be informed.

Prescription transfer limits

Non-controlled prescriptions may be transferred between pharmacies; Schedule III-V may be transferred for refills with documentation; Schedule II prescriptions cannot be transferred or refilled.

Nonresident pharmacy licensure

A pharmacy outside Minnesota that ships, mails, or delivers prescription drugs to Minnesota patients must hold a Minnesota nonresident pharmacy license and follow Minnesota labeling and counseling rules.

Pharmacist CE requirement

Minnesota pharmacists must complete 30 contact hours of continuing education during each two-year renewal cycle, including any topic-specific hours the Board requires.

Pharmacy technician registration

Minnesota technicians must be certified by a Board-recognized certifying body such as PTCB or NHA and registered with the Board before performing technician duties under pharmacist supervision.

Pharmacist-in-charge responsibility

Every licensed pharmacy must designate a pharmacist-in-charge who is accountable for legal compliance, security, recordkeeping, and supervision of all pharmacy personnel at that location.

Pharmacy intern registration

Students in an accredited pharmacy program must register with the Minnesota Board of Pharmacy before practicing as interns and must work under pharmacist supervision.

DEA registration term

A DEA registration is valid for three years, must be renewed before expiration, and is required for each principal place of business where controlled substances are handled.

Offer-to-counsel requirement

Pharmacists must offer oral counseling on each new prescription and whenever therapy changes; the patient may decline, and the duty applies regardless of payer.

Prescription label contents

Labels must show pharmacy name, address, and phone; prescription number; fill date; patient name; drug name, strength, and quantity; directions; prescriber; refills; beyond-use date; and pharmacist initials.

Counseling refusal documentation

When a patient declines the offer to counsel, the pharmacist should record the refusal in the patient record to demonstrate that the offer was in fact made.

Collaborative practice agreement

A written agreement between a Minnesota pharmacist and a prescriber that authorizes the pharmacist to initiate, modify, or discontinue drug therapy under defined protocols.

USP 795 nonaqueous BUD

Nonsterile compounded preparations that contain no water may be assigned a beyond-use date of up to 180 days when stored at controlled room temperature.

USP 797 sterile BUDs

Sterile compounded preparation beyond-use dates depend on the USP 797 category and storage; traditional low-risk limits are 48 hours at room temperature, 14 days refrigerated, and 45 days frozen.

Hazardous drug containment

USP 800 requires a negative-pressure room, a containment ventilated enclosure, closed system transfer devices, and documented training for anyone handling hazardous drugs.

Compounding documentation

Each compounded preparation requires a master formulation record and a compounding record listing ingredients, sources, lot numbers, beyond-use date, and the identity of the person who compounded it.

Controlled substance record retention

Records of controlled substance receipt, dispensing, inventory, and destruction must be kept for at least two years and be readily retrievable for DEA and Board of Pharmacy inspection.

Biennial inventory counting rules

A registrant takes an initial inventory and a biennial inventory thereafter; Schedule II requires an exact count, while Schedules III-V may be estimated unless a container holds more than 1,000 units.

DEA Form 41 destruction

DEA Form 41 documents the destruction of controlled substances by a registrant and is retained as proof that the drugs were destroyed in an approved manner.

Recall handling procedure

Recalled product must be quarantined immediately, removed from dispensing stock, documented, and returned to the manufacturer or reverse distributor; Class I recalls require prompt patient notification.