MS MPJE flashcards

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

Mississippi Pharmacy Practice Act

Mississippi statute at Title 73, Chapter 21 that defines pharmacy practice, establishes the Board of Pharmacy, and authorizes licensing, rulemaking, inspection, and discipline of pharmacists, technicians, and pharmacies.

Board rulemaking process

The Board adopts regulations under Mississippi's administrative procedures law; proposed rules receive public notice and comment and become enforceable only after adoption and filing.

Board disciplinary sanctions

Board sanctions include reprimand, civil penalty, probation, restriction, suspension, revocation, and denial of a license or registration, imposed after notice and an opportunity for hearing.

Unlicensed pharmacy practice

Practicing or dispensing pharmacy without a valid Mississippi license or registration is unlawful and exposes the person to administrative action, injunctive relief, and criminal penalties.

Board inspection authority

Duly authorized Board agents may enter a licensed pharmacy during business hours to inspect the premises, equipment, and required records and to investigate complaints.

Durham-Humphrey Amendment

1951 amendment creating the prescription-only drug class; a drug is prescription-only when it cannot be used safely without the supervision of a licensed practitioner.

ANDA generic requirements

An abbreviated application requires the same active ingredient, strength, dosage form, route of administration, bioequivalence, and labeling as the reference listed drug.

505(b)(2) application

A new drug application that relies partly on studies the applicant did not conduct, plus new data, and is used for changes such as new strengths, dosage forms, or indications.

BLA versus NDA

Biologic products are licensed under the Public Health Service Act through a BLA, while small-molecule drugs are approved under the FDCA through an NDA or ANDA.

Misbranding versus adulteration

Misbranding involves false or misleading labeling or missing required label information; adulteration concerns strength, quality, purity, contamination, or insanitary manufacturing conditions.

Schedule I criteria

Substances with high abuse potential, no currently accepted medical use in the United States, and no accepted safety for use under medical supervision.

Schedule II refill prohibition

Federal law prohibits refilling a Schedule II prescription; each dispensing requires a new and valid prescription from the practitioner.

Schedule III-V refill limits

A Schedule III, IV, or V prescription may be refilled no more than five times and never later than six months after the date it was issued.

Biennial controlled substance inventory

Every registrant takes an inventory every two years; Schedule II counts are exact, Schedule III through V may be estimated, and the record is kept two years.

DEA Form 222

Order form, or its electronic CSOS equivalent, used to transfer Schedule I and II controlled substances between registrants; the purchaser records the date received.

Emergency oral Schedule II order

An oral Schedule II order may be filled only in an emergency, and the prescriber must deliver a written or electronic prescription within seven days.

Mississippi Prescription Monitoring Program

State program administered by the Board of Pharmacy that collects dispensed controlled substance data and permits prescribers and pharmacists to query patient histories.

Prescription label requirements

Labels show pharmacy name and address, prescription number, date, patient, directions, prescriber, drug name and strength, quantity, refills, and beyond-use or expiration date.

Generic substitution rule

Dispensing a therapeutically equivalent generic is permitted unless the prescriber indicates dispense-as-written or the patient refuses; state law governs notice to the prescriber.

Patient counseling offer

Pharmacists must offer counseling on new prescriptions, document any refusal, and maintain confidentiality of the information discussed.

503A compounding limits

Patient-specific compounding under a valid prescription for an identified patient, following USP standards, with interstate distribution limited to five percent of total prescription orders.

503B outsourcing facility

An FDA-registered facility that compounds without patient-specific prescriptions, follows cGMP, reports adverse events, and meets federal labeling and reporting requirements.

Prescription transfer rules

Schedule III through V prescriptions may be transferred between pharmacies for refilling, generally only once; electronic Schedule II prescriptions may be transferred for initial fill under DEA rule.

Pharmacist licensure requirements

A degree from an ACPE-accredited program, passing NAPLEX and the Mississippi MPJE, documented internship hours, and a criminal background check.

Pharmacy technician registration

Mississippi requires pharmacy technicians to be registered with the Board of Pharmacy; they perform duties under pharmacist supervision within Board-defined limits.

Pharmacist-in-charge duties

A pharmacist-in-charge is designated for each licensed pharmacy and is accountable for compliance with licensing, recordkeeping, security, and dispensing rules.

Nonresident pharmacy registration

A pharmacy located outside Mississippi that ships prescription drugs to Mississippi patients must register with the Board and comply with Mississippi practice requirements.

Controlled substance record retention

Inventories, prescriptions, and dispensing records for controlled substances must be maintained at least two years and be readily retrievable for inspection by regulators.

DEA Form 106

Written report of theft or significant loss of controlled substances, filed with DEA within one business day of discovery, with copies to state authorities as required.

Schedule II storage security

Schedule II drugs must be kept in a securely locked, substantially constructed cabinet or dispersed through the stock so access is obstructed.

Reverse distributor role

A registered entity that receives expired or unwanted controlled substances for destruction; transfers are documented on DEA Form 222 or Form 41.

Patient information confidentiality

Prescription and patient records are protected health information under HIPAA and may be disclosed only as permitted by law or with valid patient authorization.