MS MPJE cheat sheet

The Mississippi Pharmacy Practice Act is codified at Miss. Code Ann. Title 73, Chapter 21; Board of Pharmacy regulations are published in the Mississippi Administrative Code.

The Board licenses pharmacists, registers technicians and interns, licenses in-state and nonresident pharmacies, and holds authority to inspect and discipline.

Available Board sanctions include reprimand, civil penalty, probation, restriction, suspension, revocation, and denial, imposed after notice and hearing.

Rulemaking follows the Mississippi Administrative Procedures Act: notice, public comment, adoption, and filing before a rule is enforceable.

Practicing or dispensing pharmacy without a current license or registration is unlawful and may be enjoined and criminally prosecuted.

The Board may investigate on its own motion or on complaint, subpoena records, and conduct contested case hearings.

Final Board orders are subject to judicial review under the state administrative procedures law.

Board rules set pharmacist-in-charge duties, technician supervision and ratios, counseling standards, recordkeeping, and prescription department security.

The 1938 FDCA requires new drugs to be approved through an NDA; the 1962 Kefauver-Harris amendments added proof of effectiveness and current good manufacturing practice.

A drug is an article recognized in USP/NF, intended for diagnosis, cure, mitigation, treatment, or prevention of disease, or intended to affect body structure or function.

Durham-Humphrey (1951) created the prescription class: a drug is prescription-only when it cannot be used safely without practitioner supervision.

A prescription drug is exempt from 'adequate directions for use' only when the labeling requirements of 21 CFR 201.100 are satisfied.

ANDA requires the same active ingredient, strength, dosage form, route, bioequivalence, and labeling; a 505(b)(2) application relies on existing data plus new studies.

Biologics are licensed under the Public Health Service Act through a BLA; biosimilars under 351(k); small molecules under FDCA NDA or ANDA pathways.

Adulteration involves insanitary conditions, contamination, or failure to meet strength, quality, or purity; misbranding involves false, misleading, or missing required labeling.

Prescription labeling under 21 CFR 201.57 includes boxed warning, indications, dosage and administration, contraindications, warnings, adverse reactions, and use in specific populations.

The 2013 Drug Quality and Security Act created 503A and 503B compounding categories and imposed DSCSA transaction tracing and serialization duties.

Five schedules exist; Schedule I drugs have high abuse potential, no accepted medical use, and no accepted safety under medical supervision.

Schedule II prescriptions cannot be refilled; an oral Schedule II order is valid only in an emergency with written or electronic follow-up within 7 days.

Schedule III through V prescriptions may be refilled no more than 5 times and not later than 6 months after the issue date.

Partial fills: a Schedule II remainder must be supplied within 30 days (60 days for long-term care or terminally ill patients); Schedule III-V remainder within 72 hours.

Keep controlled substance records 2 years, separate or readily retrievable; inventory every 2 years (exact count for CII, estimated for CIII-V); new registrants inventory on the registration date.

Use DEA Form 222 or CSOS to order Schedule II drugs, Form 106 for theft or significant loss, and Form 41 or 222 for destruction or transfer to a reverse distributor.

DEA registration is activity- and location-specific and renews every 3 years.

The Mississippi Controlled Substances Act (Title 41, Chapter 29) tracks federal scheduling; dispensing requires DEA registration plus any state authority the Board requires.

The Mississippi Prescription Monitoring Program, administered by the Board of Pharmacy, requires dispensers to report controlled substance dispensing and permits prescriber and pharmacist queries.

A valid prescription identifies patient, drug, strength, dosage form, quantity, directions, prescriber, and date; a Schedule II order must be signed written or valid EPCS.

Required label elements include pharmacy name and address, prescription number, date, patient name, directions, prescriber, drug name and strength, quantity, refill information, beyond-use or expiration date, and warnings.

Generic substitution is permitted unless the prescriber indicates dispense-as-written or the patient refuses; the label must identify the drug actually dispensed.

Prospective drug utilization review screens for therapeutic duplication, interactions, dose, allergies, and contraindications before dispensing.

Counseling must be offered for each new prescription, with documented refusal and confidentiality maintained.

503A compounding is patient-specific and prescriber-identified, follows USP standards, cannot essentially copy a commercially available drug, and limits interstate distribution to 5% of total prescription orders.

503B outsourcing facilities register with FDA, follow cGMP, report adverse events, and may compound without patient-specific prescriptions.

USP <795> governs nonsterile compounding, <797> sterile compounding, and <800> hazardous drugs; each sets beyond-use dates and facility controls.

DSCSA requires authorized trading partners, transaction information and statements, product serialization, and verification of suspect or illegitimate product.

Pharmacist licensure requires an ACPE-accredited degree, passing NAPLEX and the Mississippi MPJE, documented internship hours, and a background check.

License renewal cycles and continuing education hours are set by Board rule; a lapsed license may not be practiced under and must be reinstated.

Pharmacy technicians must be registered with the Board and perform duties under pharmacist supervision within Board-defined ratios and task limits.

Interns must be registered and supervised by an approved preceptor, with hours documented for licensure.

Each pharmacy location requires its own license and a designated pharmacist-in-charge accountable for compliance.

Nonresident pharmacies that ship prescription drugs to Mississippi patients must register with the Board and follow Mississippi law.

Employing unlicensed personnel to perform pharmacist-only functions and practicing on an expired credential are both violations.

Retain controlled substance prescriptions, inventories, and dispensing records at least 2 years and keep them readily retrievable for inspection.

Conduct an initial inventory on the date of registration and a biennial inventory every 2 years thereafter.

Report theft or significant loss to DEA in writing within one business day of discovery, with notice to state authorities as required.

Store Schedule II drugs in a securely locked, substantially constructed cabinet or disperse them through stock to obstruct access, limiting keys and access.

A reverse distributor receives expired or unwanted controlled substances for destruction; transfers are documented on DEA Form 222 or Form 41.

Restrict the prescription department to authorized personnel and maintain dispensing records that can be printed or produced on request, including electronic backups.

Offer counseling on new and changed prescriptions, document refusals, and provide written consumer information.

Release patient prescription information only as permitted by HIPAA or with valid patient authorization, subpoena, or legal process.