ME MPJE cheat sheet

Controlled substance schedules: CI has no accepted medical use and no refills; CII requires a written/electronic prescription with no refills; CIII–CV may be refilled up to 5 times within 6 months of the issue date; CII prescriptions cannot be refilled.

CII emergency oral prescriptions: pharmacist may dispense on an oral order only in a genuine emergency; the prescriber must deliver a written or electronic prescription within 7 days, and the pharmacist must notify DEA if it is not received.

Partial filling of CII: allowed if the pharmacist cannot supply the full quantity, with the remainder dispensed within 72 hours; otherwise the prescriber must be notified and a new prescription is required.

DEA Form 222 (or CSOS electronic equivalent) is required to transfer CII substances between registrants; CIII–CV transfers require only a record of the transaction, not a 222.

The Poison Prevention Packaging Act requires child-resistant containers for most oral prescription drugs, with exemptions including prescriber/patient-requested non-CR packaging and certain drugs (e.g., nitroglycerin sublingual, oral contraceptives in original packaging).

Prescription labeling under federal law requires the pharmacy name and address, prescription number, date, prescriber name, patient name, directions for use, and cautionary statements; federal law sets a floor, state law may add requirements.

The Durham-Humphrey Amendment created the prescription-only category and requires the legend "Rx only"; the Kefauver-Harris Amendment added the requirement for substantial evidence of effectiveness and informed consent.

DEA registration must be renewed every 3 years; a separate registration is required for each principal place of business, and a mid-cycle change of address requires a new registration.

Maine is a licensure state: pharmacists, pharmacy technicians, and pharmacies each hold separate Board of Pharmacy licenses, and technicians must be licensed before performing technician duties.

Maine requires pharmacists to complete continuing education (including jurisprudence hours) for renewal; verify current hour counts and renewal cycle on the Maine Board of Pharmacy site, since these change by rule.

Maine's prescription monitoring program (PMP) is mandatory-query: pharmacists must check the PMP before dispensing certain controlled substances (notably opioids) under specified circumstances, with defined exceptions.

Maine permits collaborative practice agreements between pharmacists and prescribers, and has expanded pharmacist authority for certain vaccines and hormonal contraception under defined protocols - confirm scope and any age limits in current Board rules.

Maine requires reporting of dispensing errors and has specific requirements for pharmacy records, prescription transfers, and retention periods; state retention periods may exceed the federal 2-year minimum.

Maine has specific rules on drug substitution: generic substitution is permitted unless the prescriber indicates "dispense as written" or the patient objects, and the patient must be informed of the substitution.

Maine's Board may discipline licensees for unprofessional conduct; grounds and hearing procedures are set by statute and Board rule, and discipline is published.

Maine requires a prescription for legend drugs and regulates the sale of certain nonprescription products (e.g., pseudoephedrine) with quantity and logbook requirements consistent with federal Combat Methamphetamine Epidemic Act limits.

The Combat Methamphetamine Epidemic Act limits retail sales of ephedrine/pseudoephedrine to 3.6 g per day and 9 g per 30 days per purchaser, requires photo ID, a written or electronic logbook, and behind-the-counter placement.

DEA recordkeeping: inventories and records of controlled substances must be kept 2 years and be readily retrievable; biennial inventory is required on the date the registrant chooses, every 2 years.

The Prescription Drug Marketing Act restricts drug sampling and prohibits the sale, purchase, or trade of drug samples; it also imposes pedigree/chain-of-custody requirements for certain prescription drugs.

The Drug Supply Chain Security Act (DSCSA) requires transaction information, transaction history, and a transaction statement (T3) for prescription drug transfers, plus verification of suspect product and quarantine of illegitimate product.

The FDA Amendments Act (FDAAA) and REMS: drugs with serious safety concerns may require a Risk Evaluation and Mitigation Strategy, which can restrict who may prescribe or dispense.

The Federal Food, Drug, and Cosmetic Act prohibits misbranding and adulteration; a prescription drug dispensed without a valid prescription is misbranded, and a pharmacist may not dispense on an invalid order.

HIPAA Privacy Rule permits disclosures for treatment, payment, and operations without patient authorization; other disclosures generally require authorization, with limited public-health and law-enforcement exceptions.

The SUPPORT Act and related federal rules allow certain partial fills of Schedule II prescriptions at the request of the patient or prescriber, with the remainder filled within 30 days of the original prescription date.

State pharmacy practice acts define the practice of pharmacy, the scope of technician duties, and the ratio of technicians to pharmacists; ratios vary by state and by practice setting.

Prescription validity: state law sets the maximum age of a prescription for dispensing and the number of refills/authorized renewals; a prescription beyond that age requires prescriber authorization.

State prescription transfer rules allow one-time or limited transfers between pharmacies, with documentation of the transferring and receiving pharmacist, date, and refills remaining; CII transfers are generally restricted.

State immunization authority: many states allow pharmacists to administer vaccines to adults and, in some states, to children above a specified age under a protocol or standing order; verify the age threshold and reporting requirements.

State counseling requirements: pharmacists must offer or provide counseling on new prescriptions and certain refills, with documentation of refusal where required by state law.

State mandatory reporting: pharmacists must report suspected prescription fraud, impaired practitioners, and dispensing errors to the Board or other authority within a defined timeframe.

State pharmacy inspection and self-inspection: the Board conducts inspections and may require self-inspection forms; deficiencies must be corrected and documented.

State drug take-back and disposal: pharmacies may serve as authorized collectors under DEA rules; state law may add requirements for collection, storage, and destruction of returned controlled substances.

A valid prescription requires a legitimate medical purpose, a prescriber acting in the usual course of professional practice, and the required elements (patient, drug, strength, directions, date, prescriber signature).

DEA registration is required for a prescriber to prescribe controlled substances; a prescriber may hold registrations in multiple states, and the pharmacist must verify the prescriber's authority in the state where the prescription is dispensed.

Electronic prescriptions for controlled substances (EPCS) require identity proofing, two-factor authentication, and audit trails; pharmacies must verify the prescriber's EPCS eligibility.

Schedule II prescriptions may be transmitted electronically only if the system meets DEA EPCS requirements; oral CII orders are limited to genuine emergencies with follow-up written/electronic prescription within 7 days.

A pharmacist may not fill a prescription they know or should know is forged, altered, or issued without a legitimate medical purpose; suspicious orders require verification with the prescriber and documentation.

Refills: CIII–CV prescriptions may be refilled up to 5 times within 6 months of issue; the prescriber may authorize additional refills only by issuing a new prescription.

Prescription monitoring: federal law does not mandate PMP queries, but states do; federal law does require dispensers to report controlled substance dispensing to the state PMP (often daily or weekly).

The Ryan Haight Act generally requires an in-person medical evaluation before a prescriber may issue a controlled substance prescription via telemedicine, subject to limited exceptions and temporary flexibilities.

State boards of pharmacy license pharmacists by examination and reciprocity/score transfer; licensure requires graduation from an ACPE-accredited program and passing the NAPLEX and MPJE.

State licensure renewal cycles vary (often annual or biennial); renewal requires continuing education hours, including law/jurisprudence hours in many states, and late renewal may require a fee and reinstatement application.

Grounds for discipline typically include fraud, negligence, incompetence, impaired practice, violation of drug laws, and failure to maintain records; discipline may include reprimand, probation, suspension, or revocation.

State boards may issue cease-and-desist orders and may impose civil penalties for unlicensed practice; unlicensed practice is generally a criminal offense as well.

Pharmacists must report changes of address and employment to the Board within a defined period; failure to do so can affect licensure status.

State pharmacy permits are location-specific; a change of location, ownership, or name generally requires a new permit or an amendment, and the pharmacy must be inspected before opening.

State law governs the pharmacist-in-charge (PIC) role: the PIC is responsible for compliance, recordkeeping, and staff supervision, and must be licensed in that state.

Reciprocity/licensure by endorsement: the candidate must hold an active license in good standing and meet the state's CE and jurisprudence requirements; some states require an additional state-specific exam.

The Controlled Substances Act (1970) created the five schedules and authorized DEA registration, recordkeeping, and enforcement; the DEA administers it under the Department of Justice.

The Food, Drug, and Cosmetic Act (1938) requires premarket approval for new drugs and prohibits adulteration and misbranding; the FDA administers it under HHS.

The Durham-Humphrey Amendment (1951) established prescription-only status; the Kefauver-Harris Amendment (1962) required proof of efficacy and informed consent; the FDA Modernization Act (1997) streamlined approval and labeling.

The Orphan Drug Act (1983) provides incentives for drugs treating rare diseases (fewer than 200,000 patients in the US); the Biologics Price Competition and Innovation Act created biosimilar pathways.

The Combat Methamphetamine Epidemic Act (2005) regulates OTC pseudoephedrine/ephedrine sales; the DSCSA (2013) created the pharmaceutical supply-chain traceability framework.

The DEA registration categories include practitioner, pharmacy, hospital/clinic, and distributor; a pharmacy registration covers dispensing but not prescribing.

FDA enforcement tools include warning letters, recalls (Class I, II, III), injunctions, and seizures; a Class I recall involves a reasonable probability of serious adverse health consequences or death.

Federal law preempts state law only where Congress intended; states may impose stricter requirements (e.g., PMP mandates) as long as they do not conflict with federal law.

States may schedule substances more restrictively than federal law; a drug may be state-controlled even if not federally scheduled, and pharmacists must follow the stricter rule.

State PMP registration and query requirements vary: some states mandate queries for opioids or benzodiazepines, others require queries only on suspicion of misuse; Maine mandates queries in specified circumstances.

State PMP data is confidential; disclosure is limited to authorized prescribers, dispensers, and law enforcement with legal process, and unauthorized access is a violation.

State rules on CII emergency dispensing, partial fills, and refills may differ from federal rules; when state and federal rules conflict, the stricter requirement generally governs.

State prescription fraud reporting: pharmacists must report forged or altered prescriptions to the Board and/or law enforcement within a defined period, and must retain the document.

State take-back and disposal rules: pharmacies may register as authorized collectors; state law may require specific packaging, storage, and destruction documentation.

State rules on prescribing to oneself or family: many states prohibit or restrict self-prescribing of controlled substances; pharmacists should verify the prescriber's authority and document concerns.

State prescription validity for controlled substances: many states set shorter expiration periods for CII prescriptions (e.g., 30 days) than for non-controlled drugs; verify the state-specific limit.