MPJE cheat sheet

Durham-Humphrey Amendment (1951) created the prescription-only legend category and permits refills only when the prescriber authorizes them; drugs not safe for lay self-use require a prescription.

The Controlled Substances Act (CSA) creates a closed system of distribution: every Schedule I-V handler must be registered with DEA, and all transfers are documented on DEA forms or electronic equivalents.

DEA registrations run three years and are site-specific; a separate registration is required for each principal place of business, including separate dispensing and distribution locations.

DSCSA requires unit-level product identifiers, transaction data exchange, verification of suspect or illegitimate product, and authorized-trading-partner licensure checks; records must be retained 6 years.

REMS tools are limited to a Medication Guide, patient package insert, communication plan, and Elements to Assure Safe Use (ETASU) such as prescriber certification or restricted dispensing.

HIPAA requires a good-faith breach risk assessment; individual notice is due without unreasonable delay and no later than 60 days after discovery, with HHS notice for breaches affecting 500 or more individuals.

USP <795>, <797>, and <800> become federally enforceable through FDA and state adoption; <797> governs sterile compounding, <795> nonsterile, and <800> hazardous drugs.

Poison Prevention Packaging Act requires child-resistant containers for most oral prescription drugs; patients or prescribers may request non-child-resistant packaging.

A state board of pharmacy derives all authority from the state pharmacy practice act; board rules interpret the statute and cannot exceed or conflict with it.

An out-of-state pharmacy shipping prescriptions into a state generally must hold a nonresident pharmacy license there and follow that state's labeling, counseling, and reporting rules.

State PDMP query mandates vary: some require a check before every controlled substance dispensing, others only on initial opioid prescriptions, with defined exceptions for hospice and LTCF.

Immunization authority is state-granted; pharmacists typically vaccinate under a protocol, standing order, or prescriber agreement, with age limits and reporting to the state immunization registry set by rule.

Prescription retention periods are set by state rule, commonly two years for non-controlled and two years for controlled substance records, with some states requiring longer.

Generic substitution is a state-law decision: many states require substitution of therapeutic equivalents unless the prescriber writes 'dispense as written' or the patient refuses.

There is no national pharmacist license; a pharmacist must hold a license in each state where practice occurs, obtained by score transfer or licensure by reciprocity.

Schedule II prescriptions may not be refilled; Schedule III-V prescriptions allow up to five refills within six months of the date issued.

A Schedule II prescription may be partially filled only in limited cases: 30 days for LTCF or terminally ill patients, 72 hours for other partial fills, and remaining quantities for LTCF/terminally ill must be supplied within 60 days of the date written.

Emergency oral Schedule II orders: the pharmacist may dispense only the quantity needed for the emergency period, and the prescriber must furnish a written or electronic prescription within 7 days.

Schedule II substances are ordered on DEA Form 222 or through CSOS; only the registrant or a holder of a valid Power of Attorney may execute the order.

DEA Form 106 reports theft or significant loss to the local DEA field division; DEA Form 41 documents destruction of controlled substances.

Controlled substance records must be kept for at least two years and a biennial inventory is required, with Schedule II counted exactly and Schedules III-V estimated unless a container holds more than 1,000 units.

Schedule II prescriptions must be written, typed, or electronic, and a pharmacist may not fill a prescription issued more than 90 days earlier unless state law permits otherwise.

Federal law allows transfer of electronic controlled substance prescriptions between retail pharmacies for initial filling only, one time.

A valid prescription requires the patient name, drug name, strength, dosage form, quantity, directions, prescriber name and address, and date of issue.

The dispensed label must include the pharmacy name and address, prescription number, date, patient name, directions for use, prescriber name, and drug name with strength and quantity.

OBRA '90 requires a prospective drug use review and an offer to counsel (with documented acceptance or refusal) for Medicaid-covered prescriptions, and most states extend this to all patients.

Medication Guides are FDA-approved patient labeling required for specified drugs and must accompany each dispensing when the REMS requires it.

A pharmacist may refuse to fill a prescription on professional judgment grounds but must return the prescription to the patient and, in many states, document the reason and notify the prescriber.

Pharmacists must verify that a prescriber holds a valid state license and a valid DEA number before dispensing a controlled substance.

Prescription transfers between pharmacies are permitted for refills of non-controlled drugs; controlled substance transfers are restricted and generally limited to a single transfer of an electronic prescription for initial filling.

Personnel credentials commonly include pharmacist license, technician registration or certification, intern registration, and pharmacy permit, plus DEA and state controlled substance registrations.

A DEA Power of Attorney authorizes an agent to execute Form 222 orders; the POA must be retained with the executed order forms and be available for inspection.

Biennial controlled substance inventory must be taken on the date the registrant chooses, kept at the registered location, and retained for at least two years.

Continuing education requirements, hours per renewal cycle, and mandatory topic hours (law, patient safety, opioids) are set by each state board.

Schedule II receiving and dispensing are typically tracked on a perpetual or running inventory to detect and reconcile losses.

Theft or significant loss of controlled substances must be reported to DEA on Form 106 and to the state board within the time frame set by state rule.

Expired or unusable controlled substances cannot be returned to a wholesaler without DEA authorization and must be destroyed in a manner documented on Form 41 or through reverse distribution.

A 503A compounder operates under a state pharmacy license and patient-specific prescriptions, and cannot regularly compound copies of commercially available drugs or in inordinate amounts.

A 503B outsourcing facility registers with FDA, may compound without patient-specific prescriptions, and must comply with current good manufacturing practice and reporting requirements.

USP <795> governs nonsterile compounding (facility, equipment, master formulation records, beyond-use dating); USP <797> governs sterile compounding and assigns Category 1, 2, and 3 beyond-use dates.

USP <800> requires hazardous drug handling controls including containment ventilated enclosures, closed system transfer devices, personal protective equipment, and designated storage.

The Combat Methamphetamine Epidemic Act limits retail pseudoephedrine sales to 3.6 g per day and 9 g per 30 days, requires photo identification, a written or electronic logbook, and restricts package access.

Behind-the-counter products such as pseudoephedrine and some emergency contraceptives are sold without a prescription but require pharmacist involvement, recordkeeping, or proof of age.

Prescription Drug Marketing Act restricts drug samples: they may be distributed only to licensed practitioners and may not be sold, traded, or resold.

Special distribution channels include DSCSA-licensed wholesalers, VA and Indian Health Service facilities, and limited-distribution or REMS-restricted products available only through certified sites.