ID MPJE key terms

1951 federal law that split medicines into two classes: those requiring a prescription and those sold over the counter, and set rules for how prescription orders may be given and refilled.

A medicine that federal law requires to be dispensed only on a prescription because it bears the caution statement about dispensing without an order.

Federal statute that places daily and monthly sales limits on ephedrine and pseudoephedrine products sold at retail and requires buyer identification, logbook records, and behind-the-counter placement.

A nonprescription drug containing ephedrine, pseudoephedrine, or phenylpropanolamine that is subject to retail sales limits, identification checks, and recordkeeping under federal chemical control rules.

A written or electronic record a retailer keeps of each regulated ephedrine or pseudoephedrine sale, showing the buyer's identification, product, quantity, and date, retained for the required period.

A unit of a prescription drug given to a practitioner for patient use at no charge, which may not be sold and must be handled under federal sample distribution and recordkeeping rules.

A documented chain of custody for a prescription drug that shows each prior owner and transaction, used to verify that a product entered the legitimate distribution system.

The federal framework requiring product identifiers on prescription drug packages and transaction data exchange among trading partners so suspect or illegitimate product can be found and removed.

A prescription drug package that a trading partner has reason to believe is counterfeit, diverted, stolen, adulterated, or otherwise unfit for distribution, triggering investigation and quarantine duties.

Physically separating a drug from saleable stock, usually in a marked secure location, while its legitimacy, condition, or legal status is investigated.

A federal safety program for certain drugs that may require prescriber training, patient enrollment, limited distribution, or laboratory monitoring before and during treatment.

Specific restrictions within a risk evaluation and mitigation strategy, such as certified prescribers, certified pharmacies, patient registries, or required tests, that must be verified before dispensing.

A patient-directed handout required for certain drugs that explains serious risks, safe use, and when to seek help, and must be given with each new and refill dispensing.

A federal ranking of drugs by abuse potential and accepted medical use, from Schedule I with no accepted use to Schedule V with the lowest potential, driving all handling rules.

A controlled substance with high abuse potential and accepted medical use that requires a written or qualifying electronic prescription, no refills, and strict inventory and storage controls.

The federal registration that allows a practitioner or pharmacy to handle controlled substances, tied to a specific location and renewed periodically.

A written authorization letting a named person order controlled substances on behalf of a registered pharmacy from a distributor, kept on file with the supplier.

A running record of controlled substances received, dispensed, and destroyed that is updated with each transaction so the expected balance can be compared with an actual count.

A complete count of all controlled substances on hand, taken at least every two years and kept with transaction records, that establishes the starting balance for accountability.

The requirement to keep receipts, dispensing records, inventories, and reports for controlled substances for a set period, usually two years, available for inspection.

A written notice filed with the federal drug enforcement agency when controlled substances are discovered missing in more than ordinary amounts, describing what happened and what was done.

Dispensing less than the full quantity prescribed, allowed for Schedule II drugs only in defined situations such as limited supply or patient or prescriber request, with the remainder handled under specific timing rules.

The number of times a prescriber permits a prescription to be repeated, which must be stated on the order and is prohibited for Schedule II drugs.

The minimum elements a valid prescription must contain, such as patient name, drug, strength, quantity, directions, prescriber signature, and date, with extra elements for controlled substances.

The pharmacist's duty to judge that a controlled substance order serves a legitimate medical purpose and was issued in the usual course of professional practice before dispensing.

A controlled substance order showing patterns linked to misuse, such as long distance travel, cash payment, early refills, or contradictory drug combinations, that requires resolution before dispensing.

A state-run database of dispensed controlled substances that pharmacists must check or report to under state law, used to identify duplicative or unsafe prescribing.

The pharmacist designated by the pharmacy owner as responsible for daily compliance with drug laws, recordkeeping, storage, and staff supervision at that licensed location.

The state-issued authorization for a specific pharmacy location to operate, which must be displayed and kept current with ownership and address changes reported to the board.

The state-set limit on how many technicians or assistants one pharmacist may supervise at a time, often adjusted for tasks or setting.

A required pharmacy system for documenting, analyzing, and preventing dispensing errors, including a written plan, staff training, and a nonpunitive review process.

A record of a prevented or actual dispensing mistake that identifies what happened and the contributing factors, used for internal learning and any required external reporting.

The pharmacist's discussion with a patient about a new or changed prescription, covering directions, common and serious risks, storage, and when to contact the prescriber.

A federal classification of a product withdrawal by the health hazard involved, from Class I for likely serious harm to Class III for unlikely harm, which determines the pharmacy's response.

A period when a drug is stored or shipped outside its labeled temperature range, requiring assessment and documentation before the product is returned to saleable stock.

The date beyond which a manufacturer no longer guarantees a product's potency and safety, after which it must be removed from dispensing stock and handled per policy.

A prescriber-approved written instruction that lets a pharmacist furnish defined products or services, such as vaccines or certain tests, without a patient-specific order.

The range of activities a license or registration legally permits a pharmacist, technician, or intern to perform, set by state law and board rules.

The board-issued credential that allows a pharmacy student to gain practice hours under pharmacist supervision before licensure, with limits on what may be done unsupervised.