MPJE flashcards
MPJE · Build recall with a focused review session.
32 cards. Read the term and the definition here. The deck at the top of this page is optional.
- Durham-Humphrey Amendment
- 1951 federal law that established the prescription-only drug category and allowed refills only when authorized by the prescriber.
- Poison Prevention Packaging Act
- Federal law requiring child-resistant containers for most prescription drugs and some OTCs, with exemptions and a patient or prescriber opt-out.
- Risk Evaluation and Mitigation Strategy
- FDA-required safety program using tools such as a Medication Guide, communication plan, or Elements to Assure Safe Use to manage serious drug risks.
- Drug Supply Chain Security Act
- Federal law requiring unit-level product identifiers, transaction data, suspect product verification, and licensure checks throughout the pharmaceutical distribution supply chain.
- HIPAA minimum necessary
- Standard requiring covered entities to limit uses and disclosures of protected health information to the least information needed, with exceptions for treatment disclosures.
- Adulterated versus misbranded drug
- Adulterated drugs are contaminated or made under substandard conditions; misbranded drugs bear false or inadequate labeling. Both support FDA enforcement action.
- State pharmacy practice act
- Statute that creates the board of pharmacy and defines pharmacy practice, licensure requirements, disciplinary authority, and delegated rulemaking power within the state.
- Nonresident pharmacy license
- Registration an out-of-state pharmacy must obtain from a state before shipping prescriptions to patients there, subject to that state's labeling and reporting rules.
- PDMP query mandate
- State requirement that prescribers or dispensers check the prescription drug monitoring program before prescribing or dispensing controlled substances, subject to state-specific exceptions.
- Board rulemaking authority
- Power of a board of pharmacy to adopt regulations interpreting the practice act; rules carry the force of law but cannot exceed statutory authority.
- Interstate licensure reciprocity
- Process by which a pharmacist obtains a license in an additional state through score transfer or licensure by reciprocity; no single national license exists.
- DEA Form 222
- Order document, or its CSOS electronic equivalent, used to obtain Schedule I or II substances; only the registrant or a Power of Attorney holder may execute it.
- Schedule II partial fill
- Allows less than the full quantity to be dispensed, with remaining amounts supplied within 60 days for LTCF or terminally ill patients, or within 72 hours otherwise.
- Emergency oral Schedule II order
- Permits dispensing only the quantity needed during the emergency, provided a written or electronic prescription reaches the pharmacy within seven days.
- Schedule III-V refills
- A prescription for these schedules may be refilled up to five times, but not after six months from the date the prescription was issued.
- DEA Form 106
- Report submitted to the DEA field division documenting theft or significant loss of controlled substances, with a copy retained by the registrant.
- Biennial controlled substance inventory
- Complete count of all controlled substances every two years; Schedule II counted exactly, others estimated unless a container exceeds 1,000 units.
- Dispensed label requirements
- Must show pharmacy name and address, prescription number, date, patient name, directions, prescriber name, and drug name, strength, and quantity.
- Prospective drug use review
- Screening of a prescription before dispensing for therapeutic duplication, interactions, allergies, and dosing problems, required under OBRA 1990 for Medicaid patients.
- Medication Guide
- FDA-approved patient labeling for specified drugs that must be given with each dispensing, often as a REMS element.
- Refusal to fill
- A pharmacist's professional judgment decision not to dispense; the prescription must be returned to the patient and the reason documented where state law requires.
- Prescriber authority verification
- Confirmation that the prescriber holds a valid state license and DEA registration before a controlled substance prescription is dispensed.
- DEA Power of Attorney
- Written authorization letting a named agent execute DEA Form 222 orders for a registrant; retained with the executed order forms.
- Perpetual controlled substance inventory
- Running record of receipts and dispensings of controlled substances, used to detect losses and reconcile against the biennial physical inventory.
- Continuing education requirement
- State-mandated hours of approved CE per license renewal cycle, often including specified hours in pharmacy law or patient safety.
- Technician registration ratio
- State rule limiting how many registered technicians may work per pharmacist and defining the supervision and task-delegation requirements.
- DEA Form 41
- Form documenting the destruction of controlled substances, completed and retained by the registrant as part of required recordkeeping.
- 503A compounding pharmacy
- State-licensed pharmacy compounding under patient-specific prescriptions; it may not regularly compound copies of commercially available drugs or in inordinate amounts.
- 503B outsourcing facility
- FDA-registered facility that compounds without patient-specific prescriptions and must follow current good manufacturing practice and federal reporting requirements.
- USP <797>
- Standards for sterile compounding covering facility design, environmental monitoring, personnel training, and assignment of beyond-use dates by risk category.
- USP <800>
- Standards for handling hazardous drugs, requiring containment ventilated enclosures, closed system transfer devices, protective equipment, and designated storage.
- Pseudoephedrine sales limit
- Federal CMEA limit of 3.6 grams per day and 9 grams per 30 days per purchaser, with photo identification and a written or electronic logbook.