NJ MPJE flashcards

32 cards. Read the term and the definition here. The deck at the top of this page is optional.

Rx-only legend

Prescription drugs must bear the federal 'Rx only' legend on the label; a drug lacking the required legend when dispensed on prescription is misbranded under the FDCA.

Adulterated drug

A drug is adulterated when it contains filth or contamination, was manufactured under substandard conditions, or fails to meet its declared strength, quality, or purity.

DSCSA transaction information

The required record of a prescription drug's ownership transfer, identifying seller, buyer, product, lot, and transaction date, which accompanies the product through the supply chain.

Schedule II refills

Federal law prohibits refills of Schedule II prescriptions, but a prescriber may issue multiple prescriptions covering up to 90 days total with earliest fill dates noted.

DEA Form 222

The order form, paper or electronic through CSOS, required to purchase Schedule I or II controlled substances; the pharmacy retains copies for two years.

DEA Form 106

The report of theft or significant loss of controlled substances, which must be filed with DEA within one business day of discovering the loss.

Schedule III-V refill limit

A prescription for a Schedule III, IV, or V controlled substance may be refilled no more than five times and not later than six months after its issue date.

Pharmacist-in-charge

The New Jersey-licensed pharmacist responsible for a pharmacy's compliance with law, including controlled substance security, recordkeeping, sanitation, and supervision of technicians and interns.

New Jersey Board of Pharmacy

The licensing body within the Division of Consumer Affairs, Department of Law and Public Safety, that licenses pharmacists, permits pharmacies, and registers technicians and interns.

Pharmacy technician scope

New Jersey-registered technicians assist under pharmacist supervision but may not counsel patients, interpret prescriptions independently, or perform the final check of a dispensed prescription.

New Jersey CDS registration

A state registration issued by the Division of Consumer Affairs that practitioners and dispensers must hold in addition to federal DEA registration to handle controlled substances in New Jersey.

NJPMP reporting deadline

New Jersey dispensers must report each controlled substance dispensing to the statewide Prescription Monitoring Program electronically, generally within 24 hours of the transaction.

New Jersey CDS prescription content

A New Jersey controlled substance prescription must show the prescriber's DEA and state CDS numbers, patient name and address, drug, strength, quantity, directions, date, and signature.

Counseling offer requirement

The pharmacist must offer counseling on every new prescription, counsel when the patient requests it, and document in the record any refusal of the offer.

Prescription label elements

The dispensed label must include pharmacy name, address and phone, prescription number, date, patient, prescriber, drug name and strength, quantity, directions, refills, and beyond-use date.

Child-resistant packaging

The Poison Prevention Packaging Act requires child-resistant containers for most prescription drugs unless the prescriber directs otherwise or the patient requests conventional packaging.

Therapeutic equivalence rating

FDA assigns an A rating to products with the same active ingredient, dosage form, strength, and route that are bioequivalent; only A-rated products may be substituted.

Prohibiting substitution

In New Jersey a prescriber blocks generic substitution by writing 'do not substitute' or 'brand medically necessary'; the patient may also refuse substitution.

503A versus 503B

503A pharmacies compound for identified patients under state board oversight; 503B outsourcing facilities register with FDA, follow cGMP, and may compound without patient-specific prescriptions.

USP 795 beyond-use dates

Nonaqueous preparations may be assigned 180 days; water-containing nonpreserved preparations 14 days refrigerated; preserved aqueous preparations 35 days; water-containing topical preparations 30 days.

Sterile compounding requalification

Personnel who prepare sterile compounds must be qualified before compounding and requalified at least every 12 months by gloved fingertip testing, media fill, and visual observation.

NJPMP authorized users

Prescribers, pharmacists, and registered delegates may query the New Jersey Prescription Monitoring Program; queries are audited and unauthorized disclosure of patient information is unlawful.

MedWatch

The FDA program for voluntary reporting of serious adverse events, product quality defects, and medication errors associated with drugs, biologics, and medical devices.

Pharmacy CQI program

New Jersey requires each pharmacy to maintain an ongoing quality improvement program that documents medication errors, analyzes causes, and implements system changes to prevent recurrence.

Immunization prerequisites

To vaccinate in New Jersey a pharmacist must complete ACPE-accredited immunization training, hold current CPR certification, and document and report each administered dose.

Collaborative practice agreement

A written agreement between a pharmacist and a prescriber defining the conditions, drugs, and monitoring the pharmacist may manage, with documentation and periodic review required.

Naloxone standing order

New Jersey's statewide standing order lets pharmacists dispense naloxone without a patient-specific prescription after providing education on overdose recognition and response.

Schedule II electronic transfer

Under the 2023 DEA rule an electronic Schedule II prescription may be transferred once to another DEA-registered pharmacy for initial dispensing; paper Schedule II prescriptions may not be transferred.

Class I recall

A recall involving a reasonable probability that the product will cause serious adverse health consequences or death, requiring immediate quarantine of stock and patient notification by the pharmacy.

Return of dispensed CDS

Controlled substances that have left the pharmacy's custody may not be returned to stock; they must be destroyed through a DEA reverse distributor or authorized collector.

Biennial inventory

A complete controlled substance count performed every two years, with exact counts for Schedule II and estimated counts for Schedules III through V, retained at least two years.

Schedule II partial fill

When a pharmacy cannot supply the full quantity, the remainder may be dispensed within 30 days, or within 60 days for long-term care residents and terminally ill patients.