NJ MPJE cheat sheet

A new drug may not be marketed without an approved NDA or ANDA (21 U.S.C. 355); dispensing an unapproved new drug violates the FDCA.

A drug is prescription-only when it cannot be used safely without practitioner supervision, and its label must carry the federal 'Rx only' legend.

21 CFR 290.5 requires a dispensed label to show pharmacy name and address, prescription number, date, patient name, prescriber name, drug name and strength, quantity, and directions.

Federal law sets no refill cap for non-controlled prescriptions; refills depend on the prescriber's authorization and state law.

DSCSA requires transaction information, transaction history, and a transaction statement for each prescription drug transfer, plus interoperable unit-level tracing.

Section 503A exemptions require a patient-specific prescription (or limited anticipatory supply), compliance with USP <795>/<797>, and no compounding of essentially copies of marketed drugs.

The Poison Prevention Packaging Act requires child-resistant containers unless the prescriber directs otherwise or the patient requests non-complying packaging.

Adulteration means contamination or failure to meet compendial or GMP standards; misbranding means labeling that is false, misleading, or missing required information.

Schedule I drugs have no accepted medical use and cannot be prescribed; Schedule II drugs have accepted medical use but high abuse potential and no refills.

No refills are permitted on Schedule II prescriptions; multiple prescriptions totaling up to a 90-day supply may be issued with earliest fill dates noted.

An emergency oral Schedule II order requires the pharmacy to receive the written or faxed prescription within 7 days.

A partial fill of a Schedule II prescription may be completed within 30 days, or 60 days for long-term care residents and terminally ill patients.

Schedule III through V prescriptions may be refilled no more than 5 times and not later than 6 months after the issue date.

DEA registration is required for each principal place of business; practitioner registrations run three years (Form 224 initial, Form 225 renewal).

Schedule I and II purchases require DEA Form 222 or CSOS; Schedule III through V purchases may be documented by invoice; all retained 2 years.

An initial inventory is taken on the registration date and a biennial inventory every 2 years thereafter, with exact counts for Schedule II and estimated counts for III through V, kept 2 years and readily retrievable.

Theft or significant loss of controlled substances is reported on DEA Form 106 within one business day of discovery.

The New Jersey Board of Pharmacy sits within the Division of Consumer Affairs, Department of Law and Public Safety, and licenses pharmacists, registers technicians and interns, and permits pharmacies.

A pharmacy may operate only under a current New Jersey pharmacy permit and must be supervised by a New Jersey-licensed pharmacist whenever it is open.

The pharmacist-in-charge is accountable for legal compliance, controlled substance security, recordkeeping, and supervision of all pharmacy personnel.

Changes of ownership, location, and pharmacist-in-charge require Board notification or application under Board rule.

The prescription area must contain a sink with hot and cold water, a refrigerator with a thermometer, locked storage for controlled substances, and the reference resources required by Board rule.

Pharmacy technicians must be registered with the Board, work under pharmacist supervision, and may not counsel patients or perform the final verification of a dispensed prescription.

Pharmacist licenses renew biennially, and the continuing education hours set by Board rule (including law hours) must be completed before renewal.

New Jersey adopts the federal five-schedule structure with state additions, and New Jersey CDS offenses and penalties apply alongside federal law.

Practitioners and dispensers need a New Jersey CDS registration from the Division of Consumer Affairs in addition to their federal DEA registration.

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

Schedule II CDS prescriptions may not be refilled; Schedule III and IV prescriptions may be refilled up to 5 times within 6 months of issue.

Pharmacists must report each CDS dispensing to the New Jersey Prescription Monitoring Program electronically, generally within 24 hours of the transaction.

CDS may be dispensed only in good faith for a legitimate medical purpose by a practitioner acting in the usual course of professional practice.

Lost or stolen CDS must be documented and reported to the Board and local police, in addition to the federal DEA Form 106 filing.

The label must show pharmacy name, address, and phone; prescription number; fill date; patient name; prescriber; drug name, strength, and dosage form; quantity; directions; refill information; and expiration or beyond-use date.

Auxiliary labels are required for storage, handling, and administration warnings such as shake well, refrigerate, or for external use only.

The pharmacist must offer counseling on every new prescription and counsel whenever the patient requests it; a refusal must be documented.

Counseling content includes drug name and description, dosage form, route and duration, special directions, common side effects, interactions, self-monitoring, storage, and refill information.

Counseling is provided by a pharmacist, or by an intern under pharmacist supervision; technicians may not counsel.

For delivered or mailed prescriptions, written patient information must accompany the drug and the patient must be given a way to reach a pharmacist.

Dispensing records must be readily retrievable, identify the responsible pharmacist, and be backed up if maintained electronically.

Substitution is permitted only for products the FDA rates therapeutically equivalent (A-rated); B-rated products are not interchangeable.

In New Jersey the prescriber blocks substitution by writing 'do not substitute,' 'brand medically necessary,' or an equivalent notation; absent that, generic substitution is permitted.

The patient may refuse substitution, and the refusal should be documented on the prescription record.

The dispensing pharmacist must record the manufacturer and the substitution on the prescription record and label the container with the product actually dispensed.

Cost savings produced by substitution must be passed on to the purchaser rather than retained by the pharmacy.

Therapeutic interchange (a different drug within the same class) requires prescriber authorization, such as a protocol, collaborative practice agreement, or P&T-approved interchange program.

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

Both must avoid compounding essentially copies of commercially available drugs and may use bulk API only from FDA-registered sources appearing on the 503A bulks list.

USP <795> beyond-use dates: 180 days for nonaqueous preparations; 14 days refrigerated for water-containing nonpreserved preparations; 35 days for preserved aqueous preparations; 30 days for water-containing topical preparations.

USP <797> assigns beyond-use dates by CSP category (1 or 2) and storage temperature, and the shortest applicable limit controls.

Sterile compounding requires an ISO 5 critical area within an ISO 7 buffer, environmental monitoring, and documented cleaning and disinfection.

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

A master formulation record and a compounding record are required for each preparation, documenting ingredients, sources, lot numbers, and the basis for the assigned beyond-use date.

New Jersey Board rules require pharmacies that compound to follow USP standards and to make compounding records available for inspection.

Dispensers report CDS data to the New Jersey Prescription Monitoring Program electronically; prescribers, pharmacists, and registered delegates may query it, and access is audited.

Unauthorized disclosure or use of prescription monitoring information is unlawful and subject to penalty.

New Jersey pharmacies must maintain an ongoing quality improvement program for medication errors, with documentation available to the Board on request.

FDA MedWatch receives voluntary reports of serious adverse events, product quality defects, and medication errors for drugs, biologics, and devices.

VAERS receives vaccine adverse event reports, and reporting is mandatory for certain events listed under the National Childhood Vaccine Injury Act.

Internal error reporting should be non-punitive and used for system change; look-alike/sound-alike and high-alert drugs warrant independent double checks.

A Class I recall requires immediate quarantine, inventory reconciliation, and patient notification.

To administer vaccines in New Jersey, a pharmacist must complete ACPE-accredited immunization training and hold current CPR/BLS certification.

Each administered dose must be documented, reported to the state immunization registry, and communicated to the patient's primary care provider.

New Jersey pharmacists may dispense naloxone without a patient-specific prescription under the statewide standing order and must provide overdose-response education.

A standing order or protocol must specify the vaccine, the eligible population, documentation, and emergency procedures including epinephrine availability.

Collaborative practice agreements must be written, define the drugs and conditions covered, require documentation, and be reviewed and updated periodically.

Expanded scope authorities are limited to pharmacists who meet the applicable training, certification, and protocol prerequisites.

Schedule III through V refill information may be transferred once between DEA-registered pharmacies, with documentation by the transferring and receiving pharmacists.

An electronic Schedule II prescription may be transferred once for initial dispensing between DEA-registered pharmacies under the 2023 DEA rule; paper Schedule II prescriptions may not be transferred.

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

Recall classes: Class I means a reasonable probability of serious harm or death; Class II means temporary or reversible harm; Class III is unlikely to cause harm.

Expired, damaged, or recalled drugs must be segregated from active stock and clearly labeled.

Controlled substance purchase and dispensing records must be kept at least 2 years, and New Jersey requires prescription records be retained 5 years, both readily retrievable for inspection.

Advertised prices must be honored, prescription prices must be disclosed to patients on request, and generic substitution savings must be passed through.

The Prescription Drug Marketing Act restricts distribution of drug samples to practitioners; pharmacies may not purchase or resell samples.