NY MPJE cheat sheet
NY MPJE · Keep the key ideas within reach.
Federal and New York Drug Laws, Statutes, and Regulations
Federal CSA schedules: I (no accepted medical use), II (high abuse, severe dependence), III (moderate), IV (low), V (lowest); NY Public Health Law Article 33 mirrors these schedules with minor additions.
New York schedules are set by PHL §3306; Schedule II stimulants and depressants have specific listing rules, and NY reschedules by regulation through the Commissioner of Health.
A prescription for a controlled substance must be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of professional practice (21 CFR §1306.04).
Federal PDMP requirement: pharmacists dispensing Schedule II-V controlled substances must report to their state PDMP, with NY's I-STOP/PMP requiring reporting by the next business day.
Combat methamphetamine provisions (federal) restrict OTC sales of ephedrine/pseudoephedrine: daily limit 3.6 g, 30-day limit 9 g, logbook and photo ID required.
NY requires electronic prescribing of all prescriptions (with limited exceptions) under I-STOP; e-prescribing of controlled substances must comply with DEA EPCS rules.
Federal law prohibits refilling Schedule II prescriptions; Schedule III-V may be refilled up to five times within six months of issue unless the prescriber specifies otherwise.
Drug Enforcement Administration registration is required for each principal place of business; NY also requires a separate NY State controlled substance registration for practitioners and pharmacies.
Pharmacist and Pharmacy Personnel Licensure, Registration, and Scope of Practice
NY pharmacist licensure requires graduation from an ACPE-accredited program, passage of NAPLEX and MPJE, and completion of 1,740 hours of practical experience (or equivalent internship).
Pharmacy interns must register with NYSED; intern registration permits practice under direct supervision and counts toward the practical experience requirement.
Pharmacy technicians in NY must be registered with NYSED; registration requires a high school diploma or equivalent and completion of an approved technician program or equivalent experience.
A NY registered pharmacy technician may assist in dispensing but may not perform final verification, patient counseling, or clinical judgment functions reserved to pharmacists.
Continuing education: NY pharmacists must complete 45 hours of CE per three-year registration period, including at least 3 hours in pharmacy law and 2 hours in medication safety/error prevention.
Unprofessional conduct under NY Education Law §6509 includes practicing beyond scope, failing to maintain records, and dispensing without a valid prescription.
A pharmacist may administer immunizations to adults and, per current NY authority, to patients aged 2 and older under a non-patient-specific order, with reporting to the state immunization registry.
Collaborative drug therapy management (CDTM) in NY requires a written agreement with a physician and is limited to specified settings and disease states under PHL §6801-a.
Prescription Requirements, Dispensing, Labeling, and Recordkeeping
A NY prescription must include the prescriber's name, address, DEA number (for controlled substances), patient name and address, drug name, strength, quantity, directions, and date.
Schedule II prescriptions must be written or electronically transmitted; oral Schedule II orders are permitted only in documented emergency situations with a follow-up written prescription within 7 days.
NY allows a pharmacist to dispense up to a 30-day supply of a non-controlled chronic medication on an expired prescription in limited emergency circumstances with prescriber notification.
Prescription labels must include pharmacy name and address, prescription number, date, patient name, directions, prescriber name, and cautionary statements required by law.
Prescriptions for controlled substances must be retained for at least 5 years; NY requires prescription records be readily retrievable and available for inspection.
Substitution of a generic equivalent is permitted unless the prescriber writes "dispense as written" or the patient requests the brand; the patient must be informed of the substitution.
A pharmacist may dispense up to a 90-day supply of certain maintenance medications when the prescription so authorizes, subject to refill limits and plan rules.
Records of controlled substance dispensing must be maintained separately or be readily retrievable and must be reconciled with inventory at least biennially under federal rules.
Drug Distribution Systems, Inventory Control, and Controlled Substance Accountability
Federal biennial inventory: complete on May 1 of even-numbered years (or the date the registrant first engages in business), and maintain for at least 2 years.
Perpetual inventory is required for Schedule II substances in NY; records must show receipt, dispensing, and destruction and be reconciled.
DEA Form 222 (or CSOS) is required for ordering Schedule I and II substances; the form must be completed accurately and retained for 2 years.
Theft or significant loss of controlled substances must be reported to the DEA field office in writing within one business day of discovery, and to NY Bureau of Narcotic Enforcement.
Destruction of controlled substances requires DEA Form 41 and, in NY, compliance with state destruction rules; reverse distributors may be used for certain returns.
Schedule III-V records must be maintained for 2 years; NY requires 5-year retention for prescription records, so the longer period controls.
A pharmacy must maintain a controlled substance registration and a DEA registration at each location; transfers between registrants require proper documentation and, for Schedule II, a 222 form or CSOS order.
Inventory records must be kept at the registered location and be available for inspection by DEA and NY Bureau of Narcotic Enforcement investigators.
Patient Counseling, Medication Safety, and Professional Ethics
NY requires the pharmacist to offer counseling on new prescriptions and on refills when the pharmacist deems it necessary; the offer must be documented if refused.
Counseling must address directions for use, common side effects, interactions, storage, and what to do if a dose is missed, using language the patient understands.
Medication error reporting: NY requires reporting of certain adverse events to the NYS Department of Health Patient Safety Center within the required timeframe.
Pharmacists must maintain patient confidentiality under HIPAA and NY law; disclosure requires patient authorization or a legal exception.
The pharmacist must exercise corresponding responsibility to resolve red flags (early refills, pattern prescribing, cash payment, distance) before dispensing controlled substances.
Professional ethics require avoiding conflicts of interest, not accepting inducements that influence clinical decisions, and disclosing errors to patients and prescribers.
Medication therapy management and comprehensive medication review should be offered to high-risk patients, including those on multiple chronic medications.
Patient records must include known allergies, diagnoses when available, and a profile of medications dispensed; the pharmacist must screen for interactions and duplicative therapy.
Pharmacy Operations, Facilities, Administrative Requirements, Inspections, and Discipline
NY pharmacies must be registered with NYSED and inspected; the pharmacy must have a designated pharmacist in charge who is responsible for compliance.
The pharmacy must provide a minimum prescription department area, adequate lighting, refrigeration, and security, and must be closed to the public when no pharmacist is present.
A pharmacist must be physically present for the pharmacy to operate; the pharmacy cannot be open without a licensed pharmacist on duty.
Records, licenses, and registrations must be displayed or readily available; inspections may occur without prior notice during business hours.
Disciplinary actions include revocation, suspension, probation, censure, reprimand, and fines; the Board of Regents acts on the recommendation of the Board of Pharmacy.
Unprofessional conduct includes fraud, incompetence, negligence, and failure to maintain records; NY Education Law §6509 and Regents Rules define these grounds.
Pharmacies must maintain a quality assurance program, including a system for identifying and preventing medication errors and a process for reporting.
Advertising and pricing must be truthful and not misleading; pharmacies must disclose prescription prices and honor advertised prices.