HI MPJE cheat sheet
HI MPJE · Keep the key ideas within reach.
Hawaii Pharmacy Practice: State-Specific Law Essentials
Hawaii pharmacy licensure is administered by the Board of Pharmacy within the Department of Commerce and Consumer Affairs (DCCA); licenses, permits, and registrations are issued under Hawaii Revised Statutes Chapter 461 and Hawaii Administrative Rules Title 16, Chapter 95.
Pharmacist licensure in Hawaii requires graduation from an ACPE-accredited program, passage of NAPLEX and MPJE, and a specified number of internship hours completed under a registered preceptor before licensure; interns register with the Board while accruing hours.
Hawaii requires a pharmacist license to be renewed biennially on a schedule set by the Board; continuing education must be completed each renewal cycle, with specific hours in law and patient-safety topics and CPR/first-aid requirements for those administering immunizations.
Prescription records in Hawaii must be retained for at least two years and be readily retrievable for Board inspection; prescription files must allow audit and must document refills, pharmacist identity, and date of dispensing.
Hawaii permits pharmacist administration of vaccines to specified age groups under a protocol or standing order consistent with federal authorizations; documentation and reporting to the state immunization registry are required.
Hawaii has specific rules on labeling requirements, patient counseling obligations, and transfer of prescriptions between pharmacies; transfers require direct communication between licensed pharmacists and documentation of the transferring and receiving pharmacist.
Hawaii's controlled substance scheduling follows federal CSA schedules, but state registration, recordkeeping, and reporting to the state prescription monitoring program are separate obligations administered by the Board and DCCA enforcement.
Hawaii disciplinary actions include license revocation, suspension, probation, fines, and required remediation; the Board may act on grounds such as unprofessional conduct, impairment, fraud, and dispensing without a valid prescription.
Hawaii pharmacy technicians are registered with the Board, work under pharmacist supervision, and have defined scope limits; pharmacists remain responsible for final verification of dispensed prescriptions.
Federal Pharmacy Law: Core Statutory and Regulatory Rules
The Controlled Substances Act (21 U.S.C. 801 et seq.) establishes five schedules based on abuse potential and accepted medical use; Schedule I has no accepted medical use, while Schedules II-V have decreasing abuse potential and correspondingly lighter controls.
A Schedule II prescription must be written, signed, and dated by the prescriber, may not be refilled, and is generally valid for 90 days; emergency oral Schedule II orders require a written prescription within seven days.
DEA registration is required for each principal place of business where controlled substances are manufactured, distributed, dispensed, or stored; registration must be renewed every three years and kept at the registered location.
The Poison Prevention Packaging Act requires child-resistant packaging for most oral prescription drugs, with exceptions for prescriber-requested noncomplying packaging and patient-requested waivers; the pharmacist must document the request.
The Durham-Humphrey Amendment created the prescription-only category and requires the legend 'Caution: Federal law prohibits dispensing without prescription' on legend drugs; the Kefauver-Harris Amendment added efficacy and informed-consent requirements.
The Orphan Drug Act and the FDA's accelerated approval pathways affect dispensing and counseling obligations; pharmacists must verify that a drug is FDA-approved for its labeled use and understand that off-label use may still be lawful when prescribed by a licensed practitioner.
The Combat Methamphetamine Epidemic Act restricts retail sales of ephedrine and pseudoephedrine, requiring behind-the-counter placement, logbook recordkeeping, daily and monthly purchase limits, and photo identification.
The Drug Enforcement Administration requires biennial inventory of controlled substances, records of receipt and distribution, and secure storage; theft or significant loss must be reported to DEA in writing within one business day of discovery.
The Health Insurance Portability and Accountability Act and its Privacy Rule govern protected health information; pharmacists may disclose PHI for treatment, payment, and operations and must apply the minimum necessary standard and patient authorization rules.