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HI MPJE cheat sheet

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Quick reference

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.

Quick reference

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.