HI MPJE: Federal Laws

The federal-law domain tests how federal statutes and regulations constrain pharmacy practice in Hawaii: the Controlled Substances Act (CSA), DEA registration and recordkeeping, FDA approval and labeling, the Drug Supply Chain Security Act (DSCSA), HIPAA privacy, and poison-prevention packaging. Federal law sets a floor; Hawaii may add stricter requirements.

Controlled substances

• DEA registration is required for each principal place of business where controlled substances are handled; a Hawaii pharmacy license alone is not enough.
• CSA schedules I–V determine handling. Schedule I has no accepted medical use and cannot be prescribed. Schedule II prescriptions must be written, signed, and dated by the prescriber, contain the required patient, drug, strength, quantity, and directions, and cannot be refilled. Emergency oral Schedule II orders require a written follow-up within 7 days.
• Schedule III–IV prescriptions may be refilled up to five times within six months of the date of issue. Schedule V refills follow the prescription and state limits.
• CII procurement uses DEA Form 222 or CSOS; records are kept two years; a biennial inventory is required; theft or significant loss is reported on DEA Form 106.

FDA, DSCSA, and privacy

FDA approval distinguishes prescription from OTC status; REMS may impose special dispensing conditions. DSCSA requires authorized trading partners, product tracing, verification of suspect product, and serialization-FDA approval alone does not satisfy DSCSA. HIPAA permits treatment, payment, and operations disclosures but requires minimum necessary use and safeguards. PPPA requires child-resistant packaging unless the prescriber or patient requests otherwise under the applicable exception.

Worked example

A Schedule III prescription is issued January 10 with five refills. The first fill occurs February 1. The refill clock runs from the issue date, not the first fill: the last refill must occur by July 10, and no more than five refills are allowed. A fill on July 11 is invalid even though only five months have passed since the first fill.

Traps

Do not refill a Schedule II prescription. Do not count the six-month Schedule III–IV window from the first fill. Do not use Form 222 for Schedule III drugs. Do not assume a state license or FDA approval covers DEA, DSCSA, or REMS obligations. Federal records retention is two years, but a longer Hawaii requirement would control.