IA MPJE cheat sheet

Controlled substances are scheduled under the federal CSA (21 U.S.C. 801 et seq.); Schedule II has accepted medical use but high abuse potential and no refills are permitted, while Schedules III-V permit refills within limits.

A Schedule II prescription must be written, typed, or electronically issued and signed by the prescriber; oral Schedule II orders are allowed only in a genuine emergency, followed by a written prescription within 7 days.

Schedule III and IV prescriptions may be refilled up to 5 times within 6 months of the issue date; Schedule V refills follow state law and labeling limits.

Under the Combat Methamphetamine Epidemic Act, OTC ephedrine/pseudoephedrine sales are limited to 3.6 g per day and 9 g per 30 days per purchaser, with logbook, ID, and storage requirements.

Drug Enforcement Administration registration is required for each location that handles controlled substances; registrations run 3 years and must be renewed, and a separate registration is needed per site.

Under the Poison Prevention Packaging Act, most oral prescription drugs must be dispensed in child-resistant containers unless the prescriber or the patient (for a specific order) requests otherwise; aspirin and certain other products have exceptions.

The FDA requires that prescription drug labeling include adequate directions for use; dispensing without a valid prescription generally makes a drug misbranded under the FD&C Act.

Under the Combat Meth and federal CSA rules, a DEA Form 222 (or CSOS electronic equivalent) is required to order Schedule I or II controlled substances; it must be completed and retained per recordkeeping rules.

The Iowa Board of Pharmacy licenses pharmacists, pharmacy technicians, and pharmacies under Iowa Code Chapter 155A and the Iowa Administrative Code 657, and adopts rules on practice, records, and discipline.

Iowa requires pharmacies to maintain prescription records and controlled substance records for the period set by Board rule (commonly 2 years); records must be readily retrievable for inspection.

Iowa pharmacists may dispense a prescription under a collaborative practice agreement or protocol with a prescriber, and may administer vaccines per Board rule and immunization certification requirements.

Iowa law requires a pharmacist to counsel patients on new prescriptions unless the patient declines; a written offer of counseling and documentation of refusal are standard practice.

Iowa permits therapeutic interchange and substitution of a therapeutically equivalent generic drug unless the prescriber indicates otherwise; the pharmacist must follow Board substitution rules and label the dispensed product.

Iowa requires reporting of theft or significant loss of controlled substances to the Board and DEA, and requires biennial (or Board-specified) inventory of controlled substances.

Iowa pharmacy technicians must be registered with the Board; the pharmacist-in-charge is responsible for supervision, ratio compliance, and task delegation under Board rule.

Continuing education: Iowa pharmacists must complete the Board-required CE hours per renewal cycle, including any mandated topic hours (e.g., law, opioid, or immunization-related hours) specified by rule.

A biennial inventory of all controlled substances must be taken every 2 years; it may be exact or estimated for Schedules III-V, but Schedule II counts must be exact.

Records of receipt, dispensing, and disposal of controlled substances must be kept for at least 2 years under federal rule, and Iowa requires comparable retention; records must be separate or readily retrievable.

Disposal of controlled substances may occur via DEA-registered reverse distributor, take-back program, or authorized destruction; a DEA Form 41 documents destruction.

A prescription for a Schedule II drug may not be refilled; partial filling is permitted in limited cases (e.g., insufficient supply, LTCF, terminally ill) with the balance dispensed within 72 hours or per rule.

Electronic prescriptions for controlled substances (EPCS) require identity proofing, two-factor authentication, and compliance with DEA interim final rule requirements.

A pharmacist may not fill a forged or altered controlled substance prescription; suspected forgery must be reported to the prescriber and law enforcement, and the prescription retained.

Iowa requires the use of the Iowa Prescription Monitoring Program (PMP); pharmacists and prescribers must check the PMP when required by law and report dispensing data per Board rule.

Theft or significant loss of controlled substances must be reported to DEA in writing within one business day of discovery, with a DEA Form 106 filed.

A prescription must contain the patient name, drug name, strength, dosage form, quantity, directions, prescriber name and DEA number (for controlled substances), and date; missing elements require clarification before dispensing.

The prescription label must include the pharmacy name and address, prescription number, date, patient name, directions, prescriber name, and any required warnings or auxiliary labels.

Refills are limited by the prescription and by law: Schedule II no refills; Schedule III-IV up to 5 refills within 6 months; other drugs per prescriber authorization and expiration.

A pharmacist must perform a prospective drug utilization review (DUR) to screen for therapeutic duplication, drug interactions, allergies, and dosing errors before dispensing.

Patient counseling must be offered on new prescriptions and on refills when appropriate; documentation of counseling or refusal is required by many state rules, including Iowa.

Prescription transfers between pharmacies are permitted for non-controlled drugs; controlled substance transfers are limited (Schedule III-V once, with specific documentation) and Schedule II generally cannot be transferred.

Expired or recalled drugs must be removed from inventory and quarantined; dispensing an expired product is a violation of pharmacy practice rules.

Iowa requires reporting of medication errors and adverse events as specified by Board rule, and pharmacists must maintain a quality-related continuous quality improvement program.

The pharmacist-in-charge is responsible for compliance with all pharmacy laws, recordkeeping, security, and staff supervision at the licensed location.

Pharmacists must maintain patient confidentiality under HIPAA and state law; protected health information may be disclosed only as permitted (treatment, payment, operations, or legal requirement).

A pharmacist has a corresponding responsibility to ensure a controlled substance prescription is issued for a legitimate medical purpose by a prescriber acting in the usual course of practice.

Pharmacists must report suspected impaired practice or diversion to the Board as required by Iowa law, and must not practice while impaired.

Compounding must follow USP standards (e.g., USP <795> nonsterile, <797> sterile) and Board rules; compounded preparations require appropriate labeling and beyond-use dating.

A pharmacist may refuse to fill a prescription based on professional judgment but must follow Iowa law on referral, documentation, and non-discrimination.

Pharmacy security requires controlled substances to be stored in a securely locked, substantially constructed cabinet or dispersed in a manner that obstructs theft, per federal rule.

Continuing professional development and license renewal are mandatory; practicing on an expired or lapsed license is a violation subject to Board discipline.

The Iowa Board of Pharmacy may investigate complaints, conduct inspections, issue citations, suspend or revoke licenses, and impose civil penalties for violations of pharmacy law.

DEA may inspect a registrant's premises and records; refusal to permit inspection can result in registration suspension or revocation.

Failure to maintain required records, falsifying records, or dispensing without a valid prescription can result in federal criminal penalties and DEA registration action.

Iowa requires self-reporting of certain arrests, convictions, or disciplinary actions to the Board within the time specified by rule.

Inspections by the Board may be unannounced; pharmacies must produce licenses, records, and inventories on request.

A pharmacist whose license is disciplined may be subject to probation, retraining, monitoring, or practice restrictions; failure to comply can lead to further discipline.

Federal and state law both prohibit dispensing controlled substances outside the scope of professional practice; Iowa may impose discipline independently of federal action.

Pharmacies must post required licenses and notices and must maintain a current list of pharmacists and technicians on staff for Board inspection.