IL MPJE cheat sheet

The Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) governs drug approval, manufacture, labeling, and adulteration or misbranding; FDA is the enforcing agency.

The Illinois Pharmacy Practice Act (225 ILCS 85) is administered by IDFPR, which issues licenses and takes disciplinary action; the Board of Pharmacy is advisory.

Board rules implementing the Pharmacy Practice Act appear in Title 68 of the Illinois Administrative Code, Part 1330.

Controlled substances are regulated federally by the Controlled Substances Act (21 U.S.C. 801 et seq.) and in Illinois by the Illinois Controlled Substances Act (720 ILCS 570).

Federal law sets a floor: Illinois may impose stricter requirements but may not authorize conduct that federal law prohibits.

The Combat Methamphetamine Epidemic Act limits over-the-counter pseudoephedrine and ephedrine sales: behind the counter, photo ID, written logbook, 3.6 g/day and 9 g per 30 days.

Violations of the Pharmacy Practice Act can produce administrative discipline by IDFPR independent of any criminal prosecution.

Statutory silence is not permission; acts outside the authority granted by the Act and rules constitute unlicensed practice.

Pharmacist licensure requires graduation from an ACPE-accredited program, passing NAPLEX and the MPJE for Illinois, and completion of internship hours; IDFPR issues the license.

Illinois pharmacist licenses renew biennially and require 30 hours of approved continuing education per renewal cycle.

Pharmacy technicians must register with IDFPR, hold a high school diploma or equivalent, and obtain national certification from a recognized body within the period set by rule.

Pharmacy interns must be registered with IDFPR and enrolled in or graduated from an ACPE-accredited college of pharmacy; they practice only under pharmacist supervision.

Every pharmacy location must hold an Illinois pharmacy license and designate a pharmacist-in-charge who is accountable for legal compliance at that site.

A pharmacy located outside Illinois that ships, mails, or delivers dispensed prescriptions to Illinois patients must register with IDFPR as a nonresident pharmacy.

Licenses and registrations must be conspicuously displayed at the practice site, and IDFPR must be notified of changes of address or employment.

Schedule I has no accepted medical use; Schedule II has accepted medical use with high abuse potential; Schedules III through V have decreasing abuse potential with accepted medical use.

Schedule II prescriptions may not be refilled; a new prescription is required, and a single Schedule II prescription may not exceed a 90-day supply.

Schedule III through V prescriptions may be refilled up to five times within six months of the date of issue.

For an emergency oral Schedule II order, the pharmacist must receive the written or electronic prescription within seven days.

A biennial inventory of all controlled substances is required every two years and must be retained with controlled substance records for at least two years.

Theft or significant loss of controlled substances must be reported to DEA on Form 106 within one business day of discovery, with a copy to local police.

Schedule II drugs are ordered on DEA Form 222 or through CSOS; Schedules III through V are ordered on invoices, which serve as records.

Illinois requires electronic prescribing of controlled substances, subject to limited statutory exceptions.

Required elements include patient name and address, drug name, strength, dosage form, quantity, directions, prescriber name and address, date issued, refill authorization, and the prescriber's DEA number for controlled substances.

A prescription for a non-controlled drug expires one year after the date issued in Illinois unless the prescriber specifies a shorter period.

No refill may be dispensed after the one-year expiration date, regardless of the number of refills originally authorized.

Generic substitution is required unless the prescriber indicates dispense as written or the patient insists on brand, and the patient must be informed of the substitution.

An electronic Schedule II prescription may be transferred between pharmacies one time, for initial filling only, with documentation in both pharmacies' records.

Schedule III through V prescriptions may be transferred between pharmacies for the remaining refills, with the transferring pharmacist recording the transfer.

Oral prescriptions may be reduced to writing by the pharmacist; a forged or altered prescription must be reported to the prescriber and, where appropriate, to law enforcement.

A prescription must be issued for a legitimate medical purpose by a practitioner acting in the usual course of professional practice.

The Drug Supply Chain Security Act requires electronic, interoperable exchange of transaction information, history, and statements at each transfer of ownership of prescription drug product.

Controlled room temperature is 20 to 25 degrees Celsius; refrigeration is 2 to 8 degrees Celsius; freezer is minus 25 to minus 10 degrees Celsius; excursions must be documented and assessed.

Destruction of controlled substances must be documented on DEA Form 41 or an equivalent destruction record, witnessed, and retained with the two-year controlled substance records.

Recalls are classified as Class I (reasonable probability of serious harm or death), Class II (temporary or reversible harm), or Class III (unlikely harm, often labeling).

Expired, recalled, or adulterated stock must be quarantined and physically separated from saleable inventory until disposition.

Prescription drugs may be purchased only from licensed wholesale distributors, and purchasers must verify licensure and retain transaction records.

Patient-returned prescription drugs may not be redispensed; returns to a wholesaler are permitted only under the wholesaler's policy and applicable state and federal rules.

Schedule II drugs require separate secure storage and perpetual accountability records.

Illinois requires the pharmacist to offer counseling to each patient or caregiver receiving a prescription, covering directions, precautions, interactions, and storage.

The primary label must show pharmacy name and address, prescription number, date filled, patient name, prescriber, drug name and strength, quantity, directions, refills, and expiration or beyond-use date.

Auxiliary labels are required for special storage, shake well, external use only, and other mandated cautions.

The Poison Prevention Packaging Act requires child-resistant containers except for exempt drugs such as sublingual nitroglycerin or when the patient or prescriber requests non-complying packaging.

Pharmacies must maintain a continuous quality improvement program to detect, document, and analyze medication errors, and must inform patients when an error reaches them.

USP 795 (nonsterile) and USP 797 (sterile) set beyond-use dates and labeling requirements for compounded preparations.

Error-prone abbreviations such as U for units and QD should be avoided on prescriptions, labels, and internal documents.

Illinois requires prescription records to be maintained at least five years and to be readily retrievable for inspection.

IDFPR may reprimand, fine, suspend, or revoke a license for felony conviction, unprofessional conduct, gross negligence, impairment, or violation of the Pharmacy Practice Act.

Disciplinary proceedings provide notice, an opportunity for hearing, written findings, and appeal rights; the Board of Pharmacy may review and recommend.

The pharmacist-in-charge is accountable for the location's compliance, including records, security, supervision, and staff training.

A DEA registration is required for each location handling controlled substances and must be renewed every three years.

Closing a pharmacy requires notification to IDFPR and arrangements for transfer of prescription records and disposition of controlled substances.

IDFPR inspectors and DEA investigators may enter and inspect prescription and controlled substance records during business hours.

Pharmacists may administer vaccines under a valid prescription or standing order after completing an accredited immunization training program and holding current CPR certification.

Administered immunizations must be reported to the Illinois Comprehensive Automated Immunization Registry (I-CARE).

A written collaborative practice agreement with a prescriber authorizes the pharmacist to modify drug therapy, order and interpret tests, and manage specified conditions within defined limits.

Pharmacists may dispense an opioid antagonist without a patient-specific prescription to a person at risk of overdose or a family member, with counseling on use.

Illinois permits pharmacists to dispense self-administered hormonal contraceptives to patients aged 18 and older under a standing order or protocol, with screening and referral.

Pharmacists acting as medical cannabis dispensing agents must be registered with the state and practice at a licensed dispensing organization.

Illinois requires prescribers to check the PMP before an initial Schedule II opioid prescription and to provide overdose and opioid antagonist information to patients at elevated risk.