IL MPJE flashcards

32 cards. Read the term and the definition here. The deck at the top of this page is optional.

Federal Food, Drug, and Cosmetic Act

21 U.S.C. 301 et seq.; governs drug approval, manufacturing, labeling, and adulteration or misbranding, and is enforced by FDA against manufacturers, distributors, and pharmacies.

Illinois Pharmacy Practice Act

225 ILCS 85; the statute that licenses and regulates Illinois pharmacists, technicians, interns, and pharmacies, administered by IDFPR with advice from the Board of Pharmacy.

Federal preemption floor

Federal law sets a minimum standard; Illinois may impose stricter requirements such as added recordkeeping or reporting, but may not authorize conduct that federal law prohibits.

Combat Methamphetamine Epidemic Act

Federal law placing pseudoephedrine and ephedrine behind the counter with photo identification, a written logbook, and daily and 30-day purchase limits of 3.6 g and 9 g.

Pharmacist license renewal

Illinois pharmacist licenses renew every two years and require 30 hours of approved continuing education per cycle, including any specific topics mandated by rule.

Technician registration requirements

Illinois 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 intern registration

Interns must be registered with IDFPR and enrolled in or graduated from an ACPE-accredited pharmacy program, and they practice only under pharmacist supervision.

Nonresident pharmacy registration

An out-of-state pharmacy that ships, mails, or delivers dispensed prescription drugs to Illinois patients must register with IDFPR and follow Illinois practice law.

Schedule II refill prohibition

Schedule II prescriptions cannot be refilled; the prescriber must issue a new order, and a single Schedule II prescription may not exceed a 90-day supply.

Schedule III-V refill limits

Up to five refills are allowed within six months of the issue date; no fill or refill may occur more than six months after the prescription was written.

DEA Form 106

The report used to notify DEA of a theft or significant loss of controlled substances, filed within one business day of discovery, with a copy to local police.

Illinois prescription monitoring program

Dispensers report Schedule II through V dispensing to the state PMP; prescribers must check it before an initial Schedule II opioid prescription and every 90 days after.

Illinois prescription expiration

A prescription for a non-controlled drug expires one year after the date issued unless the prescriber specifies a shorter period, and no refill is valid afterward.

Emergency oral Schedule II order

The pharmacist may dispense on an oral order in an emergency but must receive the written or electronic prescription within seven days or notify DEA.

Generic substitution in Illinois

The pharmacist must dispense the lower-cost equivalent unless the prescriber writes dispense as written or the patient insists on brand, and must tell the patient.

Schedule II prescription transfer

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

DSCSA transaction data

Federal law requiring electronic, interoperable exchange of transaction information, history, and statements at each transfer of ownership of prescription drug product in the supply chain.

Drug storage temperatures

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, with excursions documented.

Recall class definitions

Class I recalls involve reasonable probability of serious harm or death, Class II involve temporary or reversible harm, and Class III are unlikely to cause harm.

Controlled substance destruction record

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

Patient counseling offer

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

Child-resistant packaging requirement

Most oral prescription drugs must be dispensed in child-resistant containers, except exempt drugs such as sublingual nitroglycerin or when the patient or prescriber requests otherwise.

Beyond-use date labeling

Compounded preparations must be labeled with a beyond-use date assigned under USP 795 for nonsterile or USP 797 for sterile compounding, never exceeding the standard's limit.

Medication error quality program

Illinois pharmacies must maintain a continuous quality improvement program that detects, documents, and analyzes medication errors and informs patients when errors reach them.

Prescription record retention

Illinois requires prescription records to be kept at least five years and to be readily retrievable for inspection by IDFPR or DEA investigators.

IDFPR disciplinary authority

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

Pharmacist-in-charge responsibilities

The PIC is accountable for the licensed location's compliance with pharmacy law, including recordkeeping, security, staff supervision, and technician and intern training.

DEA registration renewal cycle

A DEA registration is required for each location handling controlled substances and must be renewed every three years; it can be surrendered or revoked.

Immunization administration authority

Illinois pharmacists may administer vaccines under a prescription or standing order after completing accredited immunization training and holding current CPR certification.

Collaborative practice agreement

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

Naloxone dispensing without prescription

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

Hormonal contraceptive dispensing

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