ID MPJE cheat sheet

FDCA definition of prescription drug: not safe for use except under professional supervision because of toxicity, method of use, or collateral measures; federal legend status requires the Rx-only legend on labeling.

Drug approval pathways: full NDA (505(b)(1)) requires full safety/effectiveness data; 505(b)(2) relies partly on prior findings; ANDA (505(j)) requires bioequivalence to an RLD and no premarket clinical studies.

Controlled Substances Act schedules: CI has no accepted medical use and high abuse potential; CII-CV have accepted medical use with decreasing abuse potential; a drug rescheduled requires DEA rulemaking, not state action.

CSA order form (DEA Form 222) for CII: single-sheet triplicate format with 11 line items per form; a power of attorney (DEA Form 222a) lets an agent order; forms expire when the purchaser's registration expires.

DSCSA: products must be serialized at the package level; transaction information, history, and statement (T3) must accompany transfers; verification of suspect product and quarantine of illegitimate product are required; saleable returns need verification.

REMS: FDA may require medication guides, patient package inserts, communication plans, elements to assure safe use (ETASU), and a timetable for assessment; ETASU can restrict who may prescribe or dispense.

PDMA restricts distribution of prescription drug samples; samples can be provided only to licensed practitioners who request them in writing, and records of receipt/distribution must be kept.

Combating Methamphetamine Epidemic Act: scheduled listed chemicals (pseudoephedrine, ephedrine) are kept behind the counter or in a locked cabinet; retail sales require photo ID, a written log, and daily/monthly quantity limits.

Orphan Drug Act and pediatric exclusivity add market exclusivity periods independent of patent life; generic ANDA filing depends on patent certification (Paragraph I-IV).

The practice act defines the practice of pharmacy, the board's authority, and grounds for discipline; rules adopted by the board implement the act and are binding on licensees.

Licensure is state-specific: a pharmacist license is required to dispense or provide pharmaceutical care; a pharmacy license is site-specific and not transferable to a new address without board approval.

Board inspections can occur without notice and may examine prescription files, controlled substance records, storage conditions, and personnel credentials.

Grounds for discipline typically include unprofessional conduct, dispensing without a valid prescription, falsifying records, diversion, practicing while impaired, and failure to report certain events.

Continuing education requirements are set by each board, including hours per renewal cycle, subject-matter mandates, and documentation retention; some states require live hours or specific topics.

Technician registration and ratio rules vary by state; tasks delegated to technicians are limited by statute or rule, and certain duties (counseling, final verification) remain pharmacist-only.

Prescription validity requirements are state-defined: patient and prescriber identifiers, drug, strength, quantity, directions, date, and prescriber signature; states also set refill and expiration limits.

Reporting obligations: pharmacists must report suspected impaired colleagues, theft or significant loss of controlled substances, and certain adverse events to the board within specified timeframes.

A valid prescription requires a legitimate medical purpose, a prescriber acting in the usual course of professional practice, and complete elements under state and federal law.

Prescription labeling must include pharmacy name and address, prescription number, date, patient name, prescriber name, drug name/strength/quantity, directions, refills remaining, and pharmacist initials or identifier where required.

Generic substitution is permitted when the prescriber has not prohibited it and the state allows substitution; the patient must be informed, and the brand or generic dispensed must be recorded.

Refill rules: CIII-CV prescriptions may be refilled up to five times within six months of the issue date; CII prescriptions cannot be refilled without a new prescription.

Oral prescriptions for CII are permitted only in limited emergencies; the prescriber must provide a written prescription within seven days, and the pharmacy must document the emergency.

Partial filling of CII prescriptions is allowed when the pharmacy cannot supply the full quantity; the remainder must be filled within 72 hours or a new prescription is required (with exceptions for LTCF and terminally ill patients).

Transfer of prescriptions between pharmacies is permitted for refill information, subject to state rules; CII prescriptions generally cannot be transferred for refill, and one-time transfer rules may apply to noncontrolled prescriptions.

Dispensing errors should be documented and disclosed per state and organizational policy; the pharmacy must maintain records of recalls, returns, and destruction of dispensed products.

DEA registration is required for each principal place of business where controlled substances are manufactured, distributed, dispensed, or stored; registration is site-specific and must be renewed every three years.

Schedule II records: a separate DEA Form 222 is required for each order; the pharmacy retains a copy, the supplier retains a copy, and the third copy goes to DEA; records must be kept for at least two years.

Schedule III-V ordering: a pharmacy may order from a distributor using invoices or a DEA Form 222; invoices must be retained and available for inspection.

Inventory: a biennial inventory of all controlled substances is required on May 1 of each odd-numbered year or on the date the registrant begins business; the inventory must be signed and dated and kept for two years.

Records: all controlled substance records - prescriptions, invoices, inventories, and DEA forms - must be maintained for at least two years and be readily retrievable for inspection.

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

Schedule II prescriptions may be filled only with a written or electronic prescription, except in emergencies; a pharmacist may not refill a CII prescription.

CSOS (Controlled Substance Ordering System) allows electronic ordering of CII substances; the pharmacy must maintain a certificate and audit trail, and the electronic order replaces the paper DEA Form 222.

Pharmacist licensure requires graduation from an accredited pharmacy program, passage of NAPLEX and MPJE, and fulfillment of state internship hours; licensure is granted by the state board.

Interns and technicians work under the direct supervision of a licensed pharmacist; the supervising pharmacist is responsible for the accuracy and legality of dispensing.

Scope of practice is defined by state law; pharmacists may administer immunizations, prescribe under collaborative practice agreements, or provide certain services only where authorized.

A pharmacist may not practice in a state where they are not licensed; multistate practice requires licensure in each state or participation in an applicable reciprocity/compact arrangement.

Pharmacy technicians must be registered or certified as required by state law; registration is not equivalent to licensure, and duties are limited by statute.

Continuing education and license renewal requirements must be met before the expiration date; late renewal may require a fee and may affect the ability to practice.

Grounds for license discipline include fraud, incompetence, unprofessional conduct, and violation of controlled substance laws; discipline can include reprimand, suspension, or revocation.

Pharmacy interns must document internship hours and have them verified by the supervising pharmacist or preceptor as required by the board.

Temperature storage standards: room temperature is 20-25°C (68-77°F); controlled room temperature allows excursions between 15-30°C; refrigeration is 2-8°C (36-46°F); freezing is -25 to -10°C.

Drugs must be stored under conditions that prevent contamination, deterioration, and unauthorized access; look-alike/sound-alike products should be separated to reduce errors.

Expired, damaged, or recalled drugs must be segregated from active inventory and disposed of according to law; controlled substance destruction requires DEA authorization and documentation.

Inventory management includes perpetual inventory for controlled substances, periodic physical counts, and reconciliation of discrepancies; discrepancies must be investigated and documented.

Returns and recalls must be documented; reverse distributors handle returns of noncontrolled and controlled drugs, and controlled substance returns require DEA Form 222 or 41 as applicable.

Security requirements include locked storage for controlled substances, limited access to the pharmacy, and alarm systems where required by state or DEA rules.

Emergency kits and crash carts must be checked for expiration and completeness; replacement must be documented, and controlled substances in kits require secure storage and records.

Hazardous drugs require handling under USP <800> standards: negative-pressure rooms, personal protective equipment, closed-system transfer devices, and documented spill procedures.

Patient counseling must be offered on new prescriptions and when the pharmacist judges it necessary; counseling includes directions, common side effects, interactions, storage, and what to do about missed doses.

The pharmacist must use professional judgment to determine whether counseling is required; if the patient declines, the refusal should be documented per policy.

Error reporting systems include internal incident reports and external reporting to patient safety organizations; reporting should be nonpunitive and focused on system improvement.

Ethical standards require honesty, confidentiality, informed consent, and avoidance of conflicts of interest; patient information must be protected under HIPAA and state privacy laws.

Medication errors should be disclosed to the patient and prescriber when appropriate, and the pharmacy should conduct a root-cause analysis to prevent recurrence.

Pharmacists must report suspected adverse drug reactions to FDA MedWatch and must report serious problems with drug quality or labeling.

Professional boundaries and impairment: pharmacists must not practice while impaired and must report impaired colleagues to the board or appropriate authority as required by law.

Documentation standards require clear, timely, and accurate records of counseling, interventions, and errors; records must be retained per state and federal requirements.