PA MPJE cheat sheet

The Pennsylvania State Board of Pharmacy licenses pharmacists and pharmacies and enforces the Pharmacy Act and 49 Pa. Code Chapter 27.

The Board is within the Department of State's Bureau of Professional and Occupational Affairs and may suspend, revoke, restrict licenses, and impose civil penalties.

DEA enforces the federal Controlled Substances Act and requires registration for entities that manufacture, distribute, dispense, or prescribe controlled substances.

FDA regulates drug approval, manufacturing, labeling, and advertising; it does not license pharmacies or define state scope of practice.

State law controls pharmacy licensure and scope of practice; federal law controls controlled substances and drug approval.

A Pennsylvania pharmacy may not operate without a valid Board-issued pharmacy permit and a pharmacist-in-charge.

Pennsylvania has its own Controlled Substance, Drug, Device and Cosmetic Act; controlled substance dispensing must satisfy both DEA and state requirements.

The Board may inspect pharmacies and require production of prescription, controlled substance, and purchasing records.

Pharmacist licensure in Pennsylvania requires graduation from an ACPE-accredited program, internship hours, NAPLEX and MPJE passage, and Board approval.

Pharmacy interns must be registered with the Board before accruing internship hours; preceptors verify and report those hours.

Pennsylvania requires pharmacy technicians to be registered with the Board; registration does not authorize independent practice.

A pharmacy permit is issued for a specific location; a change of ownership or location requires Board notification or a new permit.

Pharmacist licenses renew biennially and require continuing education, including Board-specified topics.

The pharmacist-in-charge must be a Pennsylvania-licensed pharmacist in good standing, and the Board must be notified of PIC changes.

A pharmacist licensed in another state may not practice in Pennsylvania without a Pennsylvania license.

The Board may deny licensure or registration for felony convictions, drug-related offenses, or other grounds specified in the Pharmacy Act.

The PIC is responsible for compliance with pharmacy law, recordkeeping, security, personnel supervision, and dispensing quality.

The pharmacy must be staffed by licensed pharmacists and registered technicians; technicians work only under pharmacist supervision.

Required records include prescription files, controlled substance inventories, purchase records, returns, and biennial inventory documentation.

Controlled substance theft or significant loss must be reported to DEA on Form 106 and to the Pennsylvania Board as required.

The pharmacy must be locked when no pharmacist is present, and only authorized personnel may access drug storage areas.

Policies must address drug recalls, returns, outdated drugs, storage temperatures, and removal of expired stock.

Technicians and interns must receive documented training and competency assessment for assigned duties.

The PIC must ensure labels, counseling, and dispensing procedures meet Board requirements.

A valid prescription must identify the patient, drug, strength, dosage form, quantity, directions, prescriber, date, and signature.

Schedule II prescriptions may not be refilled; an emergency oral Schedule II order requires a written prescription within seven days under federal law.

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

A prescription transfer requires pharmacist-to-pharmacist communication, documentation of the transfer, and cancellation of the original at the transferring pharmacy.

Labels must include pharmacy name and address, prescription number, date, patient name, prescriber, directions, drug name and strength, and quantity, with auxiliary and expiration information as required.

Oral prescriptions are permitted for most noncontrolled and Schedule III-V drugs; Schedule II oral orders are limited to emergencies.

Prescription records for controlled substances must be retained for at least two years under federal law.

Generic substitution requires FDA therapeutic equivalence and compliance with Pennsylvania substitution and labeling rules.

Controlled substances are classified in Schedules I-V by abuse potential and accepted medical use; Schedule I has no accepted medical use.

DEA registration is required for each registered location and must be renewed; Schedule I and II procurement uses DEA Form 222 or CSOS.

Schedule II prescriptions require written or electronic form, have no refills, and are subject to emergency oral prescription follow-up.

Schedule III-V prescriptions may have up to five refills within six months.

Pennsylvania dispensers must report controlled substance dispensing to the PDMP within the timeframe set by state regulation.

A biennial controlled substance inventory is required, and controlled substance records must be kept for at least two years.

Theft or significant loss of controlled substances requires DEA Form 106 and notification to the Pennsylvania Board.

Destruction of controlled substances must follow DEA requirements, including use of a reverse distributor or DEA Form 41 where applicable.

Pennsylvania pharmacists with required training may administer immunizations under a protocol or standing order to specified age groups.

Vaccine doses administered by pharmacists must be documented and reported to the Pennsylvania Statewide Immunization Information System.

A collaborative practice agreement must be written and define the pharmacist's scope, documentation, communication, and prescriber oversight.

Pharmacists may perform drug therapy management under protocol, including therapy modification and laboratory monitoring as authorized.

Naloxone may be dispensed by pharmacists under a Pennsylvania standing order or Board-approved protocol with documentation.

Pharmacists may not independently prescribe except where a specific statute or regulation grants limited authority.

Medication therapy management services require patient consent and documentation of findings and recommendations.

Nonsterile compounding must follow USP <795> standards for facilities, equipment, records, and beyond-use dates.

Sterile compounding must follow USP <797> standards for cleanrooms, environmental monitoring, personnel training, and process validation.

Hazardous drug compounding must follow USP <800> requirements for containment, personal protective equipment, and waste handling.

Each compounded preparation requires a master formulation record and a compounding record for the batch prepared.

Beyond-use dates must be assigned from USP standards, stability information, storage conditions, and preservative considerations.

Bulk drug substances must be USP or NF grade and obtained from registered manufacturers unless otherwise permitted.

Compounded preparations must be labeled with the drug name, strength, beyond-use date, storage conditions, and compounding pharmacy identification.

Distribution of compounded drugs is limited and must comply with state and federal requirements; compounded drugs are not approved new drugs.

Pharmacists must offer patient counseling on new prescriptions and on refills when appropriate, and must document a patient's refusal.

Counseling includes drug name, purpose, directions, storage, common side effects, interactions, and when to seek medical help.

A patient medication profile should include medications, allergies, diagnoses, and adverse reactions and is used to screen for interactions.

HIPAA protects identifiable health information; pharmacies must safeguard records and provide notice of privacy practices.

Medication errors and adverse drug events should be documented and evaluated through the pharmacy's quality improvement process.

High-alert medications and look-alike/sound-alike products require targeted error-prevention strategies such as independent double checks.

Unprofessional conduct, impaired practice, and confidentiality breaches are grounds for Board discipline.

A hospital pharmacy must hold a Pennsylvania pharmacy permit, have a pharmacist-in-charge, and comply with institutional distribution and recordkeeping rules.

Unit dose and floor stock systems must be controlled; floor stock is limited to drugs necessary for emergency or routine patient care.

Automated dispensing systems require security, accountability, audit trails, and pharmacist oversight.

Long-term care pharmacies may use unit dose packaging, emergency kits, and consultant pharmacist drug regimen review.

A hospital formulary must be approved by the pharmacy and therapeutics committee and support rational drug use.

Sterile IV admixtures prepared in hospitals must comply with USP <797> sterile compounding standards.

Institutional prescription and controlled substance records must be retained and readily retrievable for inspection.

Discharge medication processes should include reconciliation, labeling, and counseling as required by pharmacy law.