MD MPJE cheat sheet

The Maryland Board of Pharmacy regulates pharmacy practice under the Maryland Pharmacy Act (Health-General Article, Title 12, Subtitles 1–7); it is a 12-member board: 7 pharmacists, 2 pharmacy technicians, and 3 consumer members, all appointed by the Governor with Senate advice and consent.

Board members serve 4-year terms and may serve no more than two consecutive full terms; a member appointed to fill a vacancy serves the remainder of the unexpired term.

The Board elects officers annually, including a president and vice president; the Board meets at least quarterly, and public notice of meetings is required under the Open Meetings Act.

Licensure pathways: examination (NAPLEX plus MPJE-Maryland), license transfer/reciprocity (score transfer or licensure by reciprocity), and licensure by endorsement for applicants licensed in another jurisdiction.

Disciplinary and licensing actions are contested cases under the Maryland Administrative Procedure Act (State Government Article, Title 10); the Board may reprimand, suspend, revoke, impose probation, or assess civil penalties, and a licensee may appeal to the circuit court.

Grounds for discipline include fraud or deceit in obtaining a license, unprofessional conduct, incompetence, negligence, habitual intoxication, conviction of a crime involving moral turpitude, and violation of Board regulations (COMAR Title 10, Subtitle 34).

The Board may issue cease-and-desist orders and seek injunctive relief against unlicensed practice; practicing pharmacy without a license is a misdemeanor subject to criminal penalty.

License renewal is annual; a pharmacist must complete 30 contact hours of continuing education per renewal cycle, including 2 hours of opioid-related CE and other Board-specified topics.

Mandatory reporting: a licensee must report to the Board within a specified period any adverse action taken against them by another licensing authority or any arrest or conviction, and employers must report certain terminations for cause.

A pharmacy may not operate without a Maryland pharmacy permit issued by the Board; each physical location requires a separate permit, and the permit is not transferable to another owner or location without Board approval.

A pharmacy permit holder must designate a pharmacist-in-charge (PIC) who is responsible for compliance with all laws and regulations; a change of PIC must be reported to the Board within the time specified by regulation.

Pharmacists must hold an active Maryland license; interns and externs must be registered with the Board and may practice only under the direct supervision of a licensed pharmacist.

Pharmacy technicians must be registered with the Board; a technician may perform only delegated tasks under the supervision of a pharmacist, and the pharmacist retains responsibility for the final product.

Maryland requires a pharmacist to be physically present whenever the pharmacy is open for dispensing; the pharmacist on duty must be identifiable, and the pharmacy must post the pharmacist's name and license number.

Nonresident pharmacies that dispense prescription drugs to Maryland patients must obtain a Maryland nonresident pharmacy registration and comply with Maryland labeling, recordkeeping, and patient counseling requirements.

A nonresident pharmacy must maintain a toll-free telephone number for patients to obtain counseling from a pharmacist and must provide written notice of that number with each shipment.

Change of ownership, location, or name of a pharmacy requires notification to and approval by the Board; a new permit is required for a change of ownership.

A pharmacist license may be placed on inactive status; an inactive licensee may not practice until reinstated, and reinstatement may require demonstration of continued competence.

A prescription must include the patient's name and address, the drug name, strength, dosage form, quantity, directions for use, the prescriber's name, address, DEA number (for controlled substances), and the date of issuance; the prescriber must sign the prescription.

A pharmacist may dispense pursuant to an oral prescription, but the pharmacist must reduce it to writing and retain it; oral prescriptions for Schedule II controlled substances are permitted only in limited emergency situations with follow-up written prescription.

Substitution of a therapeutically equivalent generic drug is permitted unless the prescriber writes "dispense as written" or the patient requests the brand; the pharmacist must record the substitution and the name of the manufacturer.

The prescription label must include the pharmacy name and address, the prescription number, the date, the patient's name, directions for use, the prescriber's name, the drug name and strength, and cautionary statements required by law.

Prescription records must be maintained for at least 5 years and be readily retrievable; records must be available for inspection by the Board and its agents.

A pharmacist may refill a prescription only if authorized by the prescriber; the number of refills must be recorded, and the pharmacist must not exceed the authorized refills.

Patient counseling is required: before dispensing, the pharmacist must offer to counsel the patient or caregiver on proper use, storage, and potential adverse effects; counseling may be declined by the patient and the refusal documented.

Prescriptions for controlled substances must comply with federal DEA requirements and Maryland CDS law, including quantity limits and refill restrictions for Schedule II drugs.

A pharmacist may not dispense a prescription that appears forged, altered, or obtained by fraud; the pharmacist must verify with the prescriber and report suspected fraud to the Board and law enforcement.

Controlled substances are scheduled under the federal Controlled Substances Act (21 U.S.C. § 801 et seq.) in Schedules I–V; Maryland adopts the federal schedules and may add or reschedule substances under Health-General Article, Title 5.

Schedule II drugs require a written or electronic prescription; no refills are permitted, and a pharmacist may dispense only the quantity prescribed unless a partial fill is permitted by federal law.

Schedule III–V drugs may be refilled up to five times within six months of the date of issuance, unless the prescriber specifies otherwise.

Electronic prescriptions for controlled substances must comply with DEA EPCS requirements, including two-factor authentication and audit trails.

Maryland's Prescription Drug Monitoring Program (PDMP) requires dispensers to report controlled substance dispensing to the state database within 24 hours; pharmacists must review the PDMP before dispensing certain controlled substances.

CSOS (Controlled Substance Ordering System) allows electronic ordering of Schedule I and II drugs using a DEA-issued digital certificate; the order is transmitted to the supplier and a signed electronic record is retained.

A DEA Form 222 (or CSOS electronic equivalent) is required for ordering Schedule I and II controlled substances; the form must be completed accurately and retained for at least two years.

Pharmacists must maintain controlled substance inventories, including biennial inventories and records of receipt and disposition, and must report theft or significant loss to DEA and the Board.

Maryland law imposes additional requirements for prescribing and dispensing opioids, including limits on initial prescriptions for acute pain and required prescriber education.

A pharmacist may delegate tasks to pharmacy technicians and interns, but the pharmacist retains responsibility for the accuracy and appropriateness of the final product and for patient counseling.

A pharmacist must perform a prospective drug utilization review (DUR) before dispensing to screen for therapeutic duplication, drug-drug interactions, drug-disease contraindications, incorrect dosage, and allergies.

Patient counseling must be provided by a pharmacist, not a technician; the pharmacist must offer counseling and document the patient's acceptance or refusal.

A collaborative practice agreement (CPA) allows a pharmacist to initiate, modify, or discontinue drug therapy under a written protocol with a prescriber; the agreement must specify the scope, conditions, and communication requirements.

Maryland permits pharmacists to administer vaccines and certain medications under a statewide protocol or prescription, subject to Board regulations and training requirements.

A pharmacist may dispense a 90-day supply of a maintenance medication if authorized by the prescriber, subject to refill limits and the requirement to notify the prescriber.

The pharmacist-in-charge is responsible for establishing policies and procedures for safe medication use, including error reporting, quality improvement, and staff training.

A pharmacist must report suspected adverse drug reactions and medication errors to the appropriate reporting system, and must participate in continuous quality improvement activities.

A pharmacist may not dispense a drug without a valid prescription unless it is an over-the-counter product or authorized under a specific protocol (e.g., emergency contraception, naloxone).

Institutional pharmacies (hospitals, nursing homes) must comply with Board regulations, including requirements for a pharmacist-in-charge, drug storage, and records; a hospital pharmacy may dispense to inpatients and outpatients under specific conditions.

Automated dispensing devices (ADDs) must be approved by the Board and maintained under the supervision of a pharmacist; the pharmacist must establish policies for access, security, and accuracy, and must review transactions.

Repackaging of drugs from bulk to unit-dose must be done under pharmacist supervision, with records of the drug, lot number, expiration date, and repackager; the repackaged product must be labeled with the required information.

Compounding must comply with USP <795> (nonsterile) and <797> (sterile) standards; the pharmacist is responsible for ensuring the accuracy, sterility, and quality of compounded preparations.

Sterile compounding requires a designated clean room, environmental monitoring, and personnel training; the pharmacist must maintain records of equipment calibration and sterility testing.

A pharmacy may not compound a drug that is commercially available in the same dosage form unless a documented clinical need exists, and must comply with FDA restrictions on compounding.

Repackaged and compounded drugs must be assigned a beyond-use date (BUD) based on stability data, preservative efficacy, and storage conditions; the BUD may not exceed the manufacturer's expiration date.

Automated devices used for dispensing must maintain a transaction log and must be checked by a pharmacist at least daily; discrepancies must be investigated and documented.

Institutional pharmacies must have a system for reporting and investigating medication errors and adverse events, and must participate in quality improvement activities.

FDA regulates drug approval, labeling, manufacturing, and advertising; Maryland law may impose additional requirements, but a drug must be FDA-approved to be dispensed unless it is compounded or obtained under an investigational protocol.

DEA registration is required for any pharmacy that dispenses controlled substances; the registration must be renewed every three years, and a separate registration is required for each location.

HIPAA requires pharmacies to protect protected health information (PHI), provide a notice of privacy practices, and obtain patient authorization for certain uses; Maryland law may impose stricter confidentiality requirements.

Drug recalls: a pharmacy must check its inventory against recall notices, remove affected products, notify patients when required, and document the recall action; recalls are classified as Class I, II, or III based on the risk.

A pharmacy may return drugs to a wholesaler or manufacturer only under specific conditions; returned drugs may not be resold unless they are in the original sealed container and the return is authorized.

A pharmacist must report adverse drug events and serious medication errors to the FDA MedWatch program and to the Board when required by regulation.

Federal law prohibits the dispensing of a drug without a prescription except for OTC products; Maryland law may allow specific exceptions (e.g., naloxone, emergency contraception) under protocol.

A pharmacy must comply with the Drug Supply Chain Security Act (DSCSA) for track-and-trace of prescription drugs, including verification of transaction information and product tracing.

A pharmacist must report suspected diversion of controlled substances to DEA and the Board, and must maintain records of controlled substance returns and destructions.

Pharmacists must practice with honesty, integrity, and respect for patient autonomy; they must avoid conflicts of interest and disclose any financial interest in a drug or device.

A pharmacist must maintain patient confidentiality and may disclose PHI only as permitted by HIPAA and Maryland law, such as for treatment, payment, or health care operations.

Medication errors must be reported to the pharmacy's quality improvement program and, when required, to the Board and other authorities; a pharmacist must not conceal an error.

A pharmacist must participate in continuous quality improvement (CQI) activities, including root cause analysis, error tracking, and implementation of preventive strategies.

A pharmacist must provide accurate and complete information to patients and prescribers, and must not misrepresent the safety or efficacy of a drug.

A pharmacist must respect the patient's right to refuse treatment and must document the refusal; the pharmacist must not abandon a patient without ensuring continuity of care.

A pharmacist must maintain professional boundaries and avoid discriminatory practices; patient care must be provided without regard to race, religion, gender, or socioeconomic status.

A pharmacist must report impaired colleagues to the Board or a peer review organization when patient safety is at risk, and must comply with mandatory reporting laws.

A pharmacist must ensure that the pharmacy has a system for reporting and responding to medication errors, including a nonpunitive reporting culture and feedback to staff.

The Board of Pharmacy consists of 12 members: 7 pharmacists, 2 pharmacy technicians, and 3 consumer members, appointed by the Governor.

Board members serve 4-year terms and may serve no more than two consecutive full terms.

The Board meets at least quarterly and must comply with the Open Meetings Act.

Licensure by examination requires passing NAPLEX and the MPJE-Maryland.

Disciplinary actions are contested cases under the Maryland Administrative Procedure Act and may be appealed to circuit court.

Grounds for discipline include fraud, unprofessional conduct, incompetence, and violation of Board regulations.

The Board may issue cease-and-desist orders and seek injunctive relief against unlicensed practice.

Pharmacists must complete 30 contact hours of CE per renewal cycle, including 2 hours of opioid-related CE.

Licensees must report adverse actions by other licensing authorities and certain arrests or convictions to the Board.

Each pharmacy location requires a separate Maryland pharmacy permit issued by the Board.

A pharmacist-in-charge must be designated for each pharmacy and is responsible for compliance.

Pharmacy technicians must be registered with the Board and practice under pharmacist supervision.

A pharmacist must be physically present whenever the pharmacy is open for dispensing.

Nonresident pharmacies dispensing to Maryland patients must register with the Board and comply with Maryland labeling and counseling requirements.

A nonresident pharmacy must provide a toll-free number for patient counseling.

Change of ownership or location requires Board notification and approval.

A pharmacist license may be placed on inactive status; reinstatement may require demonstration of competence.

Interns and externs must be registered with the Board and supervised by a licensed pharmacist.

A prescription must include patient name and address, drug name, strength, dosage form, quantity, directions, prescriber name and address, DEA number for controlled substances, and date.

Oral prescriptions must be reduced to writing and retained by the pharmacy.

Generic substitution is permitted unless the prescriber writes "dispense as written" or the patient requests brand.

The prescription label must include pharmacy name and address, prescription number, date, patient name, directions, prescriber name, drug name and strength, and required cautions.

Prescription records must be retained for at least 5 years and be readily retrievable.

Refills may be dispensed only as authorized by the prescriber and must be recorded.

Patient counseling must be offered by a pharmacist and the patient's refusal documented.

Controlled substance prescriptions must comply with DEA and Maryland CDS requirements.

A pharmacist must verify and report suspected forged or altered prescriptions.

Controlled substances are scheduled under the federal CSA in Schedules I–V; Maryland adopts the federal schedules.

Schedule II drugs require a written or electronic prescription and no refills are permitted.

Schedule III–V drugs may be refilled up to five times within six months.

Electronic prescriptions for controlled substances must comply with DEA EPCS requirements.

Dispensers must report controlled substance dispensing to the Maryland PDMP within 24 hours.

CSOS allows electronic ordering of Schedule I and II drugs using a DEA-issued digital certificate.

DEA Form 222 is required for ordering Schedule I and II drugs and must be retained for at least two years.

Pharmacies must maintain biennial inventories and report theft or significant loss to DEA and the Board.

Maryland law imposes additional limits on opioid prescriptions for acute pain.

A pharmacist may delegate tasks to technicians and interns but retains responsibility for the final product and counseling.

A prospective drug utilization review must be performed before dispensing.

Patient counseling must be provided by a pharmacist and documented.

A collaborative practice agreement allows a pharmacist to initiate, modify, or discontinue drug therapy under a written protocol.

Pharmacists may administer vaccines under a statewide protocol or prescription.

A pharmacist may dispense a 90-day supply of a maintenance medication if authorized by the prescriber.

The pharmacist-in-charge is responsible for policies on medication safety and error reporting.

Pharmacists must report adverse drug reactions and medication errors to the appropriate system.

A pharmacist may not dispense a drug without a valid prescription unless authorized by law or protocol.

Institutional pharmacies must comply with Board regulations on drug storage, records, and pharmacist-in-charge.

Automated dispensing devices must be approved by the Board and supervised by a pharmacist.

Repackaging must be under pharmacist supervision with records of drug, lot, expiration, and repackager.

Compounding must comply with USP <795> and <797> standards.

Sterile compounding requires a clean room, environmental monitoring, and personnel training.

A pharmacy may not compound a commercially available drug unless a documented clinical need exists.

Repackaged and compounded drugs must be assigned a beyond-use date based on stability data.

Automated devices must maintain a transaction log and be checked by a pharmacist at least daily.

Institutional pharmacies must have a system for reporting and investigating medication errors.

FDA regulates drug approval, labeling, and manufacturing; Maryland may impose additional requirements.

DEA registration is required for controlled substance dispensing and must be renewed every three years.

HIPAA requires protection of PHI and a notice of privacy practices.

Drug recalls are classified as Class I, II, or III; pharmacies must remove affected products and document actions.

Returned drugs may not be resold unless authorized and in original sealed containers.

Pharmacists must report serious adverse events to FDA MedWatch and the Board when required.

Federal law prohibits dispensing without a prescription except for OTC products and specific exceptions.

Pharmacies must comply with DSCSA track-and-trace requirements.

Suspected diversion must be reported to DEA and the Board.

Pharmacists must practice with honesty and integrity and avoid conflicts of interest.

Patient confidentiality must be maintained under HIPAA and Maryland law.

Medication errors must be reported to the pharmacy's quality improvement program and, when required, to the Board.

Pharmacists must participate in continuous quality improvement activities, including root cause analysis.

Pharmacists must provide accurate information and not misrepresent drug safety or efficacy.

Pharmacists must respect patient autonomy and document refusals of treatment.

Pharmacists must avoid discriminatory practices and maintain professional boundaries.

Impaired colleagues must be reported when patient safety is at risk.

Pharmacies must maintain a nonpunitive medication error reporting culture.