NE MPJE cheat sheet
NE MPJE · Keep the key ideas within reach.
Federal and State Pharmacy Law and Regulations
Federal law sets a floor: the FDCA, CSA, and CFR requirements apply nationwide, but a stricter Minnesota statute or rule controls when the two conflict, so always apply the more restrictive standard.
Minnesota Board of Pharmacy rules are codified in Minnesota Rules Chapters 6800-6805; the Pharmacy Practice Act is Minn. Stat. ch. 151, with the Drug and Cosmetic Act in Minn. Stat. ch. 151A.
Drugs may be dispensed only pursuant to a valid prescription or a lawful exception (e.g., practitioner-administered, investigational, or emergency dispensing); a pharmacist may not dispense on an expired prescription.
Minnesota requires prescriptions to be retained for at least two years, and controlled substance records for at least two years, and they must be readily retrievable for Board inspection.
A prescription drug may not be repackaged or relabeled except by a licensed pharmacy or licensed wholesaler operating under Minnesota and federal registration.
The federal Combat Methamphetamine Epidemic Act imposes daily and monthly sales limits and logbook requirements on scheduled listed chemical products (pseudoephedrine, ephedrine, phenylpropanolamine).
Dietary supplements and nonprescription drugs are regulated differently: DSHEA governs supplements, while OTC drug monographs under the FDCA govern nonprescription drugs.
Minnesota prohibits the dispensing of a drug by a pharmacist if the prescription is known to be forged, and requires reporting suspected forgery to law enforcement and the Board.
Licensure, Registration, and Discipline of Pharmacists, Technicians, and Pharmacies
Minnesota licenses pharmacists, registers pharmacy technicians, and licenses pharmacies; each credential must be renewed and displayed or available at the practice site.
Pharmacist licensure requires graduation from an ACPE-accredited program, passage of NAPLEX and MPJE, and completion of the required internship hours under Board rules.
A pharmacy technician in Minnesota must be registered with the Board; a technician may perform only delegated tasks under the direct supervision of a licensed pharmacist.
Grounds for discipline include practicing beyond scope, unprofessional conduct, impairment, fraud in obtaining a license, and failure to maintain required records.
The Board may impose corrective action, suspension, revocation, or civil penalties; disciplinary orders are public and reported to national databases when applicable.
Continuing education is required for renewal; pharmacists must complete Board-approved CE hours including any mandated topic areas such as medication safety or law.
A pharmacy must notify the Board of a change of ownership, location, or pharmacist-in-charge within the timeframe set by rule, and the license is site-specific.
Prescription Requirements, Dispensing, and Labeling
A valid prescription must contain the patient name, drug name, strength, dosage form, quantity, directions, prescriber name and signature, and date; missing elements require prescriber verification before dispensing.
Minnesota permits electronic prescriptions and requires that they be transmitted with the prescriber's electronic signature; oral prescriptions are permitted for non-controlled drugs unless the drug is on a restricted list.
A pharmacist may dispense a therapeutic interchange or generic substitution unless the prescriber writes "dispense as written" or the patient refuses; state substitution rules apply.
The prescription label must include the pharmacy name and address, prescription number, date, patient name, directions for use, prescriber name, and cautionary statements required by law.
Refills are permitted only if authorized by the prescriber; a prescription with no refills authorized may not be refilled, and the pharmacist must contact the prescriber for authorization.
A pharmacist may not dispense a prescription that is more than one year old unless state law or the prescriber authorizes otherwise; controlled substance prescriptions have shorter validity periods.
Patient records must document the prescription, the dispensing pharmacist, the date, and any counseling provided or refused.
Controlled Substances and Drug Scheduling
The federal CSA places drugs into Schedules I-V based on abuse potential and accepted medical use; Schedule I has no accepted medical use, while Schedules II-V have accepted medical uses with decreasing abuse potential.
Minnesota adopts the federal schedules but may add or reschedule substances; a drug that is controlled federally and not controlled in Minnesota is still subject to federal requirements.
Schedule II prescriptions must be written, signed, and may not be refilled; a pharmacist may dispense up to a 90-day supply if the prescriber authorizes it, subject to state and federal rules.
Schedule III-V prescriptions may be refilled up to five times within six months of the date of issue unless the prescriber specifies otherwise.
Controlled substances must be stored in a securely locked, substantially constructed cabinet or dispersed throughout the stock in a manner that obstructs theft; perpetual inventory is required for Schedule II.
A DEA registration is required for each principal place of business where controlled substances are dispensed, and the registration must be renewed every three years.
Theft or significant loss of controlled substances must be reported to DEA and the state Board, and a DEA Form 106 must be filed.
A pharmacist may not fill a controlled substance prescription if there is a red flag indicating diversion, forgery, or improper prescribing, and must resolve the red flag before dispensing.
Pharmacy Operations, Records, and Inventory
Pharmacies must maintain a perpetual inventory of Schedule II drugs and conduct a biennial inventory of all controlled substances on May 1 of each odd-numbered year (or the date the pharmacy first engages in dispensing).
Records of receipt, sale, dispensing, and disposal of controlled substances must be maintained for at least two years and be readily retrievable for inspection.
Expired, damaged, or recalled drugs must be segregated and disposed of according to federal and state environmental rules; reverse distributors handle controlled substance returns.
A pharmacy must have a written policy and procedure manual covering dispensing, compounding, infection control, and emergency response, reviewed and updated regularly.
Prescription records may be maintained electronically if the system meets security and audit trail requirements and the records can be produced on request.
A pharmacy must report dispensing data to the Minnesota Prescription Monitoring Program (PMP) as required by law, and pharmacists must review PMP data before dispensing certain controlled substances.
Quality assurance programs must document medication errors, near misses, and corrective actions, and the records must be available to the Board.
Patient Counseling and Professional Practice Standards
A pharmacist must offer counseling to each patient receiving a new prescription, covering the drug name, purpose, directions, precautions, and potential interactions, unless the patient refuses.
Counseling may be delegated to a pharmacy technician only if the technician is trained and the pharmacist remains responsible for the accuracy of the information.
The pharmacist must counsel on the importance of adherence, proper storage, and what to do if a dose is missed, and must document the counseling in the patient record.
A pharmacist must maintain patient confidentiality under HIPAA and Minnesota law, and may release information only with patient authorization or as required by law.
Professional standards require the pharmacist to identify and resolve therapeutic duplications, drug interactions, and contraindications before dispensing.
A pharmacist must report suspected adverse drug reactions to the FDA MedWatch program and to the prescriber when appropriate.
A pharmacist may refuse to dispense a prescription if it is not in the patient's best interest, but must refer the patient to another pharmacist or source of care.
Federal and State Pharmacy Law and Regulations (continued)
The FDCA requires that drugs be safe and effective for their intended use, and the FDA may withdraw approval if a drug is misbranded or adulterated.
The Poison Prevention Packaging Act requires child-resistant packaging for most prescription drugs, with exceptions for certain drugs and patient requests for non-child-resistant packaging.
The Combat Methamphetamine Epidemic Act requires sellers of scheduled listed chemical products to maintain a logbook and verify identification for purchases above the daily limit.
Minnesota law requires pharmacies to provide a written notice of the right to receive counseling and to post the notice in a conspicuous place.
The federal HIPAA Privacy Rule permits disclosure of protected health information for treatment, payment, and health care operations without patient authorization.
State law may impose additional requirements on the dispensing of certain drugs, such as the requirement to provide a medication guide or patient package insert.
Licensure, Registration, and Discipline (continued)
A pharmacist must notify the Board within 30 days of a change of address or name, and must report any criminal conviction that may affect licensure.
The Board may conduct investigations and inspections without prior notice, and the pharmacist must cooperate with the investigation.
A pharmacy technician registration may be denied or revoked for fraud, unprofessional conduct, or failure to meet training requirements.
The Board may issue a cease-and-desist order for unlicensed practice, and violations may result in civil penalties or criminal prosecution.
A pharmacist who is impaired by alcohol or drugs may not practice, and the Board may require participation in a monitoring program as a condition of continued licensure.
Continuing education audits are conducted by the Board, and failure to complete required CE may result in a conditional license or fine.
Prescription Requirements, Dispensing, and Labeling (continued)
A pharmacist may dispense a prescription for a drug that is not a controlled substance without a written prescription if the prescriber is unavailable, but must obtain a written prescription within a specified time.
A prescription for a controlled substance in Schedule II must be filled within 90 days of the date of issue, and may not be refilled.
The pharmacist must verify the prescriber's DEA number for controlled substance prescriptions and must ensure the prescription is issued for a legitimate medical purpose.
A prescription may be transferred between pharmacies for refill purposes, but Schedule II prescriptions may not be transferred except as permitted by federal law.
The label must include the drug name, strength, quantity, directions, and the name of the prescriber, and must be affixed to the container in a manner that is legible and not easily removed.
Controlled Substances and Drug Scheduling (continued)
Schedule I drugs include heroin, LSD, and marijuana (federally), and may not be prescribed or dispensed except for research with a DEA registration.
Schedule II drugs include oxycodone, morphine, and amphetamine, and require a written prescription and a DEA Form 222 for ordering.
Schedule III drugs include anabolic steroids and ketamine, and may be refilled up to five times within six months.
Schedule IV drugs include benzodiazepines and tramadol, and Schedule V drugs include certain cough preparations with limited codeine.
A pharmacist must maintain a record of all controlled substances dispensed, including the date, patient, drug, quantity, and prescriber, for at least two years.
The DEA may conduct inspections of pharmacy records and inventory, and the pharmacist must provide access to all required records.
Pharmacy Operations, Records, and Inventory (continued)
A pharmacy must maintain a current list of all controlled substances in stock and must conduct a physical count at least every two years.
Records of controlled substances must be kept separate from other records and must be readily retrievable for inspection.
A pharmacy must have a written plan for the secure storage and disposal of controlled substances, including the use of a reverse distributor.
The pharmacy must maintain a log of all prescriptions dispensed, including the date, patient, drug, quantity, and prescriber, for at least two years.
A pharmacy must report any theft or loss of controlled substances to DEA and the Board within 24 hours of discovery.
The pharmacy must maintain a current inventory of all drugs, including expired drugs, and must remove expired drugs from stock promptly.
Patient Counseling and Professional Practice Standards (continued)
A pharmacist must provide counseling on the proper use of medical devices and diagnostic products, including glucose meters and inhalers.
A pharmacist must counsel patients on the potential for drug interactions with alcohol, food, and other drugs, and must provide written information when appropriate.
A pharmacist must document any counseling provided, including the date, the topics covered, and the patient's response.
A pharmacist must maintain a professional relationship with the patient and must not engage in any conduct that exploits the patient for financial gain.
A pharmacist must report any suspected child abuse or neglect to the appropriate authorities as required by Minnesota law.
A pharmacist must comply with the federal and state requirements for the dispensing of opioids, including the provision of naloxone and education on overdose prevention.
Federal and State Pharmacy Law and Regulations (continued)
The federal Food, Drug, and Cosmetic Act prohibits the introduction of adulterated or misbranded drugs into interstate commerce.
The FDA may require a Risk Evaluation and Mitigation Strategy (REMS) for drugs with serious safety concerns, and pharmacists must comply with REMS requirements.
The federal Drug Supply Chain Security Act requires pharmacies to verify the authenticity of drug products and to maintain transaction records.
Minnesota law requires pharmacies to provide a written notice of the right to receive counseling and to post the notice in a conspicuous place.
The federal HIPAA Privacy Rule permits disclosure of protected health information for treatment, payment, and health care operations without patient authorization.
State law may impose additional requirements on the dispensing of certain drugs, such as the requirement to provide a medication guide or patient package insert.
Licensure, Registration, and Discipline (continued)
A pharmacist must notify the Board within 30 days of a change of address or name, and must report any criminal conviction that may affect licensure.
The Board may conduct investigations and inspections without prior notice, and the pharmacist must cooperate with the investigation.
A pharmacy technician registration may be denied or revoked for fraud, unprofessional conduct, or failure to meet training requirements.
The Board may issue a cease-and-desist order for unlicensed practice, and violations may result in civil penalties or criminal prosecution.
A pharmacist who is impaired by alcohol or drugs may not practice, and the Board may require participation in a monitoring program as a condition of continued licensure.
Continuing education audits are conducted by the Board, and failure to complete required CE may result in a conditional license or fine.
Prescription Requirements, Dispensing, and Labeling (continued)
A pharmacist may dispense a prescription for a drug that is not a controlled substance without a written prescription if the prescriber is unavailable, but must obtain a written prescription within a specified time.
A prescription for a controlled substance in Schedule II must be filled within 90 days of the date of issue, and may not be refilled.
The pharmacist must verify the prescriber's DEA number for controlled substance prescriptions and must ensure the prescription is issued for a legitimate medical purpose.
A prescription may be transferred between pharmacies for refill purposes, but Schedule II prescriptions may not be transferred except as permitted by federal law.
The label must include the drug name, strength, quantity, directions, and the name of the prescriber, and must be affixed to the container in a manner that is legible and not easily removed.
Controlled Substances and Drug Scheduling (continued)
Schedule I drugs include heroin, LSD, and marijuana (federally), and may not be prescribed or dispensed except for research with a DEA registration.
Schedule II drugs include oxycodone, morphine, and amphetamine, and require a written prescription and a DEA Form 222 for ordering.
Schedule III drugs include anabolic steroids and ketamine, and may be refilled up to five times within six months.
Schedule IV drugs include benzodiazepines and tramadol, and Schedule V drugs include certain cough preparations with limited codeine.
A pharmacist must maintain a record of all controlled substances dispensed, including the date, patient, drug, quantity, and prescriber, for at least two years.
The DEA may conduct inspections of pharmacy records and inventory, and the pharmacist must provide access to all required records.
Pharmacy Operations, Records, and Inventory (continued)
A pharmacy must maintain a current list of all controlled substances in stock and must conduct a physical count at least every two years.
Records of controlled substances must be kept separate from other records and must be readily retrievable for inspection.
A pharmacy must have a written plan for the secure storage and disposal of controlled substances, including the use of a reverse distributor.
The pharmacy must maintain a log of all prescriptions dispensed, including the date, patient, drug, quantity, and prescriber, for at least two years.
A pharmacy must report any theft or loss of controlled substances to DEA and the Board within 24 hours of discovery.
The pharmacy must maintain a current inventory of all drugs, including expired drugs, and must remove expired drugs from stock promptly.
Patient Counseling and Professional Practice Standards (continued)
A pharmacist must provide counseling on the proper use of medical devices and diagnostic products, including glucose meters and inhalers.
A pharmacist must counsel patients on the potential for drug interactions with alcohol, food, and other drugs, and must provide written information when appropriate.
A pharmacist must document any counseling provided, including the date, the topics covered, and the patient's response.
A pharmacist must maintain a professional relationship with the patient and must not engage in any conduct that exploits the patient for financial gain.
A pharmacist must report any suspected child abuse or neglect to the appropriate authorities as required by Minnesota law.
A pharmacist must comply with the federal and state requirements for the dispensing of opioids, including the provision of naloxone and education on overdose prevention.