NC MPJE cheat sheet
NC MPJE · Keep the key ideas within reach.
Licensure, Registration, and Certification Requirements
North Carolina pharmacy practice requires a license issued by the NC Board of Pharmacy; a person may not compound, dispense, or distribute prescription drugs without it.
Pharmacist licensure pathway: accredited PharmD, NAPLEX, MPJE (NC), and internship hours; NC requires 1,740 intern hours obtained through a Board-approved internship program.
Pharmacy technician registration with the Board is mandatory before performing technician duties; registration is distinct from PTCB certification, which is a private credential.
Pharmacy permit types include community, hospital, and specialty permits; a permit is site-specific and a change of location or ownership requires a new or amended permit.
License and registration renewal cycles are annual with a defined expiration date; practicing on an expired license is unlicensed practice subject to discipline.
Continuing education for NC pharmacist renewal is 30 contact hours per license year, including specified topic hours such as pharmacy law and medication safety.
Reciprocity/licensure by transfer requires the applicant to hold a current license in another state, meet NC education and exam requirements, and submit verification of licensure.
Reporting obligations: a pharmacist must report certain arrests, convictions, and disciplinary actions to the Board within a defined period, typically 10 days for criminal matters.
Pharmacy Practice and Operations Standards
A pharmacy must maintain a policy and procedure manual covering dispensing, recordkeeping, security, and quality assurance; the manual must be available for Board inspection.
Prescription department requirements include a sink with hot and cold water, adequate refrigeration with temperature monitoring, and a secured area limiting access to authorized personnel.
Drugs must be stored per labeled temperature requirements; refrigerator and freezer temperatures are documented, and excursions require evaluation before dispensing affected stock.
Outdated, adulterated, or misbranded drugs must be segregated and removed from active stock; returns and destructions are documented.
Continuous quality improvement program: the pharmacy must maintain a CQI program that documents errors and near misses, analyzes causes, and implements changes to prevent recurrence.
Emergency preparedness: the pharmacy maintains a written plan for power outages, disasters, and drug shortages, including arrangements for temperature-sensitive products.
Automated devices used for storage or dispensing must be validated, secured, and have a documented accuracy and restocking process.
Signage and access requirements include posting of the pharmacy permit, hours of operation, and notice that the pharmacist in charge is available for consultation.
Prescription Processing, Dispensing, and Labeling
A prescription must contain patient name, drug name, strength, dosage form, quantity, directions, date, and prescriber signature; missing elements require prescriber verification before dispensing.
Oral prescriptions are permitted for most legend drugs but must be reduced to writing promptly and verified; Schedule II oral orders are restricted to defined emergency situations.
Refill authorization: a pharmacist may not refill a prescription beyond the authorized refills or beyond one year from the date written unless the prescriber authorizes a new prescription.
Labeling requirements include pharmacy name and address, prescription number, date, patient name, directions, drug name and strength, quantity, prescriber, and required auxiliary and federal cautionary statements.
Substitution of a therapeutically equivalent generic requires patient or prescriber authorization where state law provides, and the substitution must be recorded.
Prescription transfers between pharmacies are permitted for non-controlled drugs; controlled substance transfers are limited by federal rules, with Schedule II generally not transferable.
Patient records must be retained for the period required by state law, and prescription records must be readily retrievable for inspection.
Dispensing errors require documentation, patient notification when appropriate, and inclusion in the CQI program review.
Controlled Substances and Other Regulated Drugs
Schedules are determined by federal CSA and NC Controlled Substances Act; NC may place a substance in a stricter schedule than federal, so check both.
Schedule II prescriptions require a written or electronic prescription with no refills; emergency oral orders require a written prescription within 7 days.
Schedule III-V prescriptions are valid for up to 6 months from issue and may not exceed 5 refills unless the prescriber renews.
DEA registration is required for each principal place of business; a separate registration is needed for each location where controlled substances are stored or dispensed.
CSOS electronic prescriptions for Schedule II must meet DEA electronic prescription requirements including digital signature and two-factor authentication.
Inventory: a biennial inventory of controlled substances is required, and records of receipt, dispensing, and disposal must be maintained for at least 2 years.
Theft or significant loss of controlled substances must be reported to DEA in writing within one business day of discovery, with a follow-up report.
NC Controlled Substances Reporting System (CSRS) reporting: dispensers submit dispensing data to the state PDMP, and pharmacists must review the CSRS before dispensing certain controlled substances as required by law.
Patient Counseling, Medication Safety, and Patient Records
Pharmacist counseling is required for each new prescription and when a prescription changes; the offer to counsel must be documented, and refusal may be documented.
Counseling content includes drug name and purpose, dosage and administration, common and serious adverse effects, interactions, storage, and what to do if a dose is missed.
Medication therapy management and comprehensive medication review are documented services; documentation includes findings, recommendations, and communication with prescribers.
Patient profiles must capture allergies, diagnoses where available, current medications, and relevant history used to screen for interactions and duplications.
High-alert medications such as anticoagulants, insulin, and opioids require independent double checks and targeted counseling on bleeding, hypoglycemia, and respiratory risk.
Error reporting is non-punitive internally but mandatory reporting to the Board applies to specified serious events; documentation supports both quality improvement and regulatory compliance.
Patient records are confidential; release requires patient authorization except for permitted disclosures such as treatment, payment, and legal requirements.
Medication safety practices include tall-man lettering, look-alike/sound-alike separation, barcode verification, and reconciliation at transitions of care.
Pharmacy Personnel, Supervision, and Delegation
The pharmacist in charge is responsible for the pharmacy's compliance with law and for supervision of all personnel; the PIC must be a licensed NC pharmacist.
Technician ratio and supervision: technicians perform duties only under the direct supervision of a pharmacist, and the pharmacist verifies the final product before dispensing.
Tasks that may not be delegated include final verification of a prescription, patient counseling, and clinical judgment reserved to the pharmacist.
Pharmacy interns may perform pharmacist duties under supervision as permitted by Board rule; the supervising pharmacist remains responsible for the work.
Technician registration must be current; unregistered personnel may not handle prescription drugs except in limited clerical or cashier roles.
Training and competency documentation for technicians and clerks must be maintained, including sterile compounding qualification where applicable.
Personnel must report suspected impairment or diversion; the pharmacy maintains a process for removing impaired personnel from drug handling.
Delegation of prescription transfer and refill authorization follows written policy and remains subject to pharmacist oversight.
Drug Distribution Channels, Compounding, and Institutional Practice
Wholesale distribution requires a license; pedigree and transaction documentation must be maintained to trace drugs through the distribution chain.
Drugs may not be returned to stock for resale once dispensed to a patient; returns to wholesaler are limited to unopened, non-expired stock under defined conditions.
Compounding is governed by USP standards; nonsterile compounding follows USP <795> and sterile compounding follows USP <797>, with facility, personnel, and environmental monitoring requirements.
Sterile compounding requires documented training, media fill and glove fingertip testing, and environmental monitoring including viable and nonviable particle testing.
Institutional practice: a hospital pharmacy must have a formulary and P&T committee process, and drug orders must be reviewed by a pharmacist before administration except in emergencies.
Unit-dose and floor stock distribution require documented accountability, and controlled substances in the institution require witnessed wasting and perpetual inventory.
Compounding records must include the formula, ingredients, lot numbers, beyond-use date, and the identity of the person who compounded and verified.
Repackaging and labeling of institutional doses must include drug, strength, beyond-use date, and lot number traceable to the original product.
Federal and North Carolina Regulatory Compliance, Inspections, and Enforcement
Federal framework includes the FDCA, CSA, and DEA regulations; NC law may be stricter, and the stricter standard governs where both apply.
Board inspections may occur without prior notice; inspectors review licenses, records, drug storage, security, and compliance with prior orders.
Enforcement tools include letters of warning, consent orders, civil penalties, suspension, revocation, and referral for criminal prosecution.
Grounds for discipline include unprofessional conduct, dispensing without a valid prescription, impaired practice, and failure to maintain required records.
HIPAA privacy and security rules apply to covered pharmacies; breaches require notification and documented risk analysis.
DEA registration must be renewed and kept at the registered location; failure to maintain registration while handling controlled substances is a violation.
Advertising and internet pharmacy rules restrict dispensing to patients with a valid prescriber-patient relationship; prescribing based only on a questionnaire is prohibited.
Recordkeeping and reporting deadlines are strict; failure to report theft, loss, or changes of address or ownership within required timeframes is independently sanctionable.
Prescription Processing, Dispensing, and Labeling
Prescription validity requires a legitimate medical purpose and a prescriber acting in the usual course of professional practice; a pharmacist must resolve red flags before dispensing.
Red flags include long distances between patient, prescriber, and pharmacy, cash payment for controlled substances, and patterns of early refills; resolution must be documented.
Partial filling of Schedule II prescriptions is permitted in defined circumstances, including patient or pharmacy stock limitations, with the balance filled within 72 hours.
Emergency dispensing of a Schedule II drug is limited to the quantity needed for the emergency period, and the prescriber must supply a written prescription within 7 days.
The pharmacist must verify prescription authenticity when there is reason to doubt it, including contacting the prescriber using an independently verified number.
Labeling of controlled substances requires the federal transfer warning on Schedule II-IV prescriptions and applicable state cautionary statements.
Dispensing records must be retrievable and include the identity of the dispensing pharmacist, date, quantity, and the prescription as received.
Return or destruction of dispensed controlled substances follows DEA disposal rules, including reverse distributor or authorized collector pathways.
Pharmacy Practice and Operations Standards
Pharmacies must maintain a current list of prescribers authorized to prescribe and verify DEA numbers for controlled substance prescriptions.
Security requirements include locked storage for controlled substances, limited keys or access codes, and documented alarm or monitoring systems where required.
The pharmacy must maintain a written policy on accepting and handling returned drugs and on drug recalls, including quarantine and patient notification.
Equipment calibration and maintenance records, such as for balances and compounding equipment, must be current and available for inspection.
Hours of operation and after-hours access to a pharmacist for emergencies must be defined and communicated to patients.
Record retention: prescription and controlled substance records are retained for the period required by law and must be produced on request during an inspection.
A pharmacist must be physically present whenever the pharmacy is open for dispensing; remote or automated systems operate only as authorized by Board rule.
Quality assurance meetings and CQI documentation must occur at defined intervals and be retained as part of the pharmacy's records.
Patient Counseling, Medication Safety, and Patient Records
Counseling must be provided in a private area when practicable and in a manner the patient can understand, including interpreter services when needed.
Documentation of counseling or the patient's refusal protects the pharmacy and supports continuity of care across pharmacists.
Medication reconciliation at admission and discharge reduces discrepancies; the pharmacist compares the pre-visit list with new orders and resolves differences.
Adverse drug event reporting to FDA MedWatch is voluntary for practitioners but supports post-market surveillance and should be documented internally.
Patient-specific records must be updated with new allergies, adverse reactions, and changes in therapy at each encounter.
Look-alike/sound-alike drug pairs and high-alert drugs require targeted labels, auxiliary warnings, and counseling emphasis.
Prescription abandonment and nonadherence should be documented, and follow-up communication with the prescriber should be recorded.
Confidentiality extends to all protected health information, including prescription records, and unauthorized access is a reportable privacy incident.
Pharmacy Personnel, Supervision, and Delegation
The pharmacist in charge must ensure adequate staffing so that supervision, verification, and counseling are not compromised by workload.
Technician duties are defined by Board rule and pharmacy policy; the pharmacist must be able to verify that each delegated task was performed correctly.
Pharmacy clerks and cashiers may not handle prescription drugs or enter prescription data unless authorized and supervised as permitted by rule.
Intern and extern supervision requires the supervising pharmacist to be on site and to co-sign records as required.
Personnel files must document licensure, registration, training, and competency, and be available for inspection.
Delegation of compounding tasks requires documented training and, for sterile compounding, qualification before independent work.
A pharmacist may not supervise more pharmacies or personnel than allowed by Board rule; the pharmacist's physical presence is required for dispensing oversight.
Disciplinary history and exclusion screening (e.g., OIG exclusion list) should be checked before employment in drug handling roles.
Drug Distribution Channels, Compounding, and Institutional Practice
Manufacturer, wholesaler, and repackager registration requirements apply to entities that distribute drugs; a pharmacy distributing beyond dispensing may need a wholesale license.
Drug pedigree and transaction history must be maintained for prescription drugs to support tracing and prevent counterfeit entry.
Compounding from bulk substances is permitted only for substances that meet applicable USP monographs and are on the FDA-approved list where required.
Beyond-use dates for compounded preparations are assigned based on USP default limits and documented stability; the shorter of the assigned or default BUD applies.
Sterile compounding requires an ISO-classified environment, documented cleaning, and environmental monitoring with defined action levels.
Institutional drug distribution includes unit-dose, floor stock, and automated dispensing cabinets, each requiring accountability and controlled substance oversight.
Hospital pharmacy drug order review may be prospective or retrospective depending on policy; emergency administration without prior review must be documented and reviewed.
Compounding records and labels must be retained and must permit identification of the compounder, verifier, ingredients, and BUD.
Federal and North Carolina Regulatory Compliance, Inspections, and Enforcement
The Board may inspect at reasonable times and may take action based on inspection findings; refusal to permit inspection is itself a violation.
Board orders may include probation, monitoring, fines, additional CE, and practice restrictions; compliance is verified through follow-up inspections or reports.
Federal enforcement includes DEA registration actions, civil monetary penalties under the CSA, and FDCA misbranding or adulteration actions.
Mandatory reporting to the Board includes arrests, convictions, and certain professional actions within defined timeframes.
Wholesale and distribution violations may trigger both state Board action and federal FDA action, including injunctions and seizures.
Advertising rules prohibit false or misleading claims and restrict offers that induce dispensing without a valid prescription.
Compliance program elements include written policies, a designated compliance officer, training, monitoring, and response to detected offenses.
Recordkeeping violations are independently sanctionable; records must be complete, accurate, and produced within the time required by the inspector.
Licensure, Registration, and Certification Requirements
A pharmacy technician must be registered with the NC Board before performing technician duties; registration requires application, fee, and background information as required.
Pharmacist license renewal requires attestation of CE completion and disclosure of any disciplinary or criminal matters.
A pharmacist licensed in another state may obtain NC licensure through transfer if the license is current and the applicant meets NC requirements, including the NC MPJE.
Pharmacy permits are issued to the owner and are not transferable without Board approval; changes in ownership require a new permit application.
Continuing education audits may require documentation of completion; failure to produce records is a basis for discipline.
License reinstatement after lapse or discipline may require additional CE, examination, or practice conditions imposed by the Board.
The Board maintains a public license verification system; employers must verify current licensure and registration before employment.
Unlicensed practice and aiding unlicensed practice are both violations; the supervising pharmacist is responsible for verifying credentials.
Pharmacy Practice and Operations Standards
The pharmacy must have a designated area for prescription preparation that is separate from public access and secure when not in use.
Refrigeration units storing drugs must have a monitored thermometer and documented temperature logs; drugs exposed to out-of-range temperatures must be evaluated.
Drug recalls require immediate removal from stock, documentation of affected lots, and patient notification where the recall is serious.
The pharmacy must maintain a current reference library or electronic equivalent sufficient to support dispensing and counseling.
Prescription department housekeeping and sanitation must be documented; compounding areas require cleaning logs.
Automation and information systems must have access controls, audit trails, and backup procedures to protect prescription records.
The pharmacy must have a written policy for handling prescription errors, including root cause analysis and corrective action.
Emergency drug supplies and antidotes, where maintained, must be checked for expiration and replaced before expiry.
Prescription Processing, Dispensing, and Labeling
A prescription may be refused if the pharmacist cannot resolve red flags or verify the prescriber; the refusal and reason should be documented.
Prescriber verification requires an independent source, such as a directory or prior prescription record, not just the phone number on the suspicious prescription.
Refill-too-soon requests require prescriber authorization and documentation; the pharmacist evaluates for early refill, lost or stolen medication, or dose change.
The prescription record must show the date filled, quantity dispensed, and the pharmacist responsible for dispensing.
Auxiliary labels are required for specific hazards, such as 'may cause drowsiness' or 'take with food,' and must match the product's labeling.
Prescriptions for controlled substances must include the prescriber's DEA number, and the pharmacist must verify it is valid for the schedule prescribed.
Verbal prescription orders must be reduced to writing and read back to the prescriber to confirm accuracy.
Records of prescription transfers must include the transferring and receiving pharmacy, date, and pharmacist identity.
Controlled Substances and Other Regulated Drugs
DEA Form 222 or CSOS is required for ordering Schedule I and II substances; the form must be completed accurately and retained.
Schedule III-V substances may be ordered with invoices, which must be retained and available for inspection.
Controlled substance disposal requires DEA-compliant methods, including reverse distributors or authorized collection receptacles, with documentation.
Schedule II records must be kept separately or readily retrievable from other records, and a perpetual inventory is required in many practice settings.
Loss or theft reporting requires a DEA Form 106 and notification to the Board as required; the report must be filed within one business day of discovery.
Prescriptions for controlled substances must be dispensed in compliance with both federal and NC scheduling; a state schedule may be stricter.
The CSRS must be checked before dispensing opioids and other specified controlled substances as required by NC law, and the check documented.
DEA registration renewal occurs every three years; the registration certificate must be maintained at the registered location.
Patient Counseling, Medication Safety, and Patient Records
Patient counseling must address the name and description of the drug, dosage form, route, and duration of therapy.
Counseling must include directions for use, common side effects, interactions to avoid, and what to do if a dose is missed.
Patients must be told how to store the medication, including refrigeration and safe disposal of unused or expired drugs.
The pharmacist must offer counseling on each new prescription and document acceptance or refusal; the offer is required even when the patient declines.
Medication safety includes checking for therapeutic duplication and drug-disease contraindications using the patient profile.
Adverse events should be documented in the patient record and reported to the prescriber when clinically significant.
Patient education materials must be understandable and consistent with the prescription directions and labeling.
Records of counseling and interventions must be retained and retrievable for inspection and continuity of care.
Pharmacy Personnel, Supervision, and Delegation
The pharmacist in charge must ensure that all personnel are properly licensed or registered and that duties match their credential.
Technicians may not counsel patients or perform final verification; these functions are reserved to the pharmacist.
Delegated tasks must be within the technician's training and the pharmacy's written policy; the pharmacist retains responsibility for the outcome.
Supervision requires the pharmacist to be physically present in the pharmacy when technicians perform prescription-related duties.
Interns may perform duties under supervision as permitted by Board rule, and the supervising pharmacist must co-sign as required.
Personnel must be trained on HIPAA and confidentiality before accessing patient records.
Staffing levels must permit the pharmacist to supervise and verify without compromising safety.
Personnel records must show current credentials and training and be available for Board inspection.
Drug Distribution Channels, Compounding, and Institutional Practice
A pharmacy that distributes drugs to other pharmacies or practitioners may need a wholesale distributor license and must maintain transaction records.
Drug samples may be distributed only in compliance with federal and state rules; sample handling must be documented.
Compounding must use ingredients with valid certificates of analysis or USP grade, and bulk ingredients must be properly labeled and stored.
USP <795> nonsterile compounding requires a designated space, proper equipment, and a written master formulation record.
USP <797> sterile compounding requires an ISO Class 5 direct compounding area within an ISO Class 7 or better buffer room and documented environmental monitoring.
Institutional drug distribution requires a process for medication reconciliation and for reporting adverse drug events.
Automated dispensing cabinets in institutions require controlled substance accountability, user access controls, and discrepancy review.
Repackaged drugs must be labeled with the drug name, strength, lot number, and beyond-use date, and records retained.
Federal and North Carolina Regulatory Compliance, Inspections, and Enforcement
Board inspectors may review prescription files, controlled substance records, and the pharmacy's written policies during an inspection.
Failure to produce required records during an inspection may result in a finding and disciplinary action.
The Board may issue a letter of warning, a consent order, or a citation; repeat violations may lead to suspension or revocation.
Federal law prohibits dispensing a controlled substance without a valid prescription, and the pharmacist must resolve red flags before dispensing.
HIPAA requires safeguards for protected health information, and a breach may require notification to affected individuals and HHS.
DEA registration actions may include suspension or revocation for failure to maintain effective controls against diversion.
Compliance with Board orders is verified through follow-up inspections or reports, and noncompliance is independently sanctionable.
Advertising must not be false or misleading, and internet dispensing requires a valid prescriber-patient relationship.
Licensure, Registration, and Certification Requirements
Pharmacist licensure requires graduation from an accredited pharmacy program and passage of NAPLEX and the NC MPJE.
Intern hours must be documented and completed under a Board-approved preceptor before licensure.
Pharmacy technician registration requires an application, fee, and compliance with Board requirements; registration must be renewed.
Pharmacy permits are issued for a specific location and type of practice and must be displayed.
Continuing education requirements must be met before renewal, and records must be retained for audit.
License verification must be performed before employment and periodically thereafter.
Changes in name, address, or employment must be reported to the Board within required timeframes.
Practicing without a current license or registration is a violation subject to discipline.
Pharmacy Practice and Operations Standards
The pharmacy must maintain a written policy for accepting and processing prescriptions received by fax, telephone, or electronic means.
The prescription department must be secured when closed, and access limited to authorized personnel.
Temperature-sensitive drugs require monitored storage and documented corrective action for excursions.
Outdated drugs must be removed from active stock and segregated for return or destruction.
The CQI program must document errors and near misses, analyze causes, and implement preventive actions.
Equipment used in dispensing and compounding must be maintained and calibrated with records available for inspection.
The pharmacy must have a written emergency plan for outages, disasters, and drug shortages.
Signage must include the pharmacy permit, hours, and notice of pharmacist availability for consultation.
Prescription Processing, Dispensing, and Labeling
A prescription must be valid on its face: patient, drug, strength, dosage form, quantity, directions, date, and prescriber signature.
The pharmacist must verify prescriber authority and DEA number for controlled substances.
Oral prescriptions must be reduced to writing and read back for accuracy.
Refills may not exceed the authorized number or the one-year limit from the date written unless renewed.
Generic substitution requires patient or prescriber authorization where applicable and must be recorded.
Labels must include pharmacy name and address, prescription number, date, patient, directions, drug and strength, quantity, prescriber, and required warnings.
Prescription records must be retrievable and retained for the required period.
Dispensing errors must be documented and reviewed through the CQI program.
Controlled Substances and Other Regulated Drugs
Schedule II prescriptions require a written or electronic prescription with no refills; emergency oral orders require a written prescription within 7 days.
Schedule III-V prescriptions are valid for up to 6 months and no more than 5 refills.
DEA registration is required for each location where controlled substances are handled.
CSOS electronic prescriptions for Schedule II must meet DEA authentication requirements.
A biennial inventory is required, and records must be retained for at least 2 years.
Theft or loss must be reported to DEA within one business day of discovery.
The CSRS must be checked as required by NC law before dispensing specified controlled substances.
Partial fills and emergency dispensing are permitted only in defined circumstances and must be documented.
Patient Counseling, Medication Safety, and Patient Records
Counseling is required for each new prescription and when therapy changes, and the offer must be documented.
Counseling content includes purpose, administration, adverse effects, interactions, storage, and missed doses.
The patient profile must include allergies, current medications, and relevant history for interaction screening.
High-alert medications require targeted counseling and independent double checks.
Medication reconciliation at transitions of care reduces discrepancies and must be documented.
Adverse events should be documented and reported to the prescriber when significant.
Patient records are confidential and may be released only as permitted by law or with authorization.
Medication safety practices include tall-man lettering, look-alike/sound-alike separation, and barcode verification.
Pharmacy Personnel, Supervision, and Delegation
The pharmacist in charge is responsible for compliance and supervision of all personnel.
Technicians perform duties only under direct pharmacist supervision, and the pharmacist verifies the final product.
Final verification, counseling, and clinical judgment may not be delegated.
Interns may perform pharmacist duties under supervision as permitted by Board rule.
Technician registration must be current before performing technician duties.
Training and competency records must be maintained and available for inspection.
Personnel must report suspected impairment or diversion, and impaired personnel must be removed from drug handling.
Delegation of transfers and refill authorizations follows written policy and pharmacist oversight.
Drug Distribution Channels, Compounding, and Institutional Practice
Wholesale distribution requires a license and transaction documentation to trace drugs.
Dispensed drugs may not be returned to stock for resale; returns to wholesaler are limited to unopened, non-expired stock.
Nonsterile compounding follows USP <795> and sterile compounding follows USP <797>.
Sterile compounding requires documented training, media fill and glove fingertip testing, and environmental monitoring.
Institutional practice requires a formulary and P&T process, with pharmacist review of drug orders except in emergencies.
Unit-dose and floor stock distribution require accountability, and controlled substances require witnessed wasting and perpetual inventory.
Compounding records must include formula, ingredients, lot numbers, BUD, and the identity of the compounder and verifier.
Repackaged doses must be labeled with drug, strength, BUD, and lot number traceable to the original product.
Federal and North Carolina Regulatory Compliance, Inspections, and Enforcement
Federal law includes the FDCA, CSA, and DEA regulations; NC law may be stricter and controls where both apply.
Board inspections may occur without prior notice and cover licenses, records, storage, security, and prior orders.
Enforcement tools include letters of warning, consent orders, civil penalties, suspension, revocation, and criminal referral.
Grounds for discipline include unprofessional conduct, dispensing without a valid prescription, impairment, and recordkeeping failures.
HIPAA privacy and security rules apply, and breaches require notification and documented risk analysis.
DEA registration must be renewed and maintained at the registered location.
Internet dispensing requires a valid prescriber-patient relationship; questionnaire-only prescribing is prohibited.
Reporting deadlines for theft, loss, and changes of address or ownership are strict and independently sanctionable.
Pharmacy Practice and Operations Standards
The pharmacy must maintain a policy and procedure manual available for inspection.
Prescription department requirements include a sink with hot and cold water, refrigeration with monitoring, and secured access.
Drug storage must follow labeled temperature requirements, with documented logs and excursion evaluation.
Outdated or adulterated drugs must be segregated and removed from active stock.
The CQI program must document errors and near misses and implement preventive changes.
Emergency preparedness requires a written plan for outages, disasters, and shortages.
Automated devices must be validated, secured, and restocked with a documented process.
Signage must include the permit, hours, and notice of pharmacist availability for consultation.
Prescription Processing, Dispensing, and Labeling
A prescription must contain all required elements, and missing elements require prescriber verification before dispensing.
Oral prescriptions are permitted for most legend drugs but must be reduced to writing and verified.
Refills may not exceed the authorized number or the one-year limit unless the prescriber renews.
Labels must include pharmacy name and address, prescription number, date, patient, directions, drug and strength, quantity, prescriber, and required warnings.
Generic substitution requires authorization where applicable and must be recorded.
Prescription transfers are permitted for non-controlled drugs; Schedule II is generally not transferable.
Prescription records must be retained and retrievable for inspection.
Dispensing errors require documentation, patient notification when appropriate, and CQI review.