TN MPJE study materials
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TN MPJE cheat sheet

TN MPJE · Keep the key ideas within reach.

Quick reference

Federal Pharmacy Laws and Regulations

  • Controlled Substances Act: Schedule I drugs have no accepted medical use and may not be prescribed; Schedules II-V require a DEA-registered prescriber and a prescription issued for a legitimate medical purpose in the usual course of professional practice.

  • Schedule II prescriptions: no refills; an emergency oral order may be dispensed if the prescriber delivers a written or electronic prescription within 7 days; partial fills allowed when the full quantity is unavailable (balance within 72 hours) or for long-term care/terminally ill patients (up to 60 days).

  • Schedules III-IV: maximum of 5 refills, and no refill may be dispensed more than 6 months after the issue date; Schedule V refills follow state law.

  • DEA ordering and records: Form 222 or CSOS for Schedule I/II procurement; biennial inventory with exact counts for Schedule II and estimated counts for III-V; records kept 2 years, separate and readily retrievable; Form 106 for theft/significant loss; Form 41 for destruction.

  • DEA registration is location-specific, renewed every 3 years for practitioners and pharmacies, and separate registrations are required for each principal place of business.

  • Durham-Humphrey Amendment: created the prescription-only legend drug category and requires the label statement 'Caution: Federal law prohibits dispensing without prescription' on legend drugs unless FDA grants an exemption.

  • Poison Prevention Packaging Act: oral prescription drugs must be dispensed in child-resistant containers unless the patient or prescriber requests otherwise in writing or the drug appears on the exempt list (e.g., sublingual nitroglycerin).

  • OBRA '90 requires prospective drug utilization review and an offer to counsel for Medicaid patients; HIPAA requires a notice of privacy practices, minimum necessary use/disclosure, and reasonable safeguards for PHI.

  • Combat Methamphetamine Epidemic Act: pseudoephedrine/ephedrine sales behind the counter with photo ID and logbook, limited to 3.6 g per day and 9 g per 30 days; DSCSA requires authorized trading partners, product tracing, verification, and serialization.

Quick reference

Tennessee State Pharmacy Laws and Regulations

  • The Tennessee Board of Pharmacy regulates pharmacy practice under Title 63, Chapter 10 of the Tennessee Code and operates within the Department of Health, Division of Health Related Boards.

  • Licenses/registrations issued by the Board include the pharmacy license for each location, the pharmacist license, the pharmacy technician registration, the nonresident pharmacy license, and the wholesale distributor license; each must be current and available for inspection.

  • Every Tennessee pharmacy must designate a pharmacist-in-charge who is responsible for compliance with state pharmacy law and Board rules, security of the prescription department, and recordkeeping.

  • Dispensers must report controlled substance dispensing to the Tennessee Controlled Substance Monitoring Database (CSMD) as required by Board rule, generally by the next business day after dispensing.

  • Tennessee pharmacists may dispense naloxone without a patient-specific prescription under the state's standing order, and properly trained pharmacists may administer ACIP-recommended vaccines under a protocol subject to statutory age limits.

  • Tennessee law authorizes written consult agreements between a pharmacist and a prescriber under which the pharmacist manages, adjusts, or continues drug therapy within defined parameters.

  • Generic substitution is permitted when the substituted product is therapeutically equivalent and lower cost, unless the prescriber indicates 'dispense as written' in the manner required by Tennessee law.

  • The pharmacist must offer counseling to patients receiving prescriptions, and pharmacies must maintain prescription and patient records for the period set by Board rule and produce them for Board inspection.

  • Tennessee pharmacies must maintain a continuous quality improvement (CQI) program that documents, tracks, and reviews dispensing errors and quality-related events.