TN MPJE cheat sheet
TN MPJE · Keep the key ideas within reach.
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.
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.