TN MPJE key terms

A drug that federal law requires to be dispensed only on a prescription because it is habit-forming, unsafe for unsupervised use, or bears the legend "Caution: Federal law prohibits dispensing without prescription." Tennessee uses a parallel definition in state law.

The federal registration a person or business must hold to manufacture, distribute, or dispense controlled substances. It is issued per location, renewed periodically, and may be suspended or revoked for violations of the Controlled Substances Act.

Five federal categories that rank substances by abuse potential and accepted medical use. Schedule I drugs have no accepted medical use; Schedules II through V have accepted uses with progressively lower abuse potential and fewer recordkeeping restrictions.

The single-sheet order form registrants use to obtain Schedule I and Schedule II controlled substances from a supplier. Copies are retained as records and endorsed with the quantity received; it may not be used for Schedule III through V drugs.

DEA's electronic equivalent of the paper order form, allowing registrants to order Schedule I and II controlled substances electronically using digital certificates issued to each authorized signer, with electronic records replacing paper copies.

An inventory of all controlled substances taken every two years on a date chosen by the registrant. Schedule II counts must be exact; Schedule III through V counts may be estimated unless a container holds more than 1,000 units.

The report of theft or significant loss of controlled substances. A registrant must notify the DEA field division when the loss is discovered and keep a copy of the report with its controlled substance records.

The form used to document destruction of controlled substances. It records the drugs destroyed, the method, the date, and the persons involved, and is retained or submitted according to DEA regulations.

A pharmacist's independent legal duty to determine that a controlled substance prescription was issued for a legitimate medical purpose by a prescriber acting in the usual course of practice. The pharmacist may not rely solely on the prescriber's authorization.

Prescriptions for Schedule II controlled substances may not be refilled. The patient must obtain a new prescription from the prescriber for any additional supply after the original quantity is exhausted.

A prescriber may telephone in a Schedule II prescription in a genuine emergency. The pharmacist may dispense it, but a written prescription must arrive within seven days, and the pharmacist should make reasonable efforts to verify the order.

A pharmacist may partially fill a Schedule II prescription when the full quantity cannot be supplied. The remainder may be dispensed within 72 hours; otherwise the prescriber must be notified and no further quantity may be dispensed.

Federal law restricting retail sales of pseudoephedrine and ephedrine products. They must be kept behind the counter, sold with photo identification and a written logbook, and limited to 3.6 grams per day and 9 grams per 30 days.

Federal law creating an electronic, interoperable system to trace prescription drugs through the supply chain. Dispensers must receive and verify transaction data, quarantine suspect product, and respond to verification requests.

An FDA-required plan for certain drugs with serious safety concerns. It may include medication guides, patient registries, training for prescribers and pharmacists, or restricted distribution systems that limit which pharmacies may dispense the drug.

Federal law requiring child-resistant packaging for most oral prescription drugs and selected over-the-counter products. Exceptions include a prescriber's waiver or a patient's signed request for a conventional container.

A HIPAA privacy principle requiring covered entities to limit uses, disclosures, and requests for protected health information to the least amount reasonably needed to accomplish the intended purpose, such as a pharmacist confirming benefits coverage.

The state agency within the Department of Health's Division of Health Related Boards that licenses pharmacists, registers technicians, permits pharmacies, and investigates complaints and disciplines licensees under the Pharmacy Practice Act.

The Tennessee statute governing the practice of pharmacy, found in Title 63, Chapter 10 of the Tennessee Code. It defines pharmacy practice, sets licensing and permit requirements, and grants the Board of Pharmacy rulemaking authority.

The Tennessee pharmacist designated on a pharmacy's permit as responsible for the pharmacy's daily operation, recordkeeping, security, and compliance with state and federal law and Board rules.

Tennessee's prescription monitoring program. Dispensers must report controlled substance dispensing to the database, and practitioners are required to check it before prescribing or dispensing certain controlled substances, such as opioids and benzodiazepines.

Tennessee statute in Title 39, Chapter 17, Part 4 that establishes the state's own controlled substance schedules and criminal penalties. Tennessee schedules operate independently of, though generally similar to, the federal schedules.

A Tennessee prescription must include the patient's name and address, drug name, strength and quantity, directions for use, prescriber's name, address and DEA number when controlled, date issued, and authorized refills.

Tennessee requires the pharmacist or a supervised intern to offer counseling to the patient or caregiver at the time a prescription is dispensed, covering proper use, storage, and precautions. The patient may decline the offer.

A Board-required, ongoing program each Tennessee pharmacy must maintain to detect, analyze, and prevent medication errors and adverse events. Records of errors and corrective actions must be kept and made available to the Board.

A person registered with the Tennessee Board of Pharmacy who assists pharmacists with dispensing and related tasks under supervision. Registration requires a Board application, and technicians must work within Board-set ratios and permitted duties.

An out-of-state pharmacy that ships prescription drugs to patients in Tennessee must register with the Tennessee Board of Pharmacy and follow Tennessee labeling, counseling, and recordkeeping requirements in addition to its home-state rules.

A written agreement under which a Tennessee prescriber delegates limited authority to a pharmacist to initiate, modify, or discontinue drug therapy for specified patients, following documented protocols, patient monitoring, and communication requirements.

A standing order issued by Tennessee's chief medical officer that allows pharmacists to dispense naloxone to a person at risk of opioid overdose, or to a family member or caregiver, without an individual prescription.

Tennessee law allows pharmacists who complete required training and maintain certification to administer vaccines under a prescription or protocol, subject to age limits, documentation, and reporting requirements set by the Board.

Tennessee's Medicaid managed care program. Pharmacies must enroll as providers and submit claims through contracted managed care organizations, whose coverage rules and formularies may differ from commercial plans.

Tennessee law generally prohibits placing previously dispensed prescription drugs back into stock for resale. Such drugs may be accepted for destruction under Board rules and federal controlled substance destruction requirements.

Pharmacies that prepare sterile products must comply with Board rules and USP standards addressing facility design, environmental monitoring, personnel training and qualification, process validation, and assignment of beyond-use dates.