Tennessee enforces specific laws for legend drugs—prescription medications requiring authorization from a licensed healthcare provider. These regulations aim to ensure public safety and prevent misuse. This article outlines Tennessee’s approach to legend drug regulation.
Statutory Classification
In Tennessee, legend drugs are defined and classified under state law, linking to federal standards. Tennessee Code Annotated 53-10-101 defines a legend drug as any medication that, under the Federal Food, Drug, and Cosmetic Act, requires a label stating “Rx only,” “Caution: Federal law prohibits dispensing without prescription,” or “Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian.”1Justia Law. Tennessee Code § 53-10-101 (2024) – ‘Legend Drugs’ Defined
This classification means these drugs have a potential for harm if used without medical supervision. The state designates medications as legend drugs because their use requires professional medical judgment. The Tennessee Board of Pharmacy and other health-related boards enforce these laws to protect public health.
Prescribing Rules
Rules for prescribing legend drugs in Tennessee ensure their appropriate and safe use under qualified healthcare professionals. The authority to prescribe is limited to specific licensed practitioners, including:
- Physicians
- Osteopathic physicians
- Dentists
- Podiatrists
- Optometrists (with limitations)
- Veterinarians
- Advanced practice registered nurses (APRNs) and physician assistants (PAs) with required supervision and protocols.
Tennessee law and licensing board rules require specific information for a legend drug prescription to be valid. A prescription must include:
- Prescriber’s name, signature, and contact information
- Patient’s name and address
- Date of issuance
- Name, strength, and dosage form of the drug
- Directions for use
- Quantity prescribed
For Advanced Practice Registered Nurses (APRNs) and Physician Assistants (PAs), the name of their supervising physician may also be required.
Prescriptions can be transmitted in various ways. While written prescriptions are common, Tennessee Code Annotated 53-10-104 allows electronic transmission for legend drugs, if it meets federal and state laws for security and confidentiality.2Justia Law. Tennessee Code § 53-10-104 (2024) – Selling, Bartering, Giving Away or Obtaining Legend Drugs
Dispensing Obligations
After a legend drug is prescribed, the pharmacist is responsible for its safe and accurate dispensing. Pharmacists must review prescriptions for authenticity, completeness, and appropriateness. Under Tennessee Board of Pharmacy Rule 1140-03-.01, this includes identifying potential issues like incorrect dosages, drug interactions, or signs of forgery.
Dispensing involves selecting and preparing the correct drug and strength. The process concludes with the physical transfer of the drug to the patient or their representative.
Pharmacies must keep accurate records of all dispensed prescriptions. Tennessee law and Board of Pharmacy rules, like Rule 1140-01-.11, require these records to be kept for at least two years from the last dispensing date. These records must include:
- Prescription number
- Date of dispensing
- Identity of the dispensing pharmacist
- Quantity dispensed
- Details of the prescriber and patient
Labeling and Storage
Tennessee law requires specific labeling for legend drugs to ensure patient safety and clear usage information. The label on a legend drug container communicates important details. According to Tennessee Board of Pharmacy Rule 1140-01-.10, the label must include:
- Name and address of the pharmacy
- Serial number of the prescription
- Date the prescription was originally filled or refilled
- Name of the prescriber
- Name of the patient
- Directions for use
- Any cautionary statements as may be required by law
3Tennessee Secretary of State Publications. Tennessee Board of Pharmacy Rules, Chapter 1140-01 – General Rules Pertaining to Pharmacists, Pharmacies and Drugs
The drug’s name and strength are also usually required.
Directions for use must be unambiguous to prevent patient confusion and misuse. The label also serves as a quick reference for the patient and other healthcare providers.
Proper storage of legend drugs in pharmacies and other authorized entities is regulated to protect medication quality and prevent unauthorized access. Pharmacies must follow manufacturer or United States Pharmacopeia (USP) standards, considering temperature, light, and humidity. Tennessee Board of Pharmacy Rule 1140-02-.01 requires pharmacy drug storage areas to be well-lighted, ventilated, and kept at proper temperatures.4Legal Information Institute. Tenn. Comp. R. & Regs. 1140-02-.01 – Pharmacists and Pharmacy Interns
Secure storage for legend drugs is also important. Board Rule 1140-02-.01 mandates that pharmacies be secured against unauthorized entry when a pharmacist is not present. This involves physical security and protocols to restrict access to authorized personnel. This secure storage responsibility applies to any facility or practitioner authorized to handle legend drugs.
Penalties for Noncompliance
Not following Tennessee’s legend drug laws can lead to serious penalties, including criminal charges, civil fines, and professional disciplinary actions by licensing boards.
Violations can result in criminal prosecution. According to Tennessee Code Annotated 53-10-108, breaking legend drug laws is often a Class A misdemeanor.5Justia Law. Tennessee Code § 53-10-108 (2024) – Violation – Penalty This can mean up to 11 months and 29 days in jail, a fine up to $2,500, or both.6Justia Law. Tennessee Code § 40-35-111 (2024) – Authorized Terms of Imprisonment and Fines for Felonies and Misdemeanors Actions like illegal possession (Tennessee Code Annotated 53-10-105) or unlawful sale of legend drugs fall under these penalties.7Justia Law. Tennessee Code § 53-10-105 (2024) – Possession Without Prescription Unlawful More serious offenses, such as those involving large quantities or intent to distribute, can lead to felony charges. For instance, a Class E felony may result in one to six years in prison and a fine up to $3,000.
Licensed professionals and pharmacies can also face significant civil fines. Health-related boards, as authorized by Tennessee Code Annotated 63-1-120, can impose these fines.8Justia Law. Tennessee Code Title 63, Chapter 1, Part 1 (2024) – General Provisions The amount depends on the violation’s nature, severity, if it’s a repeat offense, and the risk to public harm. Fines can range from hundreds to thousands of dollars for issues like improper prescribing, dispensing errors, or poor record-keeping.
Healthcare professionals may face disciplinary actions from their licensing boards, from reprimands to license suspension or revocation. Boards such as the Tennessee Board of Pharmacy and the Board of Medical Examiners take action for violations like unprofessional conduct or breaking drug laws. For example, diverting legend drugs or prescribing outside legitimate medical practice can result in license revocation.