Rules & Regulations of the State of Tennessee Title 1140 - Pharmacy
Tennessee Code - Title 1140: Pharmacy outlines the rules and regulations that govern the practice of pharmacy in Tennessee. These regulations ensure that pharmacists, pharmacies, and other healthcare professionals involved in dispensing medications comply with state laws that protect public health and safety. Below are some important cases and provisions under Title 1140, broken down in detail:
1. Dispensing Medications (Rule 1140-07-.01)
Pharmacists in Tennessee must adhere to specific rules when dispensing medications. This includes verifying the validity of prescriptions, ensuring the proper dosage, and accurately labeling the medication. A violation of these rules could lead to disciplinary action by the Tennessee Board of Pharmacy.
Example Case: A pharmacist dispenses a controlled substance medication without verifying the prescription’s authenticity. In this case, if the pharmacist fails to ensure that the prescription was written by a licensed practitioner, they could face penalties ranging from fines to license suspension or revocation. It’s essential that pharmacists conduct due diligence to prevent the dispensing of drugs without valid prescriptions.
2. Record-Keeping and Maintenance of Records (Rule 1140-10-.01)
Under Tennessee regulations, pharmacies are required to maintain detailed records of all prescription drugs dispensed. These records must include the patient’s name, the prescription details, and the drug dispensed, and should be stored for a specific number of years for inspection purposes.
Example Case: A pharmacy fails to retain records for a prescription that was dispensed for a controlled substance. During an audit, it is discovered that the pharmacy cannot produce the required documentation, potentially resulting in severe consequences such as fines, mandatory audits, or suspension of the pharmacy's license.
3. Controlled Substances - Handling and Dispensing (Rule 1140-03-.01)
Tennessee has specific rules for the handling and dispensing of controlled substances, which are categorized into five schedules based on their potential for abuse. Pharmacies must adhere strictly to these regulations to prevent misuse and ensure controlled substances are dispensed appropriately.
Example Case: A pharmacist dispenses a prescription for a Schedule II controlled substance (such as oxycodone) without properly verifying the identity of the person picking up the prescription. If the pharmacist does not follow protocol, they could be subject to penalties and the pharmacy could lose the ability to dispense controlled substances. Additionally, if there are repeat violations, the pharmacist could face criminal charges.
4. Pharmacy Technician Supervision (Rule 1140-05-.01)
Pharmacy technicians in Tennessee can assist pharmacists with tasks such as dispensing medications, but they must work under the supervision of a licensed pharmacist. Tennessee regulations specify the level of supervision required, which varies depending on the task and the experience of the technician.
Example Case: A pharmacy technician works independently and dispenses medications without direct supervision or oversight from a licensed pharmacist. This is a violation of the regulations, and the pharmacy could face penalties for failure to properly supervise its staff. In some cases, the technician may also face disciplinary action, including the suspension of their license.
5. Prescription Drug Monitoring Program (PDMP) (Rule 1140-04-.01)
Tennessee requires pharmacists and prescribers to check the state’s Prescription Drug Monitoring Program (PDMP) before dispensing controlled substances. This is designed to track prescriptions and prevent "doctor shopping" where individuals try to obtain multiple prescriptions for the same drug from different providers.
Example Case: A pharmacist fails to check the PDMP before dispensing a prescription for a Schedule IV controlled substance (like Xanax). The individual picking up the prescription is a known "doctor shopper" and has been obtaining the same drug from multiple providers. Since the pharmacist did not perform the required check, the pharmacy could face penalties, including fines or suspension of the pharmacist’s license.
6. Prescription Transfers (Rule 1140-10-.02)
In Tennessee, transferring prescriptions from one pharmacy to another is governed by strict regulations. For non-controlled substances, transfers are generally allowed as long as both pharmacies comply with state law. However, for controlled substances, specific rules apply to prevent abuse and misuse.
Example Case: A patient requests a transfer of a prescription for a controlled substance (like a Schedule III drug). The transferring pharmacy fails to comply with the strict rules surrounding controlled substance transfers, which could include verifying that the receiving pharmacy is legally able to dispense that substance. The pharmacist responsible for the error could be subject to disciplinary actions.
7. Immunizations by Pharmacists (Rule 1140-08-.01)
Pharmacists in Tennessee are authorized to administer certain vaccinations, such as flu shots, under specific guidelines. To do this, pharmacists must undergo additional training and comply with state requirements, including maintaining patient records and providing necessary documentation to the patient's healthcare provider.
Example Case: A pharmacist administers a flu shot to a patient who has a contraindication for the vaccine (e.g., an allergy to eggs), and the pharmacist does not review the patient's medical history thoroughly. If an adverse reaction occurs, the pharmacist could be liable for failing to properly screen the patient and could face penalties for not adhering to proper vaccine administration protocols.
8. Drug Waste Disposal (Rule 1140-10-.03)
Pharmacies are required to follow strict guidelines for the disposal of pharmaceutical waste. This is critical to prevent environmental damage and misuse of expired or unused drugs. Pharmacies must ensure that controlled substances are disposed of properly, following both state and federal regulations.
Example Case: A pharmacy disposes of expired medications by simply throwing them in the trash, without taking proper precautions. If a government agency discovers the improper disposal, the pharmacy could face significant fines or be forced to suspend operations until compliance is ensured.
9. Unauthorized Practice of Pharmacy (Rule 1140-03-.05)
The practice of pharmacy in Tennessee is strictly regulated. Only licensed pharmacists and pharmacy technicians are authorized to perform certain tasks, such as dispensing medications or providing pharmaceutical advice. Engaging in the unauthorized practice of pharmacy is a serious offense.
Example Case: An individual without a pharmacy license operates a "pharmacy" and dispenses medications or advises patients about drugs. This is illegal under Tennessee law, and the person could face criminal charges, along with significant fines. The establishment could also be shut down for violating state regulations.
10. Advertising and Promotion of Pharmacy Services (Rule 1140-10-.04)
Pharmacies in Tennessee must ensure that their advertising practices are truthful and not misleading. This includes advertisements for prescription drugs, vaccinations, or other pharmacy services. Any form of false or deceptive advertising can result in disciplinary actions from the Board of Pharmacy.
Example Case: A pharmacy advertises a "cure-all" drug on social media, claiming it can treat conditions that it is not approved for by the FDA. If the Board of Pharmacy investigates and finds the claims misleading or unsubstantiated, the pharmacy could face a fine or a suspension of its license until compliance is achieved.
These cases represent a broad range of issues that pharmacists in Tennessee may face when adhering to the state’s pharmacy regulations. Violations of these rules can result in significant penalties, including fines, suspension, or revocation of a pharmacy or pharmacist’s license. It’s crucial for all pharmacy professionals to stay up to date with these rules and ensure that they are operating in compliance with the law.
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