Rules & Regulations of the State of Tennessee Title 1140 - Pharmacy
Tennessee Administrative Code - Title 1140: Pharmacy
Title 1140 of the Tennessee Administrative Code (TAC) pertains to the Board of Pharmacy and the practice of pharmacy in Tennessee. This title governs the operations of licensed pharmacists, pharmacies, and pharmaceutical service providers in the state. It establishes the rules and regulations that ensure pharmacies and pharmacists operate in a safe, ethical, and lawful manner to protect public health and safety.
The Tennessee Board of Pharmacy is the state agency responsible for regulating the practice of pharmacy in Tennessee, overseeing the licensure of pharmacists, and ensuring compliance with state and federal drug laws.
Overview of Title 1140 - Pharmacy
Title 1140 covers a broad range of issues related to pharmacy practice, including the licensing of pharmacists and pharmacies, the dispensing of medications, pharmaceutical education and training, regulations for controlled substances, and disciplinary actions against violators.
1. General Provisions
The general provisions of Title 1140 outline the legal framework and purpose of the Tennessee Board of Pharmacy's activities. This section sets forth the foundational rules and duties of the Board in regulating pharmacy practice within the state.
a. Authority and Purpose:
Establishment of the Board: Title 1140 is authorized by the Tennessee Pharmacy Practice Act, which grants the Board the authority to issue licenses, regulate pharmacy operations, and enforce rules governing pharmaceutical practice.
Protection of Public Health: The overall goal of Title 1140 is to protect the public by ensuring that drugs and pharmaceuticals are dispensed safely, ethically, and legally.
b. Definitions:
Terms related to pharmacy practice such as "pharmacy," "pharmacist," "prescription drug," "controlled substances," and others are clearly defined in Title 1140. These definitions help establish clear standards for all stakeholders in the pharmacy industry.
2. Licensure Requirements
Title 1140 includes detailed provisions related to the licensure of pharmacists and pharmacies in Tennessee. These rules set out the qualifications, examinations, and renewal procedures for individuals and establishments seeking to engage in the practice of pharmacy.
a. Pharmacist Licensure:
Requirements for Licensure: To become a licensed pharmacist in Tennessee, an individual must meet several key criteria:
Graduation from an accredited pharmacy school.
Successful completion of the North American Pharmacist Licensure Examination (NAPLEX).
Passing the Multistate Pharmacy Jurisprudence Examination (MPJE), which tests knowledge of state and federal pharmacy law.
Submission of an application, payment of fees, and passing a criminal background check.
Internship and Experience: Applicants must typically complete a required number of hours of pharmacy internship or practical experience in a clinical or retail setting.
License Renewal: Pharmacists must renew their licenses periodically (usually every 2 years). This process includes continuing education requirements to ensure that pharmacists stay up to date on new drugs, treatment protocols, and legal regulations.
b. Pharmacy Licensure:
Establishing a Pharmacy: In order to operate a pharmacy in Tennessee, the pharmacy must be licensed by the Board. The requirements for obtaining and renewing a pharmacy license include:
Submission of an application and payment of fees.
Compliance with physical and operational standards, including maintaining a secure facility.
Having a licensed pharmacist in charge of the pharmacy operations.
Pharmacy Technician Registration: Individuals who wish to work as pharmacy technicians must also be registered with the Board. The registration process includes completing an application and, in some cases, passing an examination.
3. Standards of Practice
Title 1140 establishes standards of practice for pharmacists and pharmacies to ensure that they provide safe and effective services. These standards include operational requirements, ethical conduct, and responsibilities of both pharmacists and pharmacy owners.
a. Pharmacist Responsibilities:
Patient Counseling: Pharmacists are required to offer counseling to patients receiving prescriptions. This counseling includes providing information about how to properly take medications, possible side effects, and potential interactions with other drugs.
Drug Dispensing: Pharmacists must dispense medications in accordance with prescriptions issued by licensed healthcare professionals and ensure that the medications are appropriate for the patient’s condition.
Record Keeping: Pharmacists are required to maintain accurate records of all prescriptions filled and dispensed, including patient information and drug details. These records must be kept for a specified period, often several years.
b. Pharmacy Operations:
Security: Pharmacies are required to maintain high levels of security, including secure storage for prescription drugs, particularly controlled substances.
Compliance with Federal Laws: Pharmacies must comply with federal drug regulations, including the Controlled Substances Act, and ensure that controlled substances are properly stored, dispensed, and documented.
Quality Assurance: Pharmacies must have systems in place to ensure the accuracy and safety of the medications they dispense. This includes checking prescriptions for potential errors, drug interactions, and patient-specific factors.
4. Controlled Substances and Drug Enforcement
Title 1140 contains important provisions regarding the handling of controlled substances. These substances are regulated under both state and federal law due to their potential for abuse and dependence.
a. Controlled Substances Schedules:
Controlled substances are categorized into schedules (Schedule I to V) based on their potential for abuse and medical use. Title 1140 outlines the specific rules for handling, dispensing, and distributing these drugs.
Prescription Requirements: Prescriptions for controlled substances must comply with specific requirements, such as the use of tamper-resistant prescription pads and restrictions on refills.
b. Dispensing of Controlled Substances:
Prescription Monitoring Program: Tennessee operates a Prescription Drug Monitoring Program (PDMP), which tracks the prescribing and dispensing of controlled substances. Pharmacies must report dispensed prescriptions to the PDMP to ensure that drugs are not being over-prescribed or abused.
Security Measures: Pharmacies must take steps to secure controlled substances to prevent theft or diversion, including maintaining strict control over the inventory and limiting access to authorized personnel.
5. Continuing Education
To maintain their licensure, pharmacists are required to complete continuing education (CE) to stay current with developments in the pharmaceutical field. Title 1140 establishes the number of CE hours that pharmacists must complete during each licensure period.
a. Requirements for Continuing Education:
Number of Hours: Pharmacists must complete a set number of CE hours (usually 30 hours every 2 years).
Approved Programs: CE programs must be approved by the Board or other recognized accrediting organizations. These programs can include topics such as new drug therapies, legal updates, and advances in pharmacy practice.
6. Disciplinary Actions and Enforcement
The Board has the authority to investigate complaints and take disciplinary actions against pharmacists and pharmacies that violate state laws, rules, or ethical standards.
a. Grounds for Disciplinary Action:
Negligence or Incompetence: Pharmacists and pharmacies may face disciplinary action for failing to provide appropriate care or for dispensing medications inappropriately.
Substance Abuse: If a pharmacist is found to be impaired due to alcohol or drug abuse, they may face disciplinary action or be required to undergo rehabilitation.
Fraud or Misrepresentation: Violations related to fraudulent activities, such as falsifying prescription records or engaging in deceptive billing practices, may result in penalties.
Failure to Comply with Continuing Education: Failure to meet CE requirements may lead to disciplinary measures, including suspension or revocation of the pharmacist’s license.
b. Penalties and Actions:
Reprimands or Fines: The Board may issue formal reprimands or impose fines for minor violations.
License Suspension or Revocation: In more severe cases, the Board may suspend or revoke a pharmacist’s or pharmacy’s license, preventing them from practicing or operating in Tennessee.
Probation: Pharmacists or pharmacies found guilty of violations may be placed on probation, requiring them to meet certain conditions before regaining full licensure.
7. Inspections and Audits
The Board may conduct inspections and audits of pharmacies to ensure compliance with state laws and regulations. These inspections can be routine or in response to specific complaints or concerns.
Inspection Criteria: Inspections typically cover the security and organization of the pharmacy, record-keeping practices, handling of controlled substances, and overall compliance with applicable laws and regulations.
Conclusion
Title 1140 of the Tennessee Administrative Code establishes comprehensive rules and regulations governing the practice of pharmacy in Tennessee. These regulations ensure that pharmacists, pharmacies, and pharmaceutical professionals in the state operate in a manner that protects public health, ensures the safety and accuracy of medications, and adheres to ethical and legal standards. By requiring rigorous licensure, continuing education, compliance with controlled substance regulations, and oversight through inspections and disciplinary actions, Title 1140 aims to maintain high standards in pharmacy practice and safeguard the well-being of the public.
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