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Board of Pharmacy

Legislative Updates

Legislative Updates:Current through July 1, 2009

Board Specific Updates

Public Chapter 228

Chapter 228 of the 2009 Public Acts provides that each practice site (prescriber's office or pharmacy that are required to report to the database) where a controlled substance is dispensed shall provide electronic access to the controlled substance monitoring database. Failure to comply may result in a one hundred dollar ($100.00) civil penalty for each day of continued violation where there is a continued pattern or practice of not providing electronic access to the database. A dispenser of controlled drugs (prescriber's, prescriber's office, pharmacist or pharmacy) shall not be subject to a civil suit or held civilly liable for failure to check the database or for actions taken after reasonable reliance on the database information.

 Public Chapter 1035
Tamper Resistant Prescription Paper

Tennessee Code Annotated, 63-3-127 governing Podiatrists, 63-5-122 governing Dentists, 63-6-236 governing Medical Doctors, 63-7-123(b)(3) governing Nurse Practitioners, 63-8-126 governing Optometrists, 63-9-116 governing Osteopathic Physicians and 63-19-107(2)(E) governing Physician Assistants are amended to add: All handwritten, typed or computer-generated prescription orders must be issued on tamper-resistant prescription paper which meets the current Centers for Medicare and Medicaid Service Guidance to State Medicaid Directors…and meets or exceeds specific TennCare requirements for tamper-resistant prescription paper. This legislation is a result of a federal law/mandate intended to reduce fraud and abuse.

All prescriptions for TennCare patients must be written using tamper resistant pads/paper. Exceptions are prescriptions sent to the pharmacy electronically, prescriptions communicated to the pharmacy by telephone and drugs administered in nursing facilities. The provisions of this act with respect to TennCare prescriptions shall take effect October 1, 2008 in compliance with federal requirements. The provisions of this act with respect to non-TennCare related prescriptions shall take effect July 1, 2009.

On October 1, 2008 prescriptions will be required to have a minimum of one feature from each of the following three CMS categories: 1) Industry-recognized feature(s) designed to prevent unauthorized copying. An example is paper that shows the word “Void” or “Illegal” if the prescription is photocopied. 2) Industry-recognized features(s) designed to prevent erasure or modification of information written by the prescriber. This may be uniform non-white background color or quantity check off boxes with refill indicator.  3) Industry-recognized feature(s) designed to prevent use of counterfeit prescription forms. Security features and descriptions are listed on prescriptions (required by TennCare tamper-resistant pads after October 1, 2008) or a heat sensing imprint, which causes the imprint to disappear if someone touches the imprint or design.

Prescribers who ordinarily transmit prescriptions via e-prescribe of fax will need a supply of tamper-resistant pads if they prescribe controlled substances since these prescriptions may not be transmitted electronically at this time.

The complete Public Act, including provisions for any areas of exemption; enforcement of the Act; and action to be taken for violations of the Act, is available on the following Web site: tennessee.gov/sos/index.htm

This law is effective October 1, 2008 in respect to TennCare prescriptions and July 1, 2009 for non-TennCare related prescriptions.

Public Chapter 936
Improving Patient Safety through Medication Use Prescription Labeling Act of 2008

Adds TCA 53-10-110:
Any person dispensing a legend drug for an elder person shall include on the label of the container in which the legend drug is dispensed the indication for which the drug is being prescribed if requested by the prescriber, patient or patient's caregiver and the prescriber, patient or patient's caregiver provides the indication or indications to the person dispensing the legend drug. For purposes of this section, "elder person" means any person who is sixty (60) years of age or older.

Public Chapter 298
CONTROLLED DRUGS RECLASSIFICATION

Public Chapter 298 primarily corrects some discrepancies between Tennessee law listing Schedules for controlled substances compared to the DEA Schedules for the same drugs or chemicals. Some of the listed drugs have had their Schedule changed in recent years by the DEA, however they had not be reclassified in Tennessee law. Although individual states may place a drug into a more restrictive Schedule than DEA, states do not have the authority to be less restrictive than DEA. The language of this Act brings Tennessee in line with DEA classifications. Some of the more frequently encountered drugs affected are listed below along with their common trade names.

  • Gamma hydroxybutyric acid (GHB) is classified by DEA as a Schedule I, however in Tennessee law it was still listed as a Schedule IV. PC 298 brought TN in line with DEA.
  • Glutethimide (Doriden) is classified by DEA as a Schedule II however TN still listed as Schedule III. PC 298 now matches DEA and Glutethimide (Doriden) is Schedule II.
  • Buprenophine (Suboxone or Subutex) is a DEA Schedule III, however TN had it listed as Schedule V. PC 298 changed it to a Schedule III in TN.
  • Some other changes for consistency include Dichloralphenazone (Midrin), Zaleplon (Sonata), Zopiclone (Lunesta), Butorphanol (Stadol), Fencamfamin (Reactivan), Fenproporex (Gacilin or Solvolip), Mefenorex (Pondonil), Modafinil (Provigil), and Sibutramine (Meridia) being listed as Schedule IV in TN to match DEA.
  • Of interest in veterinary medicine, Carfentanil (Wildnil) is now classified as Schedule II which is consistent with DEA classification. The combination drug tiletamine-zolazepam (Telazol) is now listed as Schedule III in both TN and DEA.

The complete text of the Public Act, including provisions for any areas of exemption; enforcement of the Act; and action to be taken for violations of the Act, is available at tennessee.gov/sos/acts/index.htm

Public Chapter 224
NEW GUIDELINES FOR PHARMACY BENEFIT MANAGERS

Public Chapter 224 places new requirements on pharmacy benefits managers (PBM’s). These include setting standards for when an audit may be performed, how it is to be performed, recoupment calculations and appeals processes. It also requires PBM’s to update reimbursement prices no less than every three business days.

PBM’s shall give written notice of an audit at least two weeks in advance. An audit shall not be conducted during the first seven calendar days of any month unless consented to by the pharmacy or pharmacist. Any audit involving clinical or professional judgment must be conducted in consultation with a pharmacist who has knowledge of TCA 63-10. An audit shall not use the accounting practice of extrapolation in calculating recoupments or penalties. Each PBM must establish an appeals process for unfavorable audits. Recoupment of disputed funds shall only occur after final disposition of the audit, including the appeal process.

The complete text of the Public Act, including provisions for any areas of exemption; enforcement of the Act; and action to be taken for violations of the Act, is available at tennessee.gov/sos/acts/index.htm

This law is effective July 1, 2007.

Public Chapter 370
SUBSTITUTION OF ANTI-EPILEPTIC DRUGS

Public Chapter 370 adds a new requirement relative to dispensing of anti-epileptic drugs for epilepsy or seizure patients. It requires notification to the patient or patient's representative before interchanging manufacturers of an anti-epileptic drug if the patient's seizures or epilepsy is currently being controlled on a dosage regimen from a specific manufacturer. The prescriber must also be notified.

This law does not apply to prescriptions dispensed for inpatients of a hospital, a nursing home or an assisted care living facility, or inpatients or residents of a mental health hospital or residential facility.

The complete text of the Public Act, including provisions for any areas of exemption; enforcement of the Act; and action to be taken for violations of the Act, is available at tennessee.gov/sos/acts/index.htm

This law is effective July 1, 2007.

Public Chapter 446
POSTING INFORMATION RELATIVE TO VICTIMS OF ABUSE, NEGLECT OR EXPLOITATION

Effective July 1, 2007, all pharmacies licensed by the State of Tennessee Board of Pharmacy shall post a sign(s) in their main public entrance containing the following information:

  1. The statewide toll-free number of the Tennessee Division of Adult Protective Services (APS), 1-888-APS-TENN (1-888-277-8366), the number for the local district attorney’s office and a statement that a person of advanced age who may be the victim of abuse, neglect, or exploitation may seek assistance or file a complaint with the APS Division concerning such; and,
  2. A statement that any person, regardless of age, who may be a victim of domestic violence may call the nationwide domestic violence hotline, 1-800-799-SAFE (7233) or 1-800-787-3224 (TTY), for immediate assistance, with the hotline number printed in boldface type; and,
  3. A statement that a teen involved in a relationship that includes dating violence may also call the national toll-free domestic violence hotline or the national teen dating abuse helpline, 1-866-331-9474, for immediate assistance.

You may choose to post this information on separate signs or combine it into one sign. Should you choose to post separate signs, the information in Item one (1) must be on a sign no smaller than eleven inches (11”) in width and seventeen inches (17”) in height. The information in Items two (2) and three (3) must be on signs no smaller than eight and one-half inches (8½”) in width and eleven inches (11”) in height.

Should you choose to combine all of this information into one sign, it must be at least eight and one half inches (8½”) in width and fourteen inches (14”) in height.

Toll-Free Hotline Numbers Sign (place link here). If you wish to have a copy of this statement mailed to you, please contact the State of Tennessee Board of Pharmacy toll-free at 1 800 778 4123 or 1-615-741-2718 to request the Toll-Free Hotline Numbers Notice.

The complete text of the Public act, including provisions for any areas of exemption; enforcement of the Act; and action to be taken for violations of the Act, is available at tennessee.gov/sos/acts/index.htm This law is effective July 1, 2007.

Updates Applicable to All Boards

Public Chapter 513
Domestic Abuse Reporting

This public chapter requires the Department of Health to undertake a statewide campaign to remind all health care providers of their duty to report domestic abuse. Any licensed health care practitioner who knows, or has reasonable cause to suspect, that a patient's injuries, whether or not such injuries cause a patient's death, are the result of domestic violence or domestic abuse, shall report to the department of health, office of health statistics, on a monthly basis. Health care practitioners, in active status, can report suspected domestic abuse via the Domestic Violence Reporting System. Note: the name of the victim of domestic violence is never reported!

If you are a health care practitioner, in active status, and would like instructions on how to make a report please call (615) 741-1954 or E-mail DomesticViolence.Health@tn.gov

This Public Chapter became effective on July 1, 2009.

Public Chapter 581
Voluntary Provision of Health Care Services

Chapter 581 of the 2009 Public Acts provides that a person licensed by any of the health related boards who provides voluntary health care services to a patient of a sponsoring organization shall not be civilly liable for any act or omission in rendering these services, unless the act or omission constitutes gross negligence or willful misconduct.

This Public Chapter became effective on July 1, 2009.

Public Chapter 425
Health Care Liability

This public chapter revises provisions governing notice that must be given by any person asserting a potential claim for medical malpractice to each health care provider against whom the claim is being made; revises provisions governing certificate of good faith that must be filed.

This Public Chapter became effective on July 1, 2009.

Public Chapter 1060
Child Abuse Reporting

Public Chapter 1060 provides immunity from civil and criminal liability for reporting abuse of children by a health care examiner when there is harm or reason to believe there is a mandate to report. No immunity is provided for reports by perpetrators of harm to children.

The complete Public Act, including provisions for any areas of exemption; enforcement of the Act; and action to be taken for violations of the Act, is available on the following Web site: tennessee.gov/sos/index.htm

This law is effective July 1, 2008

Public Chapter 83
Mandatory Domestic Violence Reporting

Health care practitioners shall report cases of suspected or confirmed domestic violence to the Tennessee Department of Health. The system was operational in October 2007 and requires certain data to be reported using the reporting tool located on the Department of Health website.

The complete text of the Public Act, including provisions for any areas of exemption; enforcement of the Act; and action to be taken for violations of the Act, is available on the following website: tennessee.gov/sos/acts/index.htm

Public Chapter 410
Non-Smoker Protection Act

Public Chapter 410 creates the Non-Smoker Protection Act which prohibits smoking in all enclosed public places within the State of Tennessee including, but not limited to, the following places:

(2) “Areas available to and customarily used by the general public in businesses and non-profit entities patronized by the public including, but not limited to, banks, Laundromats, factories, professional offices, and retail service establishments; and

(7) “Health care facilities”. (Nursing homes and long-term care facilities are exempted)

The legislation requires offices and health care facilities to do the following:

  • Inform all existing employees and any prospective employees upon their application for employment of the prohibition on smoking; and
  • “No Smoking” signs or the international “No Smoking” symbol, shall be clearly and conspicuously posted at every entrance to every public place and place of employment where smoking is prohibited.

The Department of Health, shall while an establishment is undergoing otherwise mandated inspections, inspect for compliance with this Act. Information about these inspections will be communicated with the appropriate offices and/or health care facilities in the future.

The complete text of the Public Act, including provisions for any areas of exemption; enforcement of the Act; and action to be taken for violations of the Act, is available on the following website:tennessee.gov/sos/acts/index.htm

Public Chapter 529
Prohibition of Employment of Illegal Aliens

If the Commissioner of Labor and Workforce Development receives a complaint that a person, licensed by a state regulatory board, knowingly employs, recruits or refers for a fee for employment an illegal alien, that person is subject to an investigation and contested case hearing.

If there is proof a person knowingly employed, recruited or referred for a fee for employment, an illegal alien, which occurred while acting within the scope of practice of his/her license, the regulatory board will be required to revoke, suspend, or deny the person’s license.

For the first violation, the regulatory board will be required to suspend the person’s license until they show they no longer employ, recruit or refer for a fee for employment, an illegal alien. This can be made by the person filing a sworn statement that they no longer employ illegal aliens.

If a second violation occurs within three (3) years from the first order, the regulatory agency will be required to suspend the person’s license for one (1) year.

The complete text of the Public Act, including provisions for any areas of exemption; enforcement of the Act; and action to be taken for violations of the Act, is available on the following website: tennessee.gov/sos/acts/index.htm.

The act shall take effect January 1, 2008

Public Chapter 1190
Long Term Care

The long term care system shall recognize that aging is not a disease, but rather a natural process that often includes increasing needs for assistance with daily living activities. To the maximum extent possible and appropriate, the system shall be based on a model of care delivery which acknowledges that services delivered in the home and community-based settings are not primarily medical in nature, but rather, support services that will provide needed assistance with activities of daily living and that will allow persons to "age in place" in their homes and communities.

The complete text of the Public Act, including provisions for any areas of exemption; enforcement of the Act; and action to be taken for violations of the Act, is available on the following website: Tennessee.gov/sos/acts/index.htm

Public Chapter 864
Restroom Access Act

PC 864 requires any place of business that is open to the general public for the sale of goods or services ("retail establishment") that has an employee toilet facility to allow a customer to use such facility during normal business hours, if:

  1. The customer requesting the use of the employee toilet facility suffers from a medical condition that requires immediate access to a toilet facility or utilizes an ostomy device; the customer must present the employee with proof of an eligible medical condition, such as a document issued by a licensed medical provider;
  2. Three or more employees of the retail establishment are working at the time of the request;
  3. There is not a restroom available for public use in the retail establishment or otherwise immediately accessible to the customer; and
  4. The employee toilet facility is not located in an area that poses an obvious safety or security risk.

This bill provides immunity from civil damages to any retail establishment or an employee of a retail establishment for any act or omission in allowing a customer to use an employee toilet facility that is not a public restroom if the act or omission:

  1. Is not willful or grossly negligent;
  2. Occurs in an area that is not accessible to the public; and
  3. Results in an injury to or death of the customer or any individual other than an employee accompanying the customer.

This bill does not require any retail establishment to make any physical changes to an employee toilet facility. Any retail establishment or employee of a retail establishment that does not comply with the toilet facility access requirements of this bill commits a Class C misdemeanor punishable only by a fine of up to $50.


Statutes and Rules

Statutes

LexisNexis Law (off site)

LexisNexis Law publishes the Tennessee Code Annotated. This is the only company authorized to publish Tennessee Consumer Laws on the Internet. Follow the directions below on how to use LexisNexis.

§ Title - Chapter - Part
Pharmacy Practice § 63 - 10 - 201
Board of Pharmacy § 63 - 10 - 301

Once you have entered LexisNexis Law web site, on the left side of the page, next to Tennessee Code, change the plus sign to a negative sign by clicking on the plus sign. Then scroll down to the bottom of the page and click on the plus sign next to "More…" again changing the plus sign to a negative sign. Continue scrolling down and click on the plus sign next to Title "XX" you want to preview (For you convenience we have listed some of the most popular Titles and Chapters above). Finally, scroll down and click on the plus sign next to the specific Chapter "XX" you want to preview. Highlight the actual words of that Chapter by clicking on it and the law will displayed on the right side of the page for you to review.

To print the Law; on the left side of the page, click in the box next to Chapter "XX", a check mark will display in the box. If you change the plus sign to a negative sign by clicking on the plus sign next to Chapter "XX" you will notice check marks in all the documents below that Chapter, which means you have chosen to print all the Parts within the Chapter. If you only want to print a certain document, place a check mark on that Part only. For example, to print the Beauty Pageants Law, Bonded Credit Services Law or Health Clubs Law only, on the left side of the page, click in the box next to their specific Part "XX" listed under Chapter 18. Then go to the top of the right side of the page and click on Print. This will print only the documents chosen in the table of contents. Click Here to go to LexisNexis Law website.

 

 

Rules

Click here for Rules and Regulations pertaining to the Tennessee Board of Pharmacy

Policies

Policies

No information on Policy Statements is available at this time