Tennessee Pharmacists Association
Know the Rules

TennCare Cuts Restored
As a result of recent legislation, several new laws affecting pharmacy are in effect as of July 1, 2015. Here’s what you need to know to stay in compliance:

Diabetes Sales Tax:
Public Chapter 274 amends Tennessee Code Annotated Section 67-6-314(7) and exempts the sale of diabetic testing supplies from state and local tax, including any syringe used to dispense insulin for human use and diabetic testing supplies for human use, as well as lancets, test strips for blood glucose monitors, visual read test strips, and urine test strips.

What you need to know about this law:

  • Under the Durable Medical Equipment Act, glucometers used for diabetic testing are defined as durable medical equipment and are exempt from state and local tax pursuant to a prescription order.
  • Syringes used to dispense insulin for human use are also exempt from state and local tax.
  • Diabetes testing supplies for human use, including lancets, test strips for blood glucose monitors, visual read test strips, and urine test strips, are now exempt from state and local sales tax.

Pharmacy Drug Disposal:
Public Chapter 40 enacts the “Ensuring Patient Access to Pharmacy Drug Disposal Programs Act of 2015,” which authorizes pharmacies to voluntarily participate in pharmacy drug disposal programs.

What you need to know about this law:

  • Authorizes any Tennessee-licensed pharmacy located within the state to participate in a pharmacy drug disposal program that meets or exceeds the minimum requirements set forth in federal rules and regulations regarding collection and destruction of prescription drugs, including controlled and non-controlled substances.
  • Establishes that pharmacy participation in drug disposal programs is voluntary.
  • States that the pharmacist-in-charge is responsible for deciding whether the pharmacy participates in a pharmacy drug disposal program.
  • Protects the pharmacy practice site participating in the voluntary program from liability for theft, robbery, or other criminal activity related to its participation, assuming the program complies with applicable state and federal rules and regulations.

Addiction Treatment Act:
Public Chapter 396, the “Addiction Treatment Act,” was brought by the Tennessee Medical Association to provide protection and help for those who are suffering from the disease of addiction.

What you need to know about this law:

  • Provides Good Samaritan protections for an individual who is having a drug overdose or in good faith seeks medical assistance for a person experiencing or believed to be experiencing a drug overdose.
  • Limits the prescribing of buprenorphine/naloxone to a healthcare provider with a DEA X license and only in circumstances in which the FDA has approved the use of the drug.
  • Limits prescriptions for buprenorphine monotherapy or for buprenorphine without the use of naloxone for the treatment of substance use disorder to a patient who is either pregnant, a nursing mother, or has a documented history of an adverse reaction or hypersensitivity to naloxone.
  • Repeals a section of the code that allows an insurer to prohibit payment to a provider if the patient seeks treatment and it is determined that the patient is under the influence of alcohol or illegal drugs.

Pain Management Clinic Requirements:
Public Chapter 475 revises the requirements for medical directors and those participating in the operation of pain management clinics. Before this legislation was passed, any licensed physician could be the medical director of a pain management clinic.

What you need to know about this law:

  • Requires that medical directors of pain management clinics practice in Tennessee with an unrestricted, unencumbered license, and hold a specialty license in pain management on or after July 1, 2016.
  • Requires that the Commissioner of Health develop recommended treatment guidelines for prescribing opioids that can be used by prescribers in this state as a guide for caring for patients by January 1, 2016.
  • Requires that the Commissioner of Health develop recommended pain clinic standards for the operation of a pain management clinic that can be used by certified pain clinics in this state as a guide for operating a pain clinic by January 1, 2017.

Right to Try Act:
Public Chapter 376, the “Tennessee Right to Try Act,” allows Tennessee prescribers to prescribe, to select eligible patients, an investigational drug, biological product, or device that has successfully completed phase one of a clinical trial but has not yet been approved for general use by the FDA and remains under investigation in a clinical trial that is approved by the FDA.

What you need to know about this law:

  • A manufacturer of an investigational drug, biological product, or device may make available, and an eligible patient may request, the manufacturer’s investigational drug, biological product, or device. Patients will receive these investigational drugs, biological products, or devices directly from manufacturers, not through licensed pharmacies.
  • Patients with an advanced illness, which is a ‘progressive disease or medical or surgical condition that entails significant functional impairment, that is not considered by a treating physician to be reversible even with administration of current federal drug administration approved and available treatments, and that, without life-sustaining procedures, will soon result in death’, are allowed to request these medications.
  • Requires written, informed consent signed by the patient, the patient’s parent (if the patient is a minor), the patient’s legal guardian, or the patient’s attorney-in-fact designated by the patient, and attested to by the patient’s physician and a witness.

Federal FDA Track and Trace Requirements (Drug Supply Chain Security Act):

On November 27, 2013, the Drug Supply Chain Security Act (DSCSA) was signed into law. Section 202 of the DSCSA sets forth new definitions and requirements related to product tracing. Starting in 2015, trading partners (manufacturers, repackagers, wholesale distributors, and dispensers) are required to provide the subsequent purchaser with product tracing information, including transaction history, transaction information, and a transaction statement, for each transaction in which the dispenser transfers ownership of a product (but not including dispensing to a patient or returns). Trading partners are also required to capture and maintain the applicable product tracing information for not less than 6 years after the date of the transaction. Product tracing requirements are scheduled to take effect for all trading partners, including dispensers, on July 1, 2015.

Several national pharmacy organization partners, including the National Community Pharmacists Association (NCPA), American Pharmacists Association (APhA), and National Alliance of State Pharmacy Associations (NASPA), sent a joint letter to the Food and Drug Administration (FDA) on behalf of pharmacists and pharmacy members expressing concern that electronic dispensing systems used to exchange, capture, and maintain product tracing information will not be operational by July 1, 2015.

TPA staff members participated on a call with the FDA today regarding the implementation of the DSCSA, and the following information is being provided to assist you in complying with the requirements outlined in the DSCSA.

What you need to know:

  • FDA released the DSCSA Implementation: Product Tracing Requirements for Dispensers – Compliance Policy on June 30, 2015.
  • FDA recognizes that some dispensers may need additional time beyond July 1, 2015, to work with trading partners to ensure that the product tracing information required by the DSCSA is captured and maintained by dispensers.
  • FDA will delay any action against dispensers who accept ownership of product without receiving the product tracing information until November 1, 2015.
  • This compliance policy does not extend to transactions in which dispensers must provide the subsequent owner with product tracing information, including transaction history. If a dispenser has not received product tracing information prior to or at the time it takes ownership of a product, FDA recommends that the dispenser work with the previous owner to receive this information. The product tracing requirements do not apply to sales by a dispenser to another dispenser to fulfill a ‘specific patient need’ which is defined as the transfer of a product from one pharmacy to another to fill a prescription for an identified patient. Such term does not include the transfer of a product from one pharmacy to another for the purpose of increasing or replenishing stock in anticipation of a potential need.
  • This compliance policy also does not extend to the requirements that trading partners other than dispensers (i.e., manufacturers, wholesale distributors, and repackagers) provide product tracing information to dispensers.
  • For more information on the DSCSA, CLICK HERE.

TPA will continue to monitor the implementation of these and other state and federal laws and will provide members with additional information as it becomes available. For more detailed information regarding TPA’s activities during the Tennessee General Assembly 2015 legislative session, CLICK HERE.