North Carolina § 90-113 - 73. Requirements for controlled substances reporting system; civil penalties for failure to properly report.

§ 90-113. 73. Requirements for controlled substances reporting system; civil penalties for failure to properly report.

The Department shall establish and maintain a reporting system of prescriptions for all Schedule II through V controlled substances. Each dispenser shall submit the information in accordance with transmission methods and frequency established by rule by the Commission. The Department may issue a waiver to a dispenser who is unable to submit prescription information by electronic means. The waiver may permit the dispenser to submit prescription information by paper form or other means, provided all information required of electronically submitted data is submitted. The dispenser shall report the information required under this section no later than the close of the next business day after the prescription is delivered; however, dispensers are encouraged to report the information no later than 24 hours after the prescription was delivered. The information shall be submitted in a format as determined annually by the Department based on the format used in the majority of the states operating a controlled substances reporting system. In the event the dispenser is unable to report the information within the time frame required by this section because the system is not operational or there is some other temporary electrical or technological failure, this inability shall be documented in the dispenser's records. Once the electrical or technological failure has been resolved, the dispenser shall promptly report the information. The Commission shall adopt rules requiring dispensers to report the following information. The Commission may modify these requirements as necessary to carry out the purposes of this Article. The dispenser shall report: The dispenser's DEA number. The name of the patient for whom the controlled substance is being dispensed, and the patient's: Full address, including city, state, and zip code. Telephone number. Date of birth. The date the prescription was written. The date the prescription was filled. The prescription number. Whether the prescription is new or a refill. Metric quantity of the dispensed drug. Estimated days of supply of dispensed drug, if provided to the dispenser. National Drug Code of dispensed drug. Prescriber's DEA number. Prescriber's national provider identification number, for any prescriber that has a national provider identification number. A pharmacy shall not be subject to a civil penalty under subsection (e) of this section for failure to report the prescriber's national provider identification number when it is not received by the pharmacy. Method of payment for the prescription. A dispenser shall not be required to report instances in which a controlled substance is provided directly to the ultimate user and the quantity provided does not exceed a 48-hour supply. A dispenser shall not be required to report instances in which a Schedule V non-narcotic, non-anorectic Schedule V controlled substance is provided directly to the ultimate user for the purpose of assessing a therapeutic response when prescribed according to indications approved by the United States Food and Drug Administration. The Department shall assess, against any pharmacy that employs dispensers found to have failed to report information in the manner required by this section within a reasonable period of time after being informed by the Department that the required information is missing or incomplete, a civil penalty of not more than one hundred dollars ($100.00) for a first violation, two hundred fifty dollars ($250.00) for a second violation, and five hundred dollars ($500.00) for each subsequent violation if the pharmacy fails to report as required under this section, up to a maximum of five thousand dollars ($5,000) per pharmacy per calendar year. Each day of a continuing violation shall constitute a separate violation. A pharmacy acting in good faith that attempts to report the information required by this section shall not be assessed any civil penalty. The clear proceeds of penalties assessed under this section shall be deposited to the Civil Penalty and Forfeiture Fund in accordance with Article 31A of Chapter 115C of the General Statutes. The Commission shall adopt rules to implement this subsection that include factors to be considered in determining the amount of the penalty to be assessed. For purposes of this section, a "dispenser" includes a person licensed to practice veterinary medicine pursuant to Article 11 of Chapter 90 of the General Statutes when that person dispenses any Schedule II through V controlled substances. Notwithstanding subsection (b) of this section, the Commission shall adopt rules requiring the information to be reported by a person licensed to practice veterinary medicine pursuant to Article 11 of Chapter 90 of the General Statutes. Expired pursuant to Session Laws 2018-76, s. 10, effective October 1, 2019. History (2005-276, s. 10.36(a); 2005-345, s. 17; 2009-438, s. 1; 2013-152, s. 2; 2014-115, s. 41.5; 2017-74, s. 10; 2018-44, s. 10; 2018-76, ss. 6, 10.) Editor's Note. - Session Laws 2013-152, s. 6, made the amendment to this section by Session Laws 2013-152, s. 2, applicable to prescriptions delivered on or after January 1, 2014. Session Laws 2015-241, s. 12F.16(h) and (i)(3), as amended by Session Laws 2017-74, s. 13(a) and (b), each provide: "The Department of Health and Human Services, Division of Mental Health, Developmental Disabilities, and Substance Abuse Services, shall continue to work toward establishing interstate connectivity for the Controlled Substances Reporting System established under G.S. 90-113.73 ." Session Laws 2017-74, provides in its preamble: "Whereas, the General Assembly recognizes the substantial impact the nationwide opioid epidemic continues to have on the State of North Carolina; and "Whereas, North Carolina has seen a 442% increase in overdose deaths caused by commonly prescribed opioids between 1999 and 2015; and "Whereas, the General Assembly fully recognizes the appropriate use of opioids in the treatment of acute and chronic pain; Now, therefore," Session Laws 2017-74, s. 1, provides: "This act shall be known and may be cited as the 'Strengthen Opioid Misuse Prevention Act of 2017' or the 'STOP Act.'" Session Laws 2017-74, s, 14, provides: "The Department of Health and Human Services shall conduct a study, in consultation with the Office of the Attorney General and the North Carolina Veterinary Medical Board, on how to implement the provisions of this act pertaining to electronic prescriptions and the submission of data to the Controlled Substances Reporting System as they relate to the practice of veterinary medicine. The Department shall submit a report to the Joint Legislative Oversight Committee on Health and Human Services no later than February 1, 2018." Session Laws 2018-44, s. 1, provides: "This act shall be known and may be cited as "The Heroin and Opioid Prevention and Enforcement (HOPE) Act of 2018." Session Laws 2018-44, s. 16, is a severability clause. Session Laws 2018-76, s. 10, provides, in part: "G.S. 90-113.73(g), as enacted by Section 6 of this act, expires effective October 1, 2019." Effect of Amendments. - Session Laws 2005-345, s. 17, effective July 1, 2005, deleted "for Health Services" following "The Commission" in the introductory paragraph of subsection (b). Session Laws 2009-438, s. 1, effective August 7, 2009, added the language following "twice monthly thereafter" in subsection (a). Session Laws 2013-152, s. 2, effective January 1, 2014, in subsection (a), substituted "who" for "that" in the third sentence, rewrote the fifth sentence, which read: "The dispenser shall report the information required under this section on a monthly basis for the first 12 months of the Controlled Substances Reporting System's operation, and twice monthly thereafter, until January 2, 2010, at which time dispensers shall report no later than seven days after the prescription is dispensed in a format as determined annually by the Department based on the format used in the majority of the states operating a controlled substances reporting system" and added the last sentence; and added subdivision (b)(11) and subsection (c). For applicability, see Editor's note. Session Laws 2014-115, s. 41.5, effective August 11, 2014, added subsection (d). Session Laws 2017-74, s. 10, effective September 1, 2017, in subsection (a) substituted "the close of the next business day after the prescription is delivered; however, dispensers are encouraged to report the information no later than 24 hours" for "the close of business three business days after the day when the prescription was delivered, beginning the next day after the delivery date; however, dispensers are encouraged to report the information no later than 24 hours" in the fifth sentence, added the last two sentences; and added subsection (e). Session Laws 2018-44, s. 10, effective September 1, 2018, added subdivision (b)(10a), and made minor stylistic changes throughout subdivision (b)(2). Session Laws 2018-76, s. 6, effective January 1, 2019, added subsections (f) and (g). For expiration of subsection (g), see editor's note.