Tennessee § 53-10-312 - Minimum reporting requirements for wholesalers and manufacturers — Establishment of rules as to reporting requirements.

§ 53-10-312. Minimum reporting requirements for wholesalers and manufacturers — Establishment of rules as to reporting requirements.

Wholesalers and manufacturers, as defined in § 63-10-204, that sell controlled substances at wholesale must at least report the following information to the committee in Automation of Reports and Consolidated Orders System (ARCOS) format or other mutually acceptable format: Wholesaler or manufacturer with a drug enforcement administration registration number; provided, that if this number is not applicable, then another mutually acceptable identifier; Purchaser's drug enforcement administration registration number; provided, that if this number is not applicable, then another mutually acceptable identifier; National drug code number of the actual drug sold; Quantity of the drug sold; Date of sale; and Transaction identifier or invoice number. The board may establish such rules as are necessary to specify which medications shall be reported, the time frames for such reporting, and other reporting requirements as required. A wholesaler shall design and operate a system to disclose to the wholesaler suspicious orders of controlled substances. A wholesaler shall inform the board of pharmacy and the boards whose licensees have prescribing authority of suspicious orders when discovered. Suspicious orders include orders of unusual size, orders deviating substantially from a normal pattern, and orders of unusual frequency. In the event of the discovery of the theft or significant loss of controlled substances, a wholesaler shall report such theft or significant loss to the committee and local law enforcement within one (1) business day of discovery of the theft or loss. Acts 2016, ch. 1002, § 12. Compiler's Notes. Former part 3, §§ 53-10-301 — 53-10-312 (Acts 2002, ch. 840, § 1; 2004, ch. 673, §§ 24-27; 2005, ch. 474, § 7; 2007, ch. 498, §§ 1-3; 2007, ch. 518, §§ 1-4; 2008, ch. 914, § 1; Acts 2009, ch. 228, § 1; 2011, ch. 310, §§ 1-5; 2012, ch. 575, § 1; 2012, ch. 880, §§ 1-21; 2012, ch. 915, § 1; 2012, ch. 924, §§ 1-5; 2013, ch. 236, § 50; 2013, ch. 430, §§ 3, 5, 6, 15; 2014, ch. 622, §§ 1, 2; 2014, ch. 791, §§ 1-6; 2014, ch. 983, § 2; 2014, ch. 1011, §§ 1, 2), concerning the Tennessee Prescription Safety Act of 2012, was repealed and reenacted by Acts 2016, ch. 1002, §§ 1-12, effective April 27, 2016. Acts 2016, ch. 1002, § 16 provided that notwithstanding this act or the Uniform Administrative Procedures Act, compiled in title 4, chapter 5, any rule promulgated to implement the provisions of this act shall be provided to the chairs of the health committee of the house of representatives and the health and welfare committee of the senate by the secretary of state, after approval by the attorney general and reporter, at the same time the text of the rule is made available to the government operations committees of the senate and the house of representatives for purposes of conducting the review required by § 4-5-226 in order for the health committee of the house of representatives and the health and welfare committee of the senate to be afforded the opportunity to comment on the rule. Effective Dates. Acts 2016, ch. 1002, § 17. April 27, 2016. Law Reviews. Defining the Opioid Crisis and the Limited Role of the Criminal Justice System Resolving It, 48 U. Mem. L. Rev. 1206 (Summer 2018).