(a) 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:

Terms Used In Tennessee Code 53-10-312

  • Board: means the board of pharmacy created by title 63, chapter 10, part 3. See Tennessee Code 53-10-302
  • Code: includes the Tennessee Code and all amendments and revisions to the code and all additions and supplements to the code. See Tennessee Code 1-3-105
  • Committee: means the controlled substance database committee created by §. See Tennessee Code 53-10-302
  • Controlled substances: means a drug, substance, or immediate precursor in Schedules I through VI defined or listed in the Tennessee Drug Control Act of 1989, compiled in title 39, chapter 17, part 4. See Tennessee Code 53-10-302
  • Discovery: Lawyers' examination, before trial, of facts and documents in possession of the opponents to help the lawyers prepare for trial.
  • Manufacturer: means any person, except a pharmacist compounding in the normal course of professional practice, engaged in the commercial production, preparation, propagation, conversion, or processing of a drug, either directly or indirectly, by extraction from substances of natural origin or independently by means of chemical synthesis, or both, and includes any packaging or repackaging of a drug or the labeling or relabeling of its container and the promotion and marketing of such drugs or devices. See Tennessee Code 53-10-302
(1) Wholesaler or manufacturer with a drug enforcement administration registration number; provided, that if this number is not applicable, then another mutually acceptable identifier;
(2) Purchaser’s drug enforcement administration registration number; provided, that if this number is not applicable, then another mutually acceptable identifier;
(3) National drug code number of the actual drug sold;
(4) Quantity of the drug sold;
(5) Date of sale; and
(6) Transaction identifier or invoice number.
(b) 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.
(c) 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.
(d) 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.
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