for Nonpractitioners

PURPOSE: This rule describes specific actions required of nonpractitioner registrants to maintain effective security. PUBLISHER’S NOTE: The secretary of state has determined that the publication of the entire text of the material which is incorporated by reference as a portion of this rule would be unduly cumbersome or expensive. This material as incorporated by reference in this rule shall be maintained by the agency at its headquarters and shall be made available to the public for inspection and copying at no more than the actual cost of reproduction. This note applies only to the reference material. The entire text of the rule is printed here. (1) Before distributing a controlled substance to any person who the registrant does not know to be registered to possess the controlled substance, the registrant shall make a good faith inquiry either with the federal Drug Enforcement Administration (DEA) or with the Department of Health and Senior Services to determine that the person is registered to possess the controlled substance. (2) The registrant shall design and operate a system to disclose to the registrant suspicious orders of controlled substances. The registrant shall inform the Department of Health and Senior Services of suspicious orders when discovered by the registrant. Suspicious orders include orders of unusual size, orders deviating substantially from a normal pattern and orders of unusual frequency. (3) The registrant shall notify the Department of Health and Senior Services of any theft or significant loss of any controlled substances upon discovery of this theft or loss. (A) The registrant shall complete and submit a Report of Loss, Theft or Diversion of Controlled Substances or Regulated Chemicals to the Department of Health and Senior Services no later than seven (7) business days after the discovery of such a loss. If the extent of the loss cannot be fully determined in that time frame, the registrant shall contact the Department of Health and Senior Services to request permission to submit an interim report and arrange for a complete report to be completed and submitted. The registrant may attach a copy of a completed Drug Enforcement Administration Loss Form in lieu of completing the back or second page of a Report of Loss, Theft or Diversion of Controlled Substances or Regulated Chemicals form. In the event of theft, diversion or suspected theft or diversion, the report submitted to the Department of Health and Senior Services shall be accompanied by or followed by a summary of the internal investigation performed, the outcome of the investigation, and a copy of any law enforcement agency report completed if applicable. (B) If an insignificant amount of a controlled substance is lost during lawful activities authorized under Chapter 195, RSMo, the reason for the loss or a description of what occurred, the name of the drug and the amount lost shall be documented in writing, signed by the registrant and attached or filed with the last completed annual inventory. (4) The registrant shall not distribute any controlled substance as a complimentary sample to any potential or current customer without the prior written request of the customer, to be used only for satisfying the legitimate medical needs of patients of the customer and only in reasonable quantities. The request must contain the name, address and registration number of the customer and the name of the specific controlled substance desired. The request shall be preserved by the registrant with other records of distribution of controlled substances. In addition, the requirements for order forms shall be complied with for any distribution of a controlled substance listed in Schedule I or II. (5) Entities registered with the Department of Health and Senior Services as distributors shall be deemed to have met security requirements for storage of Schedule V controlled substance drug products containing ephedrine or pseudoephedrine if those products are stored in compliance and consistent with the regulated chemicals requirements set forth by the United States Drug Enforcement Administration and 21 CFR 1309.71 which is hereby incorporated by reference in this rule, as published on April 1, 2005 by the U.S. Government Printing Office, U.S. Superintendent of Documents, Washington, DC 20402-001; www.gpoaccess.gov/cfr/retrieve.html. This rule does not incorporate any subsequent amendments or additions. Distributors will be required to conduct background checks on employees with access to these substances and to report losses of controlled substances as required in 19 CSR 30-1.034. AUTHORITY: sections 195.017, RSMo Supp. 2005 and 195.195, RSMo 2000.* Original rule filed April 14, 2000, effective Nov. 30, 2000. Emergency amendment filed Aug. 18, 2005, effective Aug. 28, 2005, expired Feb. 23, 2006. Amended: Filed Sept. 1, 2005, effective Feb. 28, 2006. *Original authority: 195.017, RSMo 1971, amended 1987, 1989, 1994, 1996, 1997, 1998, 2001, 2005 and 195.195, RSMo 1957, amended 1971, 1989, 1993.