for Practitioners

PURPOSE: This rule describes specific actions required of practitioner registrants to maintain effective security. This rule also creates and defines the form which must be used by a registrant to report any theft or loss of controlled substances to the Department of Health. (1) Physical Security. (A) Controlled substances listed in Schedules I and II shall be stored in a securely locked, substantially constructed cabinet. (B) Controlled substances listed in Schedules III, IV and V shall be stored in a securely locked, substantially constructed cabinet. However, pharmacies may disperse these substances throughout the stock of noncontrolled substances in such a manner as to obstruct the theft or diversion of the controlled substances. (C) This rule also shall apply to nonpractitioners authorized to conduct research or chemical analysis under another registration. (2) Other Security. (A) The registrant shall not employ as an agent or employee who has access to controlled substances any person who has been found guilty or entered a plea of guilty or nolo contendere in a criminal prosecution under the laws of any state or of the United States for any offense related to controlled substances or who has had an application for a state or federal controlled substance registration denied or has had his/her registration revoked or surrendered for cause at any time. For purposes of this subsection, the term for cause means a surrender in place of or as a consequence of any federal or state administrative, civil or criminal action resulting from an investigation of the individual’s handling of controlled substances. 1. A registrant may apply in writing to the Department of Health and Senior Services for a waiver of subsection (2)(A) of this rule for a specific employee. 2. The Department of Health and Senior Services may issue a written waiver to any registrant upon determination that a waiver would be consistent with the public health and safety. In making this determination, the Department of Health and Senior Services shall consider—the duties of the employee, the circumstances surrounding the conviction, the length of time since the conviction was entered, whether a waiver has been granted by the federal Drug Enforcement Administration (DEA) pursuant to 21 CFR 1301.76, the security measures taken by the employer to prevent the theft and diversion of controlled substances, and any other factors consistent with public health and safety. (B) A registrant shall notify the Department of Health and Senior Services of the theft, diversion or significant loss of any controlled substances or regulated chemicals upon discovery. 1. The registrant shall complete and submit a report of the loss or diversion of controlled substances to the Department of Health and Senior Services no later than seven (7) business days after the discovery of such a loss. The loss report form shall contain the following information: name and address of registrant, business phone number; Missouri Controlled Substance Registration Number; federal Drug Enforcement Administration Registration number; date of theft or loss; date of discovery of theft or loss; county of location; principal type of registration such as M.D., D.O., D.P.M., O.D., D.V.M., D.D.S., D.M.D., A.N.P., emergency medical service, pharmacy, hospital, manufacturer, nursing home kit, narcotic treatment program, teaching institution, distributor, importer, exporter, or other specified business; whether or not the loss or theft was reported to law enforcement; the name and phone number of the law enforcement agency reported to; the number of losses or thefts the registrant has experienced in the past twenty-four (24) months; the type of loss or diversion such as, break in/burglary, robbery, employee theft, forged or falsified records, lost in transit, or other explained type of loss; if lost in transit, the name of the common carrier and name of consignee; the name(s) of the individual diverting controlled substances who was responsible for the theft or loss; copy of registrant’s internal investigative report involving the loss or theft; the full name, date of birth and Social Security number of the individual(s) responsible for the theft or diversion, if known; a copy of the police report if law enforcement was notified; if the loss or diversion was in transit, identify the origin of the delivery, the name of the carrier(s) used and the name of the consignee; a list of all controlled substances lost, stolen or diverted by their generic name, trade name, the dosage strength, dosage form and quantity; the signature of the person completing the loss report and their title and the date of their signature. 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 loss report form provided by the Department of Health and Senior Services. 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. 2. 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. AUTHORITY: section 195.195, RSMo 2000.* Original rule filed April 14, 2000, effective Nov. 30, 2000. Amended: Filed Jan. 31, 2003, effective July 30, 2003. *Original authority: 195.195, RSMo 1957, amended 1971, 1989, 1993.