Missouri Code of State Regulations
Title 19 - DEPARTMENT OF HEALTH AND SENIOR SERVICES
Division 30 - Division of Regulation and Licensure
Chapter 1 - Controlled Substances
Section 19 CSR 30-1.034 - Security for Practitioners
Universal Citation: 19 MO Code of State Regs 30-1.034
Current through Register Vol. 49, No. 18, September 16, 2024
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.
*Original authority: 195.195, RSMo 1957, amended 1971, 1989, 1993.
Disclaimer: These regulations may not be the most recent version. Missouri may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the state site. Please check official sources.
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