Current through Register Vol. 49, No. 18, September 16, 2024
PURPOSE: This amendment changes requirements related
to controlled substance registrations for separate locations of emergency
medical services vehicles to comply with the Protecting Patient Access to
Emergency Medications Act, which amended
21 U.S.C. section
823(j), effective November
17, 2017.
(1) Independent
Activities. The following eight groups of activities are deemed to be
independent of each other and require separate registration:
(A) Manufacturing controlled
substances;
(B) Distributing
controlled substances, except:
1. A dispenser
distributing less than 5% of the total combined dosage units of controlled
substances distributed and dispensed in a calendar year shall be exempt from
obtaining a separate registration for distributing;
2. A dispenser distributing more than 5% of
the total combined dosage units of controlled substances distributed and
dispensed in a calendar year must obtain a separate registration as a
distributor but shall be exempt from maintaining separate inventories under
19 CSR
30-1.042;
(C) Dispensing controlled substances listed
in Schedules II-V;
(D) Conducting
research and instructional activities with controlled substances listed in
Schedule I;
(E) Conducting research
with controlled substances listed in Schedules II-V;
(F) Conducting a narcotic treatment program
with narcotic controlled substances listed in Schedules II-V;
(G) Conducting instructional activities with
controlled substances listed in Schedules II-V;
(H) Importing controlled substances;
(I) Exporting controlled
substances;
(J) Conducting chemical
analysis with controlled substances listed in any schedule.
(2) No activity shall be conducted
with any controlled substance in any schedule not requested for and shown on
the current registration.
(3)
Separate Locations. A separate registration is required for each principal
place of business or professional practice at one (1) general physical location
where controlled substances are manufactured, distributed, or dispensed by a
person.
(A) For purposes of registration
only, the following locations shall be deemed not to be places where controlled
substances are manufactured, distributed, or dispensed:
1. A warehouse where controlled substances
are stored by or on behalf of a registered person, unless these substances are
distributed directly from the warehouse to registrants other than the
registered person or to persons not required to register;
2. An office used by agents of a registrant
where sales of controlled substances are solicited, made, or supervised but
which neither contains these substances (other than substances for display
purposes or lawful distribution as samples only) nor serves as a distribution
point for filling sales orders;
3.
An office used by a practitioner (who is registered at another location) where
controlled substances are prescribed but neither administered nor otherwise
dispensed as a regular part of the professional practice of the practitioner at
the office and where no supplies of controlled substances are
maintained;
4. A location on the
immediate or contiguous property of a hospital, provided that the location is
owned and operated by the hospital and controlled substances are not dispensed
for use away from the location;
5.
A separate location from a registered pre-hospital emergency medical service
location where an emergency vehicle is housed that does not have a permanent
location of operation; and
6. A
pre-hospital emergency medical service located outside the state of Missouri
that renders assistance to a pre-hospital emergency medical service located in
the state of Missouri under a mutual aid contract in the case of an emergency,
major catastrophe, or other unforeseen event that jeopardizes the ability of
the local Missouri pre-hospital emergency medical service to promptly
respond.
(B) A separate
registration is not required for each separate practice location for an
individual practitioner who has a temporary location
registration.
*Original authority: 195.195, RSMo 1957, amended 1971,
1989, 1993.
