19 CSR 30-1.026 - Separate Registrations

Current through Register Vol. 47, No. 7, April 1, 2022

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.

Notes

19 CSR 30-1.026
AUTHORITY: section 195.195, RSMo 1994.* Original rule filed April 14, 2000, effective Nov. 30, 2000. Amended by Missouri Register March 15, 2021/Volume 46, Number 06, effective 4/30/2021

*Original authority: 195.195, RSMo 1957, amended 1971, 1989, 1993.

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