Current through Register Vol. 49, No. 18, September 16, 2024
PURPOSE: This rule defines the record keeping and
inventory requirements for various classes of registrants.
(1) Persons Required to Keep Records.
(A) Each registrant shall maintain the
records and inventory required by
19 CSR
30-1.041-19 CSR
30-1.052, except as exempted by
19 CSR
30-1.041-19 CSR
30-1.052.
(B) Registered individual practitioners and
institutional practitioners are required to keep records with respect to
controlled substances which are prescribed, administered or
dispensed.
(C) A registered person
using any controlled substance in research conducted in conformity with an
exemption granted under section 505(i) or 512(j) of the federal Food, Drug and
Cosmetic Act (
21
U.S.C. 355(i) or
360(j)
) at a registered establishment which maintains records in accordance with
either of those sections is not required to keep records if s/he notifies the
Department of Health of the name, address and registration number of the
establishment maintaining these records.
(D) A registered person using any controlled
substance in preclinical research or in teaching at a registered establishment
which maintains records with respect to these substances is not required to
keep records if s/he notifies the Department of Health of the name, address and
registration number of the establishment maintaining the records.
(E) Notice required by subsection (1)(D) of
this rule shall be given at the time the person applies for registration or
re-registration and shall be made in the form of an attachment to the
application, which shall be filed with the application.
(2) Maintenance of Records and Inventories.
Every inventory and other record required to be kept under
19 CSR
30-1.041-19 CSR
30-1.052, shall be kept by the registrant and be
available, for at least two years from the date of the inventory or record, for
inspecting and copying by authorized employees of the Department of Health,
except that financial and shipping records (such as invoices and packing slips,
but not executed order forms) may be kept at a central location rather than at
the registered location if the registrant obtains from the Department of Health
approval of his/her central record keeping system and a permit to keep central
records. The permit to keep central records shall be subject to the following
conditions:
(A) The permit shall specify the
nature of the records to be kept centrally and the exact location where the
records will be kept;
(B) The
registrant agrees to deliver all or any part of these records to the registered
location within three working days of receipt of a written request from the
Department of Health for these records and if the Department of Health chooses
to do so in lieu of requiring delivery of records to the registered location,
to allow authorized employees of the Department of Health to inspect the
records at the central location upon request by the employees without a warrant
of any kind;
(C) The failure of the
registrant to perform his/her agreements under the permit shall revoke, without
further action, the permit and all other such permits held by the registrant
under other registrations. In the event of a revocation of other permits under
subsection (2)(C) of this rule, the registrant, within 30 days after the
revocation, shall comply with the requirement that all records be kept at the
registered location.
(3)
Each registered individual practitioner, institutional practitioner,
manufacturer, distributor, importer and exporter shall maintain inventories and
records of controlled substances as follows:
(A) Inventories and records of controlled
substances listed in Schedules I and II shall be maintained separately from all
of the records of the registrant;
(B) Inventories and records of controlled
substances listed in Schedules III, IV and V shall be maintained either
separately from all other records of the registrant or in a form that the
information required is readily retrievable from the ordinary business records
of the registrant.
(4)
Each registered pharmacy shall maintain the inventories and records of
controlled substances as follows:
(A)
Inventories and records of all controlled substances listed in Schedules I and
II shall be maintained separately from all other records of the pharmacy and
prescriptions for these substances shall be maintained in a separate
prescription file;
(B) Inventories
and records of controlled substances listed in Schedules III, IV and V shall be
maintained either separately from all other records of the pharmacy or in a
form that the information required is readily retrievable from ordinary
business records of the pharmacy and prescriptions for those substances shall
be maintained in a separate prescription file.
*Original authority: 195.030, RSMo 1939, amended 1971,
1989, 1993, 1997, 1999; 195.050, RSMo 1939, amended 1971, 1989; and 195.195,
RSMo 1957, amended 1971, 1989, 1993.
