19 CSR 30-1.048 - Records for Practitioners and Researchers
PURPOSE: This amendment will allow prescriptions for controlled substances to be transmitted electronically provided federal laws relating to electronic prescribing of controlled substances are followed.
PURPOSE: This rule sets requirements for record keeping for practitioners and researchers. It also sets requirements for the use of facsimile and electronic prescriptions.
(1) Each individual practitioner,
institutional practitioner and pharmacy shall maintain records with the
following information for each controlled substance received, maintained,
dispensed or disposed:
(A) The name of the
substance;
(B) Each finished form
(for example, ten milligram (10 mg) tablet or ten milligram (10 mg)
concentration per fluid ounce or milliliter) and the number of units or volume
of finished form in each commercial container (for example, 100 tablet bottle
or three milliliter (3 ml) vial);
(C) The number of commercial containers of
each finished form received from other persons, including the date of and
number of containers in each receipt and the name, address and registration
number of the person from whom the containers were received;
(D) The number of units or volume of the
finished form dispensed including the name and address of the person to whom it
was dispensed, the date of dispensing, the number of units or volume dispensed
and the written or typewritten name or initials of the individual who dispensed
or administered the substance;
(E)
The number of units or volume of the finished forms, commercial containers, or
both, disposed of in any other manner by the registrant, including the date and
manner of disposal and the quantity of the substance in finished form
disposed.
(2) Each
individual practitioner shall maintain a record of the date, full name and
address of the patient, the drug name, strength, dosage form and quantity for
all controlled substances prescribed or administered. This record may be
maintained in the patient's medical record. When the controlled substance
record is maintained in the patient's medical record and the practitioner is
not the custodian of the medical record, the practitioner shall make the
controlled substance record available as required in
19 CSR
30-1.041 and
19 CSR
30-1.044.
(3) Individual practitioners shall maintain
the records listed in subsections (1)(A)-(E) of this rule separately from
patient medical records.
(4) A
registrant who transfers a controlled substance to or receives a controlled
substance from another registrant shall maintain a written record of the
transfer which contains the following information: the date of transfer, drug
name, strength, dosage form, quantity, name, address and registration number of
the transferring registrant and the name, address and registration number of
the receiving registrant.
(5) Drug
Enforcement Administration official order forms shall be used for transfers of
Schedule II controlled substances.
(6) A prescription may not be issued for an
individual practitioner to obtain controlled substances for dispensing or
administering to patients.
(7)
Prescriptions which are transmitted by facsimile to a pharmacy for dispensing
shall include the telephone number of the facsimile machine or computer from
which it is sent and the date and time of transmission. Immediately after a
Schedule III, IV or V prescription or a Schedule II prescription for a
long-term care facility patient or hospice patient or for a Schedule II
narcotic substance to be compounded for the direct administration to a patient
by parenteral, intravenous, intramuscular, subcutaneous or intraspinal infusion
is transmitted to a pharmacy by facsimile equipment, the practitioner or the
practitioner's agent shall sign and date the face of the prescription. The
prescriptions shall be maintained in chronological order separately from
patient medical records in a manner so each prescription is readily retrievable
for inspection at the transmitting practitioner's office. In the event the
facsimile is transmitted from a long-term care facility or hospital, the
prescription shall be maintained at the long-term care facility or hospital in
chronological order separately from the patient medical records in a manner so
each prescription is readily retrievable, or maintained in the patient medical
records.
(8) Any pharmacy receiving
a controlled substance prescription transmitted by facsimile equipment shall
maintain the facsimile copy of the prescription along with the date and time of
transmission and the telephone number of the facsimile machine from which it
originated, as a part of its original prescription records.
(9) The creation, signature, transmission,
and processing of controlled substance prescriptions electronically and record
keeping for electronic controlled substance prescriptions shall meet the
requirements of 21 CFR Parts 1300 to End, which are hereby incorporated by
reference in this rule as published April 1, 2014, by the Office of Federal
Register, National Archives and Records Administration, and are made available
to the public by the U.S. Government Printing Office, 732 N. Capitol Street N
W, Washington, D.C. 20401, or at www.gpoaccess.gov/cfr/. This rule does not
incorporate any subsequent amendments or additions.
Notes
*Original authority: 195.050, RSMo 1939, amended 1971, 1989 and 195.195, RSMo 1957, amended 1971, 1989, 1993.
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