19 CSR 30-1.048 - Records for Practitioners and Researchers

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

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

19 CSR 30-1.048
AUTHORITY: sections 195.050 and 195.195, RSMo 1994.* Original rule filed April 14, 2000, effective Nov. 30, 2000. Amended by Missouri Register June 15, 2015/Volume 40, Number 12, effective 7/31/2015

*Original authority: 195.050, RSMo 1939, amended 1971, 1989 and 195.195, RSMo 1957, amended 1971, 1989, 1993.

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