PURPOSE: This rule sets requirements for record keeping for individual practitioners and researchers. It also sets requirements for the use of facsimile and electronic computer transmission of controlled substance prescriptions.

1. (1) Each individual practitioner, institutional practitioner and pharmacy shall maintain records with the following information for each controlled substance received, maintained, dispensed or disposed:

   1. (A) The name of the substance;
   2. (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);
   3. (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;
   4. (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;
   5. (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. (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. (3) Individual practitioners shall maintain the records listed in subsections (1)(A)–(E) of this rule separately from patient medical records.
4. (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. (5) Drug Enforcement Administration official order forms shall be used for transfers of Schedule II controlled substances.
6. (6) A prescription may not be issued for an individual practitioner to obtain controlled substances for dispensing or administering to patients.
7. (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. (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. (9) Any practitioner or practitioner’s agent who transmits a controlled substance prescription by electronic computer transmission shall maintain a printout of each day’s transmissions. The practitioner or practitioner’s agent shall verify that the information in the printout is correct and shall sign the printout.
10. (10) Each pharmacist who dispenses controlled substances under a prescription transmitted by electronic computer transmission, shall verify with the practitioner within 30 days of the filling such prescription that the prescription was authorized by the practitioner. If verification is made by telephone, the pharmacist shall document the verification on the reverse of the prescription or in the computer. If verification is made by sending the practitioner a copy of a computer printout, the practitioner shall verify, sign and return the printout to the pharmacy. The pharmacy shall maintain the verified printout in a separate file.

AUTHORITY: sections 195.050 and 195.195, RSMo 1994.* Original rule filed April 14, 2000, effective Nov. 30, 2000. *Original authority: 195.050, RSMo 1939, amended 1971, 1989 and 195.195, RSMo 1957, amended 1971, 1989, 1993.