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(a) An individual practitioner may sign and transmit electronic prescriptions for controlled substances provided the practitioner meets all of the following requirements:
(1) The practitioner must comply with all other requirements for issuing controlled substance prescriptions in this part;
(2) The practitioner must use an application that meets the requirements of part 1311 of this chapter; and
(3) The practitioner must comply with the requirements for practitioners in part 1311 of this chapter.
(b) A pharmacy may fill an electronically transmitted prescription for a controlled substance provided the pharmacy complies with all other requirements for filling controlled substance prescriptions in this part and with the requirements of part 1311 of this chapter.
(c) To annotate an electronic prescription, a pharmacist must include all of the information that this part requires in the prescription record.
(d) If the content of any of the information required under § 1306.05 for a controlled substance prescription is altered during the transmission, the prescription is deemed to be invalid and the pharmacy may not dispense the controlled substance.
(e) The transfer for initial dispensing of an electronic prescription for a controlled substance in Schedule II-V is permissible between retail pharmacies, upon request from the patient, on a one-time basis only. If the transferred prescription is for a controlled substance in Schedule III, IV, or V and includes authorized refills, the refills are transferred with the initial prescription to the pharmacy receiving the transfer.
(f) The transfer of an electronic prescription for a controlled substance in Schedule II-V between retail pharmacies for the purpose of initial dispensing is subject to the following requirements:
(1) The prescription must be transferred from one retail pharmacy to another retail pharmacy in its electronic form. At no time may an intermediary convert an electronic prescription to another form (e.g., facsimile) for transmission.
(2) The contents of the prescription required by this part must not be altered during transfer between retail pharmacies. Any change to the content during transfer, including truncation or removal of data, will render the electronic prescription invalid.
(3) The transfer must be communicated directly between two licensed pharmacists.
(4) The transferring pharmacist must add the following to the electronic prescription record:
(i) Information that the prescription has been transferred.
(ii) The name, address, and DEA registration number of the pharmacy to which the prescription was transferred and the name of the pharmacist receiving the prescription information.
(iii) The date of the transfer and the name of the pharmacist transferring the prescription information.
(5) The receiving pharmacist must do the following:
(i) Add the word "transfer" to the electronic prescription record at the receiving pharmacy.
(ii) Annotate the prescription record with the name, address, and DEA registration number of the pharmacy from which the prescription was transferred and the name of the pharmacist who transferred the prescription.
(iii) Record the date of the transfer and the name of the pharmacist receiving the prescription information.
(6) In lieu of manual data entry, the transferring or receiving pharmacy's prescription processing software may, if capable, capture the information required, as outlined in this paragraph (f), from the electronic prescription and automatically populate the corresponding data fields to document the transfer of an electronic controlled substance prescription between pharmacies. The transferring or receiving pharmacist, as applicable, must ensure that the populated information is complete and accurate.
(g) The transfer of an electronic prescription for a controlled substance in Schedule II-V for the purpose of initial dispensing is permissible only if allowable under existing State or other applicable law.
(h) The electronic records documenting the transfer of the electronic prescription must be maintained for a period of two years from the date of the transfer by both the pharmacy transferring the electronic prescription and the pharmacy receiving the electronic prescription.
(i) A pharmacy may transfer electronic prescription information for a controlled substance in Schedule III, IV, and V to another pharmacy for the purpose of refill dispensing pursuant to § 1306.25.
[75 FR 16307, Mar. 31, 2010, as amended at 88 FR 48379, July 27, 2023]
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