---
kind: "section"
citation: "21 C.F.R. § 1311.140"
title: "21"
number: "1311.140"
heading: "Requirements for signing a controlled substance prescription."
url: "https://uscodex.org/cfr/21/1311.140"
---

# §1311.140. Requirements for signing a controlled substance prescription.

- (a) For a practitioner to sign an electronic prescription for a controlled substance the following must occur:
  - (1) The practitioner must access a list of one or more controlled substance prescriptions for a single patient. The list must display the information required by [§ 1311.120(b)(9)](/cfr/21/1311.120.md?p=b-9).
  - (2) The practitioner must indicate the prescriptions that are ready to be signed.
  - (3) While the prescription information required in [§ 1311.120(b)(9)](/cfr/21/1311.120.md?p=b-9) is displayed, the following statement or its substantial equivalent is displayed: “By completing the two-factor authentication protocol at this time, you are legally signing the prescription(s) and authorizing the transmission of the above information to the pharmacy for dispensing. The two-factor authentication protocol may only be completed by the practitioner whose name and DEA registration number appear above.”
  - (4) While the prescription information required in [§ 1311.120(b)(9)](/cfr/21/1311.120.md?p=b-9) and the statement required by [paragraph (a)(3)](#a-3) of this section remain displayed, the practitioner must be prompted to complete the two-factor authentication protocol.
  - (5) The completion by the practitioner of the two-factor authentication protocol in the manner provided in [paragraph (a)(4)](#a-4) of this section will constitute the signing of the prescription by the practitioner for purposes of § [1306.05(a)](/cfr/21/1306.05.md?p=a) and [(e)](/cfr/21/1306.05.md?p=e) of this chapter.
  - (6) Except as provided under [§ 1311.145](/cfr/21/1311.145.md), the practitioner's completion of the two-factor authentication protocol must cause the application to digitally sign and electronically archive the information required under [part 1306](/cfr/21/part1306.md) of this chapter.
- (b) The electronic prescription application must clearly label as the signing function the function that prompts the practitioner to execute the two-factor authentication protocol using his credential.
- (c) Any prescription not signed in the manner required by this section shall not be transmitted.

## Notes

### Source

Source: 75 FR 16310, Mar. 31, 2010, unless otherwise noted.

### Authority

Authority: 21 U.S.C. 821, 828, 829, 871(b), 958(e), 965, unless otherwise noted.

### Source

Source: 70 FR 16915, Apr. 1, 2005, unless otherwise noted.