---
kind: "section"
citation: "21 C.F.R. § 1311.100"
title: "21"
number: "1311.100"
heading: "General."
url: "https://uscodex.org/cfr/21/1311.100"
---

# §1311.100. General.

- (a) This subpart addresses the requirements that must be met to issue and process Schedule II, III, IV, and V controlled substance prescriptions electronically.
- (b) A practitioner may issue a prescription for a Schedule II, III, IV, or V controlled substance electronically if all of the following conditions are met:
  - (1) The practitioner is registered as an individual practitioner or exempt from the requirement of registration under [part 1301](/cfr/21/part1301.md) of this chapter and is authorized under the registration or exemption to dispense the controlled substance;
  - (2) The practitioner uses an electronic prescription application that meets all of the applicable requirements of this subpart; and
  - (3) **The prescription is otherwise in conformity with the requirements of the Act and this chapter.**
- (c) An electronic prescription for a Schedule II, III, IV, or V controlled substance created using an electronic prescription application that does not meet the requirements of this subpart is not a valid prescription, as that term is defined in [§ 1300.03](/cfr/21/1300.03.md) of this chapter.
- (d) A controlled substance prescription created using an electronic prescription application that meets the requirements of this subpart is not a valid prescription if any of the functions required under this subpart were disabled when the prescription was indicated as ready for signature and signed.
- (e) A registered pharmacy may process electronic prescriptions for controlled substances only if all of the following conditions are met:
  - (1) The pharmacy uses a pharmacy application that meets all of the applicable requirements of this subpart; and
  - (2) **The prescription is otherwise in conformity with the requirements of the Act and this chapter.**
- (f) Nothing in this part alters the responsibilities of the practitioner and pharmacy, specified in [part 1306](/cfr/21/part1306.md) of this chapter, to ensure the validity of a controlled substance prescription.

## 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.