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Code · CFR · Title 21 — Food and Drugs · Part 1311 — Requirements for Electronic Orders and Prescriptions · § 1311.100

§ 1311.100. General.

293 words·~1 min read·/us/cfr/t21/s§ 1311.100·

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(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 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 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 of this chapter, to ensure the validity of a controlled substance prescription.
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