§1311.145. Digitally signing the prescription with the individual practitioner's private key. — Inbound Citations
21 C.F.R. § 1311.145
Statutory Authority
Cited by 2 regulations in release Current.
Citations to 21 C.F.R. § 1311.145 as a whole
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(15) When the practitioner uses his two-factor authentication credential as specified in § 1311.140(a)(4), the electronic prescription application must digitally sign at least the information required by part 1306 of this chapter and electronically archive the digitally signed record. If the practitioner signs the prescription with his own private key, as provided in § 1311.145, the electronic prescription application must electronically archive a copy of the digitally signed record, but need not apply the application's digital signature to the record.
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(6) Except as provided under § 1311.145, 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 of this chapter.