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§1311.105. Requirements for obtaining an authentication credential—Individual practitioners. — Inbound Citations

21 C.F.R. § 1311.105

Cited by 4 regulations in release Current.

Citations to 21 C.F.R. § 1311.105 as a whole

  • (a) At each registered location where one or more individual practitioners wish to use an electronic prescription application meeting the requirements of this subpart to issue controlled substance prescriptions, the registrant(s) must designate at least two individuals to manage access control to the application. At least one of the designated individuals must be a registrant who is authorized to issue controlled substance prescriptions and who has obtained a two-factor authentication credential as provided in § 1311.105.
  • (a) An individual practitioner who has obtained a digital certificate as provided in § 1311.105 may digitally sign a controlled substance prescription using the private key associated with his digital certificate.

Citations to §1311.105(a)

  • (6) Draft NIST Special Publication 800-63-1, Electronic Authentication Guideline, December 8, 2008 (NIST SP 800-63-1); Burr, W. et al.; incorporation by reference approved for § 1311.105(a).
  • (b) An institutional practitioner that elects to conduct identity proofing must provide authorization to issue the authentication credentials to a separate entity within the institutional practitioner or to an outside credential Service provider or certification authority that meets the requirements of § 1311.105(a).