For electronic prescription applications, what must the third-party auditor or certification organization determine?
A. For electronic prescription applications, the third-party auditor or certification organization must make the following determinations: • If the information required in 21 C.F.R. 1306.05(a), the indication that the prescription was signed as required by 21 C.F.R. 1311.120(b)(17) or the digital signature created by the practitioner’s private key, if transmitted, and the number of refills as required by 21 C.F.R. 1306.22, cannot be consistently and accurately recorded, stored, and transmitted, the third-party auditor or certification organization must indicate that the application does not meet DEA’s requirements. • If other information required by 21 C.F.R. parts 1300 to 1321 cannot be consistently and accurately recorded, stored, and transmitted, the third-party auditor or certification organization must indicate that the application has failed to meet the requirements for the specific information and should not be used to create, sign, and transmit prescriptions that require the ad
Related Questions
- What do we do regarding the electronic signature if our mission or organization usually prepares applications for staff?
- Where are DEA’s specific requirements for electronic prescription applications and pharmacy applications found?
- For pharmacy applications, what must the third-party auditor or certification organization determine?
