§1311.205. Pharmacy application requirements. — Inbound Citations

(c) As required by § 1311.205 of this chapter, a pharmacy that processes electronic prescriptions for controlled substances must use an application that retains the following:

(1) All of the information required under § 1304.22(c) and part 1306 of this chapter.

(2) The digitally signed record of the prescription as received as required by § 1311.210 of this chapter.

(3) The internal audit trail and any auditable event identified by the internal audit as required by § 1311.215 of this chapter.

(1) Federal Information Processing Standard Publication (FIPS PUB) 140-2, Change Notices (12-03-2002), Security Requirements for Cryptographic Modules, May 25, 2001 (FIPS 140-2) including Annexes A through D; incorporation by reference approved for §§ 1311.30(b), 1311.55(b), 1311.115(b), 1311.120(b), 1311.205(b).

(i) Approved Security Functions for FIPS PUB 140-2, Security Requirements for Cryptographic Modules, September 23, 2004.

(ii) Approved Protection Profiles for FIPS PUB 140-2, Security Requirements for Cryptographic Modules, November 4, 2004.

(iii) Approved Random Number Generators for FIPS PUB 140-2, Security Requirements for Cryptographic Modules, January 31, 2005.

(iv) Approved Key Establishment Techniques for FIPS PUB 140-2, Security Requirements for Cryptographic Modules, February 23, 2004.

(1) If the information required in § 1306.05(a) of this chapter, the indication that the prescription was signed as required by § 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 § 1306.22 of this chapter, cannot be consistently and accurately recorded, stored, and transmitted, the third-party auditor or certification organization must indicate that the application does not meet the requirements of this part.