21 CFR 1311.200 - Pharmacy responsibilities.

§ 1311.200 Pharmacy responsibilities.
(a) Before initially using a pharmacy application to process controlled substance prescriptions, the pharmacy must determine that the third-party auditor or certification organization has found that the pharmacy application does the following accurately and consistently:
(1) Import, store, and display the information required for prescriptions under § 1306.05(a) of this chapter.
(2) Import, store, and display the indication of signing as required by § 1311.120(b)(17).
(3) Import, store, and display the number of refills as required by § 1306.22 of this chapter.
(4) Import, store, and verify the practitioner's digital signature, as provided in § 1311.210(c), where applicable.
(b) If the third-party auditor or certification organization has found that a pharmacy application does not accurately and consistently import, store, and display other information required for prescriptions under this chapter, the pharmacy must not process electronic prescriptions for controlled substances that are subject to the additional information requirements.
(c) If a pharmacy application provider notifies a pharmacy that a third-party audit or certification report indicates that the application or the application provider no longer meets the requirements of this part or notifies it that the application provider has identified an issue that makes the application non-compliant, the pharmacy must immediately cease to process controlled substance prescriptions using the application.
(d) A pharmacy that receives a notification that the pharmacy application is not in compliance with the requirements of this part must not use the application to process controlled substance prescriptions until it is notified that the application is again compliant and all relevant updates to the application have been installed.
(e) The pharmacy must determine which employees are authorized to enter information regarding the dispensing of controlled substance prescriptions and annotate or alter records of these prescriptions (to the extent such alterations are permitted under this chapter). The pharmacy must ensure that logical access controls in the pharmacy application are set so that only such employees are granted access to perform these functions.
(f) When a pharmacist fills a prescription in a manner that would require, under part 1306 of this chapter, the pharmacist to make a notation on the prescription if the prescription were a paper prescription, the pharmacist must make the same notation electronically when filling an electronic prescription and retain the annotation electronically in the prescription record or in linked files. When a prescription is received electronically, the prescription and all required annotations must be retained electronically.
(g) When a pharmacist receives a paper or oral prescription that indicates that it was originally transmitted electronically to the pharmacy, the pharmacist must check its records to ensure that the electronic version was not received and the prescription dispensed. If both prescriptions were received, the pharmacist must mark one as void.
(h) When a pharmacist receives a paper or oral prescription that indicates that it was originally transmitted electronically to another pharmacy, the pharmacist must check with that pharmacy to determine whether the prescription was received and dispensed. If the pharmacy that received the original electronic prescription had not dispensed the prescription, that pharmacy must mark the electronic version as void or canceled. If the pharmacy that received the original electronic prescription dispensed the prescription, the pharmacy with the paper version must not dispense the paper prescription and must mark the prescription as void.
(i) Nothing in this part relieves a pharmacy and pharmacist of the responsibility to dispense controlled substances only pursuant to a prescription issued for a legitimate medical purpose by a practitioner acting in the usual course of professional practice.

Title 21 published on 2013-04-01

no entries appear in the Federal Register after this date.

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