Questions and Answers
What is the minimum retention period for electronic prescription records?
Which of the following must be true about records regarding controlled substances?
What capability must an electronic prescription application have regarding records?
What is a requirement for electronic prescription records when transmitted and received?
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What must happen if longer retention periods are mandated by other laws?
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How must electronic copies of prescription records be organized?
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Where can the computers that maintain electronic prescription records be located?
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What must be true for electronic records to be compliant with federal regulations?
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Study Notes
Electronic Prescription Records Regulations
- All records associated with electronically created, signed, transmitted, and received prescriptions must be retained electronically according to 21 CFR 1311.305(a).
Record Retention Requirements
- Electronic records must be maintained for a minimum of two years from their creation or receipt, as specified in 21 CFR 1311.305(b).
- Record retention may be extended if federal or state laws require longer retention periods for pharmacists or pharmacies.
Accessibility and Retrieval of Records
- Records of controlled substances must be easily retrievable from other records to ensure quick access, per 21 CFR 1311.305(c).
- Electronic records must be readable or convertible into an understandable format for any individual.
Compliance with Specific Regulations
- Electronic prescriptions for controlled substances must adhere to 21 CFR Part 1311 and 21 CFR 1304.04(h)(5).
- Records can be maintained on computers at different locations, but must be retrievable at the registered location upon request by DEA or law enforcement.
Record Organization and Format
- The electronic application managing these records must allow printing or transferring records in a format understandable to law enforcement.
- Electronic copies of prescription records should be sortable by prescriber name, patient name, drug dispensed, and date filled, ensuring efficient access and organization.
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Description
Test your knowledge on the regulations governing electronic prescription records. This quiz covers key aspects such as record retention requirements and compliance guidelines as outlined in 21 CFR 1311.305(a). Perfect for professionals in healthcare and pharmacy settings.
