---
kind: "section"
citation: "21 C.F.R. § 1311.305"
title: "21"
number: "1311.305"
heading: "Recordkeeping."
url: "https://uscodex.org/cfr/21/1311.305"
---

# §1311.305. Recordkeeping.

- (a) If a prescription is created, signed, transmitted, and received electronically, all records related to that prescription must be retained electronically.
- (b) Records required by this subpart must be maintained electronically for two years from the date of their creation or receipt. This record retention requirement shall not pre-empt any longer period of retention which may be required now or in the future, by any other Federal or State law or regulation, applicable to practitioners, pharmacists, or pharmacies.
- (c) Records regarding controlled substances prescriptions must be readily retrievable from all other records. Electronic records must be easily readable or easily rendered into a format that a person can read.
- (d) Records required by this part must be made available to the Administration upon request.
- (e) If an application service provider ceases to provide an electronic prescription application or an electronic pharmacy application or if a registrant ceases to use an application service provider, the application service provider must transfer any records subject to this part to the registrant in a format that the registrant's applications are capable of retrieving, displaying, and printing in a readable format.
- (f) If a registrant changes application providers, the registrant must ensure that any records subject to this part are migrated to the new application or are stored in a format that can be retrieved, displayed, and printed in a readable format.
- (g) If a registrant transfers its electronic prescription files to another registrant, both registrants must ensure that the records are migrated to the new application or are stored in a format that can be retrieved, displayed, and printed in a readable format.
- (h) Digitally signed prescription records must be transferred or migrated with the digital signature.

## Notes

### Source

Source: 75 FR 16310, Mar. 31, 2010, unless otherwise noted.

### Authority

Authority: 21 U.S.C. 821, 828, 829, 871(b), 958(e), 965, unless otherwise noted.

### Source

Source: 70 FR 16915, Apr. 1, 2005, unless otherwise noted.