21 CFR §1311.305
Verified against eCFR.gov as of June 20, 2026View official text on eCFR.gov ↗
- (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.