21 CFR 1311.305 - Recordkeeping.

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§ 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.

Title 21 published on 2014-04-01

no entries appear in the Federal Register after this date.

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