---
kind: "section"
citation: "21 C.F.R. § 1311.210"
title: "21"
number: "1311.210"
heading: "Archiving the initial record."
url: "https://uscodex.org/cfr/21/1311.210"
---

# §1311.210. Archiving the initial record.

- (a) Except as provided in [paragraph (c)](#c) of this section, a copy of each electronic controlled substance prescription record that a pharmacy receives must be digitally signed by one of the following:
  - (1) The last intermediary transmitting the record to the pharmacy must digitally sign the prescription immediately prior to transmission to the pharmacy.
  - (2) The first pharmacy application that receives the electronic prescription must digitally sign the prescription immediately on receipt.
- (b) If the last intermediary digitally signs the record, it must forward the digitally signed copy to the pharmacy.
- (c) If a pharmacy receives a digitally signed prescription that includes the individual practitioner's digital signature, the pharmacy application must do the following:
  - (1) Verify the digital signature as provided in FIPS 186-3, as incorporated by reference in [§ 1311.08](/cfr/21/1311.08.md).
  - (2) Check the validity of the certificate holder's digital certificate by checking the certificate revocation list. The pharmacy may cache the CRL until it expires.
  - (3) **Archive the digitally signed record.** The pharmacy record must retain an indication that the prescription was verified upon receipt. No additional digital signature is required.

## 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.