yourstate.us
21 CFR 11.300

§ 11.300 Controls for identification codes/passwords.

United States · 21 CFR — Food and Drugs · Status: effective

Get this as JSONEmbed this
Cite this
Citation
21 CFR 11.300, § 11.300 Controls for identification codes/passwords, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/83092
Permanent ID
ys:prov:83092@1
SHA-256
f8bf9ff5dda4f59dcb272826520589dcf5c62edb9dacee2e3449cc4a0cc32ce3

The hash is SHA-256 of this version's text, with every run of whitespace collapsed to a single space and the ends trimmed. The ID always leads back here, and checking it says whether the text you cited is still the current version.

Full text

Persons who use electronic signatures based upon use of identification codes in combination with passwords shall employ controls to ensure their security and integrity. Such controls shall include: (a) Maintaining the uniqueness of each combined identification code and password, such that no two individuals have the same combination of identification code and password. (b) Ensuring that identification code and password issuances are periodically checked, recalled, or revised (e.g., to cover such events as password aging). (c) Following loss management procedures to electronically deauthorize lost, stolen, missing, or otherwise potentially compromised tokens, cards, and other devices that bear or generate identification code or password information, and to issue temporary or permanent replacements using suitable, rigorous controls. (d) Use of transaction safeguards to prevent unauthorized use of passwords and/or identification codes, and to detect and report in an immediate and urgent manner any attempts at their unauthorized use to the system security unit, and, as appropriate, to organizational management. (e) Initial and periodic testing of devices, such as tokens or cards, that bear or generate identification code or password information to ensure that they function properly and have not been altered in an unauthorized manner.

Legislative history

This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.