21 CFR 211.111 - Time limitations on production.

Regulations last checked for updates: Feb 11, 2026

Title 21 - Food and Drugs last revised: Dec 18, 2026

View all text of Subpart F [§ 211.100 - § 211.115]

§ 211.111 - Time limitations on production.

When appropriate, time limits for the completion of each phase of production shall be established to assure the quality of the drug product. Deviation from established time limits may be acceptable if such deviation does not compromise the quality of the drug product. Such deviation shall be justified and documented.

authority: 21 U.S.C. 321,351,352,355,360b,360ddd,360ddd-1,371,374; 42 U.S.C. 216,262,263a,264

source: 43 FR 45077, Sept. 29, 1978, unless otherwise noted.

cite as: 21 CFR 211.111