21 CFR 1.233 - Are there optional items included in the registration form?

Regulations last checked for updates: May 01, 2025

Title 21 - Food and Drugs last revised: Apr 28, 2025

§ 1.233 - Are there optional items included in the registration form?

Yes. FDA encourages, but does not require, you to submit items that are indicated as optional on the Form FDA 3537 that you submit.

[81 FR 45952, July 14, 2016]

authority: 15 U.S.C. 1333,1453,1454,1455,4402; 19 U.S.C. 1490,1491; 21 U.S.C. 321,331,332,333,334,335a,342,343,350c,350d,350j,352,355,360b,360ccc,360ccc-1,360ccc-2,362,371,374,381,382,384a,387,387a,387c,393,and; 42 U.S.C. 216,241,243,262,264,271

source: 42 FR 15553, Mar. 22, 1977, unless otherwise noted.

cite as: 21 CFR 1.233