§ 207.3 - Bulk drug substance.

Latest version.

§ 207.3 Bulk drug substance.
Bulk drug substance, as referenced in sections 503A(b)(1)(A) and 503B(a)(2) of the Federal Food, Drug, and Cosmetic Act, previously defined in § 207.3(a)(4), means the same as “active pharmaceutical ingredient” as defined in § 207.1(b). .
[81 FR 60212, Aug. 31, 2016, as amended at 86 FR 17061, Apr. 1, 2021]

                    
                        var val = document.getElementById('citecontent').innerHTML;
                        art.dialog.defaults.title = window.location.href;
                        art.dialog.data('cite', val);
                        art.dialog.data('homeDemoPath', '/Scripts/plus/artDialog/');
                        art.dialog.open('/Scripts/plus/artDialog/citeiframe.html');

§ 207.3 - Bulk drug substance.

§ 207.3 Bulk drug substance.