eCFR Reference Browser

---

title: "21 CFR §1301.31"

source: "https://www.ecfr.gov/current/title-21/section-1301.31"

title_number: "21"

volume_number: "9"

chapter_number: "Unknown"

subchapter_code: "Unknown"

subchapter_subject: "Unknown"

part_code: "1301"

part_subject: "REGISTRATION OF MANUFACTURERS, DISTRIBUTORS, AND DISPENSERS OF CONTROLLED SUBSTANCES"

subpart_code: "A"

subpart_subject: "General Requirements"

section_number: "1301.31"

section_subject: "Administrative review generally."

cfr_reference: "21 CFR 1301.31"

title_name: "Title 21"

title_subject: "Food and Drugs"

parts_covered: "Part 1300 to End"

revised_date: "Revised as of April 1, 2019"

publication_date: "As of April 1, 2019"

contains_description: "Containing a codification of documents of general applicability and future effect"

publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"

---

The Administrator may inspect, or cause to be inspected, the establishment of an applicant or registrant, pursuant to subpart A of part 1316 of this chapter. The Administrator shall review the application for registration and other information gathered by the Administrator regarding an applicant in order to determine whether the applicable standards of section 303 (21 U.S.C. 823) or section 1008 (21 U.S.C. 958) of the Act have been met by the applicant.

§1301.31 - Administrative review generally.