eCFR Reference Browser

---

title: "21 CFR §316.28"

source: "https://www.ecfr.gov/current/title-21/section-316.28"

title_number: "21"

volume_number: "5"

chapter_number: "Unknown"

subchapter_code: "D"

subchapter_subject: "DRUGS FOR HUMAN USE"

part_code: "316"

part_subject: "ORPHAN DRUGS"

subpart_code: "C"

subpart_subject: "Designation of an Orphan Drug"

section_number: "316.28"

section_subject: "Publication of orphan-drug designations."

cfr_reference: "21 CFR 316.28"

title_name: "Title 21"

title_subject: "Food and Drugs"

parts_covered: "Parts 300 to 499"

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"

---

Each month FDA will update a publicly available cumulative posting of all drugs designated as orphan drugs. These postings will contain the following information:

(a)The name and address of the sponsor;

(b)The generic name and trade name, if any, or, if neither is available, the chemical name or a meaningful descriptive name of the drug;

(c)The date of the granting of orphan-drug designation;

(d)The designated use in the rare disease or condition; and

(e)If the drug loses designation after August 12, 2013, the date of it no longer having designation.

§316.28 - Publication of orphan-drug designations.