Description
This guidance is intended to provide information for those using radioactive drugs for certain research purposes to help determine whether research studies can be conducted under 21 CFR 361. Prescription Drugs for Human Use Generally Recognized as Safe and Effective and Not Misbranded: Drugs Used in Research, or whether research studies must be conducted under 21 CFR part 312, Investigational New Drug Application (IND).
Scope & Applicability
Product Classes
6Includes radioactive biological products labeled with a radionuclide; Compounds with radionuclides used in research studies.; Drugs labeled with a radionuclide used in research.; Drugs labeled with radionuclides used in human research.; subject of the guidance and dose limits; Drugs used in basic science research under 21 CFR 361.1.; Subject of the RDRC review and checklist
investigational Positron Emission Tomography drugs; Positron Emission Tomography drugs discussed throughout the guidance
Biological products labeled with a radionuclide.
Regulated under section 351(i) of the PHS Act; Virus, therapeutic serum, toxin, vaccine, or protein applicable to prevention or treatment; Alternative regulation category for products meeting device definition
Drugs produced in accordance with USP <823> or PET CGMP.
Drugs that must comply with 21 CFR parts 210 and 211.
Stakeholders
8committee that approves human research using radioactive drugs
Individual with competence in radiation safety and dosimetry.
Pharmacists with specific credentials for handling radioactive drugs.
Required physician member of the RDRC.
responsible for verifying current methods
Governs top dose in clinical studies
Personnel required to have specific training and experience.
Responsible for qualifications, training, and trial conduct; Individual responsible for trial conduct and data governance at a site.; May delegate tasks but retains overall responsibility; Person responsible for the conduct of the clinical trial at a trial site; Responsible for trial conduct and participant safety; Responsible for trial conduct, data integrity, and investigational product management.; Individual responsible for trial conduct at a site and informing the institution.; maintaining
Regulatory Context
Attributes
10Dose must be known not to cause any clinically detectable pharmacological effect
Requirement for parenteral radioactive materials
Requirement for parenteral radioactive materials
Calculations based on biologic distribution data
Quality standard for the radioactive drug.
equates partial body doses to a whole body dose
clinically detectable effect triggers IND requirement
A state that disqualifies a study from RDRC oversight.
The No Observed Effect Level (NOEL) of this study was 247 ppm.
Total amount of radiation must be within specified limits
Related CFR Sections (5)
- 21CFR361.1§ 361.1 Radioactive drugs for certain research uses.
(a) Radioactive drugs (as defined in § 310.3(n) of this chapter ) are generally recognized as safe and effective when administered, under the conditions set forth in paragraph (b) of this section, to human research subjects during the course of a research project intended to obtain basic informationRead full regulation →
- 21CFR312.2§ 312.2 Applicability.
(a) Applicability. Except as provided in this section, this part applies to all clinical investigations of products that are subject to section 505 of the Federal Food, Drug, and Cosmetic Act or to the licensing provisions of the Public Health Service Act (58 Stat. 632, as amended ( 42 U.S.C. 201 etRead full regulation →
- 21CFR310.3§ 310.3 Definitions and interpretations.
As used in this part:Read full regulation →
- 21CFR600.3§ 600.3 Definitions.
As used in this subchapter:Read full regulation →
- 21CFR20.61§ 20.61 Trade secrets and commercial or financial information which is privileged or confidential.
(a) A trade secret may consist of any commercially valuable plan, formula, process, or device that is used for the making, preparing, compounding, or processing of trade commodities and that can be said to be the end product of either innovation or substantial effort. There must be a direct relationRead full regulation →
Related Warning Letters (10)
- 2025-12-23
In Vivo Bioavailability-Bioequivalence Studies – Clinical
Maria A. Carballosa, M.D.
- 2025-12-23
CGMP/Finished Pharmaceuticals/Adulterated
SV Labs Corporation
- 2025-12-23
CGMP/Finished Pharmaceuticals/Adulterated
Guangdong Renhe Guozhuang Biotechnology Co., Ltd.
- 2025-12-23
CGMP/Finished Pharmaceuticals/Adulterated
Medinatura New Mexico, Inc.
- 2025-12-16
CGMP/Finished Pharmaceuticals/Adulterated
Sklar Personal Care Inc.
- 2025-12-16
CGMP/Deviations/Biologics License Application (BLA)
Microvascular Tissue, Inc.
- 2025-12-11
CGMP/Finished Pharmaceuticals/Adulterated
Catalent Indiana, LLC
- 2025-12-09
CGMP/Finished Pharmaceuticals/Adulterated
DeVere Manufacturing Inc.
- 2025-12-09
CGMP/Finished Pharmaceuticals/Adulterated
CDL Services, Inc. DBA Technichem
- 2025-12-09
CGMP/Finished Pharmaceuticals/Adulterated
Seaway Pharma Inc.
See Also (8)
- Oncology Therapeutic Radiopharmaceuticals: Nonclinical Studies and Labeling Recommendations Guidance for Industry (Status: Final)
- Institutional Review Boards Frequently Asked Questions: Guidance for Institutional Review Boards and Clinical Investigators (Status: Final)
- Microdose Radiopharmaceutical Diagnostic Drugs: Nonclinical Study Recommendations: Guidance for Industry (Status: Final)
- Investigational New Drug Applications (INDs) - Determining Whether Human Research Studies Can Be Conducted Without an IND: Guidance for Clinical Investigators, Sponsors, and IRBs (Status: Final)
- Investigational New Drug Applications for Positron Emission Tomography (PET) Drugs (Status: Final)
- PET Drugs--Current Good Manufacturing Practice (CGMP); Small Entity Compliance Guide (Status: Final)
- PET Drug Products - Current Good Manufacturing Practice (CGMP) (Status: Final)
- Exploratory IND Studies: Guidance for Industry, Investigators, and Reviewers (Status: Final)