Description
The Food and Drug Administration (FDA or the Agency) is announcing the availability of a guidance for industry entitled “Compounding and Repackaging of Radiopharmaceuticals by State-Licensed Nuclear Pharmacies, Federal Facilities, and Certain Other Entities.” This guidance sets forth FDA's policy regarding compounding and repackaging of radiopharmaceuticals for human use by State-licensed nuclear pharmacies, Federal facilities, and other entities that hold a radioactive materials (RAM) license for medical use issued by the Nuclear Regulatory Commission (NRC) or by an Agreement State. Because such radiopharmaceuticals are not eligible for exemptions from provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act) related to the production of drugs, FDA is issuing this guidance to describe the conditions under which it generally does not intend to take action for violations of certain provisions of the FD&C Act when these entities compound or repackage radiopharmaceuticals.
Scope & Applicability
Product Classes
4Guidance does not specifically provide recommendations addressing dosage optimization for radiopharmaceuticals
Excluded from the scope of this guidance
Subject to licensure under section 351 of the PHS Act
FDA considers these essentially a copy of marketed drugs under certain conditions
Stakeholders
4Entities compounding and repackaging radiopharmaceuticals
Facilities compounding drug products pursuant to section 503B.
Individual permitted to compound or supervise compounding of radiopharmaceuticals.; Individual who compounds or supervises the compounding
Determines clinical difference for an identified individual patient
Regulatory Context
Attributes
2Beyond-use date restricted to the last time point at which data remained within specifications
The date after which a compounded drug should not be used.
Related CFR Sections (3)
- 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 →
- 21CFR216.24§ 216.24 Drug products withdrawn or removed from the market for reasons of safety or effectiveness.
The following drug products were withdrawn or removed from the market because such drug products or components of such drug products have been found to be unsafe or not effective. The following drug products may not be compounded under the exemptions provided by section 503A(a) or section 503B(a) ofRead full regulation →
Related Warning Letters (1)
- 2020-06-16
Compounding Pharmacy/Adulterated Drug Products
The Compounding Pharmacy
See Also (8)
- Chapter 48 7348.809A Radioactive Drug Research Committee (Status: Final)
- Developing Medical Imaging Drug and Biological Products Part 3: Design, Analysis, and Interpretation of Clinical Studies (Status: Final)
- Developing Medical Imaging Drug and Biological Products Part 2: Clinical Indications (Status: Final)
- Developing Medical Imaging Drug and Biological Products Part 1: Conducting Safety Assessments (Status: Final)
- Radioactive Drug Research Committee: Human Research Without An Investigational New Drug Application (Status: Final)
- Compounding and Repackaging of Radiopharmaceuticals By Outsourcing Facilities Guidance for Industry (Status: Final)
- Product Identifiers under the Drug Supply Chain Security Act - Questions and Answers: Guidance for Industry (Status: Final)
- Oncology Therapeutic Radiopharmaceuticals: Dosage Optimization During Clinical Development: Draft Guidance for Industry (Status: Draft)