Compounding and Repackaging of Radiopharmaceuticals By Outsourcing Facilities Guidance for Industry | Guideline Explorer

Description

This guidance sets forth the FDA’s policy regarding compounding and repackaging ofradiopharmaceuticals for human use by entities that are registered with FDA as outsourcingfacilities under section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act or the Act).This guidance describes how FDA generally intends to apply section 503B of the FD&C Act toradiopharmaceuticals compounded by outsourcing facilities. It also describes the conditions underwhich FDA generally does not intend to take action for violations of sections 505 and 502(f)(1) ofthe FD&C Act when an outsourcing facility repackages radiopharmaceuticals.

Scope & Applicability

Product Classes

4

radiopharmaceuticals

Radioactive sterile and non-sterile drugs; Drugs with short half-lives requiring administration soon after production.

Positron emission tomography (PET) drugs

Excluded from the scope of this guidance

Radioactive biological products

Subject to licensure under section 351 of the PHS Act

radiopharmaceutical

Drug products containing radioactive isotopes

Stakeholders

4

outsourcing facilities

Facilities registered under section 503B; Entities reporting adverse events under Section 503B.

Outsourcing Facility

Entities operating under section 503B of the FD&C Act; entity responsible for compounding under Section 503B; Entities compounding drug products under section 503B; Entity responsible for compounding drug products under section 503B.; entity responsible for compounding and labeling; Entity subject to release testing requirements under Section 503B.; entities compounding drugs under Section 503B

Nuclear Pharmacist

Pharmacists with specific credentials for handling radioactive drugs.

authorized nuclear pharmacist

Individual supervising the repackaging of radiopharmaceuticals

Regulatory Context

Attributes

3

Minor Deviation

Changes in radioactivity, volume, or procedure that do not adversely affect quality.

demonstrable difficulties for compounding

A list published by FDA of drugs that present specific challenges.

beyond use date

Default BUD assigned to compounded products; Assigned date for compounded drug products

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 →

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