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FDA Issues Draft Guidances on Compounding and Repackaging Radiopharmaceuticals

[12/28/2016] Today the FDA issued two draft guidances that describe FDA’s proposed policies regarding the compounding and repackaging of radiopharmaceuticals for human use by state-licensed nuclear pharmacies or federal facilities, and outsourcing facilities. Radiopharmaceuticals are radioactive drugs that are used in nuclear medicine procedures to diagnose, monitor, and treat diseases.

The policies proposed in the draft guidances attempt to strike an important balance between patient access to radiopharmaceuticals compounded or repackaged by state-licensed nuclear pharmacies, federal facilities, and outsourcing facilities, and the risks that such unapproved drugs present to patients.

Draft Guidance: Compounding and Repackaging of Radiopharmaceuticals by State-Licensed Nuclear Pharmacies (PDF - 107KB)

The draft guidance explains that, under current law, radiopharmaceuticals compounded or repackaged by state-licensed nuclear pharmacies and federal facilities are subject to all applicable provision of the FD&C Act related to the production of drugs. However, FDA recognizes that state-licensed pharmacies and federal facilities sometimes compound or repackage radiopharmaceuticals for patients who need them without obtaining FDA approval or meeting certain other requirements.

The draft guidance proposes FDA’s policy regarding the conditions under which FDA does not intend to take action for violations of sections of the FD&C Act concerning new drug approval requirements, labeling with adequate directions for use, and compliance with current good manufacturing practice requirements, against a state-licensed nuclear pharmacy or federal facility that compounds or repackages radiopharmaceuticals.

Draft Guidance: Compounding and Repackaging of Radiopharmaceuticals by Outsourcing Facilities (PDF - 122KB)

The draft guidance explains that section 503B of the Federal Food, Drug, and Cosmetic Act applies to the compounding of radiopharmaceuticals, but not to radiopharmaceuticals that are repackaged, by outsourcing facilities. It proposes how FDA would apply the conditions of section 503B to radiopharmaceuticals compounded by outsourcing facilities.

The draft guidance also proposes FDA policy regarding the conditions under which FDA does not intend to take action for violations of provisions of the FD&C Act regarding new drug approval requirements and labeling with adequate directions for use against an outsourcing facility that repackages radiopharmaceuticals.

The comment period on each of the draft guidances closes in 60 days.  Information on how to comment on the guidances is available in the Federal Register:

 
FDA’s website has additional information on compounding.

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