FDA-approved radiopharmaceuticals
FDA-approved. Formulary. Patient safety.
The Cardinal Health compliance resource library can help to ensure that your facility uses FDA-approved radiopharmaceuticals and that they are included on formulary.
Are your radiopharmaceuticals on formulary?
In 2004, The Joint Commission (TJC) expanded the definition of medications to include radiopharmaceuticals. Since then, accreditation agencies categorize them as legend drugs subject to medication management standards.
Since radiopharmaceuticals are radioactive, nuclear medicine departments have historically managed their use by complying with Nuclear Regulatory Commission (NRC) regulations. However, as legend drugs, accreditation agencies denote that the director of pharmacy has oversight responsibility for their use based on medication management standards. A key element in managing medications is the hospital formulary.
Has your Pharmacy and Therapeutics (P&T) committee, or similar review board, approved the use of radiopharmaceuticals used in your hospital? Are they included on formulary?
The Cardinal Health compliance resource library can help with your collaborative efforts to ensure that your facility uses FDA-approved radiopharmaceuticals and that they are included on formulary.
Ensure patient safety
- One of the first steps to help ensure patient safety is to use FDA-approved radiopharmaceuticals.
- Using a licensed nuclear pharmacy does not always guarantee the use of FDA-approved radiopharmaceuticals.
- If your nuclear medicine department uses radiopharmaceuticals that originate from sources other than the approved manufacturer(s) they may be administering unapproved copies of commercially available FDA-approved drugs.
Resources for formulary development:
Current list of FDA-approved radiopharmaceuticals
Current list of FDA-approved radiopharmaceuticals and contraindications
To assist with formulary development and to help ensure your nuclear medicine department uses appropriate FDA-approved radiopharmaceuticals.
Disclaimer: Any reader of this document is cautioned that Cardinal Health makes no representation, guarantee, or warranty, express or implied as to the accuracy and appropriateness of the information contained in this web page, and will bear no responsibility or liability for the results or consequences of its use. The information provided on this web page is non-promotional. ?It is intended for informational purposes only and is not intended to promote or recommend any individual product. ?Contact the applicable manufacturer if you have any questions regarding a product listed on this web page.
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Package inserts and material safety data sheets
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Easy access to detailed information on medications, radioactive and non-radioactive, used in nuclear medicine.
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Industry perspective on FDA-approved radiopharmaceuticals:
Statements from key industry groups that outline recommended guidelines on nuclear pharmacy compounding and the use of FDA-approved radiopharmaceuticals.
SNM Committee on Pharmacopeia and Commission on Radiopharmaceuticals position statement on compounding and associated risks that should be considered.
National Association of Nuclear Pharmacies
NANP statement on recommended compounding practices for nuclear pharmacists, which stipulates that the compounding of copies of FDA-approved radiopharmaceuticals should be avoided.
Are non-FDA approved drugs used in your hospital?
