FDA-approved radiopharmaceuticals and formulary
FDA-approved. Formulary. Patient safety.


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Are non-FDA approved drugs used in your hospital?

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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:

Updated December 4, 2012
Current list of FDA-approved radiopharmaceuticals (PDF)

To assist with formulary development and to help ensure your nuclear medicine department uses appropriate FDA-approved radiopharmaceuticals.
Package inserts and material safety data sheets
Easy access to detailed information on medications, radioactive and non-radioactive, used in nuclear medicine.


 

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.
Society of Nuclear Medicine (PDF)
SNM Committee on Pharmacopeia and Commission on Radiopharmaceuticals position statement on compounding and associated risks that should be considered.
National Association of Nuclear Pharmacies (PDF)
NANP statement on recommended compounding practices for nuclear pharmacists, which stipulates that the compounding of copies of FDA-approved radiopharmaceuticals should be avoided.
Food and Drug Administration (PDF)
FDA Compliance Policy Guide Sec. 460.200 Pharmacy Compounding that defines compounding practices that may violate the provisions of the Food, Drug and Cosmetic Act, such as compounding drugs that are copies of commercially available FDA-approved drugs.

For more information contact us.