The United States Federal Drug Administration (FDA) approves the use of radiopharmaceuticals as safe for human use. Using non FDA-approved radiopharmaceuticals and drugs that originate from sources other than FDA-approved manufacturers could place you, your patients and your facility at risk. CMS, and most third-party payers, reimburse only FDA-approved drug products. Be advised that, while payers require a National Drug Code (NDC) number for reimbursement, that number does not mean that the drug has FDA approval and does not denote eligibility for reimbursement.
You can be assured that the compounded preparations you receive from Triad Isotopes, Inc. comply with the highest regulatory standards and are safe for patient use.
In accordance with Board of Pharmacy regulations, prescription orders are required for all radiopharmaceutical products compounded and dispensed by Triad Isotopes, Inc.
Prior to delivery, a specially trained Triad Isotopes team member performs radiopharmaceutical quality assurance testing (QC) on every compounded preparation before it leaves the pharmacy.
Triad Isotopes procures and supplies FDA-approved radiopharmaceutical products exclusively from FDA-approved cGMP compliant manufacturers. Our company does not procure products from other compounding pharmacies or gray market sources.
Our company fully supports FDA compounding guidelines as provided by SNMMI, NANP, ASHP, APhA and others.
For a complete for list of FDA-approved radiopharmaceuticals available through Triad Isotopes, click here.