Merry X-Ray / SourceOne Healthcare on pedigrees for barium and Contrast.
To whom it may concern:
Merry X-Ray/SourceOne Healthcare("MXR/S1") is a Distributor for several Manufactures that sell Barium and Contrast ("Imaging Products") to hospitals, doctors and clinics throughout the United States.
Under Title 21, Code of Federal Regulations defines the term "Product" means a prescription drug in a finished dosage form for administration to a patient without substantial further manufacturing (such as capsules, tables, and lyophilized products before reconstitution), but for purposes of section 582, does not include blood or blood components intended for transfusion, radioactive drugs or radioactive biological products (as defined in section 600.3(ee) of title 21, Code of Federal Regulations) that are regulated by the Nuclear Regulatory Commission or by a State pursuant to an agreement with such Commission under section 274 of the Atomic Energy Act of 1954 (42 U.S.C. 2021), imaging drugs, an intravenous product described in clause (xiv),(xv), or (xbi) of paragraph (24)(B), any medical gas (as defined in section 575), homeopathic drugs marketed in accordance with applicable guidance under this Act, or a drug compounded in compliance with section 503A or 503B".(Emphasis added)
Thus, it is MXR/S1 understanding that the barium and contrast identified as imaging drugs in the above referenced CFR code is exempt from the requirements of this law.
We no longer provide pedigrees for these products
Merry X-Ray / SourceOne Healthcare