Comment Letter to Drug Enforcement Administration Regarding Removal of [123I]Ilflupane from Schedule II of the Controlled Substances Act

Drug Enforcement Administration
Office of Diversion Control
8701 Morrissette Drive
Springfield, VA 22152
Attn: John R Scherbenske

Re: Docket No. DEA-415; Schedules of Controlled Substances: Removal of [123I]Ilflupane from Schedule II of the Controlled Substances Act

Dear Mr Scherbenske,

The Medical Imaging & Technology Alliance (MITA) is pleased to submit the following comment in support of the removal of [123I]Ioflupane from Schedule II of the Controlled Substances Act (CSA).
As the leading trade association representing medical imaging, radiotherapy, and radiopharmaceutical manufacturers, we have in-depth knowledge of the significant benefits to the health of Americans that medical imaging and radiopharmaceuticals provide. Medical imaging encompasses X-ray imaging, computed tomography (CT) scans, related image acquisitions, diagnostic ultrasound, nuclear medicine imaging (including positron emission tomography (PET)), and magnetic resonance imaging (MRI). MITA’s members also develop and manufacture innovative radiopharmaceuticals to help in the diagnosis and staging of disease.

MITA agrees with the conclusion of the DEA that [123I]Ioflupane does not possess abuse or dependence potential and as such, does not meet the requirements for inclusion in any schedule and should be removed from control under the CSA. [123I]Ioflupane is a unique and important tool to help visualize striatal dopamine transporters (DAT) in suspected Parkinsonian syndromes through single photon emission computed tomography (SPECT) brain imaging. While [123I]Ioflupane is derived from cocaine, a schedule II substance, it is not abusable due to several factors determined in the DEA’s eight-factor review; specifically, the product’s low concentration, the impossibility of meaningful extraction, the lack of practical risk to public health, the lack of pharmacological effects in over 168,000 doses worldwide, and other stringent regulatory controls which are in place for radiopharmaceuticals. Currently, [123I]Ioflupane is used widely around the world to help diagnose patients with Parkinsonian syndromes; removing it from control under the CSA will improve patient access to this important diagnostic tool in the United States as well.

In conclusion, MITA urges DEA to act on the proposed removal of [123I]Ioflupane from control under the Controlled Substances Act.

Thank you very much for the opportunity to provide comments on this important topic. Please feel free to contact Terri Wilson at or (703) 841-3258 if you have any questions or require further information.

Terri Wilson
Director, PET & Molecular Imaging

Click here to read the full comment letter.