Current and resolved drug shortages and discontinuations reported to FDA are found here. Below, please find shortages and other isotope supply news reported by our members and industry partners.
Last week, the Department of Energy (DOE) and Department of Health and Human Services (HHS), in accordance with the American Medical Isotopes Production Act of 2012 (AMIPA), issued a joint Secretarial certification that there is a sufficient global supply available of Mo-99 produced without the use of highly enriched uranium (HEU) to meet the needs of patients in the United States and that it is not necessary to export United States-origin HEU for the purposes of medical isotope production in order to meet patient needs in the United States. This certification triggers a congressionally mandated ban on exports of HEU for foreign medical isotope production effective January 2, 2022. The Federal Register notice may be viewed here.
On January 2, 2020, DOE published a Federal Register notice (85 FR 3362) certifying that, at the time, there was an insufficient global supply of Mo-99 produced without the use of HEU and that the export of U.S.-origin HEU for the purposes of medical isotope production was the most effective temporary means to increase the supply of Mo-99 to the domestic U.S. market. This certification was effective for no more than two years from the effective date of January 2, 2020. The Federal Register notice stated that DOE would conduct periodic reviews of the domestic U.S. and global Mo-99 market and would work toward a certification to Congress, regarding the sufficiency of supply as soon as the statutory conditions are satisfied.
In October 2021, DOE sought public input as part of its certification development process and analysis to determine the sufficiency of Mo-99 supply to meet U.S. patient needs. SNMMI's comments may be found here.
Yesterday, Jubilant Pharma of Greater New York announced that its supplier is experiencing shortages of Sulfur Colloid that may extend until December. Therefore, the following ordering restrictions will be implemented for all Sulfur Colloid doses:
To request an accommodation, please contact your pharmacist.
As of today, Choletec commercial availability from one manufacturer is anticipated for August 30th. That manufacturer is working on a routine production plan. Customer orders will be filled based on order date and available inventory. Until the manufacturer achieves a routine production schedule, product allocation will be in place due to the limited inventory.
While a global shortage of Choletec (technetium (99mTc) mebrofenin) persists due to a vial shortage, we have reached out to various suppliers. More supply is on the way and should be released beginning mid-July.
Today, one of our members reported an isotope shortage of Choletec (technetium (99mTc) mebrofenin). After conducting further research as to the cause of the shortage, the Society learned that the culprit is a shortage of vials. This shortage is not unprecedented. Some time ago, there was a DTPA shortage because of a shortage of caps for the vials.
SNMMI President Dr. Vasken Dilsizian released the following statement addressing how the COVID-19 pandemic may affect the supply of Mo-99.
Dear Fellow SNMMI Members,
Much like you, the SNMMI leadership has been closely following the rapidly evolving COVID-19 situation—monitoring the latest recommendations provided by the U.S. Centers for Disease Control and Prevention (CDC) and the World Health Organization (WHO) to help address its inevitable impact on the nuclear medicine and molecular imaging community. In line with the SNMMI’s mission to improve human health by advancing nuclear medicine, molecular imaging, and radionuclide therapy; SNMMI’s primary focus is on how this issue may affect our ability to care for patients; more specifically, how the COVID-19 pandemic may affect the Mo-99 supply situation.
The SNMMI is particularly paying close attention to how the COVID-19 pandemic might affect different parts of the Mo-99 supply chain including production, target processing, and transportation. As you may imagine, many factors can affect this supply chain, including quarantines and closures of schools that result in the absence of key staff, as well as disruptions in the international transportation network. In order to keep our members as informed as possible, SNMMI is currently taking the following steps:
At this time, no Mo-99 shortages have been reported. Moving forward, SNMMI will remain in close contact with government agencies, trade organizations, and other stakeholders in the nuclear medicine and molecular imaging community to help to ensure an adequate supply of Mo-99.
Vasken Dilsizian, MD
A significant shortage of Mo-99 is expected for the first half of November. The NTP facility in South Africa, which has experienced problems since late last year, has not yet been able to return to service, and a technical issue has developed with the High-Flux Reactor (HFR) in the Netherlands, which is now on unplanned shutdown.
The unexpected HFR shutdown coincides with a planned 11-day shutdown of the OPAL reactor in Australia that began October 29, so significant shortages of Mo-99 are anticipated starting in early November. With significant shortages anticipated, it is essential that users contact their generator/nuclear pharmacy providers for advice about their local situation. The Association of Imaging Producers & Equipment Suppliers (AIPES) Emergency Response Team is closely following the situation. The group issued an update on October 30, and SNMMI will post updates as they become available.
NTP Radioisotopes in South Africa reports that they expect to meet with regulators this week regarding their request to resume Mo-99 production operations. With OPAL having a scheduled shutdown from July 16 – 20 will make things more challenging. The AIPES Emergency Response Team is scheduled to meet again on July 23, 2018.