- The Food and Drug Administration continued to step up its regulation of compounded drugs this week, issuing a risk alert on cesium chloride, a bulk drug substance used in compounding for alternative cancer treatments.
- Along with the warning on cesium chloride, the FDA announced they intend to move the active ingredient from its category 1 list of substances to the category 2 list, which flags substances with significant safety risks. Should a compounder be found using a category 2 substance, the FDA can issue a warning letter and has the right to seize the product.
- These changes followed a complaint in the form of a citizen's petition, as well as a subsequent lawsuit, from the consumer watchdog group Public Citizen that sought reclassification of the drug. The FDA sent the organization a response on July 23.
In January, the agency rolled out its 2018 Compounding Policy Priorities Plan, which intends to further implement the Drug Quality Security Act (DQSA) passed in 2013.
Compounded drugs are when a pharmacist combines, mixes or alters ingredients to tailor a medication to an individual patient. Traditionally, they are intended to provide for patients that need different dosing or formulations — like when a patient is unable to swallow a capsule and needs a liquid.
The DQSA gave the FDA more authority to regulate and oversee compounded drugs and their makers, filling a regulatory black hole between states and the FDA. Also known as the Compounding Quality Act, the DQSA was written into existence in response to a fungal meningitis outbreak caused by a compounding pharmacy that killed 76 people in 2012.
Since its advent, the FDA has conducted hundreds of inspections, and issued warning letters to compounders and referred findings from inspections to state regulatory agencies. The agency has also overseen more than 125 recalls involving compounded drugs as of June 1, 2017, per the agency.
"Our actions underscore our focus on protecting patients while making sure we have an enduring framework for better compounding that is well informed by input from the clinical community," FDA Commissioner Scott Gottlieb said in a July 23 statement.
The agency's actions are attempting to find the balance between keeping access to compounded drugs for patients that need them, while also limiting safety risks and maintaining the integrity of the drug approval process, Gottlieb said.
Cesium chloride is a mineral salt sometimes used as an alternative cancer treatment. The FDA has not approved any products with cesium chloride to date, and identified 23 reports in medical journals through June 30, that described serious side effects.
A group of natural and alternative medicine organizations nominated the bulk drug substance for an exemption under Section 503A of the Federal Food, Drug and Cosmetic Act. The FDA placed it in category 1, for substances currently under evaluation.
At an FDA Advisory Committee meeting last June that focused on pharmacy compounding, the panel noted "serious toxicities" that resulted from cesium chloride's use, including hypokalemia, seizures, heart arrhythmias, fainting and death.
Yet, cesium remained under category 1 at that time, spurring Public Citizen to file a citizen petition in December asking for it to be immediately changed to category 2, for substances with significant safety risks. Public Citizen filed a lawsuit against the FDA on Monday in the district court for the District of Columbia seeking the reclassification of the drug and looking to get it taken off the list of bulk drug substances that can be used for compounding.
This week the FDA declared its intent to re-categorize it accordingly. The regulator also announced collaborations with Johns Hopkins University and the University of Maryland for developing the list of bulk drug substances that can be compounded under Section 503B, which focuses on outsourcing facilities.
The Pharmacy Compounding Advisory Committee is set to meet again on Sept. 12 to discuss six more bulk drug substances: alpha lipoic acid, coenzyme Q10, creatine monohydrate, pyridoxal 5 phosphate, choline chloride and quercetin dihydrate.