FDA Takes Actions to Secure Safety of Compounded Drugs

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The agency announced two research collaborations on bulk lists, updates to categories of bulk drug substances, and issued a warning about a bulk drug substance used in compounding.

On July 23, 2018, FDA announced efforts to protect public health by taking actions regarding drug compounding. The efforts are part of the implementation of the Drug Quality and Security Act and the agency’s 2018 Compounding Policy Priorities Plan. These new actions focus on bulk drug substances used in compounding.

“Addressing bulk drug substances used in compounding is an important priority for the agency,” said Anna Abram, Deputy Commissioner for FDA’s Policy, Planning, Legislation and Analysis, in a press statement. “The FDA seeks to implement the statutory requirements for bulk drug substances that can be used in compounding in a way that strikes a balance between preserving access to compounded drugs for patients who have a medical need for them while reducing the safety risks and protecting the FDA drug approval process. Input from stakeholders, including healthcare professionals, is critical to achieving this balance.”

As part of these efforts, the agency issued an alert on July 23 about the risk of cesium chloride, which is sometimes used by cancer patients, and announced it was moving the substance to category 2 under the agency’s interim policy on compounding with bulk drug substances under section 503A of the Food, Drug, and Cosmetic Act (FD&C). FDA stated that cesium chloride has not been proven safe or effective and possible serious adverse events associated with the use of the ingredient include abnormal heart rhythms, low potassium, seizures, fainting, cardiac arrest, and death.

According to FDA, category 2 bulk drug substances are substances nominated with sufficient supporting information to be evaluated by FDA for their eligibility to be included in the 503A bulks list but raise significant safety risks in compounding.  The agency intends to take regulatory action against compounders that use category 2 substances.

To develop a list of bulk drug substances compounded under section 503B of the FD&C, FDA will be working with the University of Maryland and Johns Hopkins University to gather and analyze information. The University of Maryland will work with medical specialty groups about the use of drug products in clinical practice. Johns Hopkins will study safety and effectiveness information on bulk drug substances used in compounding drugs for patients with autism.


The agency is also working to update the categories of substances that are subject to FDA’s interim policies on compounding bulk drug substances. Newly nominated or re-nominated substances with adequate support that do not present significant safety risk will be placed in category 1. Substances without adequate support will be placed in category 3 and will not be eligible for the interim policies.

“The FDA designed its interim policies to avoid unnecessary disruption to patient treatment. During this interim period, the FDA will continue to restrict compounding of essentially copies of FDA-approved products. If the FDA encounters such compounding during an inspection or otherwise, the agency intends to take action, such as issuing a warning letter or pursuing an injunction,” the agency stated.

Source: FDA