United States: USFDA Continues Taking Key Actions On Regulating Safety Of Compounded Drugs To Protect Public Health

On July 23, 2018, the U.S. Food and Drug Administration (USFDA) announced several actions to protect public health related to the compounding of human drug products, as part of its ongoing implementation of the Drug Quality and Security Act and to advance the goals of its 2018 Compounding Policy Priorities Plan1. The key steps regarding its approach to bulk drug substances that are used to make compounded drugs are:

  1. Risk alert and citizen petition on Cesium chloride compounding

The FDA issued a compounding risk alert to warn health care providers, compounders and patients of the dangers of using the bulk drug substance cesium chloride. Cesium chloride is sometimes used by cancer patients despite never having been proven safe and effective for any use. Serious adverse events associated with the use of Cesium chloride and other Cesium salts include abnormal heart rhythms (arrhythmias), low potassium (hypokalemia), seizures, fainting (syncope), cardiac arrest and death.

The FDA is also announcing that it intends to move Cesium chloride to category 2 under the FDA's interim policy on compounding with bulk drug substances under section 503A. Under the interim policy, a bulk drug substance placed in category 2 raises significant safety risks in compounding and is not subject to the FDA's enforcement policy on compounding with the bulk drug substance while the FDA is formally evaluating that substance for use in compounding through the rulemaking process.

  1. Collaborations with universities on bulks list projects

The FDA is announcing two new research collaborations to support its goal of developing the list of bulk drug substances that can be compounded under section 503B and to help inform public for understanding of the use of bulk drug substances in compounding. The FDA is collaborating with the University of Maryland and Johns Hopkins University, two of the agency's Center of Excellence in Regulatory Science and Innovation (CERSI) partners, to gather and analyze information important for developing the list of bulk drug substances that may be used in compounding.

  • The University of Maryland will be working closely with medical specialty groups and researching information about the use of drug products including certain bulk drug substances historically and in current clinical practice.
  • The Johns Hopkins University will systematically study available safety and effectiveness information on certain bulk drug substances for use in compounding drug products for patients with autism spectrum disorder.

These projects will help inform the FDA's regulatory decision-making, including whether to place the evaluated substances on the list of bulk drug substances that outsourcing facilities can use in compounding under section 503B, and help promote public awareness and understanding.

  1. Bulks category updates

The FDA has developed interim policies on the use of bulk drug substances in compounding while the 503A and 503B bulks lists are being developed through procedures involving notice and comment. Under these interim policies, the FDA does not intend to object to compounding with a bulk drug substance if it meets certain conditions including being nominated with adequate supporting information for the FDA to evaluate it and it not having been identified by the agency as a substance that presents significant safety risks. The FDA is currently updating the categories of substances that are subject to its interim policies on compounding with bulk drug substances:

  • Category 1 – These substances may be eligible for inclusion on the 503B bulks list, were nominated with sufficient information for FDA to evaluate them, and do not appear on any other list. FDA does not intend to take action against an outsourcing facility for compounding drugs using bulk drug substances identified in Category 1 provided that the conditions described in the guidance document are met.
  • Category 2 – These are bulk drug substances that were nominated with sufficient supporting information for FDA to evaluate them, but FDA has identified significant safety risks relating to the use of these substances in compounding pending further evaluation. Drug products compounded using these substances are not eligible for the policy described for the substances in Category 1. FDA would consider taking action against an outsourcing facility for compounding drug products with this bulk drug substance under its general enforcement policies.
  • Category 3 – These substances may be eligible for inclusion on the 503B bulks list but were nominated with insufficient supporting information for FDA to evaluate them. The substances are not eligible for the policy that applies to substances in Category 1. FDA would consider taking action against an outsourcing facility for compounding drug products with any of these bulk drug substances under its general enforcement policies. These bulk drug substances can be re-nominated with sufficient supporting information through Bulk Drug Substances That Can Be Used To Compound Drug Products in Accordance With Section 503B of the Federal Food, Drug, and Cosmetic (FD&C) Act; Establishment of a Public Docket2.

The FDA designed its interim policies to avoid unnecessary disruptions to any 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.

  1. Pharmacy Compounding Advisory Committee Meeting

To continue to seek public input on its policies around compounding, the ninth Pharmacy Compounding Advisory Committee meeting is scheduled for September 12, 2018. The committee will discuss six bulk drug substances that were nominated for use in compounding by 503A facilities: alpha lipoic acid, coenzyme Q10, creatine monohydrate, pyridoxal 5 phosphate, choline chloride and quercetin dihydrate. The FDA is dedicated towards developing the framework for evaluating bulk drug substances and will continue to update the public on the progress being made in the coming months.

Note – Compounded drugs are not FDA-approved. This means that FDA does not review these drugs to evaluate their safety, effectiveness, or quality before they reach patients. In 2012, contaminated drugs compounded by a Massachusetts pharmacy led to more than 750 cases of infection and more than 60 deaths of patients in 20 states. Since then, FDA has taken many steps and planning more in future as a part of its ongoing implementation of the Drug Quality and Security Act and to advance the goals of its 2018 Compounding Policy Priorities Plan for public safety.


1 https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm614281.htm

2 https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/PharmacyCompounding/ucm614205.htm?utm_campaign=CDER%20New%207%

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