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# Increased Focus on Drug Compounding Facilities
- URL: https://www.fdaweb.com/increased-focus-on-drug-compounding-facilities/
- Published: 2018-06-29T12:00:00.000Z
- Updated: 2026-09-15T00:17:06.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5141806

FDA says it is stepping up pressure on drug compounding facilities, particularly those preparing topical pain creams comprised of multiple ingredients. “Oftentimes, at least one of the ingredients is an active ingredient in an FDA-approved topical pain cream, such as lidocaine,” an [agency release](https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm612193.htm?utm%5Fcampaign=06282018%5FStatement%5FStatement%20from%20FDA%20Commissioner%20Scott%20Gottlieb%2C%20M.D.%2C%20on%20compounded%20drugs&utm%5Fmedium=email&utm%5Fsource=Eloqua) says. Other ingredients is these topicals may be active ingredients in drugs approved by the agency for non-topical administration to treat non-pain related indications, such as antidepressants, anticonvulsants, antivirals and narcotics. “Clinicians and patients may not be aware of potential safety risks, or the potential lack of effectiveness, associated with certain ingredients and combinations of ingredients in their compounded topical pain creams,” it says.

In a few months, FDA says it will announce its plan to improve the information available about compounded topical pain creams, which will help inform reimbursors’ and the medical community’s decisions about these products. “The FDA is also taking steps to ensure that outsourcing facilities, a new type of compounder created by federal legislation enacted in 2013, are compounding drugs from bulk drug substances for which there is a clinical need,” the release says. “In March of this year, the agency [issued a draft guidance](https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm602316.htm?ref=fdaweb.com) that describes how the FDA proposes to evaluate clinical need. Soon, the FDA will be announcing its plan to secure input from medical professionals about clinical need for the nominated substances.”

Additionally, the agency says it is inspecting compounding facilities to determine whether drugs that are essentially copies of FDA-approved drugs are being compounded for patients who could use an FDA-approved drug. Such practices increase public health risks, the agency says, and “undermines the integrity of the premarket approval processes.” And, inspections at compounders not registered as outsourcing facilities will check to make sure that compounded drugs are distributed pursuant to valid patient-specific prescriptions.