You’ve probably encountered compounded medications at some point. Maybe a pharmacy-made topical anesthetic or a customized rinse for a sensitive patient. Simply put, compounding means a pharmacist mixes or alters ingredients to create a medication tailored to an individual’s needs, such as changing the flavor, adjusting the concentration, or modifying how it’s delivered.
Dr. Richard Nagelberg.
In dentistry, the kind of customization that compounding brings to a medication can be beneficial. Think of patients who can’t tolerate certain ingredients or who need a formulation you just can’t buy off the shelf. That’s where compounding shines: filling gaps that commercial products can’t.
But here’s where things get complicated. Some compounded products are now being marketed as substitutes for U.S. Food and Drug Administration (FDA)-approved medications. They may look similar, but they’re not equivalent, and using them without a clear medical reason can introduce real risks for your patients and your practice.
The right time -- and the wrong time -- to use compounded medications
Let’s start with where compounding makes sense. In dentistry, customized rinses for oral ulcerations, special topical anesthetics for patients with allergies, or even anxiety medications formulated into lollipops for needle-phobic patients are all good examples of appropriate use. Compounding can also help patients with burning mouth syndrome or severe xerostomia, situations where commercial options fall short.
The problems begin when we reach for compounded versions of drugs that already have an FDA-approved counterpart on the market. Unless there’s a clear, documented medical need, that substitution can create legal and ethical gray zones that are best avoided.
A closer look: Why compounded minocycline gels aren’t the same thing
One case that keeps surfacing involves compounded minocycline gels being advertised as alternatives to Arestin (minocycline hydrochloride) -- the FDA-approved, locally delivered antibiotic used as an adjunctive treatment for periodontitis.
The differences are not minor. Some distinctions clinicians should be aware of include the following:
- Regulatory status. Compounded gels don’t go through the FDA approval process. They skip the rigorous clinical trials, safety testing, and manufacturing oversight required of commercial drugs. Section 503A of the Federal Food, Drug, and Cosmetic Act specifically prohibits compounding “essentially copies” of approved drugs unless there’s a valid medical reason.
- Clinical performance. Arestin uses microsphere technology to deliver minocycline steadily into periodontal pockets for at least 14 days. Most compounded gels, by contrast, dissipate after just a few days, potentially undermining treatment outcomes.
- Stability and sterility. Minocycline is unstable when exposed to light, heat, or moisture. Without validated stability data and specialized packaging, compounded versions risk degradation or contamination.
What we have learned from the past
This isn’t a hypothetical issue. Compounding has a history, and not all of it is good.
Several years ago, two patient deaths were linked to compounded topical anesthetics containing lidocaine, epinephrine, and tetracaine that were prepared and used without proper oversight. These tragedies underscored why the FDA approval process exists in the first place: to ensure safety, potency, and consistency.
When something goes wrong with a compounded medication, the blame almost always lands squarely on the prescribing clinician, not the pharmacy. And that’s a position none of us want to find ourselves in.
The legal and ethical gray zones
Substituting compounded versions of FDA-approved drugs can open several doors to risk exposure, including:
- Malpractice insurance. Many policies exclude incidents involving compounded drugs if an FDA-approved alternative was available. If a patient is harmed, coverage could be denied, leaving the clinician personally liable.
- Informed consent: Dentists are ethically obligated to tell patients when they’re using a compounded product rather than an approved one. Patients should understand that these products haven’t been studied for safety or efficacy to the same standard. A clear statement might be: “This medication has been compounded, meaning it hasn’t been FDA-approved or tested in the same way as commercial drugs. We’re using it because …”
- Standard of care: Choosing a short-acting, unproven compounded gel over a proven, longer-lasting FDA-approved medication could be seen as deviating from accepted standards.
The bigger picture: Health, trust, and the profession
Compounded substitutes not only introduce legal risk, they can also compromise clinical outcomes. When periodontitis isn’t managed effectively, the cascade can lead to bone loss, tooth loss, and heightened systemic risk for conditions like cardiovascular disease and diabetes.
Beyond that, there’s the trust factor. If patients learn they were given an unapproved substitute without their knowledge, it can erode confidence not only in your practice, but in the profession as a whole.
The FDA’s position is unambiguous: Compounded drugs must not be “essentially copies” of existing FDA-approved products unless there’s a documented clinical justification.
Practical steps to stay on the right side of safety
If you’re currently using compounded products, or considering it, it’s worth taking a moment to review how and why. Here are a few practical steps:
- Audit your current use. Identify where compounded drugs are being used and whether an FDA-approved alternative exists. Document your rationale wherever appropriate.
- Obtain informed consent. Develop standardized language for disclosure so patients are fully aware of what’s being prescribed.
- Check your malpractice policy. Contact your carrier to confirm how they handle compounded drug incidents.
- Document medical necessity. Keep thorough records when compounding is clinically required and no suitable commercial option exists.
Use compounding wisely
Compounding will always have a place in dentistry, especially for patients with allergies, unusual dosing needs, or unique conditions. But we have to use it judiciously.
Choosing compounded alternatives simply because they’re cheaper or more convenient can create far bigger problems down the road. When an FDA-approved, well-studied therapy is available, it remains the gold standard, both clinically and ethically.
At the end of the day, protecting your patients and your practice go hand in hand. The safest path is clear: Stick with evidence-based, FDA-approved medications whenever possible.
Disclosure: Dr. Richard Nagelberg is the director of medical affairs at OraPharma, a division of Bausch Health.
Editor's note: References are available upon request.
The comments and observations expressed herein do not necessarily reflect the opinions of DrBicuspid.com, nor should they be construed as an endorsement or admonishment of any particular idea, vendor, or organization.
