A Trend Beyond Dentistry
The national spotlight is currently on compounded versions of semaglutide, the active ingredient in brand-name GLP-1 weight-loss and diabetes medications.1 Many patients continue to receive compounded medications that have not been tested for safety or efficacy and may contain unapproved chemical forms. The surge reflects a combination of past availability challenges and the appeal of lower-cost alternatives, highlighting both the risks of compounding and market forces driving its growth.
This also happens in dentistry. Compounded minocycline gels are being marketed as substitutes for minocycline microspheres such as Arestin®, an FDA-approved, locally delivered antibiotic for adjunctive treatment of periodontitis. This raises significant safety, efficacy, regulatory, and ethical concerns. Arestin is always available through normal channels, unlike the GLP-1 category.
Compounding: A Useful Practice with Drawbacks
Compounding is very important in medicine. Custom formulations may be useful when a patient needs a drug that isn’t available, has an allergy, needs a different dose form, or when there is a real drug shortage.
The Federal Food, Drug and Cosmetic Act (FDCA) prohibits compounding drugs that are “essentially copies” of FDA-approved medications unless there is a documented medical need for the variation.2,3
This ensures that patients do not receive compounded drugs that have not undergone FDA approval when their needs could be met by approved products. This rule protects patients by ensuring compounding does not become a back door for untested drugs that already exist in safe, effective, and regulated form.
Unlike protocols for drugs that the FDA approves to ensure that a safe and effective product results every time, compounding procedures are not standardized or tested.4 Delivery of active ingredient doses above the desired therapeutic level could result from miscalculation, including too much API (active pharmaceutical ingredients) in the formulation, or from poor-quality formulation that results in an erratic and unpredictable release rate; the latter has been observed with compounded pellet formulations.5
Prescription Requirements
Compounded drugs may only be dispensed for an individual patient. Unlike FDA-approved medications that can be stocked and prescribed broadly, compounded formulations cannot. Each prescription must document the patient’s name and need. This ensures compounding remains a patient-specific practice. Failing to do so places providers at risk.
Why Compounded Minocycline Gels Raise Concerns
Compounded minocycline gels differ fundamentally from Arestin:
• No FDA approval — These formulations have not undergone FDA review, clinical trials, or stability testing. Arestin has decades of clinical data supporting its safety and efficacy.
• No sustained release — Arestin uses microsphere technology that delivers minocycline into periodontal pockets for at least 14 days. Compounded gels typically remain for only 1–3 days.
• Stability and contamination risks — Minocycline is sensitive to light, heat, and moisture. Without proven testing and packaging, potency and purity are uncertain. Poor compounding practices have led to public health tragedies, such as the 2012 fungal meningitis outbreak linked to contaminated compounded steroid injections, which caused over 100 deaths.6
• Ethical and malpractice considerations — Some practices may bill patients at the same rate as FDA-approved medications. This creates both ethical dilemmas and malpractice exposure if patients are not informed.
Informed Consent and Professional Liability
Dentists and hygienists must disclose when a compounded product is used. Aaron Levine, CEO and founder of LG Insurance Agency, emphasizes the potential malpractice implications: “If an adverse event occurs and the provider failed to disclose the use of a non-FDA approved compounded drug, malpractice insurers may deny coverage. That could leave the dentist personally liable for damages.”
Patient Health at the Center
Undertreating periodontitis has serious consequences. Disease progression leads to bone and tooth loss, with inflammatory burden linked to cardiovascular disease and diabetes. Using short-acting, unproven alternatives instead of sustained-release therapies potentially increases the risk of poor outcomes.
Uduak Ntuen, associate director of medical affairs at Bausch Health and a pharmacist with compounding experience, notes: “Many providers don’t realize therapeutic failure is classified as an adverse event with serious implications for patient health and standard of care. When compounded products lack the potency or stability of FDA-approved counterparts, disease progression may go unnoticed until irreversible damage occurs.”
The Broader Regulatory Landscape
The FDA has taken a firm stance against compounded copies of available drugs. Its 2018 guidance reiterates that compounded drugs must not be “essentially copies” unless there is a documented clinical reason.2 State pharmacy boards echo this, reinforcing that providers must document why an alternative was chosen.
Practical Guidance for Teams
For dentists and hygienists, consider:
- Evaluate your current prescribing practices — If compounded minocycline gels or other compounded drugs are being used, reassess whether their risks outweigh the benefits.
- Prioritize informed consent — Let patients know if a compounded drug is being used.
- Consult malpractice carriers — Confirm with insurers how coverage applies when prescribing compounded drugs.
- Stay informed — Review FDA and state pharmacy board updates and rely on peer-reviewed literature for decision-making.
- Educate patients proactively — Highlight that your practice uses FDA-approved, clinically tested treatments. Transparency builds trust.
A Call to Protect Patients and the Profession
This issue is not about resisting innovation. Just as the medical field grapples with risks tied to compounded GLP-1 drugs, dentistry must recognize the hazards of compounded minocycline gels.
Patient safety must always come first. When FDA-approved, clinically proven options like Arestin exist. Substituting them with untested compounded versions introduces risks to patients, to providers, and to the profession at large. As dental professionals, we have an ethical and clinical obligation to uphold the highest standards of care. That means rejecting shortcuts that compromise safety and reinforcing the trust that patients place in us every day.
ABOUT THE AUTHOR
Richard H. Nagelberg, DDS, is Director of Medical Affairs at OraPharma, a division of Bausch Health US, LLC, and practiced general dentistry in suburban Philadelphia for more than 40 years.
References
1. FDA Safety Communication on Compounded Semaglutide, 2023.
2. U.S. Food and Drug Administration. Compounded Drug Products That Are Essentially Copies of Commercially Available Drug Products Under Section 503A of the FDCA. Guidance for Industry, January 2018.
3. Federal Food, Drug, and Cosmetic Act, Sections 503A and 503B.
4. National Institutes of Health. Drug Compounding and the FDA: Questions and Answers. In: Drug Compounding for Human Use. Bethesda (MD): National Center for Biotechnology Information (US); 2020. Available from: https://www.ncbi.nlm.nih.gov/books/NBK562888/. Accessed January 29, 2026.
5. Jiang X. Postmenopausal pellet vs. FDA approved hormonal therapy: An assessment of serum estradiol and testosterone levels. Paper presented at the North American Menopause Society 29th Annual Scientific Meeting; Chicago, IL: 2019.
6. Raymond N. Pharmacy exec in plea deal in Michigan over 2012 meningitis outbreak deaths. March 5, 2024. Reuters. Available at: https://www.reuters.com/legal/pharmacy-exec-plea-deal-michigan-over-2012-meningitis-outbreak-deaths-2024-03-05. Accessed January 29, 2026.
Figures and Images
Richard H. Nagelberg, DDS
