The Official Definition: Why Eyedrops Are Drugs
According to the U.S. Food, Drug, and Cosmetic Act, any product "intended to mitigate, treat or prevent disease…or to affect the structure or function of the body is classified as a drug" [1.2.1]. Eyedrops fall squarely into this category. Whether they are designed to relieve dryness, reduce itchiness, combat an infection, or lower intraocular pressure, they are making a medical claim and affecting the function of the eye [1.2.1].
The U.S. Food and Drug Administration (FDA) has authority over all drugs sold in America and is responsible for regulating all ophthalmic preparations [1.2.1, 1.6.3]. Products intended for ophthalmic use must be sterile to be considered safe, as they bypass some of the body's natural defenses [1.2.6, 1.6.3]. Any claims that eyedrops can reduce symptoms like redness, nourish the eye, or treat conditions are considered drug claims, meaning they cannot be legally marketed as cosmetics or nutritional supplements in the United States [1.2.1].
A New Layer of Regulation: Drug-Device Combination Products
A significant recent development in regulation is that the FDA now classifies most eyedrops as "drug-device combination products" [1.2.2, 1.2.3]. This is because the medication (the drug) is delivered via a dropper or bottle (the device) [1.2.2]. This change, prompted by a 2021 court decision, means that manufacturers must meet regulatory requirements for both the drug and the delivery device, adding complexity to the approval and manufacturing process [1.2.2, 1.6.2]. The dispenser itself is considered a Class 2 medical device [1.6.4].
Prescription vs. Over-the-Counter (OTC): A Tale of Two Systems
While all eyedrops are drugs, how they get to market differs significantly depending on their classification as either prescription (Rx) or over-the-counter (OTC) [1.2.1].
Prescription (Rx) Eyedrops
Prescription eyedrops are medications prescribed by a healthcare provider for a specific patient and purchased at a pharmacy [1.2.1]. These drops are used to treat more serious conditions that require medical diagnosis and supervision. Before a prescription eyedrop can be sold, it must go through a rigorous, multi-phase FDA approval process to prove it is both safe and effective for its intended use [1.2.1, 1.2.7]. This process includes extensive human clinical trials [1.2.1].
Examples of conditions treated with prescription eyedrops include:
- Glaucoma: These drops work to lower pressure inside the eye [1.4.2, 1.8.5].
- Bacterial Infections: Antibiotic drops are required to treat bacterial conjunctivitis (pink eye) [1.4.2, 1.8.6].
- Viral Infections: Antiviral drops may be prescribed for infections caused by viruses [1.8.5].
- Severe Inflammation: Corticosteroid drops reduce inflammation but require careful monitoring [1.8.2, 1.8.5].
- Chronic Dry Eye: Medications like cyclosporine (Restasis) or lifitegrast (Xiidra) treat the underlying inflammation that causes chronic dry eye [1.4.3, 1.8.1].
Over-the-Counter (OTC) Eyedrops
OTC eyedrops can be purchased without a prescription from stores or online retailers [1.2.1]. These products are intended for minor eye ailments like mild dryness, redness, or allergy-related itching [1.4.2].
Unlike prescription drugs, OTC eyedrops are not individually FDA-approved [1.2.1]. Instead, they are regulated through an OTC drug monograph system. This monograph acts as a "recipe book" that specifies acceptable active ingredients, dosages, formulations, and labeling requirements [1.2.1, 1.2.7]. As long as a manufacturer's product conforms to the monograph, it can be marketed without pre-approval from the FDA [1.2.1]. The FDA does not typically review these products for compliance unless a problem arises, and official drug listings often state that the FDA has not evaluated whether the product complies [1.2.1].
Comparison of Eyedrop Categories
| Feature | Prescription (Rx) Eyedrops | Over-the-Counter (OTC) Eyedrops |
|---|---|---|
| Regulation | FDA-approved through a rigorous review process, including clinical trials [1.2.1]. | Regulated via an OTC monograph; not individually FDA-approved [1.2.1, 1.2.7]. |
| How to Obtain | Must be prescribed by a licensed healthcare provider [1.2.1]. | Purchased directly from a store or online without a prescription [1.2.1]. |
| Common Uses | Glaucoma, bacterial/viral infections, severe inflammation, chronic dry eye disease [1.4.2, 1.8.5]. | Mild dry eye (artificial tears), redness relief, allergies, contact lens rewetting [1.4.1, 1.4.2]. |
| Active Ingredients | Often contain potent active ingredients like beta-blockers, prostaglandins, antibiotics, or corticosteroids [1.5.2]. | Contain ingredients listed in the OTC monograph, such as lubricants (demulcents), antihistamines, and vasoconstrictors [1.4.1, 1.5.5]. |
| Safety Oversight | Manufacturing facilities are typically inspected by the FDA before the drug is sold [1.2.7]. | Facilities do not require pre-market inspection; manufacturers self-attest to following the monograph [1.2.7]. |
Common Types of Active Ingredients and How They Work
- Lubricants (Demulcents): Found in artificial tears, ingredients like Carboxymethylcellulose (CMC) and Polyethylene Glycol help lubricate the eye's surface and relieve dryness [1.5.1, 1.8.1].
- Antihistamines: Used for allergies, these drops (e.g., ketotifen) block the body's histamine response to allergens, reducing itching and watering [1.4.1, 1.8.1].
- Vasoconstrictors: Found in redness-relief drops, ingredients like tetrahydrozoline shrink swollen blood vessels in the eye. However, overuse can lead to "rebound redness" [1.5.1, 1.8.4].
- Antibiotics & Antivirals: These prescription ingredients kill or inhibit the growth of bacteria or viruses causing infections [1.8.5].
- Prostaglandin Analogs & Beta-Blockers: These are common prescription treatments for glaucoma that work by either increasing fluid drainage from the eye or reducing fluid production to lower eye pressure [1.5.2, 1.8.5].
Conclusion
Unquestionably, all eyedrops are classified as drugs by the FDA. This classification stems from their intended use to treat, prevent, or affect the eyes. The regulatory pathway, however, diverges significantly between the rigorously tested, FDA-approved prescription options and the monograph-governed over-the-counter products. Recent changes have further defined eyedrops as drug-device combinations, increasing regulatory scrutiny [1.2.2]. For consumers, this means understanding that even a simple bottle of artificial tears is a medication that must be used responsibly and according to its directions to ensure eye health and safety.
For more information on drug regulation, you can visit the U.S. Food and Drug Administration's website.
