How are over-the-counter eye drops regulated?

Over-the-counter eye drops are regulated by the FDA as drugs. Most are sold under an OTC monograph, a set of conditions covering which active ingredients, uses, doses and label wording are allowed for a category. The FDA says monograph drugs that meet those conditions can be marketed without an individually approved application. The 2020 CARES Act modernized how those monographs are made and changed.

Are eye drops regulated by the FDA?

They are. An eye drop that claims to relieve dryness or irritation is a drug under federal law, which brings it under the Food and Drug Administration’s rules on ingredients, labeling and manufacturing. Prescription eye drops go through FDA review of a drug application before they’re sold. Most over-the-counter drops take a different route: the monograph.

What an OTC monograph is

The FDA describes an OTC monograph as establishing conditions, such as active ingredients, uses (indications) and doses, under which a category of drugs is generally recognized as safe and effective. Think of it as a published recipe book for a whole category, rather than a review of one brand. A product that stays within the monograph’s conditions and meets the other legal requirements can be sold without its own approved application.

That’s why it isn’t accurate to describe an over-the-counter monograph eye drop as individually approved by the FDA. The FDA set the rules for the category; the maker is responsible for following them.

The ophthalmic monograph and its ingredient categories

Eye drops fall under the monograph for ophthalmic drug products. For decades it lived in the Code of Federal Regulations as 21 CFR part 349; today the FDA publishes it as OTC Monograph M018. Part 349 sorted active ingredients into categories, each with its own allowed ingredients and label wording:

• Astringents.
• Demulcents, which include liquid polyols such as glycerin and polysorbate 80, along with cellulose derivatives and others.
• Emollients, which include oily ingredients such as light mineral oil.
• Hypertonicity agents.
• Vasoconstrictors.
• Eyewashes.

Quell’s active ingredients are Glycerol (1.0%), Polysorbate 80 (1.0%) and Light Mineral Oil (0.5%). On the Drug Facts panel, glycerol and polysorbate 80 are listed as lubricants and light mineral oil as an emollient. What is a demulcent in eye drops? explains the terms.

What the CARES Act changed in 2020

According to the FDA, the Coronavirus Aid, Relief, and Economic Security Act was signed on March 27, 2020, and added section 505G to the federal Food, Drug, and Cosmetic Act. Before that, changing a monograph meant a slow, multi-step rulemaking process. Section 505G replaced it with administrative orders, which the FDA can issue to add, revise or remove monograph conditions.

Existing final monographs, including the ophthalmic one, became what the law calls deemed final orders on the day the act took effect. That’s how part 349 became Monograph M018. For shoppers, very little changed on the shelf; the change was in how quickly the FDA can update the rules.

The same act also made over-the-counter medicines eligible for HSA and FSA funds without a prescription, a separate change covered in why OTC eye drops count for HSA and FSA.

The Drug Facts label is regulated too

Every OTC drug label follows the FDA’s Drug Facts format, set out in 21 CFR 201.66. It fixes the headings and their order, so every carton reads the same way: active ingredients with their purpose, uses, warnings, directions, other information and inactive ingredients. The monograph decides much of what goes under those headings, including the wording of the uses and certain required warnings.

On Quell’s carton, for example, the Uses line reads: For use as a protectant against further irritation or to relieve dryness of the eye. The directions read: Apply 1 drop 3 times per day in each eye. You can read the whole panel on our Drug Facts page, or see how to read an eye drop Drug Facts label.

Manufacturing, warning letters and recalls

• Manufacturing: OTC eye drops must be made under the FDA’s current good manufacturing practice requirements, the same quality rules that apply to other drugs.
• Warning letters: when the FDA finds an eye product making claims outside the monograph, or quality problems at a plant, it can issue a public warning letter.
• Recalls: when a problem is found after products ship, companies recall affected lots, and the FDA lists recalls publicly.

How to check if your eye drops were recalled explains where to look and how to match a recall to the lot number on your bottle.

What regulation doesn’t tell you

Meeting the monograph means a product uses allowed ingredients and allowed claims. It doesn’t mean one brand works better than another, and it doesn’t mean a drop is right for every eye problem. Ongoing discomfort, pain or vision changes call for an eye doctor, not a different bottle. Quell’s label states: Stop use and ask a doctor if you feel eye pain or changes in your vision, if irritation or redness continues, or if the condition worsens or persists for 72 hours.

Reading claims with this in mind

• Be wary of any OTC eye drop described as “FDA-cleared” or as having special FDA status; monograph drops don’t get individual approval.
• Check that the uses on the website match the Uses line on the label.
• Look for a complete Drug Facts panel, including the maker’s name and a way to contact them.
• Compare active ingredients, not marketing names.