Quick facts
- United States: ophthalmic drug products sold without a prescription are grouped by the 21 CFR 349 monograph into astringents (21 CFR 349.10), demulcents (21 CFR 349.12), emollients (21 CFR 349.14) and eyewashes (21 CFR 349.20).
- Canada: an ophthalmic preparation is authorised as a drug and carries a Drug Identification Number; an artificial tear record held by Health Canada is filed as "LUBRICANT EYE DROPS / ARTIFICIAL TEARS" with a DIN rather than as an over-the-counter monograph entry.
- United States: the demulcent monograph lists cellulose derivatives such as carboxymethylcellulose sodium at 0.2 to 2.5 percent, polyvinyl alcohol at 0.1 to 4 percent and povidone at 0.1 to 2 percent as the active ingredients a lubricant drop may carry.
- Both countries: a red or pink eye is most often viral, and a viral conjunctivitis does not respond to an antibacterial drop. A drop decision turns on the discharge, the eyelids and the time course, not on the colour of the eye alone.
- Canada: the regulation text cited here is current to 2026-10-03; the American ophthalmic monograph sections were last touched by 53 FR 7090, March 4, 1988, as amended 68 FR 32982, June 3, 2003.
- Both countries: eye wash and eye shield products sit on the device route rather than the drug route, through 21 CFR 886.4750 in the United States and through the general classification rules in Canada.
A red eye walks into a clinic on most days of the week. Sometimes it is an allergy, sometimes a viral infection, sometimes a bacterial one, and sometimes it is a dry eye that has been rubbed. The drop that leaves the room depends on which of those it is, and for a buyer the harder part is that the same drop sits on two different regulatory routes on the two sides of the border.
What decides whether an antibiotic eye drop is needed at all?
The discharge and the eyelids decide, and the answer is that most pink eye does not need an antibiotic at all.
The American Academy of Ophthalmology describes conjunctivitis as an inflammation of the conjunctiva that is most often caused by a virus, and it groups the presentations by what the eye looks like and what it discharges. A watery discharge with an eye that is red but not stuck shut points toward a viral cause. A thick purulent discharge with lids that are matted in the morning points toward a bacterial cause. An itchy eye with both sides red at once points toward allergy.
That picture is the first thing a drop decision turns on, and it is the reason a clinic can hold a lubricant on the shelf and still not hand out an antibacterial on request. A viral conjunctivitis runs its course, and an antibiotic changes nothing about it. A bacterial conjunctivitis is where an antibacterial drop earns its place, and that drop is a prescription product in Canada and, for the agents in common use, a prescription product in the United States as well.
For the clinic that supports that decision, the Public Health Ontario laboratory services index is where the specimen and referral pathway for an infected eye begins, and CCOHS OSH answers carries the workplace guidance for staff whose duties bring them into contact with an infected patient.
| Presentation | Likely cause | Drop that fits |
|---|---|---|
| Watery discharge, eye red but not matted | Viral | A lubricant; antibiotic does not change the course |
| Thick purulent discharge, lids matted on waking | Bacterial | An antibacterial drop on prescription |
| Itchy, both eyes red at once, seasonal | Allergic | An anti-allergy or lubricant drop per the prescriber |
| Gritty, burning, worse through the day | Dry eye | A demulcent or emollient lubricant |
Are conjunctivitis eye drops over the counter or prescription in each country?
The active ingredient decides, and the two countries draw the over-the-counter line in different places.
In the United States a lubricant drop can reach the shelf through the ophthalmic monograph without a product-specific approval, provided its active ingredients and their concentrations match the monograph. Section 349.12 lists the demulcents — the agents that draw water to the surface — with a concentration range for each. Section 349.14 lists the emollients, the oily agents that slow evaporation, including light mineral oil up to 50 percent, petrolatum up to 100 percent, and white petrolatum up to 100 percent.
In Canada the same type of product is authorised as a drug and receives a Drug Identification Number. A Health Canada record for lubricant eye drops and artificial tears shows the product filed under that description in the Drug and Health Product Portal. The practical difference for a buyer is the route to the shelf: an American lubricant can be placed under a monograph that already exists, while a Canadian lubricant product is tied to a specific authorisation.
For an antibacterial drop, both countries treat the ingredients used for conjunctivitis as prescription medicines. That is the single fact that most often surprises a front desk being asked for "pink eye drops" — in neither country is a common antibacterial ophthalmic agent a walk-up purchase.
How does the American monograph route differ from the Canadian authorisation route?
One is a category rule and the other is a product-by-product record, and the difference shows up in how a new drop reaches the shelf.
The American route is written as a monograph. A manufacturer that matches an active ingredient and concentration already listed in 21 CFR 349.12 for a demulcent, or in 21 CFR 349.14 for an emollient, can label the product as an over-the-counter ophthalmic and market it under that category. The monograph is a standing condition rather than a decision about one bottle.
The Canadian route is written as an authorisation. A lubricant eye drop is a drug under the Food and Drugs Act, and it is placed on the market only after an authorisation that assigns it a Drug Identification Number. A buyer comparing two shelves — one in Buffalo and one in Hamilton — is comparing a monograph category against a set of individually authorised products.
The difference matters most when a product is reformulated. A change that stays inside the American monograph is a labelling change, while the same change on the Canadian side runs through the product's own authorisation.
| Item | Canada | United States |
|---|---|---|
| Route for a lubricant drop | Drug authorisation, Drug Identification Number | OTC ophthalmic monograph, 21 CFR 349 |
| Route for an astringent drop | Drug authorisation | 21 CFR 349.10 cross-reference |
| Route for an eyewash | Drug or device, depending on the claim | 21 CFR 349.20 or a device entry |
| Basis of the list | The product's own authorisation | A standing monograph category |
| Reformulation | Through the product authorisation | Permitted inside the monograph conditions |
Which drop categories does each system recognise?
Four categories on the American side map onto a simpler split on the Canadian side, and knowing the categories keeps a shelf order accurate.
The American monograph splits the over-the-counter ophthalmic into astringents, demulcents, emollients and eyewashes. An astringent under 21 CFR 349.10 is a product intended to reduce the redness of the eye surface. A demulcent under 349.12 is the water-attracting lubricant. An emollient under 349.14 is the oily lubricant. An eyewash under 21 CFR 349.20 is a sterile solution for irrigating the eye.
The vocabulary behind the product, rather than its regulatory split, is set out in the ophthalmic instrument and optics standards. ISO 15004-1:2020 covers the general requirements for ophthalmic instruments, and ISO 18369-1:2017 carries the vocabulary for the optics products used beside them.
| American category | Section | What it does | Common example |
|---|---|---|---|
| Astringent | 21 CFR 349.10 | Reduces surface redness | A redness-relief drop |
| Demulcent | 21 CFR 349.12 | Attracts and holds water | Carboxymethylcellulose sodium |
| Emollient | 21 CFR 349.14 | Slows evaporation | Light mineral oil, petrolatum |
| Eyewash | 21 CFR 349.20 | Irrigates the eye | A sterile saline wash |
What does an eye clinic keep beside the drop shelf?
A short list of consumables, and the two that run out fastest are the swab and the paper.
An infected or irritated eye is examined on a clean surface, so the exam table paper is replaced between patients, and the double-tipped cotton swabs are kept for lid margin cleaning and for the swab the laboratory asks for. A practice that also runs its own steriliser pairs the sterilization monitoring collection with the biological indicator 5-pack trial, which keeps the spore test record current for instruments that touch the eye.
For clinics and multi-site groups buying at case level, the wholesale ordering page sets out account and case terms, and the B2B wholesale collection lists the lines held for institutional buyers. The Canadian Ophthalmological Society resources are the clinical reference most often reached for when a practice is building the written protocol that sits beside that shelf. Reselling? become a distributor.
Sources
- 21 CFR 349.10, ophthalmic astringent
- 21 CFR 349.12, ophthalmic demulcents
- 21 CFR 349.14, ophthalmic emollients
- 21 CFR 349.20, eyewashes
- 21 CFR 886.4750, ophthalmic eye shield
- 21 CFR 886.1150, visual acuity chart
- 21 CFR 886.1170, colour vision tester
- Medical Devices Regulations, SOR/98-282
- Health Canada, drug and health product portal
- Health Canada, lubricant eye drops and artificial tears record
- ISO 15004-1:2020, ophthalmic instruments
- ISO 18369-1:2017, ophthalmic optics vocabulary
- ISO 13485:2016, medical device quality management
- ISO 14971:2019, risk management of medical devices
- American Academy of Ophthalmology, pink eye
- American Academy of Ophthalmology, dry eye
- College of Optometrists of Ontario, standards of practice
- Public Health Ontario, laboratory services test index
- CCOHS, OSH answers
- openFDA device classification API
A drop schedule is only as good as the record sheet under it. The printable clinic log sheet is a free sheet with columns for the date, the drop dispensed and the lot, so a pink-eye walk-in does not depend on a memory of which bottle was opened. The log generator sized to a single eye room builds the sheet from the number of patients a practice sees in a day, which keeps a small practice from being handed a hospital form. No account and no sign-up are needed to open either one.
Where the route of a drop or the record expected for it needs to be explained for an inspection, the written answer is the one worth having. Ask a compliance specialist and a written answer comes back specific to your equipment and province, with the regulation or standard it is based on cited.
Related reading
- Eye Drops in Canada vs the US: Which Route Applies
- Cold Compress Eye Care in Canada vs the US: Which Rules Apply
- Eye Clinic Consumables: Gloves, Swabs and Tape for Optometry
CliniEco Medical supplies laboratory, eye care and dental consumables of the kind described in this article. MDEL #35334. This article is written for optometry, laboratory and procurement professionals and is not legal advice; the selection of a drop and the records kept by a practice belong to the practice and to the requirements that apply to it.
Frequently Asked Questions
Are conjunctivitis eye drops over the counter in Canada?
A lubricant drop is authorised as a drug with a Drug Identification Number and is placed on the market after that authorisation. An antibacterial drop used for conjunctivitis is a prescription product. A front desk should not treat a common pink-eye drop as a walk-up purchase in Canada.
Do I need a prescription for pink eye drops in the United States?
For the antibacterial agents used for bacterial conjunctivitis, yes. A lubricant or emollient drop that matches the 21 CFR 349 monograph can be sold without a prescription.
What is the difference between a demulcent and an emollient eye drop?
A demulcent attracts and holds water on the surface of the eye, and the monograph lists cellulose derivatives and polyvinyl alcohol as examples. An emollient is an oily agent that slows evaporation, and the monograph lists light mineral oil and petrolatum as examples.
Which extract of the American rule lists the lubricant ingredients?
Section 21 CFR 349.12 lists the demulcents with a concentration range for each, and section 21 CFR 349.14 lists the emollients.
Does a viral conjunctivitis need an antibiotic drop?
No. A viral conjunctivitis runs its course, and an antibacterial drop does not change it. The discharge, the eyelids and the time course are what separate a viral from a bacterial presentation.
Why do the two countries list eye drops differently?
The United States groups over-the-counter ophthalmic drugs by category in a standing monograph, while Canada authorises each drug product and assigns it a Drug Identification Number. One list is a category rule and the other is a set of product records.
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