21 CFR 200.50
Ophthalmic preparations and dispensers
21 CFR 200.50 is the regulation titled “Ophthalmic preparations and dispensers” in 21 CFR Part 200, General. Since 2021, 8 FDA warning letters have cited it.
- Letters citing it
- 8 since 2021
- Jan 1 to Oct 30, 2026
- 0 against 0 on the same dates in 2025
- Most often cited with
- 21 CFR 201.128, in 4 letters
- Closed out
- 13% of these letters have a published close-out
Letters citing it, by year issued
Most are drug letters (7 of 8). 2026 runs to Oct 30, 2026. Pick a year to see its letters.
What FDA writes when it cites it
The finding headings that cite 21 CFR 200.50 most often, as written in the letters.
- 1 letterDelsam Pharma’s ARTIFICIAL TEARS and Delsam Pharma’s ARTIFICIAL EYE OINTMENT are misbranded under section 502(j) of the FD&C Act, 21 U.S.C. 352(j), because they are not sterile
- 1 letterEZRICARE Artificial Tears is misbranded under section 502(j) of the FD&C Act, 21 U.S.C. 352(j), because it is not sterile
The regulation
Read the text of 21 CFR 200.50 (eCFR, as of Sep 1, 2026)
(a)(1) Informed medical opinion is in agreement that all preparations offered or intended for ophthalmic use, including preparations for cleansing the eyes, should be sterile. It is further evident that such preparations purport to be of such purity and quality as to be suitable for safe use in the eye.
(2) The Food and Drug Administration concludes that all such preparations, if they are not sterile, fall below their professed standard of purity or quality and may be unsafe. In a statement of policy issued on September 1, 1964, the Food and Drug Administration ruled that liquid preparations offered or intended for ophthalmic use that are not sterile may be regarded as adulterated within the meaning of section 501(c) of the Federal Food, Drug, and Cosmetic Act (the act), and, further, may be deemed misbranded within the meaning of section 502(j) of the act. This ruling is extended to affect all preparations for ophthalmic use. By this regulation, this ruling is applicable to ophthalmic preparations that are regulated as drugs. By the regulation in § 800.10 of this chapter, this ruling is applicable to ophthalmic preparations that are regulated as medical devices.
(3) The containers of ophthalmic preparations shall be sterile at the time of filling and closing, and the container or individual carton shall be so sealed that the contents cannot be used without destroying the seal. The packaging and labeling of ophthalmic preparations that are over-the-counter drugs shall also comply with § 211.132 of this chapter on tamper-resistant packaging requirements.
(b) Liquid ophthalmic preparations packed in multiple-dose containers should:
(1) Contain one or more suitable and harmless substances that will inhibit the growth of microorganisms; or
(2) Be so packaged as to volume and type of container and so labeled as to duration of use and with such necessary warnings as to afford adequate protection and minimize the hazard of injury resulting from contamination during use.
(c) Eye cups, eye droppers, and other dispensers intended for ophthalmic use should be sterile, and may be regarded as falling below their professed standard of purity or quality if they are not sterile. These articles, which are regulated as drugs if packaged with the drugs with which they are to be used, should be packaged so as to maintain sterility until the package is opened and be labeled, on or within the retail package, so as to afford adequate directions and necessary warnings to minimize the hazard of injury resulting from contamination during use.
[40 FR 13996, Mar. 27, 1975, as amended at 47 FR 50455, Nov. 5, 1982]
Text from eCFR as of Sep 1, 2026.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 200.50.
- 21 CFR 201.128Meaning of “intended uses”4 letters cite both
- 21 CFR 211.113Control of microbiological contamination4 letters cite both
- 21 CFR 211.166Stability testing2 letters cite both
- 21 CFR 211.22Responsibilities of quality control unit2 letters cite both
- 21 CFR 211.42Design and construction features2 letters cite both
- 21 CFR 211.84Testing and approval or rejection of components, drug product containers, and closures2 letters cite both
- 21 CFR 1271.3How does FDA define important terms in this part?1 letter cites both
- 21 CFR 207.1What definitions and interpretations of terms apply to this part?1 letter cites both
Latest letters citing it
The 3 letters citing 21 CFR 200.50 that FDA posted most recently.
- BiologicsView Regenerative Processing Plant, LLCRegener-Eyes PRO and LITE ophthalmic solutionsIssuedAug 16, 2024PostedSep 6, 2024
- DrugsView Delsam Pharma LLCDistributor of ophthalmic artificial tears and eye ointmentIssuedFeb 13, 2024PostedFeb 27, 2024
- DrugsView EzriCare LLCEZRICARE Artificial TearsIssuedFeb 13, 2024PostedFeb 27, 2024
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Counts include every citation in a letter, as the Letters filter does. How this database is built.