[Code of Federal Regulations]
[Title 21, Volume 4]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR200.50]
[Page 6-7]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 200 GENERAL--Table of Contents
Subpart C Requirements for Specific Classes of Drugs
Sec. 200.50 Ophthalmic preparations and dispensers.
(a)(1) Informed medical opinion is in agreement that all
preparations offered
[[Page 7]]
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 Sec. 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 Sec. 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]
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