[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR800.10]

[Page 5]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 800--GENERAL--Table of Contents
 
          Subpart B--Requirements for Specific Medical Devices
 
Sec. 800.10  Contact lens solutions; sterility.


    (a)(1) Informed medical opinion is in agreement that all 
preparations offered or intended for ophthalmic use, including contact 
lens solutions, 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. By this regulation, this ruling is applicable to all 
preparations for ophthalmic use that are regulated as medical devices, 
i.e., contact lens solutions. By the regulation in Sec. 200.50 of this 
chapter, this ruling is applicable to ophthalmic preparations that are 
regulated as drugs.
    (3) The containers 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 these solutions shall also comply with Sec. 800.12 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 medical devices unless 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.

[47 FR 50455, Nov. 5, 1982]