[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR800.12]

[Page 5-7]
 
                        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. 800.12  Contact lens solutions and tablets; tamper-resistant packaging.

    (a) General. Unless contact lens solutions used, for example, to 
clean, disinfect, wet, lubricate, rinse, soak, or store contact lenses 
and salt tablets or other dosage forms to be used to make any such 
solutions are packaged in tamper-resistant retail packages, there is the 
opportunity for the malicious adulteration of these products with

[[Page 6]]

risks both to individuals who unknowingly purchase adulterated products 
and with loss of consumer confidence in the security of the packages of 
over-the-counter (OTC) health care products. The Food and Drug 
Administration has the authority and responsibility under the Federal 
Food, Drug, and Cosmetic Act (the act) to establish a uniform national 
standard for tamper-resistant packaging of those OTC products vulnerable 
to malicious adulteration that will improve the security of OTC 
packaging and help assure the safety and effectiveness of the products 
contained therein. A contact lens solution or tablet or other dosage 
form to be used to make such a solution for retail sale that is not 
packaged in a tamper-resistant package and labeled in accordance with 
this section is adulterated under section 501 of the act or misbranded 
under section 502 of the act, or both.
    (b) Requirement for tamper-resistant package. Each manufacturer and 
packer who packages for retail sale a product regulated as a medical 
device that is a solution intended for use with contact lenses, e.g., 
for cleaning, disinfecting, wetting, lubricating, rinsing, soaking, or 
storing contact lenses or tablets or other dosage forms to be used to 
make any such solution shall package the product in a tamper-resistant 
package, if this product is accessible to the public while held for 
sale. A tamper-resistant package is one having an indicator or barrier 
to entry which, if breached or missing, can reasonably be expected to 
provide visible evidence to consumers that tampering has occurred. To 
reduce the likelihood of substitution of a tamper-resistant feature 
after tampering, the indicator or barrier to entry is required to be 
distinctive by design or by the use of an identifying characteristic 
(e.g., a pattern, name, registered trademark, logo, or picture). For 
purposes of this section, the term ``distinctive by design'' means the 
package cannot be duplicated with commonly available material or through 
commonly available processes. A tamper-resistant package may involve an 
immediate-container and closure system or secondary-container or carton 
system or any combination of systems intended to provide a visual 
indication of package integrity. The tamper-resistant feature shall be 
designed to and shall remain intact when handled in a reasonable manner 
during manufacture, distribution, and retail display.
    (c) Labeling. Each retail package of a product covered by this 
section is required to bear a statement that is prominently placed so 
that consumers are alerted to the tamper-resistant feature of the 
package. The labeling statement is also required to be so placed that it 
will be unaffected if the tamper-resistant feature of the package is 
breached or missing. If the tamper-resistant feature chosen to meet the 
requirement in paragraph (b) of this section is one that uses an 
identifying characteristic, that characteristic is required to be 
referred to in the labeling statement. For example, the labeling 
statement on a bottle with a shrink band could say ``For your 
protection, this bottle has an imprinted seal around the neck.''
    (d) Requests for exemptions from packaging and labeling 
requirements. A manufacturer or packer may request an exemption from the 
packaging and labeling requirements of this section. A request for an 
exemption is required to be submitted in the form of a citizen petition 
under Sec. 10.30 of this chapter and should be clearly identified on the 
envelope as a ``Request for Exemption from Tamper-resistant Rule.'' A 
petition for an exemption from a requirement of this section is required 
to contain the same kind of information about the product as is 
specified for OTC drugs in Sec. 211.132(d) of this chapter. This 
information collection requirement has been approved by the Office of 
Management and Budget under number 0910-0150.
    (e) Products subject to approved premarket approval applications. 
Holders of approved premarket approval applications for products subject 
to this section are required to submit supplements to provide for 
changes in packaging to comply with the requirement of paragraph (b) of 
this section unless these changes do not affect the composition of the 
container, the torque (tightness) of the container, or the composition 
of the closure component in contact with the contents (cap liner

[[Page 7]]

or innerseal) as these features are described in the approved premarket 
approval application. Any supplemental premarket approval application 
under this paragraph is required to include data sufficient to show that 
these changes do not adversely affect the product.
    (f) Effective date. Each product subject to this section is required 
to comply with the requirements of this section on the dates listed 
below except to the extent that a product's manufacturer or packer has 
obtained an exemption from a packaging or labeling requirement:
    (1) Initial effective date for packaging requirements. (i) The 
packaging requirement in paragraph (b) of this section is effective on 
February 7, 1983 for each contact lens solution packaged for retail sale 
on or after that date, except for the requirement in paragraph (b) of 
this section for a distinctive indicator or barrier to entry.
    (ii) The packaging requirement in paragraph (b) of this section is 
effective on May 5, 1983 for each tablet that is to be used to make a 
contact lens solution and that is packaged for retail sale on or after 
that date.
    (2) Initial effective date for labeling requirements. The 
requirement in paragraph (b) of this section that the indicator or 
barrier to entry be distinctive by design and the requirement in 
paragraph (c) of this section for a labeling statement are effective on 
May 5, 1983 for each product subject to this section packaged for retail 
sale on or after that date, except that the requirement for a specific 
label reference to any identifying characteristic is effective on 
February 6, 1984 for each affected product subject to this section 
packaged for retail sale on or after that date.
    (3) Retail level effective date. The tamper-resistant packaging 
requirement of paragraph (b) of this section is effective on February 6, 
1984 for each product subject to this section that is held for sale at 
retail level on or after that date that was packaged for retail sale 
before May 5, 1983. This does not include the requirement in paragraph 
(b) of this section that the indicator or barrier to entry be 
distinctive by design. Products packaged for retail sale after May 5, 
1983, are required to be in compliance with all aspects of the 
regulations without regard to the retail level effective date.

[47 FR 50455, Nov. 5, 1982; 48 FR 1706, Jan. 14, 1983, as amended at 48 
FR 16666, Apr. 19, 1983; 48 FR 37625, Aug. 19, 1983; 53 FR 11252, Apr. 
6, 1988]

    Effective Date Note:  A document published at 48 FR 41579, Sept. 16, 
1983, stayed the effective date of Sec. 800.12(f)(3) until further 
notice.