[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: 21CFR801.435]

[Page 36-37]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES--(Continued)
 
PART 801--LABELING--Table of Contents
 
          Subpart H--Special Requirements for Specific Devices
 
Sec. 801.435   User labeling for latex condoms.

    (a) This section applies to the subset of condoms as identified in 
Sec. 884.5300 of this chapter, and condoms with spermicidal lubricant as 
identified in Sec. 884.5310 of this chapter, which products are formed 
from latex films.
    (b) Data show that the material integrity of latex condoms degrade 
over time. To protect the public health and minimize the risk of device 
failure, latex condoms must bear an expiration date which is supported 
by testing as described in paragraphs (d) and (h) of this section.
    (c) The expiration date, as demonstrated by testing procedures 
required by paragraphs (d) and (h) of this section, must be displayed 
prominently and legibly on the primary packaging (i.e., individual 
package), and higher levels of packaging (e.g., boxes of condoms), in 
order to ensure visibility of the expiration date by consumers.
    (d) Except as provided under paragraph (f) of this section, the 
expiration date must be supported by data demonstrating physical and 
mechanical integrity of the product after three discrete and 
representative lots of the product have been subjected to each of the 
following conditions:
    (1) Storage of unpackaged bulk product for the maximum amount of 
time the manufacturer allows the product to remain unpackaged, followed 
by storage of the packaged product at 70 1/2C (plus or minus 2 1/2C) for 
7 days;
    (2) Storage of unpackaged bulk product for the maximum amount of 
time the manufacturer allows the product to remain unpackaged, followed 
by storage of the packaged product at a selected temperature between 40 
and 50 1/2C (plus or minus 2 1/2C) for 90 days; and
    (3) Storage of unpackaged bulk product for the maximum amount of 
time the manufacturer allows the product to remain unpackaged, followed 
by storage of the packaged product at a monitored or controlled 
temperature between 15 and 30 1/2C for the lifetime of the product (real 
time storage).
    (e) If a product fails the physical and mechanical integrity tests 
commonly used by industry after the completion of the accelerated 
storage tests described in paragraphs (d)(1) and (d)(2) of this section, 
the product expiration date must be demonstrated by real time storage 
conditions described in paragraph (d)(3) of this section. If all of the 
products tested after storage at temperatures as described in paragraphs 
(d)(1) and (d)(2) of this section pass the manufacturer's physical and 
mechanical integrity tests, the manufacturer may label the product with 
an expiration date of up to 5 years from the date of product packaging. 
If the extrapolated expiration date under paragraphs (d)(1) and (d)(2) 
of this section is used, the labeled expiration date must be confirmed 
by physical and mechanical integrity tests performed at the end of the 
stated expiration period as described in paragraph (d)(3) of this 
section. If the data from tests following real time storage described in 
paragraph (d)(3) of this section fails to confirm the extrapolated 
expiration date, the manufacturer must, at that time, relabel the 
product to reflect the actual shelf life.
    (f) Products that already have established shelf life data based 
upon real time storage and testing and have such storage and testing 
data available for inspection are not required to confirm such data 
using accelerated and intermediate aging data described in paragraphs 
(d)(1) and (d)(2) of this section. If, however, such real time 
expiration dates were based upon testing of products that were not first 
left unpackaged for the maximum amount of time as described in paragraph 
(d)(3) of this section, the real time testing must be confirmed by 
testing products consistent with the requirements of paragraph (d)(3) of 
this section. This testing shall be initiated no later than the 
effective date of this regulation. Until the confirmation testing in 
accordance with paragraph (d)(3) of this section is completed, the 
product may remain on the market labeled with the expiration date based 
upon previous real time testing.
    (g) If a manufacturer uses testing data from one product to support 
expiration dating on any variation of that

[[Page 37]]

product, the manufacturer must document and provide, upon request, an 
appropriate justification for the application of the testing data to the 
variation of the tested product.
    (h) If a latex condom contains a spermicide, and the expiration date 
based on spermicidal stability testing is different from the expiration 
date based upon latex integrity testing, the product shall bear only the 
earlier expiration date.
    (i) The time period upon which the expiration date is based shall 
start with the date of packaging.
    (j) As provided in part 820 of this chapter, all testing data must 
be retained in each company's files, and shall be made available upon 
request for inspection by the Food and Drug Administration.
    (k) Any latex condom not labeled with an expiration date as required 
by paragraph (c) of this section, and initially delivered for 
introduction into interstate commerce after the effective date of this 
regulation is misbranded under sections 201(n) and 502(a) and (f) of 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(n) and 352(a) and 
(f)).

[62 FR 50501, Sept. 26, 1997]