[Federal Register Volume 62, Number 187 (Friday, September 26, 1997)]
[Rules and Regulations]
[Pages 50497-50502]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-25587]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 801
[Docket No. 95N-0374]
RIN 0910-AA32
Latex Condoms; User Labeling; Expiration Dating
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
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SUMMARY: The Food and Drug Administration (FDA) is issuing a final rule
that requires the labeling of latex condoms to contain an expiration
date based upon physical and mechanical testing performed after
exposing the product to varying conditions that age latex. Studies show
that latex condoms degrade over time. Such degradation has a
significant effect on the product's ability to provide a barrier to
sexually transmitted diseases (STD's), including human immunodeficiency
virus (HIV). This requirement is established in order to provide
consumers with essential information regarding the safe use of these
products.
EFFECTIVE DATE: March 25, 1998.
FOR FURTHER INFORMATION CONTACT: Donald E. Marlowe, Center for Devices
and Radiological Health (HFZ-100), Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850, 301-443-2444.
SUPPLEMENTARY INFORMATION:
I. Background
It is estimated that over 1 million persons in the United States
are infected with HIV (Ref. 1). Although nonsexual transmission can
occur, HIV is transmitted primarily through sexual contact. With the
prevalence of HIV infection and the risk of transmission of other
STD's, the importance of the quality of an effective barrier to the
transmission of infection is crucial. Because latex membranes, such as
condoms and medical gloves, are effective barriers against the spread
of various diseases, including hepatitis, HIV, and other STD's (Refs.
2, 4, and 5), the Centers for Disease Control and Prevention and the
Surgeon General of the Public Health Service have recommended that
latex condoms be used according to instructions with every act of
intercourse for maximum protection against STD's (Ref. 3).
The effectiveness of latex condoms as a barrier, however, is
dependent upon the integrity of the latex material. Degradation of
latex film products (e.g., the embrittlement of the latex film, an
increase in the porosity of the membrane, or other loss of physical
properties) occurs when latex is exposed to various types of
environmental conditions (such as elevated temperature, fluorescent
lights, or ozone) normally experienced in product use, shipment, or
storage conditions. Exposure to these environmental conditions degrade
the film progressively over time and may result in bursts, rips, tears,
or seepages that allow the transmission of disease.
To understand the effects of aging and other storage conditions on
latex properties, the State of Washington's Board of Pharmacy initiated
an FDA-sponsored study of the material integrity of latex condoms (the
FDA/Washington study) in July of 1989 (Ref. 6). At the laboratories of
the FDA/Washington study, packaged and unpackaged latex condoms were
exposed to 20 and 30 deg.C (representing room temperature) for up to 5
years. In order to represent exposure to the upper extreme of
environmental temperatures, condoms were exposed for 100 days to a
temperature of 45 deg.C. Also, to accelerate the aging process of the
latex, condoms were exposed to temperatures of 70 and 85 deg.C for up
to 100 days (Refs. 7 through 9).
The study revealed that exposed condoms (i.e., condoms not
protected by packaging) degraded to the point of being unusable within
1 year at room temperature, and at higher temperatures in as little as
10 days. The FDA/Washington study further shows that latex condoms
stored in intact plastic packages also degrade over time, though at a
much slower rate. The results of the FDA/Washington study demonstrate
that aging and other conditions can significantly affect the integrity,
strength, and quality of latex essential to maintaining a barrier
against the transmission of disease.
Based upon these findings, using standards established by the
American Society for Testing and Materials (ASTM), and following
meetings with condom manufacturers, the agency published in the Federal
Register of May 24, 1996 (61 FR 26140), a proposed rule that would
require latex condoms to be labeled with an expiration date.
Specifically, FDA proposed that, to ensure visibility of the expiration
date by customers, an expiration date must appear on the primary
packaging (i.e., the individual package), as well as higher levels of
labeling, such as the case containing individually packaged products.
To establish the expiration date, FDA proposed that a manufacturer,
before performing tests on products that demonstrate physical and
mechanical integrity of the product, subject products from three
discrete and random lots to each of the following conditions: (1)
Storage unpackaged for the maximum amount of time the manufacturer
allows the product to remain unpackaged after manufacture, followed by
storage of the packaged product at 70 deg.C (plus or minus 2 deg.C)
for 7 days; (2) storage unpackaged for the maximum amount of time the
manufacturer allows the product to remain unpackaged after manufacture,
followed by storage of the packaged product at 40 to 50 deg.C (plus or
minus
[[Page 50498]]
2 deg.C) for 90 days; and (3) storage unpackaged for the maximum
amount of time the manufacturer allows the product to remain unpackaged
after manufacture, followed by storage of the packaged product at 15 to
30 deg.C for the stated shelf life of the product.
If the latex barrier properties are adequate (i.e., pass the
manufacturer's physical and mechanical integrity tests) after
undergoing the 70 deg.C/7-day and 40 to 50 deg.C/90-day tests, the
proposal provided for that product to be labeled with an expiration
date of up to 5 years. If the product, after storage at either 7- or
90-day test conditions, fails to meet the manufacturer's physical or
mechanical integrity tests, the labeled shelf life of the product would
be required to be demonstrated by real-time storage data at 15 to 30
deg.C. Products that pass the 7- and 90-day test conditions would be
required to undergo confirmation tests after the product has been
stored at 15 to 30 deg.C for the stated shelf life. If the product
fails the 15 to 30 deg.C confirmation test, the product would be
required to be relabeled to represent the actual shelf life supported
by real time data.
This final rule incorporates the principles described in the
proposed rule and requires latex condoms to bear expiration dates after
being subjected to appropriate testing. When a labeling change is made
to comply with this rule, products currently cleared for marketing
would not be required to submit a new 510(k). FDA will modify agency
guidance to reflect this policy. Of course, latex condom products that
have not been cleared for marketing are still required to submit to FDA
a 510(k) premarket notification.
II. Summary of Comments
The agency received only three comments on the proposed rule, two
of which addressed the economic impact of the rule, but not its
content. The remaining comment, submitted by a trade association, was
generally supportive of the proposed rule but raised several issues
warranting further consideration.
A. General
1. The comment stated that the proposed rule did not distinguish
between the testing requirements applicable to new products as opposed
to currently marketed products. The comment suggests that some
currently marketed products may already be labeled with an expiration
date that has been cleared by the agency. To require these products to
undergo testing following accelerated and intermediate aging would be
unnecessarily redundant if the existing cleared expiration date has
been established by real time testing.
The agency agrees that, where a product bears an expiration date
based on appropriate integrity tests following storage in real time,
accelerated aging and testing are redundant and should not be required.
This position is reflected in the final rule that has been modified
accordingly in new Sec. 801.435(f).
The agency stresses that testing data supporting an expiration date
must be available for inspection by the agency, regardless of whether
the agency previously cleared product labeling which bears an
expiration date. If such data is not available for inspection, the
manufacturer must generate shelf life data with accelerated and real
time storage and testing.
2. The comment suggested that the introductory paragraph of
proposed Sec. 801.435(d) be modified to read,
``The expiration date must be supported by the data from
reasonable quality control tests demonstrating the physical and
mechanical integrity of the product after three discrete and typical
lots of the product have been subjected to each of the following
conditions.'' (Emphasis added.)
The language in the proposed rule stated, ``* * * after three discrete
and random lots of the same product have been subjected to each of the
following conditions.'' (Emphasis added.)
The agency recognizes that manufacturers of new products, or new
formulations, may not have produced a sufficient number of lots to
allow a truly random selection for testing. The purpose of selecting
random lots is to ensure that the tests are conducted on products that
are representative of the products being produced. The word
``representative'' is more commonly used in the context of sampling
analyses than its synonym, ``typical.'' The agency believes the comment
that suggested substituting the word ``typical'' for ``random'' is
appropriately addressed by substituting the word ``representative'' for
the word ``random.'' The final regulation has been modified
accordingly.
The agency also recognizes that the proposed requirement to conduct
testing on lots of the same product needs further clarification in
light of the agency's October 1989 ``General Guidance for Modifying
Condom Labeling to Include Shelf Life,'' that states that shelf life
data may not be needed for each variation from a ``standard'' condom.
The agency continues to consider its October 1989 guidance to be an
accurate statement of agency policy. FDA recognizes that a manufacturer
may produce several variations of a tested condom, including variations
of packaging, design (e.g., texture, thickness, etc.), latex
formulation (including color additives), dusting powders, spermicides,
desensitizers, and lubricants. As stated in the agency guidance, ``FDA
recognizes that some variations may not warrant separate shelf life
testing.'' Certain variations, however, may affect condom strength,
integrity, and even response to environmental factors in a variety of
ways. Therefore, the regulation has been revised to state in
Sec. 801.435(g) that, if a manufacturer applies shelf life data to a
variation of the tested condom, the manufacturer must document and
provide upon request appropriate justification.
3. The comment stated that the requirement that the condoms to be
tested be stored unpackaged for the maximum amount of time the
manufacturer allows the product to remain unpackaged, before packaging,
storage, and testing, is unnecessary and overly burdensome. The comment
states that this provision would require manufacturers to develop new
data for holding periods with respect to products that are currently
labeled with approved expiration dating.
The agency disagrees that this provision is unnecessary and overly
burdensome. Degradation of latex films is cumulative. Shelf life data
derived from a lot of condoms that were packaged the day following
production may not necessarily be applicable to the same product that
is left unpackaged for 180 days. In requiring a manufacturer to conduct
tests on products that have been stored unpackaged for the maximum time
the manufacturer allows the product to remain unpackaged, the agency is
ensuring that the integrity of the tested products would be
representative of the products receiving the greatest exposure to
environmental conditions. Thus, shelf life data generated by testing
these products could be applied with the greatest confidence.
As discussed in comment 1 in section II.A of this document, the
agency believes that currently cleared expiration dates that have been
determined by real time testing of the product may continue to be
applied. In the event this real time testing did not account for time
periods products remain unpackaged, however, manufacturers would be
required to perform confirmation testing to account for maximum holding
periods for their products that are already labeled with an expiration
date. This testing will be initiated by the effective date of the
[[Page 50499]]
regulation. Until the confirmation tests are completed, the previously
cleared products may remain on the market labeled with the expiration
date based on previous real time testing. The regulation has been
modified in Sec. 801.435(f) to clarify this issue.
4. The comment objected to the requirement that new premarket
notification submissions, required under section 510(k) of the Federal
Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360(k)), for latex
condoms should include data to establish labeled expiration dates,
especially in light of the agency's allowance that such data need only
be held as part of the manufacturing records for currently marketed
products. This comment suggested that new 510(k) submissions only be
required to state the claimed expiration dating period, and identify
whether it has been tentatively established through accelerated aging
or established under real time conditions consistent with the
requirements of Sec. 801.435.
The agency agrees with this comment. The agency believes that a
510(k) submission that includes statements that appropriate tests were
performed and that the condoms passed appropriate mechanical and
physical integrity tests should not generally have to include
underlying test data. FDA intends to revise its existing guidance on
510(k) submissions for latex condoms to reflect its position that
underlying data for expiration dating should not be submitted. All
shelf life data generated under the requirements of this final rule
shall be retained in each company's files, as required by Sec. 820.180
(21 CFR 820.180), and shall be made available upon request for
inspection by FDA.
5. The comment requests that the agency draw a clear distinction in
the regulation between closed-ended latex condoms, that are used for
prevention of STD transmission and pregnancy, and open-ended condom
catheters that are used for continence and chronic care.
The agency confirms that the rule does not apply to open-ended
condom catheters. The agency, however, does not believe that the
regulation requires any modification to clarify this issue. As proposed
and finalized, the regulation states that ``this section applies to the
subset of condoms as identified in Sec. 884.5300, and condoms with
spermicidal lubricant as identified in Sec. 884.5310 of this chapter,
which products are formed from latex films.'' Sections 884.5300 and
884.5310 (21 CFR 884.5300 and 884.5310) specifically describe the
intended uses of closed ended condoms. The regulation, therefore,
clearly establishes that open-ended condom catheters are not subject to
this rule.
Moreover, in order to avoid future confusion, the agency is taking
this opportunity to clarify the fact that this rule does not apply to
female condoms. Female condoms are distinguished from the products
identified in the scope of this rule in two significant details: (1)
Sections 884.5300 and 884.5310 do not describe female condoms, and (2)
female condoms are formed from polyurethane, not latex.
6. The agency is also taking this opportunity to clarify its
position regarding latex condoms that are sold with spermicidal
lubricants. Such products are currently cleared for marketing provided
they bear labeling that reflects expiration dates and statements
relating to the spermicidal agents. On August 9, 1982, in response to a
petition by Schmidt Laboratories, Inc., FDA issued an order
reclassifying a condom with a spermicidal lubricant (nonoxyl-9) from
class III to class II. In the preamble to the final rule published in
the Federal Register of October 29, 1982 (47 FR 49021), which
reclassified generic condoms with spermicidal lubricants into class II,
FDA advised that the generic device was reclassified into class II only
insofar as its labeling bore an expiration date for the spermicidal
agent and the following statement ``The expiration date on this product
applies only to the spermicidal agent in it.''
Because the effectiveness of condoms with spermicidal lubricants
depends on both the integrity of the latex and the stability of the
spermicide, the expiration date should warn against use of the product
after a date that either the spermicide or the latex could be
ineffective. FDA is advising that it would consider a condom with
spermicidal lubricant that bears the earlier expiration date that is
related to the condom's latex or spermicidal properties, substantially
equivalent to a class II condom with spermicidal lubricant under
Sec. 884.5310.
FDA has added Sec. 801.435(h) to the final rule to state that if a
latex condom contains spermicide, and the expiration date based upon
spermicidal stability testing is different from the expiration date
based on latex integrity testing, the product shall bear only the
earlier expiration date. Accordingly, the statement required by the
August 9, 1982, Reclassification Order that ``The expiration date on
this product applies only to the spermicidal agent in it'' would be
incorrect and shall not appear on the labeling of latex condoms with
spermicidal lubricants following the effective date of this regulation.
Any labeling changes to comply with Sec. 801.435(h) will not require
the filing of a new 510(k).
This regulation does not impose new testing requirements to
determine expiration dates based upon spermicide stability.
Manufacturers should continue to perform the appropriate tests to
determine spermicide amount and biological activity that have supported
the expiration dating for the spermicide in the past.
B. Comments on the Economic Impact
7. The agency received two comments addressing the economic impact
of the proposed rule. One comment stated that the agency significantly
underestimated the cost burden of establishing an expiration date for
latex condoms because, in order to accurately establish shelf life
data, a manufacturer would need to test packaging integrity, packaging
material, and lubricants used, as well as latex compound integrity.
The agency disagrees. The testing requirements in the proposed and
final rules would provide shelf life data based upon the aggregate
effect of the factors identified by the comment. The agency believes
that no real purpose would be served by additionally requiring the
suggested tests.
8. One comment suggested that requiring manufacturers of new
products to submit shelf life data with their 510(k) submissions
subjects manufacturers of those products to an additional
administrative burden that is unnecessarily restrictive and may delay
the public access to new and improved products.
As discussed in comment 4 in section II.A of this document, the
agency has revised its position and is not requiring that manufacturers
submit shelf life data with their 510(k) submissions. Instead, shelf
life data shall be retained in each company's files, as required by
Sec. 820.180, and shall be made available upon request for inspection
by FDA.
C. Comments on the Estimated Recordkeeping Burden
9. One comment stated that the agency significantly underestimated
the recordkeeping burden that would be created by shelf life testing.
The comment stated that the number of condom variations that would
require testing is much higher than estimated, however, no guidance was
given for estimating the number more accurately. The comment also
stated that the industry practice in gathering real time testing data
is to test the product each year. That is, instead of testing the
product at 0 days, 7 days (accelerated
[[Page 50500]]
aging), 90 days (intermediate aging), and 5 years (real time) as
discussed in the paperwork burden section of the proposed rule (61 FR
26140 at 26143), manufacturers would actually be testing at 0 days, 7
days, 90 days, 1 year, 2 years, 3 years, 4 years, and 5 years. This
would represent a doubling of the testing burden for each product over
the course of 5 years.
The agency agrees that the testing of products in intermediate
years 1, 2, 3, and 4 is an appropriate and customary method of
gathering real time shelf life data. This would be reflected in the
burden chart as a doubling of the estimated burden. However, in
response to other comments, the agency has required manufacturers of
latex condoms that already have expiration dating data, based on real
time testing, to do only a confirmation test, as appropriate. These
products would be required to be tested only once in 5 years. The
Paperwork Reduction Act analysis is modified to address these changes
in testing frequency.
Moreover, the agency has adjusted the Paperwork Reduction statement
to address the comment stating that manufacturers would be required to
collect expiration dating data for more than one variation of a
standard condom. The agency has attributed an average of two variations
that would require testing for each standard condom considered in its
original estimate. Furthermore, the agency has provided that
manufacturers may apply expiration dating data collected on a standard
to a variation of the standard, provided the manufacturer documents its
justification. The burden estimates have been modified to reflect the
cost of such documentation.
The Paperwork Reduction Act analysis is further modified to
annualize the cost of shelf life testing over 5 years. Whereas the
proposed Paperwork Reduction Act analysis reflected an annual burden of
testing products at 0 days, 7 days, 90 days, and 5 years, the agency
has determined that it would be more appropriate to consider the
testing of products at 0 days, 7 days, 90 days, 1 year, 2 years, 3
years, 4 years, and 5 years, as a burden spread out over the 5 years it
would take to complete the tests.
III. Environmental Impact
The agency has determined under 21 CFR 25.24(a)(11) that this
action is of a type that does not individually or cumulatively have a
significant effect on the human environment. Therefore, neither an
environmental assessment nor an environmental impact statement is
required.
IV. Analysis of Impacts
FDA has examined the impacts of the final rule under Executive
Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612), as
amended by Subtitle D of the Small Business Regulatory Fairness Act of
1996 (Pub. L. 104-121), and the Unfunded Mandates Reform Act of 1995
(Pub. L. 104-4). Executive Order 12866 directs agencies to assess all
costs and benefits of available regulatory alternatives and, when
regulation is necessary, to select regulatory approaches that maximize
net benefits (including potential economic, environmental, public
health and safety, and other advantages; distributive impacts; and
equity). The agency believes that this final rule is consistent with
the regulatory philosophy and principles identified in the Executive
Order. In addition, the final rule is not a significant regulatory
action as defined by the Executive Order and so is not subject to
review under the Executive Order.
The Regulatory Flexibility Act requires agencies to analyze
regulatory options that would minimize any significant impact of a rule
on small entities. This regulation requires physical and mechanical
integrity tests. Because condom manufacturers routinely conduct such
tests on their products as part of their quality control practices, the
required testing would affect manufacturers primarily by establishing
storage conditions prior to testing such products, and increasing
sampling sizes subjected to testing. This rule also requires a labeling
change. However, the 180-day time period between the publication date
and effective date of this rule will allow most manufacturers to
exhaust their existing supply of labels. Accordingly, the agency
certifies that the final rule will not have a significant economic
impact on small entities. Therefore, under the Regulatory Flexibility
Act, no further analysis is required.
V. Paperwork Reduction Act of 1995
This final rule contains information collections which are subject
to review by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995. The title, description, and respondent
description of the information collections are shown below and an
estimate of the annual recordkeeping and periodic reporting burden.
Included in the estimate is the time for reviewing instructions,
gathering and maintaining the data needed, and completing and reviewing
the collection of information.
Title: Labeling Requirements for Latex Condoms--Expiration Date
Labeling.
Description: These information collection requirements apply to
manufacturers of latex condoms. This rule expands the labeling of latex
condoms to include an expiration date. The expiration date must be
supported by data from quality control tests demonstrating physical and
mechanical integrity of three sample lots of the product being tested
that were stored under accelerated and real time aging conditions.
Quality control testing under accelerated aging conditions must include
tests of unpackaged bulk product for the maximum amount of time the
manufacturer allows the product to remain unpackaged, followed by: (1)
Storage of the packaged product at 70 deg.C (plus or minus 2 deg.C)
for 7 days; (2) storage of the packaged product at a selected
temperature between 40 and 50 deg.C (plus or minus 2 deg.C) for 90
days; and (3) storage of the packaged product at a monitored or
controlled temperature between 15 and 30 deg.C for the lifetime of the
product (up to 5 years). Manufacturers who already have shelf life data
based upon real time testing are not required to perform the 7-day and
90-day accelerated aging testing.
The recording of shelf life testing by condom manufacturers is used
to support the inclusion of expiration dating on the labeling of latex
condoms. Information concerning latex condom shelf life is necessary to
allow lay users to use these products safely by avoiding use of
products that have degraded. The effectiveness of latex condoms as a
barrier is dependent upon the integrity of the latex material. The
shelf life of latex condoms is material information that consumers need
in order to safely use the product.
Condom manufacturers will use the information collected from the
testing to establish the expiration date to be printed on the labeling,
and purchasers will use the information collected to determine the
likely effectiveness of the product.
Section 510(h) of the act, requires that condom manufacturers, as
device manufacturers, be inspected at least once in a 2-year period.
During that inspection, FDA inspectors will review the test records
used to support the expiration date in order to ensure that the
expiration date is accurate.
Description of Respondents: Businesses or other for profit
organizations.
[[Page 50501]]
Estimated Annual Recordkeeping Burden
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Annual Total Operating
21 CFR Section No. of Frequency per Total Annual Hours per Total Hours Total Capital and Maintenance
Recordkeepers Recordkeeping Records Recordkeeper Costs Costs
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801.435(d) 58 1 58 96 5,568 $1,856\1\ $94,655\2\
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\1\ Capital costs are one time start-up costs and consist of a revision of policies and procedures. These costs have been annualized over a period of 5
years.
\2\ The annual burden reported here represents the recordkeeping burden of testing a product of 0 days, 7 days, 90 days, 1 year, 2 years, 3 years, 4
years, and 5 years. The cost of this burden is annualized over the 5-year period required to conduct all the necessary testing.
The agency received one comment on the Paperwork Reduction Act
statement of the proposed rule. As discussed in comment 9 in section
II.C of this document, the agency has adjusted the estimated burden
according to the suggestions made by the comment. The revised estimated
burden has been adjusted to include the burden of testing a product at
intermediate years during real time aging, and the burden of testing
more than one variation on a standard condom. The revised estimated
burden reflects a burden annualized over the 5 years required to
perform all necessary testing.
Persons are not required to respond to a collection of information
unless it displays a currently valid OMB control number. This final
rule contains information collection requirements which have been
submitted to OMB for approval. FDA will publish a notice in the Federal
Register prior to the effective date of this final rule of OMB's
decision to approve, modify, or disapprove the information collection
requirements.
VI. References
The following references have been placed on display in the Dockets
Management Branch (address above) and may be seen by interested persons
between 9 a.m. and 4 p.m., Monday through Friday.
1. Center for Disease Control and Prevention, ``HIV Prevalence
Estimates and AIDS Case Projections for The United States: Report
Based Upon a Workshop,'' Morbidity and Mortality Weekly Report, vol.
39/No. RR-16, November 30, 1990.
2. Conference on Latex as a Barrier Material, University of
Maryland, (sponsored by FDA), May 1989.
3. Center for Disease Control and Prevention, ``Update: Barrier
Protection Against HIV Infection and Other Sexually Transmitted
Diseases,'' Morbidity and Mortality Weekly Report, vol. 42/No. 30,
August 6, 1993.
4. DeVincenzi, L., European Study Group on Heterosexual
Transmission of HIV, Heterosexual Transmission of HIV in a European
Cohort of Couples (abstract No. WS-CO2-1), vol. 1, IXth
International Conference on AIDS/IVth STD World Congress, Berlin,
83, June 9, 1993.
5. Saracco, A., M. Musicco, A. Nicolosi, et al., ``Man-to-Woman
Sexual Transmission of HIV: Longitudinal Study of 343 Steady
Partners of Infected Men,'' Journal of Acquired Immune Deficiency
Syndrome, 6:497-502, 1993.
6. Final Report: Lubricated Latex Condoms--Study of the Effects
of Environmental Parameters on Deterioration: Program for
Appropriate Technology in Health (PATH), FDA Contract No. 223-88-
4285, October 1993.
7. Mandel, J. et al., ``Measurement of the Aging of Rubber
Vulcanizates,'' Journal of Research of the National Bureau of
Standards, vol. 63C, No. 2, October-December, 1959.
8. Barker, L. R., ``Accelerated and Long-Term Ageing of Natural
Rubber Vulcanizates,'' Journal of Natural Rubber Research, vol. 2,
No. 4, pp. 201-213, 1987.
9. Barker, L. R., ``Accelerated Long-Term Ageing of Natural
Rubber Vulcanizates, Part 2: Results From Aging Tests at 40 C,''
Journal of Natural Rubber Research, vol. 5, No. 3, pp. 266-274,
1990.
10. ASTM D 3492, Standard Specification for Rubber
Contraceptives (Condoms), American Society for Testing and
Materials, Philadelphia, PA.
11. ``General Guidance for Modifying Condom Labeling to Include
Shelf Life,'' FDA Guidance Document.
List of Subjects in 21 CFR Part 801
Labeling, Medical devices, Reporting and recordkeeping
requirements.
Therefore, under the Federal Food, Drug, and Cosmetic Act, and
under authority delegated to the Commissioner of Food and Drugs, 21 CFR
part 801 is amended as follows:
1. The authority citation for 21 CFR part 801 continues to read as
follows:
Authority: Secs. 201, 301, 501, 502, 507, 519, 520, 701, 704 of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 331, 351,
352, 357, 360i, 360j, 371, 374).
2. New Sec. 801.435 is added to subpart H to read as follows:
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 deg.C (plus or minus 2
deg.C) 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 deg.C (plus or minus 2 deg.C) 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 deg.C 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
[[Page 50502]]
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 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)).
Dated: August 20, 1997.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 97-25587 Filed 9-25-97; 8:45 am]
BILLING CODE 4160-01-F