Latex Condoms; User Labeling; Expiration Dating

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.

-----------------------------------------------------------------------

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

--------------------------------------------------------------------------------------------------------------------------------------------------------

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

--------------------------------------------------------------------------------------------------------------------------------------------------------

801.435(d) 58 1 58 96 5,568 $1,856\1\ $94,655\2\

--------------------------------------------------------------------------------------------------------------------------------------------------------

\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