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Society for Testing and Materials (ASTM) D 3492–97, “Standard Specification for Rubber Contraceptives (Male Condoms)"1 for determining tensile strength, which is incorporated by reference in accordance with 5 U.S.C. 552(a), is attached to the large end of a glass chamber (or a chamber made from hard transparent plastic) with a rubber band (see figure 1) and pushed through the small end of the chamber using a smooth finished rod. The condom is pulled through until all slack is removed. The tip of the condom is cut off and the remaining end of the condom is stretched over the end of the tube and secured with a rubber band. A preweighed (to the nearest 0.01 gram) tampon is placed within the condom membrane so that the center of gravity of the tampon is at the cen
ter of the chamber. An infusion needle (14 gauge) is inserted through the septum created by the condom tip until it contacts the end of the tampon. The outer chamber is filled with water pumped from a temperature-controlled waterbath to maintain the average temperature at 27+1 °C. The water returns to the waterbath as shown in figure 2. Syngyna fluid (10 grams sodium chloride, 0.5 gram Certified Reagent Acid Fushsin, 1,000 milliliters distilled Acid Fushsin. 10 water) is then pumped through the infusion needle at a rate of 50 milliliters per hour. The test shall be terminated when the tampon is saturated and the first drop of fluid exits the apparatus. (The test result shall be discarded if fluid is detected in the folds of the condom before the tampon is saturated). The water is then drained and the tampon is removed and immediately weighed to the nearest 0.01 gram. The absorbency of the tampon is determined by subtracting its dry weight from this value. The condom shall be replaced after 10 tests or at the end of the day during which the condom is used in testing, whichever occurs first.
1 Copies of the standard are available from the American Society for Testing and Materials, 100 Barr Harbor Dr., West Conshohocken, PA 19428, or available for inspection at the Center for Devices and Radiological Health's Library, 9200 Corporate Blvd., Rockville, MD 20850, or at the Office of the Federal Register, 800 North Capitol St.. NW., suite 700, Washington, DC.
submitted in accordance with the re- stood by consumers under normal conquirements of $10.30 of this chapter, ditions of purchase. demonstrating that the alternative (b)(1) For prescription and restricted test method will yield results that are device products, the following alterequivalent to the results yielded by the native warning statement may be used: test method specified in this section; NOTE: The indented statement below is reand
quired by the Federal government's Clean (ii) FDA approves the method and
Air Act for all products containing or manuhas published notice of its approval of factured with chlorofluorocarbons (CFC's) the alternative test method in the FED- [or name of other class I substance, if appliERAL REGISTER.
cable): (g) Any menstrual tampon intended This product contains (or is manufactured to be dispensed by a vending machine with, if applicable] [insert name of substance), is exempt from the requirements of a substance which harms the environment by this section.
destroying ozone in the upper atmosphere. (h) Any menstrual tampon that is not Your physician has determined that this labeled as required by paragraphs (c),
product is likely to help your personal (d), and (e) of this section and that is
health. USE THIS PRODUCT AS DIRECTED,
UNLESS INSTRUCTED TO DO OTHERWISE initially introduced or initially delivered for introduction into commerce
BY YOUR PHYSICIAN. If you have any ques
tions about alternatives, consult with your after March 1, 1990, is misbranded
physician. under sections 201(n), 502 (a) and (f) of
(2) The warning statement shall be the act.
clearly legible and conspicuous on the (Information collection requirements con product, its immediate container, its tained in paragraphs (e) and (f) were ap
outer packaging, or other labeling in proved by the Office of Management and
accordance with the requirements of 40 Budget under control number 0910-0257)
CFR part 82 and appear with such [47 FR 26989, June 22, 1982, as amended at 54
prominence and conspicuousness as to FR 43771, Oct. 26, 1989; 55 FR 17600, Apr. 26,
render it likely to be read and under1990; 65 FR 3586, Jan. 24, 2000; 65 FR 44436, July 18, 2000; 65 FR 62284, Oct. 18, 2000)
stood by consumers under normal con
ditions of purchase. 8801.433 Warning statements for pre (3) If the warning statement in para
scription and restricted device graph (b)(1) of this section is used, the products containing or manufac following warning statement must be tured with chlorofluorocarbons or
placed on the package labeling inother ozone-depleting substances.
tended to be read by the physician (a)(1) All prescription and restricted (physician package insert) after the device products containing or manufac “How supplied” section, which detured with chlorofluorocarbons, halons,
scribes special handling and storage carbon tetrachloride, methyl chloride,
conditions on the physician labeling: or any other class I substance des
NOTE: The indented statement below is reignated by the Environmental Protec
quired by the Federal government's Clean tion Agency (EPA) shall, except as pro
Air Act for all products containing or manuvided in paragraph (b) of this section, factured with chlorofluorocarbons (CFC's) bear the following warning statement: (or name of other class I substance, if appli
cable] WARNING: Contains (or Manufactured with, if applicable] [insert name of substance), a sub WARNING: Contains (or Manufactured with, stance which harms public health and envi if applicable] [insert name of substance), a subronment by destroying ozone in the upper at stance which harms public health and envimosphere.
ronment by destroying ozone in the upper at
mosphere. (2) The warning statement shall be
A notice similar to the above WARNING clearly legible and conspicuous on the
has been placed in the information for the product, its immediate container, its
patient (or patient information leaflet, if apouter packaging, or other labeling in
plicable) of this product under Environaccordance with the requirements of 40
mental Protection Agency (EPA) regulaCFR part 82 and appear with such tions. The patient's warning states that the prominence and conspicuousness as to patient should consult his or her physician if render it likely to be read and under- there are questions about alternatives.
(c) This section does not replace or relieve a person from any requirements imposed under 40 CFR part 82. [61 FR 20101, May 3, 1996] $801.435 User labeling for latex
condoms. (a) This section applies to the subset of condoms as identified in $ 884.5300 of this chapter, and condoms with spermicidal lubricant as identified in 8884.5310 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 para graph (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 C (plus or minus 2 +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 C (plus or minus 2 +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 °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 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