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lot, or batch by rounding to the nearest 0.1 gram.
(1) A manufacturer shall design and implement a sampling plan that includes collection of probability samples of adequate size to yield consistent tolerance intervals such that the probability is 90 percent that at least 90 percent of the absorbencies of individual tampons within a brand and type are within the range of absorbency stated on the package label.
(2) In the absorbency test, an unlubricated condom, with tensile strength between 17 Mega Pascals (MPa) and 30 MPa, as measured according to the procedure in the American Society for Testing and Materials (ASTM) D 3492–97, “Standard Specification for Rubber Contraceptives (Male Condoms)”i 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 center 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 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 National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202–741-6030, or go to: http://www.archives.gov/ federal register/code of federal regulations ibr locations.html.
submitted in accordance with the requirements of $10.30 of this chapter, demonstrating that the alternative test method will yield results that are equivalent to the results yielded by the test method specified in this section; and
(ii) FDA approves the method and has published notice of its approval of the alternative test method in the FEDERAL REGISTER.
(g) Any menstrual tampon intended to be dispensed by a vending machine is exempt from the requirements of this section.
(h) Any menstrual tampon that is not labeled as required by paragraphs (c), (d), and (e) of this section and that is initially introduced or initially delivered for introduction into commerce after March 1, 1990, is misbranded under sections 201(n), 502 (a) and (f) of the act. (Information collection requirements contained in paragraphs (e) and (f) were approved by the Office of Management and Budget under control number 0910-0257) (47 FR 26989, June 22, 1982, as amended at 54 FR 43771, Oct. 26, 1989; 55 FR 17600, Apr. 26, 1990; 65 FR 3586, Jan. 24, 2000; 65 FR 44436, July 18, 2000; 65 FR 62284, Oct. 18, 2000; 69 FR 18803, Apr. 9, 2004; 69 FR 52171, Aug. 25, 2004)
render it likely to be read and understood by consumers under normal conditions of purchase.
(b)(1) For prescription and restricted device products, the following alternative warning statement may be used:
NOTE: The indented statement below is required by the Federal government's Clean Air Act for all products containing or manufactured with chlorofluorocarbons (CFC's) (or name of other class I substance, if applicable):
This product contains (or is manufactured with, if applicable) [insert name of substance), a substance which harms the environment by destroying ozone in the upper atmosphere.
Your physician has determined that this product is likely to help your personal health. USE THIS PRODUCT AS DIRECTED, UNLESS INSTRUCTED TO DO OTHERWISE BY YOUR PHYSICIAN. If you have any questions about alternatives, consult with your physician.
(2) The warning statement shall be clearly legible and conspicuous on the product, its immediate container, its outer packaging, or other labeling in accordance with the requirements of 40 CFR part 82 and appear with such prominence and conspicuousness as to prominence ana render it likely to be read and understood by consumers under normal conditions of purchase.
(3) If the warning statement in paragraph (b)(1) of this section is used, the following warning statement must be placed on the package labeling intended to be read by the physician (physician package insert) after the "How supplied" section, which describes special handling and storage conditions on the physician labeling:
NOTE: The indented statement below is required by the Federal government's Clean Air Act for all products containing or manufactured with chlorofluorocarbons (CFC's) for name of other class I substance, if applicable):
WARNING: Contains (or Manufactured with, if applicable) [insert name of substance), a substance which harms public health and environment by destroying ozone in the upper atmosphere.
A notice similar to the above WARNING has been placed in the information for the patient (or patient information leaflet, if applicable] of this product under Environmental Protection Agency (EPA) regulations. The patient's warning states that the patient should consult his or her physician if there are questions about alternatives.
$801.433 Warning statements for pre
scription and restricted device products containing or manufactured with chlorofluorocarbons or
other ozone-depleting substances. (a)(1) All prescription and restricted device products containing or manufactured with chlorofluorocarbons, halons, carbon tetrachloride, methyl chloride, or any other class I substance designated by the Environmental Protection Agency (EPA) shall, except as provided in paragraph (b) of this section, bear the following warning statement:
WARNING: Contains (or Manufactured with, if applicable] [insert name of substance), a substance which harms public health and environment by destroying ozone in the upper atmosphere.
(2) The warning statement shall be clearly legible and conspicuous on the product, its immediate container, its outer packaging, or other labeling in accordance with the requirements of 40 CFR part 82 and appear with such prominence and conspicuousness as to
(c) This section does not replace or (e) If a product fails the physical and relieve a person from any requirements mechanical integrity tests commonly imposed under 40 CFR part 82.
used by industry after the completion [61 FR 20101, May 3, 1996)
of the accelerated storage tests de
scribed in paragraphs (d)(1) and (d)(2) of $ 801.435 User labeling for latex this section, the product expiration condoms.
date must be demonstrated by real (a) This section applies to the subset
time storage conditions described in of condoms as identified in $ 884.5300 of
paragraph (d)(3) of this section. If all of this chapter, and condoms with
the products tested after storage at spermicidal lubricant as identified in
temperatures as described in para$ 884.5310 of this chapter, which prod
graphs (d)(1) and (d)(2) of this section ucts are formed from latex films.
pass the manufacturer's physical and (b) Data show that the material in
mechanical integrity tests, the manutegrity of latex condoms degrade over facturer may label the product with an time. To protect the public health and
expiration date of up to 5 years from minimize the risk of device failure,
the date of product packaging. If the latex condoms must bear an expiration extrapolated expiration date under date which is supported by testing as
paragraphs (d)(1) and (d)(2) of this secdescribed in paragraphs (d) and (h) of
tion is used, the labeled expiration date this section.
must be confirmed by physical and me(c) The expiration date, as dem- chanical integrity tests performed at onstrated by testing procedures re the end of the stated expiration period quired by paragraphs (d) and (h) of this as described in paragraph (d)(3) of this section, must be displayed prominently section. If the data from tests foland legibly on the primary packaging lowing real time storage described in (i.e., individual package), and higher paragraph (d)(3) of this section fails to levels of packaging (e.g., boxes of confirm the extrapolated expiration condoms), in order to ensure visibility date, the manufacturer must, at that of the expiration date by consumers. time, relabel the product to reflect the
(d) Except as provided under paragraph (f) of this section, the expiration (f) Products that already have estabdate must be supported by data dem- lished shelf life data based upon real onstrating physical and mechanical in- time storage and testing and have such tegrity of the product after three dis- storage and testing data available for crete and representative lots of the inspection are not required to confirm product have been subjected to each of such data using accelerated and interthe following conditions:
mediate aging data described in para(1) Storage of unpackaged bulk prod- graphs (d)(1) and (d)(2) of this section. uct for the maximum amount of time If, however, such real time expiration the manufacturer allows the product to dates were based upon testing of prodremain unpackaged, followed by stor ucts that were not first left age of the packaged product at 70 °C unpackaged for the maximum amount (plus or minus 2 °C) for 7 days;
of time as described in paragraph (d)(3) (2) Storage of unpackaged bulk prod of this section, the real time testing uct for the maximum amount of time must be confirmed by testing products the manufacturer allows the product to consistent with the requirements of remain unpackaged, followed by stor- paragraph (d)(3) of this section. This age of the packaged product at a se- testing shall be initiated no later than lected temperature between 40 and 50 the effective date of this regulation. °C (plus or minus 2 °C) for 90 days; and Until the confirmation testing in ac
(3) Storage of unpackaged bulk prod- cordance with paragraph (d)(3) of this uct for the maximum amount of time section is completed, the product may the manufacturer allows the product to remain on the market labeled with the remain unpackaged, followed by stor- expiration date based upon previous age of the packaged product at a mon- real time testing. itored or controlled temperature be- (g) If a manufacturer uses testing tween 15 and 30 °C for the lifetime of data from one product to support expithe product (real time storage).
ration dating on any variation of that