D.C. Mun. Regs. tit. 22, r. 22-B10326
This section applies to the subset of condoms as identified in 21 C.F.R. § 884.5300, and condoms with spermicidal lubricant identified in 21 C.F.R. § 884.5310, whose products are formed from latex films.
Data show that the material integrity of latex condoms degrades over time. To protect the public health and minimize the risk of device failure, latex condoms must bear an expiration date.
The expiration date, as demonstrated by testing procedures required by §§ 10326.4 and 10326.8, must be displayed prominently and legibly on the primary packaging (such as individual package), and higher levels of packaging (such as boxes of condoms), in order to ensure visibility of the expiration date by consumers.
Except as provided under § 10326.6, the expiration date must be supported by data demonstrating physical and mechanical integrity of the product after three (3) discrete and representative lots of the product have been subjected to each of the following conditions:
If a product fails the physical and mechanical integrity tests commonly used by industry after the completion of the accelerated storage tests described in §§ 10326.4(a) and(b), the product expiration date must be demonstrated by real time storage conditions described in § 10326.4(c). If all of the products tested after storage at temperatures pass the manufacturer's physical and mechanical integrity tests, the manufacturer may label the product with an expiration date of up to five (5) years from the date of product packaging. If the extrapolated expiration date under §§ 10326.4(a) and(b) 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 section § 10326.4(c). If the data from tests following real time storage described in § 10326.4(c) of this section fail to confirm the extrapolated expiration date, the manufacturer must, at that time, re-label the product to reflect the actual shelf life.
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 §§ 10326.4(a) and (b). 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 § 10326.4(c), the real time testing must be confirmed by testing products consistent with the requirements of § 10326.4(c). Until the confirmation testing in accordance with § 10326.4(c) is completed, the product may remain on the market labeled with the expiration date based upon previous real time testing.
If a manufacturer uses testing data from one (1) product to support expiration 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.
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.
The time period upon which the expiration date is based shall start with the date of packaging.
As provided in Chapter 107 of this subtitle, all testing data must be retained in each company's files, and shall be made available upon request for inspection by the FDA of the Department.
Any latex condom not labeled with an expiration date as required by § 10326.3 and initially delivered for introduction into interstate commerce after the effective date of this regulation is misbranded under 21 U.S.C. §§ 321(n) and 352(a) and (f).
D.C. Mun. Regs. tit. 22, r. 22-B10326