Statutes, codes, and regulations
District Of Columbia Administrative Code
Title 22 - HEALTHSubtitle 22-B - PUBLIC HEALTH AND MEDICINE
Chapter 22-B103 - LABELING OF MEDICAL DEVICES
Rule 22-B10309 - MEDICAL DEVICES: WARNING STATEMENTS FOR DEVICES CONTAINING OR MANUFACTURED WITH CHLOROFLUOROCARBONS AND OTHER CLASS I OZONE-DEPLETING SUBSTANCES

D.C. Mun. Regs. tit. 22, r. 22-B10309

Download
PDF
Current through Register Vol. 71, No. 49, December 6, 2024
Rule 22-B10309 - MEDICAL DEVICES: WARNING STATEMENTS FOR DEVICES CONTAINING OR MANUFACTURED WITH CHLOROFLUOROCARBONS AND OTHER CLASS I OZONE-DEPLETING SUBSTANCES
10309.1

All over-the-counter devices containing or manufactured with chlorofluorocarbons, halons, carbon tetrachloride, methyl chloride, or any other class I substance designated by the Environmental Protection Agency (EPA) shall carry one (1) of the following warnings:

(a) The EPA 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; or

(b) The alternative statement, which is as follows:

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.

CONSULT WITH YOUR PHYSICIAN, HEALTH PROFESSIONAL, OR SUPPLIER IF YOU HAVE ANY QUESTION ABOUT THE USE OF THIS PRODUCT.

Note: The indented statement above is required by the Federal government's Clean Air Act for all products containing or manufactured with chlorofluorocarbons (CFCs) [or other class I substance, if applicable].

10309.2

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 and appear with such prominence and conspicuousness as to render it likely to be read and understood by consumers under normal conditions of purchase.

D.C. Mun. Regs. tit. 22, r. 22-B10309

Final Rulemaking published at 60 DCR 10252 (July 12, 2013)
Authority: Section 19(a)(3) of the District of Columbia Pharmacist and Pharmacy Regulation Act of 1980, effective September 16, 1980 (D.C. Law 3-98; D.C. Official Code § 47-2885.18(a)(3) (2005 Repl.)); Mayor's Order 98-48, dated April 15, 1998; Section 4902 of the Fiscal Year 2002 Budget Support Act of 2001, effective October 3, 2001 (D.C. Law 14-28; D.C. Official Code § 7-731 (2008 Repl.)); Section 15 of the District of Columbia Medical Device Manufacture and Distribution Licensure Act of 1990, effective June 13, 1990 (D.C. Law 8-137; D.C. Official Code § 48-714(a) (2005 Repl.)); and Mayor's Order 98-88, dated May 29, 1998.