 |
D.C. Municipal Regulations (Last Updated: September 13, 2017) |
 |
Title 22. HEALTH |
|
SubTilte 22-B. PUBLIC HEALTH AND MEDICINE |
|
Chapter 22-B103. LABELING OF MEDICAL DEVICES |
Section 22-B10325. WARNING STATEMENTS FOR PRESCRIPTION AND RESTRICTED DEVICE PRODUCTS CONTAINING OR MANUFACTURED WITH CHLOROFLUOROCARBONS OR OTHER OZONE-DEPLETING SUBSTANCES
-
10325.1All 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 § 10325.3, bear the following warning statement:
“Warning: Contains [or Manufactured with, if applicable] [insert name of substance], a substance which harms public health and the environment by destroying ozone in the upper atmosphere.”
10325.2The 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 C.F.R. part 82 and appear with such prominence and conspicuousness as to render it likely to be read and understood by consumers under normal conditions of purchase.
10325.3For prescription and restricted device products, the following alternative warning statement may be used:
“Note: The indented statement below is required by the District of Columbia for all products containing or manufactured with chlorofluorocarbons (CFCs) [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 your physician.”
10325.4The warning statement shall be clearly legible and conspicuous on the product, its immediate container, its outer packaging, or other labeling and appear with such prominence and conspicuousness so that it is likely to be read and understood by consumers under normal conditions of purchase.
10325.5If the warning statement in Paragraph § 10325.3 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 District of Columbia for all products containing or manufactured with chlorofluorocarbons (CFCs) [or 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.”10325.6This section does not replace or relieve a person from any requirements imposed under 40 C.F.R., part 82.