Section 22-B10327. USER LABELING FOR DEVICES THAT CONTAIN NATURAL RUBBER

 

10327.1Data in the Medical Device Reporting System and the scientific literature indicate that some individuals are at risk of severe anaphylactic reactions to natural latex proteins. This labeling regulation is intended to minimize the risk to individuals sensitive to natural latex proteins and to protect the public health.

 

10327.2 This section applies to all devices composed of or containing, or having packaging or components that are composed of or contain, natural rubber that contacts humans.

 

10327.3For purposes of this section, the term "natural rubber" includes natural rubber latex, dry natural rubber, and synthetic latex or synthetic rubber that contains natural rubber in its formulation.

 

10327.4  For purposes of this section, the term "natural rubber latex" means rubber that is produced by the natural rubber latex process that involves the use of natural latex in a concentrated colloidal suspension. Products are formed from natural rubber latex by dipping, extruding, or coating.

 

10327.5  For purposes of this section, the term "dry natural rubber" means rubber that is produced by the dry natural rubber process that involves the use of coagulated natural latex in the form of dried or milled sheets. Products are formed from dry natural rubber by compression molding, extrusion, or converting the sheets into a solution for dipping.

 

10327.6  For purposes of this section, the term "contacts humans" means that the natural rubber contained in a device is intended to contact or is likely to contact the user or patient. This includes contact when the device that contains natural rubber is connected to the patient by a liquid path or an enclosed gas path; or the device containing the natural rubber is fully or partially coated with a powder, and such powder may carry natural rubber proteins that may contaminate the environment of the user or patient.

 

10327.7Devices containing natural rubber shall be labeled as set forth in §§ 10327.5 through 10327.9.  Each required labeling statement shall be prominently and legibly displayed in accordance with 21 U.S.C. § 352(c).

 

10327.8Devices containing natural rubber latex that contacts humans, as described in § 10327.2, shall bear the following statement in bold print on the device labeling:

"Caution: This Product Contains Natural Rubber Latex Which May Cause Allergic Reactions."

This statement shall appear on all device labels, and other labeling, and shall appear on the principal display panel of the device packaging; the outside package, container, or wrapper; and the immediate device package, container, or wrapper.

 

10327.9Devices containing dry natural rubber that contacts humans, as described in § 10327.2, shall bear the following statement in bold print on the device labeling:

"This Product Contains Dry Natural Rubber."

This statement shall appear on all device labels, and other labeling, and shall appear on the principal display panel of the device packaging; the outside package, container, or wrapper; and the immediate device package, container, or wrapper.

 

10327.10Devices that have packaging containing natural rubber latex that contacts humans shall bear the following statement in bold print on the device labeling:

"Caution: The Packaging of This Product Contains Natural Rubber Latex Which May Cause Allergic Reactions."

This statement shall appear on the packaging that contains the natural rubber, and the outside package, container, or wrapper.

 

10327.11Devices that have packaging containing dry natural rubber that contacts as described in § 10327.2, shall bear the following statement in bold print on the device labeling:

"The Packaging of This Product Contains Dry Natural Rubber."

This statement shall appear on the packaging that contains the natural rubber and the outside package, container, or wrapper.

 

10237.12Devices that contain natural rubber that contacts humans shall not contain the term "hypoallergenic" on their labeling.

 

10327.13Any affected person may request an exemption or variance from the requirements of this section by submitting a citizen petition in accordance with 21 C.F.R. § 10.30.

 

10327.14Any device subject to this section that is not labeled in accordance with §§ 10327.4 through 10327.8 and that is initially introduced or 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), (c), and (f).

 

 

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.

source

Final Rulemaking published at 60 DCR 10252 (July 12, 2013).