D.C. Mun. Regs. tit. 22, r. 22-B10304

Current through Register Vol. 71, No. 49, December 6, 2024

Rule 22-B10304 - MEDICAL DEVICES: PROMINENCE OF REQUIRED LABEL STATEMENTS

10304.1

A word, statement, or other information required by or under the authority of the Act to appear on the label may lack prominence and conspicuousness, for the following:

(a) Such word, statement, or information fails to appear on the part or panel of the label which is presented or displayed under customary conditions of purchase;

(b) Such word, statement, or information fails to appear on two (2) or more parts or panels of the label, each of which has sufficient space therefore, and each of which is so designed as to render it likely to be, under customary conditions of purchase, the part or panel displayed;

(c) The label fails to extend over the area of the container or package available for such extension, so as to provide sufficient label space for the prominent placing of such word, statement, or information;

(d) The label space is insufficient for the prominent placing of such word, statement, or information, resulting from the use of label space for any other word, statement, design, or device that is not required by or under authority of the Act to appear on the label;

(e) Label space is insufficient for the placing of such word, statement, or information, resulting from the use of label space to give materially greater conspicuousness to any other word, statement, or information, or to any design or device; or

(f) Type style in which such word, statement, or information appears is small, there is insufficient background contrast or obscuring designs or vignettes, or the label is crowded with other written, printed, or graphic matter.

10304.2

No exemption depending on insufficiency of label space, as prescribed in regulations promulgated under 21 USC § 352(b) of the act, shall apply if such insufficiency is caused by:

(a) The use of label space for any word, statement, design, or device which is not required by or under authority of the Act to appear on the label;

(b) The use of label space to give greater conspicuousness to any word, statement, or other information than is required by 21 USC § 352(c); or

(c) The use of label space for any representation in a foreign language.

10304.3

All words, statements, and other information required by or under authority of the Act to appear on the label or labeling shall appear thereon in the English language; provided, however, that in case of articles distributed solely in the Commonwealth of Puerto Rico or in a territory where the predominant language is one other than English, the predominant language may be substituted for English.

10304.4

If the label contains any representation in a foreign language, all words, statements, and other information required by or under authority of the Act to appear on the label shall appear thereon in the foreign language.

D.C. Mun. Regs. tit. 22, r. 22-B10304

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.