D.C. Mun. Regs. tit. 22, r. 22-B10307

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

Rule 22-B10307 - STATEMENT OF IDENTITY

10307.1

The principal display panel of an over-the-counter device in package form shall bear as one (1) of its principal features a statement of the identity of the commodity.

10307.2

The statement of identity shall be in terms of the common name of the device followed by an accurate statement of the principal intended action(s) of the device. The statement shall be placed in direct conjunction with the most prominent display of the name and shall employ terms descriptive of the principal intended action(s). The indications for use shall be included in the directions for use of the device, as required by 21 U.S.C. § 352(f)(1) and by the regulations in this section.

10307.3

The statement of identity shall be presented in bold face type on the principal display panel, shall be in a size reasonably related to the most prominent printed matter on the panel, and shall be in lines generally parallel to the base on which the package rests as it is designed to be displayed.

D.C. Mun. Regs. tit. 22, r. 22-B10307

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.