D.C. Mun. Regs. tit. 22, r. 22-B10209

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

Rule 22-B10209 - ADVERTISING

10209.1

An advertisement of a device shall be deemed to be false if it is misleading in any particular.

10209.2

An advertisement of a device is false if the advertisement represents that the device affects:

(a) Infectious and parasitic diseases;

(b) Neoplasms;

(c) Endocrine, nutritional, and metabolic diseases and immunity disorders;

(d) Diseases of blood and blood-forming organs;

(e) Mental disorders;

(f) Diseases of the nervous system and sense organs;

(g) Diseases of the circulatory system;

(h) Diseases of the respiratory system;

(i) Diseases of the digestive system;

(j) Diseases of the genitourinary system;

(k) Complications of pregnancy, childbirth, and the puerperium;

(l) Diseases of the skin and subcutaneous tissue;

(m) Diseases of the musculoskeletal system and connective tissue;

(n) Congenital anomalies;

(o) Certain conditions originating in the perinatal period;

(p) Symptoms, signs, and ill-defined conditions; or

(q) Injury and poisoning.

10209.3

Subsection 10209.2 shall not apply to an advertisement of a device if the advertisement does not violate the Act and is disseminated:

(a) To the public for self-medication and is consistent with the FDA's labeling claims;

(b) Only to members of the medical, dental, and veterinary professions and appears only in the scientific periodicals of those professions; or

(c) Only for the purpose of public health education by a person not commercially interested, directly or indirectly, in the sale of the device.

10209.4

Nothing in this section shall be construed as establishing any official policy of the Department concerning self-medication for a disease, other than a disease listed under § 10209.2, including any official policy that such self-medication is safe and effective.

D.C. Mun. Regs. tit. 22, r. 22-B10209

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.