Current through Register Vol. 71, No. 49, December 6, 2024
Rule 22-B10209 - ADVERTISING10209.1An advertisement of a device shall be deemed to be false if it is misleading in any particular.
10209.2An advertisement of a device is false if the advertisement represents that the device affects:
(a) Infectious and parasitic diseases;(c) Endocrine, nutritional, and metabolic diseases and immunity disorders;(d) Diseases of blood and blood-forming organs;(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.10209.3Subsection 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.10209.4Nothing 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.