CA Health & Safety Code Section 110405

An advertisement that is not unlawful under Section 110390 is not unlawful under Section 110403 if it is either one of the following:

(a)

Disseminated only to members of the medical, dental, pharmaceutical, or veterinary professions, or appears only in the scientific periodicals of these professions, or is disseminated only for the purpose of public health education by persons not commercially interested, directly or indirectly, in the sale of drugs or devices.

(b)

An advertisement that a drug or device has a specific curative or therapeutic effect on a condition, disorder, or disease listed in Section 110403 if the drug or device is approved or cleared for marketing for that specific curative or therapeutic effect through any of the following means:

(1)

A new drug application approved pursuant to Section 111500, or Section 505 of the federal act (21 U.S.C. Sec. 355).

(2)

An abbreviated new drug application approved pursuant to Section 505 of the federal act (21 U.S.C. Sec. 355).

(3)

A licensed biological product pursuant to Section 351 of the Public Health Service Act (42 U.S.C. Sec. 262).

(4)

A nonprescription drug that meets the requirements of Part 330 of Title 21 of the Code of Federal Regulations.

(5)

A new animal drug application approved under Section 512 of the federal act (21 U.S.C. Sec. 360b).

(6)

An abbreviated new animal drug application approved pursuant to Section 512 of the federal act (21 U.S.C. Sec. 360b).

(7)

A new device application approved pursuant to Section 111550.

(8)

A device premarket approval application approved under Section 515 of the federal act (21 U.S.C. Sec. 360e).

(9)

A determination of substantial equivalence for a device pursuant to Section 513(f)(1) of the federal act (21 U.S.C. Sec. 360c(i)).