§ 310.506 - Use of vinyl chloride as an ingredient, including propellant, of aerosol drug products.

(a) Vinyl chloride has been used as a propellant in aerosol drug preparations. Evidence indicates that vinyl chloride inhalation can result in acute toxicity manifested by dizziness, headache, disorientation, and unconsciousness where inhaled at high concentrations. Cardiac effects, bone changes, and degenerative changes in the brain, liver, and kidneys have been reported in animals. Studies also demonstrate carcinogenic effects in animals as a result of inhalation exposure to vinyl chloride. Recently, vinyl chloride has been linked to liver disease, including liver cancer, in workers engaged in the polymerization of vinyl chloride.

(b) The Commissioner finds that there is a lack of general recognition by qualified experts of the safety or effectiveness of aerosol drug preparations containing vinyl chloride as an ingredient, including propellant. Therefore, any such product containing vinyl chloride is a new drug and a new drug application approved under section 505 of the Federal Food, Drug, and Cosmetic Act is required for marketing.

(c) Clinical investigations designed to obtain evidence that any aerosol drug preparation containing vinyl chloride as an ingredient, including propellant, is safe and effective for the purpose intended, must comply with the requirements and procedures governing the use of investigational new drugs set forth in part 312 of this chapter.

(d) Any such drug within the jurisdiction of the act which is not in accord with this regulation is subject to regulatory action.