§ 310.507 - Aerosol drug products for human use containing 1,1,1-trichloroethane.

(a) Trichloroethane has been used in aerosol drug products as a solvent for the active ingredients and to reduce the vapor pressure of the propellants. It is potentially toxic to the cardiovascular system, i.e., can sensitize the heart to epinephrine. At a sufficiently large concentration, it is a potent anesthetic agent. Deaths associated with aerosol decongestant products intended to be inhaled and containing trichloroethane have been reported. Most of the deaths resulted from abuse or gross misuse of the preparations.

(b) The Food and Drug Administration finds that there is a lack of general recognition by qualified experts of the safety or effectiveness of trichloroethane in aerosol drug products intended for inhalation either directly or indirectly. Any aerosol drug product containing trichloroethane and labeled, represented, or advertised for use by inhalation is a new drug and subject to regulatory proceedings unless it is the subject of a new drug application approved pursuant to section 505 of the Federal Food, Drug, and Cosmetic Act.

(c) Clinical investigations designed to obtain evidence that any aerosol drug product containing trichloroethane and labeled, represented, or advertised for use by inhalation either directly or indirectly is safe and effective for the purposes intended must comply with the requirements and procedures governing the use of investigational new drugs set forth in part 312 of this chapter.

(d) Regulatory proceedings will be initiated with regard to any such drug within the jurisdiction of the act which is not in accord with this regulation on January 16, 1978.