Title 21 CFR reference

The use of chlorofluorocarbons in human drugs as propellants in self-pressurized containers is generally prohibited except as provided by § 2.125 of this chapter. [43 FR 11317, Mar. 17, 1978]

(a) Definitions: The following definitions of terms apply only to this section: Eligible investigational drug.(1) An eligible investigational drug is as defined in section 561B(a)(2) of the Federal Food, Drug, and Cosmetic Act. Eligible patient.(2) An eligible patient is as defined in section 561B(a)(1) of the Federal Food, Drug, and Cosmetic Act. Investigational New Drug (IND).(3) An IND is as defined in § 312.3 of this chapter. Known serious adverse event.(4) A serious adverse event (as defined in § 312.32 of this chapter) is considered “known” if the manufacturer or sponsor is aware of it. Manufacturer or sponsor.(5) A manufacturer or sponsor is the person who: (i) Meets the definition of “sponsor” in § 312.3 of this chapter for the eligible investigational drug; (ii) Has submitted an application for the eligible investigational drug under section 505(b) of the Federal Food, Drug, and Cosmetic Act or section 351(a) of the Public Health Service Act; or (iii) Is other than a contract manufacturer acting on behalf of a manufacturer or sponsor, producing the eligible investigational drug provided to an eligible patient on behalf of the persons described in paragraph…

The Food and Drug Administration's policy in administering the new-drug, antibiotic, and other regulatory provisions of the Federal Food, Drug, and Cosmetic Act regarding fixed combination dosage form prescription drugs for humans is as follows: (a) Two or more drugs may be combined in a single dosage form when each component makes a contribution to the claimed effects and the dosage of each component (amount, frequency, duration) is such that the combination is safe and effective for a significant patient population requiring such concurrent therapy as defined in the labeling for the drug. Special cases of this general rule are where a component is added: (1) To enhance the safety or effectiveness of the principal active component; and (2) To minimize the potential for abuse of the principal active component. (b) If a combination drug presently the subject of an approved new-drug application has not been recognized as effective by the Commissioner of Food and Drugs based on his evaluation of the appropriate National Academy of Sciences-National Research Council panel report, or if substantial evidence of effectiveness has not otherwise been presented for it, then formulation,…