Conn. Agencies Regs. § 21a-115-22
Newness of a drug may arise by reason, among other reasons, of (a) the newness for drug use of any substance which composes such drug, in whole or in part, whether it is an active substance or a menstruum, excipient, carrier, coating or other component; (b) the newness for drug use of a combination of two or more substances, none of which is a new drug; (c) the newness for drug use of the proportion of a substance in a combination, even though such combination containing such substance in other proportion is not a new drug; (d) the newness of use of such drug in diagnosing, curing, mitigating, treating or preventing a disease, or to affect a structure or function of the body, even though such drug is not a new drug when used in another disease or to affect another structure or function of the body; or (e) the newness of a dosage, or method or duration of administration or application, or other condition of use prescribed, recommended or suggested in the labeling of such drug, even though such drug when used in other dosage, or other method or duration of administration or application, or different condition, is not a new drug.
(See 1963 Supp. § 21a-92(17).)
Conn. Agencies Regs. § 21a-115-22