65-669a.New drugs; selling, offering or giving away, restrictions;investigational uses.(a) No person shall sell, deliver, offer for sale, hold for sale or giveaway any new drug unless (1) an application with respect thereto hasbeen approved and such approval has not been withdrawn under 21 U.S.C.A.355, or (2) when not subject to the federal act, unless such drug hasbeen tested and has been found to be safe for use and effective in useunder the conditions prescribed, recommended, or suggested in thelabeling thereof, and prior to selling or offering for sale such drug,there has been filed with the secretary an application setting forth (A)full reports of investigations which have been made to show whether ornot such drug is safe for use and whether such drug is effective in use;(B) a full list of the articles used as components of such drug; (C) afull statement of the composition of such drug; (D) a full descriptionof the methods used in, and the facilities and controls used for, themanufacture, processing and packing of such drug; (E) such samples ofsuch drug and of the articles used as components thereof as thesecretary may require; and (F) specimens of the labeling proposed to beused for such drug.
(b) An application provided for in subsection (a)(2) of thissection shall become effective 180 days afterthe filing thereof, except that if the secretary finds, after due noticeto the applicant and giving the applicant an opportunity for ahearing, that thedrug is not safe or not effective for use under the conditionsprescribed, recommended or suggested in the proposed labeling thereof,the secretary shall, prior to the effective date of the application,issue an order refusing to permit the application to become effective.Hearings under this subsection shall be conducted in accordance with theprovisions of the Kansas administrative procedure act.
(c) An order refusing to permit an application under this section tobecome effective may be revoked by the secretary.
(d) This section shall not apply to: (1) A drug intended solely forinvestigational use by experts qualified by scientific training andexperience to investigate the safety and effectiveness of drugs,provided the drug is plainly labeled in compliance with regulationsissued by the secretary or pursuant to 21 U.S.C.A. 355 or 21 U.S.C.A.357; or (2) a drug sold in this state at any time prior to theenactment of this act or introduced into interstate commerce at any timeprior to the enactment of the federal act; or (3) any drug which islicensed under the virus, serum, and toxin act of July 1, 1902 (U.S.C.1958 ed. title 42, chapter 6A, sec. 262); or (4) any drug which issubject to subsection (1) of K.S.A. 65-669 and amendments thereto.
(e) The provisions of subsection (n) of K.S.A. 65-656and amendments theretoshall not apply to any drug which was, on October 9, 1962, or on the dateimmediately preceding the enactment of this subsection, (1)commercially sold or used in this state or in the United States, (2)not a new drug as defined by subsection (n) of K.S.A. 65-656 andamendments thereto as then inforce, and (3) was not covered by an effective application under thissection or under 21 U.S.C.A. 355, when such drug is intended solely foruse under conditions prescribed, recommended or suggested in labelingwith respect to such drug.
History: L. 1965, ch. 377, § 7; L. 1974, ch. 352, §109;L. 1988, ch. 356, § 187; July 1, 1989.
65-669a.New drugs; selling, offering or giving away, restrictions;investigational uses.(a) No person shall sell, deliver, offer for sale, hold for sale or giveaway any new drug unless (1) an application with respect thereto hasbeen approved and such approval has not been withdrawn under 21 U.S.C.A.355, or (2) when not subject to the federal act, unless such drug hasbeen tested and has been found to be safe for use and effective in useunder the conditions prescribed, recommended, or suggested in thelabeling thereof, and prior to selling or offering for sale such drug,there has been filed with the secretary an application setting forth (A)full reports of investigations which have been made to show whether ornot such drug is safe for use and whether such drug is effective in use;(B) a full list of the articles used as components of such drug; (C) afull statement of the composition of such drug; (D) a full descriptionof the methods used in, and the facilities and controls used for, themanufacture, processing and packing of such drug; (E) such samples ofsuch drug and of the articles used as components thereof as thesecretary may require; and (F) specimens of the labeling proposed to beused for such drug.
(b) An application provided for in subsection (a)(2) of thissection shall become effective 180 days afterthe filing thereof, except that if the secretary finds, after due noticeto the applicant and giving the applicant an opportunity for ahearing, that thedrug is not safe or not effective for use under the conditionsprescribed, recommended or suggested in the proposed labeling thereof,the secretary shall, prior to the effective date of the application,issue an order refusing to permit the application to become effective.Hearings under this subsection shall be conducted in accordance with theprovisions of the Kansas administrative procedure act.
(c) An order refusing to permit an application under this section tobecome effective may be revoked by the secretary.
(d) This section shall not apply to: (1) A drug intended solely forinvestigational use by experts qualified by scientific training andexperience to investigate the safety and effectiveness of drugs,provided the drug is plainly labeled in compliance with regulationsissued by the secretary or pursuant to 21 U.S.C.A. 355 or 21 U.S.C.A.357; or (2) a drug sold in this state at any time prior to theenactment of this act or introduced into interstate commerce at any timeprior to the enactment of the federal act; or (3) any drug which islicensed under the virus, serum, and toxin act of July 1, 1902 (U.S.C.1958 ed. title 42, chapter 6A, sec. 262); or (4) any drug which issubject to subsection (1) of K.S.A. 65-669 and amendments thereto.
(e) The provisions of subsection (n) of K.S.A. 65-656and amendments theretoshall not apply to any drug which was, on October 9, 1962, or on the dateimmediately preceding the enactment of this subsection, (1)commercially sold or used in this state or in the United States, (2)not a new drug as defined by subsection (n) of K.S.A. 65-656 andamendments thereto as then inforce, and (3) was not covered by an effective application under thissection or under 21 U.S.C.A. 355, when such drug is intended solely foruse under conditions prescribed, recommended or suggested in labelingwith respect to such drug.
History: L. 1965, ch. 377, § 7; L. 1974, ch. 352, §109;L. 1988, ch. 356, § 187; July 1, 1989.
65-669a.New drugs; selling, offering or giving away, restrictions;investigational uses.(a) No person shall sell, deliver, offer for sale, hold for sale or giveaway any new drug unless (1) an application with respect thereto hasbeen approved and such approval has not been withdrawn under 21 U.S.C.A.355, or (2) when not subject to the federal act, unless such drug hasbeen tested and has been found to be safe for use and effective in useunder the conditions prescribed, recommended, or suggested in thelabeling thereof, and prior to selling or offering for sale such drug,there has been filed with the secretary an application setting forth (A)full reports of investigations which have been made to show whether ornot such drug is safe for use and whether such drug is effective in use;(B) a full list of the articles used as components of such drug; (C) afull statement of the composition of such drug; (D) a full descriptionof the methods used in, and the facilities and controls used for, themanufacture, processing and packing of such drug; (E) such samples ofsuch drug and of the articles used as components thereof as thesecretary may require; and (F) specimens of the labeling proposed to beused for such drug.
(b) An application provided for in subsection (a)(2) of thissection shall become effective 180 days afterthe filing thereof, except that if the secretary finds, after due noticeto the applicant and giving the applicant an opportunity for ahearing, that thedrug is not safe or not effective for use under the conditionsprescribed, recommended or suggested in the proposed labeling thereof,the secretary shall, prior to the effective date of the application,issue an order refusing to permit the application to become effective.Hearings under this subsection shall be conducted in accordance with theprovisions of the Kansas administrative procedure act.
(c) An order refusing to permit an application under this section tobecome effective may be revoked by the secretary.
(d) This section shall not apply to: (1) A drug intended solely forinvestigational use by experts qualified by scientific training andexperience to investigate the safety and effectiveness of drugs,provided the drug is plainly labeled in compliance with regulationsissued by the secretary or pursuant to 21 U.S.C.A. 355 or 21 U.S.C.A.357; or (2) a drug sold in this state at any time prior to theenactment of this act or introduced into interstate commerce at any timeprior to the enactment of the federal act; or (3) any drug which islicensed under the virus, serum, and toxin act of July 1, 1902 (U.S.C.1958 ed. title 42, chapter 6A, sec. 262); or (4) any drug which issubject to subsection (1) of K.S.A. 65-669 and amendments thereto.
(e) The provisions of subsection (n) of K.S.A. 65-656and amendments theretoshall not apply to any drug which was, on October 9, 1962, or on the dateimmediately preceding the enactment of this subsection, (1)commercially sold or used in this state or in the United States, (2)not a new drug as defined by subsection (n) of K.S.A. 65-656 andamendments thereto as then inforce, and (3) was not covered by an effective application under thissection or under 21 U.S.C.A. 355, when such drug is intended solely foruse under conditions prescribed, recommended or suggested in labelingwith respect to such drug.
History: L. 1965, ch. 377, § 7; L. 1974, ch. 352, §109;L. 1988, ch. 356, § 187; July 1, 1989.
