Provisions governing selling or delivering new drug.
196.105. 1. No person shall sell, deliver, offer for sale, hold forsale or give away any new drug unless:
(1) An application with respect thereto has become effective under 21U.S.C.A. § 355; or
(2) When not subject to the federal act unless such drug has been testedand has not been found to be unsafe for use under the conditions prescribed,recommended, or suggested in the labeling thereof, and prior to selling oroffering for sale such drug, there has been filed with the department anapplication setting forth full reports of investigations which have been madeto show whether or not such drug is safe for use; a full list of the articlesused as components of such drug; a full statement of the composition of suchdrug; a full description of the methods used in, and the facilities andcontrols used for, the manufacture, processing, and packing of such drug; suchsamples of such drug and of the articles used as components thereof as thedepartment may require; and specimens of the labeling proposed to be used forsuch drug.
2. An application provided for in subdivision (2) of subsection 1 shallbecome effective on the sixtieth day after the filing thereof, except that ifthe department finds after due notice to the applicant and giving him anopportunity for a hearing, that the drug is not safe for use under theconditions prescribed, recommended, or suggested in the proposed labelingthereof, the department shall, prior to the effective date of the application,issue an order refusing to permit the application to become effective.
3. This section shall not apply:
(1) To a drug intended solely for investigational use by expertsqualified by scientific training and experience to investigate the safety indrugs provided the drug is plainly labeled "For investigational use only"; or
(2) To a drug sold in this state at any time prior to the enactment ofsections 196.010 to 196.120 or introduced into interstate commerce at any timeprior to the enactment of the federal act; or
(3) To any drug which is licensed under the Virus, Serum, and Toxin Actof July 1, 1902 (U.S.C. 1934 cd. title 42. Chapter 4).
4. An order refusing to permit an application under this section tobecome effective may be revoked by the department of health and seniorservices.
Provisions governing selling or delivering new drug.
196.105. 1. No person shall sell, deliver, offer for sale, hold forsale or give away any new drug unless:
(1) An application with respect thereto has become effective under 21U.S.C.A. § 355; or
(2) When not subject to the federal act unless such drug has been testedand has not been found to be unsafe for use under the conditions prescribed,recommended, or suggested in the labeling thereof, and prior to selling oroffering for sale such drug, there has been filed with the department anapplication setting forth full reports of investigations which have been madeto show whether or not such drug is safe for use; a full list of the articlesused as components of such drug; a full statement of the composition of suchdrug; a full description of the methods used in, and the facilities andcontrols used for, the manufacture, processing, and packing of such drug; suchsamples of such drug and of the articles used as components thereof as thedepartment may require; and specimens of the labeling proposed to be used forsuch drug.
2. An application provided for in subdivision (2) of subsection 1 shallbecome effective on the sixtieth day after the filing thereof, except that ifthe department finds after due notice to the applicant and giving him anopportunity for a hearing, that the drug is not safe for use under theconditions prescribed, recommended, or suggested in the proposed labelingthereof, the department shall, prior to the effective date of the application,issue an order refusing to permit the application to become effective.
3. This section shall not apply:
(1) To a drug intended solely for investigational use by expertsqualified by scientific training and experience to investigate the safety indrugs provided the drug is plainly labeled "For investigational use only"; or
(2) To a drug sold in this state at any time prior to the enactment ofsections 196.010 to 196.120 or introduced into interstate commerce at any timeprior to the enactment of the federal act; or
(3) To any drug which is licensed under the Virus, Serum, and Toxin Actof July 1, 1902 (U.S.C. 1934 cd. title 42. Chapter 4).
4. An order refusing to permit an application under this section tobecome effective may be revoked by the department of health and seniorservices.
Provisions governing selling or delivering new drug.
196.105. 1. No person shall sell, deliver, offer for sale, hold forsale or give away any new drug unless:
(1) An application with respect thereto has become effective under 21U.S.C.A. § 355; or
(2) When not subject to the federal act unless such drug has been testedand has not been found to be unsafe for use under the conditions prescribed,recommended, or suggested in the labeling thereof, and prior to selling oroffering for sale such drug, there has been filed with the department anapplication setting forth full reports of investigations which have been madeto show whether or not such drug is safe for use; a full list of the articlesused as components of such drug; a full statement of the composition of suchdrug; a full description of the methods used in, and the facilities andcontrols used for, the manufacture, processing, and packing of such drug; suchsamples of such drug and of the articles used as components thereof as thedepartment may require; and specimens of the labeling proposed to be used forsuch drug.
2. An application provided for in subdivision (2) of subsection 1 shallbecome effective on the sixtieth day after the filing thereof, except that ifthe department finds after due notice to the applicant and giving him anopportunity for a hearing, that the drug is not safe for use under theconditions prescribed, recommended, or suggested in the proposed labelingthereof, the department shall, prior to the effective date of the application,issue an order refusing to permit the application to become effective.
3. This section shall not apply:
(1) To a drug intended solely for investigational use by expertsqualified by scientific training and experience to investigate the safety indrugs provided the drug is plainly labeled "For investigational use only"; or
(2) To a drug sold in this state at any time prior to the enactment ofsections 196.010 to 196.120 or introduced into interstate commerce at any timeprior to the enactment of the federal act; or
(3) To any drug which is licensed under the Virus, Serum, and Toxin Actof July 1, 1902 (U.S.C. 1934 cd. title 42. Chapter 4).
4. An order refusing to permit an application under this section tobecome effective may be revoked by the department of health and seniorservices.
