(a) No person shall sell, deliver, offer for sale, hold for saleor give away any new drug unless:
(1) An application with respect thereto has been approved andsaid approval has not been withdrawn under section 505 of the federal act, or
(2) When not subject to the federal act, by virtue of not beinga drug in interstate commerce, unless such drug has been tested and has beenfound to be safe for use and effective in 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 Commissioner anapplication setting forth
a. Full reports of investigations which have been made to showwhether or not such drug is safe for use and whether such drug is effective inuse;
b. A full list of the articles used as components of such drug;
c. A full statement of the composition of such drug;
d. A full description of the methods used in, and thefacilities and controls used for, the manufacture, processing, and packing ofsuch drug;
e. Such samples of such drug and of the articles used ascomponents thereof as the Commissioner may require; and
f. Specimens of the labeling proposed to be used for suchdrug.
(b) An application provided for in subdivision (a)(2) of thissection shall become effective on the one hundred eightieth day after thefiling thereof, except that if the Commissioner finds, after due notice to theapplicant and giving him an opportunity for hearing,
(1) That the drug is not safe or not effective for use under theconditions prescribed, recommended or suggested in the proposed labelingthereof; or
(2) The methods used in, and the facilities and controls usedfor, the manufacture, processing and packing of such drug is inadequate topreserve its identity, strength, quality, and purity; or
(3) Based on a fair evaluation of all material facts, suchlabeling is false or misleading in any particular; he shall, prior to theeffective date of the application, issue an order refusing to permit theapplication to become effective.
(c) An order refusing to permit an application under thissection to become effective may be revoked by the Commissioner.
(d) The Commissioner shall promulgate regulations for exempting fromthe operation of the foregoing subsections and subdivisions of this sectiondrugs intended solely for investigational use by experts qualified byscientific training and experience to investigate the safety and effectivenessof drugs. Such regulations may, within the discretion of the Commissioner amongother conditions relating to the protection of the public health, provide forconditioning such exemption upon
(1) The submission to the Commissioner, before any clinicaltesting of a new drug is undertaken, of reports, by the manufacturer or thesponsor of the investigation of such drug, of preclinical tests (includingtests on animals) of such drug adequate to justify the proposed clinicaltesting;
(2) The manufacturer or the sponsor of the investigation of anew drug proposed to be distributed to investigators for clinical testingobtaining a signed agreement from each of such investigators that patients towhom the drug is administered will be under his personal supervision, or underthe supervision of investigators responsible to him, and that he will notsupply such drug to any other investigator, or to clinics, for administrationto human beings; and
(3) The establishment and maintenance of such records, and themaking of such reports to the Commissioner, by the manufacturer or the sponsorof the investigation of such drug, of data (including but not limited toanalytical reports by investigators) obtained as the result of suchinvestigational use of such drug, as the Commissioner finds will enable him toevaluate the safety and effectiveness of such drug in the event of the filingof an application pursuant to subsection (b).
Suchregulations shall provide that such exemption shall be conditioned upon themanufacturer, or the sponsor of the investigation, requiring that experts usingsuch drugs for investigational purposes certify to such manufacturer or sponsorthat they will inform any human beings to whom such drugs, or any controls usedin connection therewith, are being administered, or their representatives, thatsuch drugs are being used for investigational purposes and will obtain theconsent of such human beings or their representatives, except where they deemit not feasible, or, in their professional judgment, contrary to the bestinterests of such human beings. Nothing in this subsection shall be construedto require any clinical investigator to submit directly to the Commissionerreports on the investigational use of drugs; provided, that regulations adoptedunder section 505(i) of the federal act may be adopted by the Commissioner asthe regulations in this State.
(e) (1) In the case of any drug forwhich an approval of an application filed pursuant to this section is ineffect, the applicant shall establish and maintain such records, and make suchreports to the Commissioner, of data relating to clinical experience and otherdata or information, received or otherwise obtained by such applicant withrespect to such drug, as the Commissioner may by general regulation, or byorder with respect to such application, prescribe: Provided, however, thatregulations and orders issued under this subsection and under subsection (d)shall have due regard for the professional ethics of the medical profession andthe interests of patients and shall provide, where the Commissioner deems it tobe appropriate, for the examination, upon request, by the persons to whom suchregulations or orders are applicable, of similar information received orotherwise obtained by the Commissioner.
(2) Every person required under this section to maintainrecords, and every person in charge or custody thereof, shall, upon request ofan officer or employee designated by the Commissioner, permit such officer oremployee at all reasonable times to have access to and copy and certify suchrecords.
(f) The Commissioner may, after affording an opportunity forpublic hearing, revoke an application approved pursuant to this section if hefinds that the drug, based on evidence acquired after such approval, may not besafe or effective for its intended use, or that the facilities or controls usedin the manufacture, processing, or labeling of such drug may present a hazardto the public health.
(g) This section shall not apply:
(1) To a drug sold in this State or introduced into interstatecommerce at any time prior to the enactment of the federal act, if its labelingcontained the same representations concerning the conditions of its use; or
(2) To any drug which is licensed under the Public HealthService Act of July 1, 1944 (58 Stat. 682, as amended; 42 U.S.C. 201 et seq.)or under the Animal Virus‑Serum‑Toxin Act of March 4, 1913 (13Stat. 832; 21 U.S.C. 151 et seq.); or
(3) To any drug which is subject to G.S. 106‑134 (14) ofthis Article. (1939, c. 320, s.16; 1975, c. 614, s. 31.)
(a) No person shall sell, deliver, offer for sale, hold for saleor give away any new drug unless:
(1) An application with respect thereto has been approved andsaid approval has not been withdrawn under section 505 of the federal act, or
(2) When not subject to the federal act, by virtue of not beinga drug in interstate commerce, unless such drug has been tested and has beenfound to be safe for use and effective in 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 Commissioner anapplication setting forth
a. Full reports of investigations which have been made to showwhether or not such drug is safe for use and whether such drug is effective inuse;
b. A full list of the articles used as components of such drug;
c. A full statement of the composition of such drug;
d. A full description of the methods used in, and thefacilities and controls used for, the manufacture, processing, and packing ofsuch drug;
e. Such samples of such drug and of the articles used ascomponents thereof as the Commissioner may require; and
f. Specimens of the labeling proposed to be used for suchdrug.
(b) An application provided for in subdivision (a)(2) of thissection shall become effective on the one hundred eightieth day after thefiling thereof, except that if the Commissioner finds, after due notice to theapplicant and giving him an opportunity for hearing,
(1) That the drug is not safe or not effective for use under theconditions prescribed, recommended or suggested in the proposed labelingthereof; or
(2) The methods used in, and the facilities and controls usedfor, the manufacture, processing and packing of such drug is inadequate topreserve its identity, strength, quality, and purity; or
(3) Based on a fair evaluation of all material facts, suchlabeling is false or misleading in any particular; he shall, prior to theeffective date of the application, issue an order refusing to permit theapplication to become effective.
(c) An order refusing to permit an application under thissection to become effective may be revoked by the Commissioner.
(d) The Commissioner shall promulgate regulations for exempting fromthe operation of the foregoing subsections and subdivisions of this sectiondrugs intended solely for investigational use by experts qualified byscientific training and experience to investigate the safety and effectivenessof drugs. Such regulations may, within the discretion of the Commissioner amongother conditions relating to the protection of the public health, provide forconditioning such exemption upon
(1) The submission to the Commissioner, before any clinicaltesting of a new drug is undertaken, of reports, by the manufacturer or thesponsor of the investigation of such drug, of preclinical tests (includingtests on animals) of such drug adequate to justify the proposed clinicaltesting;
(2) The manufacturer or the sponsor of the investigation of anew drug proposed to be distributed to investigators for clinical testingobtaining a signed agreement from each of such investigators that patients towhom the drug is administered will be under his personal supervision, or underthe supervision of investigators responsible to him, and that he will notsupply such drug to any other investigator, or to clinics, for administrationto human beings; and
(3) The establishment and maintenance of such records, and themaking of such reports to the Commissioner, by the manufacturer or the sponsorof the investigation of such drug, of data (including but not limited toanalytical reports by investigators) obtained as the result of suchinvestigational use of such drug, as the Commissioner finds will enable him toevaluate the safety and effectiveness of such drug in the event of the filingof an application pursuant to subsection (b).
Suchregulations shall provide that such exemption shall be conditioned upon themanufacturer, or the sponsor of the investigation, requiring that experts usingsuch drugs for investigational purposes certify to such manufacturer or sponsorthat they will inform any human beings to whom such drugs, or any controls usedin connection therewith, are being administered, or their representatives, thatsuch drugs are being used for investigational purposes and will obtain theconsent of such human beings or their representatives, except where they deemit not feasible, or, in their professional judgment, contrary to the bestinterests of such human beings. Nothing in this subsection shall be construedto require any clinical investigator to submit directly to the Commissionerreports on the investigational use of drugs; provided, that regulations adoptedunder section 505(i) of the federal act may be adopted by the Commissioner asthe regulations in this State.
(e) (1) In the case of any drug forwhich an approval of an application filed pursuant to this section is ineffect, the applicant shall establish and maintain such records, and make suchreports to the Commissioner, of data relating to clinical experience and otherdata or information, received or otherwise obtained by such applicant withrespect to such drug, as the Commissioner may by general regulation, or byorder with respect to such application, prescribe: Provided, however, thatregulations and orders issued under this subsection and under subsection (d)shall have due regard for the professional ethics of the medical profession andthe interests of patients and shall provide, where the Commissioner deems it tobe appropriate, for the examination, upon request, by the persons to whom suchregulations or orders are applicable, of similar information received orotherwise obtained by the Commissioner.
(2) Every person required under this section to maintainrecords, and every person in charge or custody thereof, shall, upon request ofan officer or employee designated by the Commissioner, permit such officer oremployee at all reasonable times to have access to and copy and certify suchrecords.
(f) The Commissioner may, after affording an opportunity forpublic hearing, revoke an application approved pursuant to this section if hefinds that the drug, based on evidence acquired after such approval, may not besafe or effective for its intended use, or that the facilities or controls usedin the manufacture, processing, or labeling of such drug may present a hazardto the public health.
(g) This section shall not apply:
(1) To a drug sold in this State or introduced into interstatecommerce at any time prior to the enactment of the federal act, if its labelingcontained the same representations concerning the conditions of its use; or
(2) To any drug which is licensed under the Public HealthService Act of July 1, 1944 (58 Stat. 682, as amended; 42 U.S.C. 201 et seq.)or under the Animal Virus‑Serum‑Toxin Act of March 4, 1913 (13Stat. 832; 21 U.S.C. 151 et seq.); or
(3) To any drug which is subject to G.S. 106‑134 (14) ofthis Article. (1939, c. 320, s.16; 1975, c. 614, s. 31.)
(a) No person shall sell, deliver, offer for sale, hold for saleor give away any new drug unless:
(1) An application with respect thereto has been approved andsaid approval has not been withdrawn under section 505 of the federal act, or
(2) When not subject to the federal act, by virtue of not beinga drug in interstate commerce, unless such drug has been tested and has beenfound to be safe for use and effective in 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 Commissioner anapplication setting forth
a. Full reports of investigations which have been made to showwhether or not such drug is safe for use and whether such drug is effective inuse;
b. A full list of the articles used as components of such drug;
c. A full statement of the composition of such drug;
d. A full description of the methods used in, and thefacilities and controls used for, the manufacture, processing, and packing ofsuch drug;
e. Such samples of such drug and of the articles used ascomponents thereof as the Commissioner may require; and
f. Specimens of the labeling proposed to be used for suchdrug.
(b) An application provided for in subdivision (a)(2) of thissection shall become effective on the one hundred eightieth day after thefiling thereof, except that if the Commissioner finds, after due notice to theapplicant and giving him an opportunity for hearing,
(1) That the drug is not safe or not effective for use under theconditions prescribed, recommended or suggested in the proposed labelingthereof; or
(2) The methods used in, and the facilities and controls usedfor, the manufacture, processing and packing of such drug is inadequate topreserve its identity, strength, quality, and purity; or
(3) Based on a fair evaluation of all material facts, suchlabeling is false or misleading in any particular; he shall, prior to theeffective date of the application, issue an order refusing to permit theapplication to become effective.
(c) An order refusing to permit an application under thissection to become effective may be revoked by the Commissioner.
(d) The Commissioner shall promulgate regulations for exempting fromthe operation of the foregoing subsections and subdivisions of this sectiondrugs intended solely for investigational use by experts qualified byscientific training and experience to investigate the safety and effectivenessof drugs. Such regulations may, within the discretion of the Commissioner amongother conditions relating to the protection of the public health, provide forconditioning such exemption upon
(1) The submission to the Commissioner, before any clinicaltesting of a new drug is undertaken, of reports, by the manufacturer or thesponsor of the investigation of such drug, of preclinical tests (includingtests on animals) of such drug adequate to justify the proposed clinicaltesting;
(2) The manufacturer or the sponsor of the investigation of anew drug proposed to be distributed to investigators for clinical testingobtaining a signed agreement from each of such investigators that patients towhom the drug is administered will be under his personal supervision, or underthe supervision of investigators responsible to him, and that he will notsupply such drug to any other investigator, or to clinics, for administrationto human beings; and
(3) The establishment and maintenance of such records, and themaking of such reports to the Commissioner, by the manufacturer or the sponsorof the investigation of such drug, of data (including but not limited toanalytical reports by investigators) obtained as the result of suchinvestigational use of such drug, as the Commissioner finds will enable him toevaluate the safety and effectiveness of such drug in the event of the filingof an application pursuant to subsection (b).
Suchregulations shall provide that such exemption shall be conditioned upon themanufacturer, or the sponsor of the investigation, requiring that experts usingsuch drugs for investigational purposes certify to such manufacturer or sponsorthat they will inform any human beings to whom such drugs, or any controls usedin connection therewith, are being administered, or their representatives, thatsuch drugs are being used for investigational purposes and will obtain theconsent of such human beings or their representatives, except where they deemit not feasible, or, in their professional judgment, contrary to the bestinterests of such human beings. Nothing in this subsection shall be construedto require any clinical investigator to submit directly to the Commissionerreports on the investigational use of drugs; provided, that regulations adoptedunder section 505(i) of the federal act may be adopted by the Commissioner asthe regulations in this State.
(e) (1) In the case of any drug forwhich an approval of an application filed pursuant to this section is ineffect, the applicant shall establish and maintain such records, and make suchreports to the Commissioner, of data relating to clinical experience and otherdata or information, received or otherwise obtained by such applicant withrespect to such drug, as the Commissioner may by general regulation, or byorder with respect to such application, prescribe: Provided, however, thatregulations and orders issued under this subsection and under subsection (d)shall have due regard for the professional ethics of the medical profession andthe interests of patients and shall provide, where the Commissioner deems it tobe appropriate, for the examination, upon request, by the persons to whom suchregulations or orders are applicable, of similar information received orotherwise obtained by the Commissioner.
(2) Every person required under this section to maintainrecords, and every person in charge or custody thereof, shall, upon request ofan officer or employee designated by the Commissioner, permit such officer oremployee at all reasonable times to have access to and copy and certify suchrecords.
(f) The Commissioner may, after affording an opportunity forpublic hearing, revoke an application approved pursuant to this section if hefinds that the drug, based on evidence acquired after such approval, may not besafe or effective for its intended use, or that the facilities or controls usedin the manufacture, processing, or labeling of such drug may present a hazardto the public health.
(g) This section shall not apply:
(1) To a drug sold in this State or introduced into interstatecommerce at any time prior to the enactment of the federal act, if its labelingcontained the same representations concerning the conditions of its use; or
(2) To any drug which is licensed under the Public HealthService Act of July 1, 1944 (58 Stat. 682, as amended; 42 U.S.C. 201 et seq.)or under the Animal Virus‑Serum‑Toxin Act of March 4, 1913 (13Stat. 832; 21 U.S.C. 151 et seq.); or
(3) To any drug which is subject to G.S. 106‑134 (14) ofthis Article. (1939, c. 320, s.16; 1975, c. 614, s. 31.)
