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Article 5. New Drugs Or Devices of California Health And Safety Code >> Division 104. >> Part 5. >> Chapter 6. >> Article 5.
No person shall sell, deliver, or give away any new drug or
new device unless it satisfies either of the following:
(a) It is one of the following:
(1) A new drug, and a new drug application has been approved for it and that approval has not been withdrawn, terminated, or suspended under Section 505 of the federal act (21 U.S.C. Sec. 355).
(2) A new biologic product for which a license has been issued as required by the federal Public Health Service Act (42 U.S.C. Sec. 262).
(3) A device that is reported under Section 510(k) of the federal act (21 U.S.C. Sec. 360(k)), or is a device exempted pursuant to subsection (l) or (m) of Section 360 of Title 21 of the United States Code, or it is a new device for which a premarket approval application has been approved, and that approval has not been withdrawn, terminated, or suspended under Section 515 of the federal act (21 U.S.C. Sec. 360e).
(b) The department has approved a new drug or device application for that new drug or new device and that approval has not been withdrawn, terminated, or suspended. Any person who files a new drug or device application with the department shall submit, as part of the application, all of the following information:
(1) Full reports of investigations that have been made to show whether or not the new drug or device is safe for use and whether the new drug or device is effective in use under the conditions prescribed, recommended, or suggested in the labeling or advertising of the new drug or device.
(2) A full list of the articles used as components of the new drug or device.
(3) A full statement of the composition of the new drug or device.
(4) A full description of the methods used in, and the facilities and controls used for, the manufacture, processing, and packing of the new drug, or in the case of a new device, a full statement of its composition, properties, and construction, and the principles of its operation.
(5) Samples of the new drug or device and of the articles used as components of the drug or device as the department may require.
(6) Specimens of the labeling and advertisements proposed to be used for the new drug or device.
(a) It is one of the following:
(1) A new drug, and a new drug application has been approved for it and that approval has not been withdrawn, terminated, or suspended under Section 505 of the federal act (21 U.S.C. Sec. 355).
(2) A new biologic product for which a license has been issued as required by the federal Public Health Service Act (42 U.S.C. Sec. 262).
(3) A device that is reported under Section 510(k) of the federal act (21 U.S.C. Sec. 360(k)), or is a device exempted pursuant to subsection (l) or (m) of Section 360 of Title 21 of the United States Code, or it is a new device for which a premarket approval application has been approved, and that approval has not been withdrawn, terminated, or suspended under Section 515 of the federal act (21 U.S.C. Sec. 360e).
(b) The department has approved a new drug or device application for that new drug or new device and that approval has not been withdrawn, terminated, or suspended. Any person who files a new drug or device application with the department shall submit, as part of the application, all of the following information:
(1) Full reports of investigations that have been made to show whether or not the new drug or device is safe for use and whether the new drug or device is effective in use under the conditions prescribed, recommended, or suggested in the labeling or advertising of the new drug or device.
(2) A full list of the articles used as components of the new drug or device.
(3) A full statement of the composition of the new drug or device.
(4) A full description of the methods used in, and the facilities and controls used for, the manufacture, processing, and packing of the new drug, or in the case of a new device, a full statement of its composition, properties, and construction, and the principles of its operation.
(5) Samples of the new drug or device and of the articles used as components of the drug or device as the department may require.
(6) Specimens of the labeling and advertisements proposed to be used for the new drug or device.
Within 180 days after the filing of an application provided
for in Section 111550, or an additional period as shall be agreed
upon by the department and the applicant, the department shall do
either of the following:
(a) Approve the application, if it finds that none of the grounds for denying approval specified in Section 111550 apply.
(b) Give the applicant written notice for an opportunity for a hearing before the department on the question of whether the application is approvable. If the applicant elects to accept the opportunity for hearing by written request within 30 days after the notice, the hearing shall commence not more than 90 days after the expiration of the 30 days unless the department and the applicant otherwise agree. Any such hearing shall thereafter be conducted on an expedited basis and the department's order thereon shall be issued within 90 days after the date fixed by the department for filing final briefs.
(a) Approve the application, if it finds that none of the grounds for denying approval specified in Section 111550 apply.
(b) Give the applicant written notice for an opportunity for a hearing before the department on the question of whether the application is approvable. If the applicant elects to accept the opportunity for hearing by written request within 30 days after the notice, the hearing shall commence not more than 90 days after the expiration of the 30 days unless the department and the applicant otherwise agree. Any such hearing shall thereafter be conducted on an expedited basis and the department's order thereon shall be issued within 90 days after the date fixed by the department for filing final briefs.
The department shall issue an order refusing to approve an
application if, after written notice to the applicant and after
giving him or her an opportunity for a hearing, the department makes
any of the following findings:
(a) That the reports of investigation, that are required to be submitted to the department pursuant to Section 111550, do not include adequate tests by all methods reasonably applicable to show whether or not the new drug or device is safe for use under the conditions prescribed, recommended, or suggested in the proposed labeling and advertisement of the new drug or device.
(b) That the results of the tests submitted pursuant to Section 111550 to show whether or not the new drug or device is safe for use under the conditions prescribed, recommended, or suggested in the proposed labeling and advertisement of the new drug or device show that the drug or device is unsafe for use under these conditions or do not show that the new drug or device is safe for use under the conditions prescribed, recommended, or suggested in the proposed labeling and advertisement.
(c) That the methods, facilities, and controls used in the manufacture, processing, or packing of the new drug or device are inadequate to preserve its identity, strength, quality, purity, composition, or other characteristics.
(d) That upon the basis of information submitted as part of the application, or upon the basis of any other information before it with respect to the new drug or device, that the department has insufficient information to determine whether the drug or device is safe for use under the conditions prescribed, recommended, or suggested in the proposed labeling and advertisement.
(e) That evaluated on the basis of the information submitted as part of the application and any other information before it with respect to the new drug or device, that there is a lack of substantial evidence that the new drug or device will have the effect it purports or is represented to have under the conditions of use prescribed, recommended, or suggested in the proposed labeling or advertisement of the new drug or device.
(f) That based on an evaluation by the department of all material facts, that the proposed labeling or advertising of the new drug or device is false or misleading in any particular.
(a) That the reports of investigation, that are required to be submitted to the department pursuant to Section 111550, do not include adequate tests by all methods reasonably applicable to show whether or not the new drug or device is safe for use under the conditions prescribed, recommended, or suggested in the proposed labeling and advertisement of the new drug or device.
(b) That the results of the tests submitted pursuant to Section 111550 to show whether or not the new drug or device is safe for use under the conditions prescribed, recommended, or suggested in the proposed labeling and advertisement of the new drug or device show that the drug or device is unsafe for use under these conditions or do not show that the new drug or device is safe for use under the conditions prescribed, recommended, or suggested in the proposed labeling and advertisement.
(c) That the methods, facilities, and controls used in the manufacture, processing, or packing of the new drug or device are inadequate to preserve its identity, strength, quality, purity, composition, or other characteristics.
(d) That upon the basis of information submitted as part of the application, or upon the basis of any other information before it with respect to the new drug or device, that the department has insufficient information to determine whether the drug or device is safe for use under the conditions prescribed, recommended, or suggested in the proposed labeling and advertisement.
(e) That evaluated on the basis of the information submitted as part of the application and any other information before it with respect to the new drug or device, that there is a lack of substantial evidence that the new drug or device will have the effect it purports or is represented to have under the conditions of use prescribed, recommended, or suggested in the proposed labeling or advertisement of the new drug or device.
(f) That based on an evaluation by the department of all material facts, that the proposed labeling or advertising of the new drug or device is false or misleading in any particular.
An order pursuant to Section 111560 refusing approval of a
new drug application or a new device application shall be revoked
whenever the department finds that the facts justify the action.
In the case of any new drug or device for which an approval
of an application filed pursuant to Section 111550 is in effect, the
applicant shall establish and maintain records, and make reports to
the department, of data relating to clinical experience and other
data or information, received or otherwise obtained by the applicant
with respect to the new drug or device, as the department may by
general regulation, or by order with respect to the application,
prescribe. Any regulation or order issued pursuant to this section or
pursuant to Section 111595 shall have due regard for the
professional ethics of the medical profession and the interest of
patients and shall provide, where the department determines that it
is reasonably necessary, for the examination upon request, by the
persons to whom the regulation or order is applicable, of similar
information received or otherwise obtained by the department. Every
person required pursuant to this section to maintain records, and
every person in charge or in custody of the records, shall, upon
request of an authorized agent of the department, permit the agent at
all reasonable time to have access to, and copy and verify, the
records.
The department shall issue an order withdrawing approval of
an application concerning any new drug or device if, after giving
written notice to the applicant and an opportunity for a hearing, the
department makes any of the following findings:
(a) That clinical or other experience, tests, or other scientific data show that the new drug or device is unsafe for use under the conditions of use upon the basis of which the application was approved.
(b) That new evidence of clinical experience, not contained in the application or not available to the department until after the application was approved, or tests by new methods, or tests by methods not deemed reasonably applicable when the application was approved, evaluated together with the evidence available to the department when the application was approved, shows that the new drug or device is not shown to be safe for use under the conditions of use upon the basis of which the application was approved.
(c) On the basis of new information with respect to the new drug or device, evaluated together with the evidence available to the department when the application was approved, that there is a lack of substantial evidence that the new drug or device will have the effect it purports or is represented to have, under the conditions of use prescribed, recommended, or suggested in the labeling or advertising of the new drug or device.
(d) That the application contains any untrue statement of a material fact.
(e) That the applicant has failed to establish a system for maintaining required records, or has repeatedly or deliberately failed to maintain the records or to make required reports, or the applicant has refused to permit access to, or copying or verification of, the records.
(f) That on the basis of new information before the department, evaluated together with the evidence before it when the application was approved, the methods used in, or the facilities and controls used for, the manufacture, processing, and packing of the new drug or device are inadequate to assure and preserve its identity, strength, quality, purity, composition, and characteristics as determined by qualified experts selected by the department, and were not made adequate within a reasonable time after receipt of written notice from the department specifying the matter complained of.
(g) That on the basis of new information before it, evaluated together with the evidence before it when the application was approved, the labeling or advertisement of the new drug or device, based on an evaluation of all material facts, is false or misleading in any particular and is not corrected within a reasonable time after receipt of written notice from the department specifying the matter complained of.
(a) That clinical or other experience, tests, or other scientific data show that the new drug or device is unsafe for use under the conditions of use upon the basis of which the application was approved.
(b) That new evidence of clinical experience, not contained in the application or not available to the department until after the application was approved, or tests by new methods, or tests by methods not deemed reasonably applicable when the application was approved, evaluated together with the evidence available to the department when the application was approved, shows that the new drug or device is not shown to be safe for use under the conditions of use upon the basis of which the application was approved.
(c) On the basis of new information with respect to the new drug or device, evaluated together with the evidence available to the department when the application was approved, that there is a lack of substantial evidence that the new drug or device will have the effect it purports or is represented to have, under the conditions of use prescribed, recommended, or suggested in the labeling or advertising of the new drug or device.
(d) That the application contains any untrue statement of a material fact.
(e) That the applicant has failed to establish a system for maintaining required records, or has repeatedly or deliberately failed to maintain the records or to make required reports, or the applicant has refused to permit access to, or copying or verification of, the records.
(f) That on the basis of new information before the department, evaluated together with the evidence before it when the application was approved, the methods used in, or the facilities and controls used for, the manufacture, processing, and packing of the new drug or device are inadequate to assure and preserve its identity, strength, quality, purity, composition, and characteristics as determined by qualified experts selected by the department, and were not made adequate within a reasonable time after receipt of written notice from the department specifying the matter complained of.
(g) That on the basis of new information before it, evaluated together with the evidence before it when the application was approved, the labeling or advertisement of the new drug or device, based on an evaluation of all material facts, is false or misleading in any particular and is not corrected within a reasonable time after receipt of written notice from the department specifying the matter complained of.
When the department finds that there is an imminent hazard
to the public health, it may suspend the approval for the application
immediately.
An order pursuant to Section 111575 or 111580 withdrawing
approval of an application concerning any new drug or device shall be
revoked whenever the department finds that the facts justify the
action.
Section 111550 does not apply to a drug or device intended
solely for investigational use by experts qualified by scientific
training and experience to investigate the safety and effectiveness
of drugs or devices if the investigation is conducted in accordance
with the requirements of Section 505(i) of the federal act (21 U.S.C.
Sec. 355(i)) or Section 520(g) thereof (21 U.S.C. Secs. 352 and 360)
and the regulations adopted pursuant to the federal act.
Section 111550 does not apply to any drug or device
intended solely for investigational use by experts qualified by
scientific training and experience to investigate the safety and
effectiveness of drugs or devices if all the following conditions are
complied with:
(a) The submission to the department, before any clinical testing of a drug or device is undertaken, of reports, by the manufacturer or the sponsor of the investigation of the drug or device, of preclinical tests including tests on animals, of the drug or device adequate to justify the proposed clinical testing.
(b) The manufacturer or the sponsor of the investigation of a drug or a device proposed to be distributed to investigators for clinical testing obtaining a signed, notarized agreement from each of the investigators that patients to whom the drug or device is administered will be under his or her personal supervision, or under the supervision of investigators responsible to him or her, and that he or she will not supply the drug or device to any other investigator, or to clinics, for administration to human beings.
(c) The establishment and maintenance of the records, and the making of the reports to the department, by the manufacturer or the sponsor of the investigation of the drug or device, of data, including but not limited to, analytical reports by investigators, obtained as a result of the investigational use of the drug or device, as the department finds will enable it to evaluate the safety and effectiveness of the drug or device in the event of the filing of an application pursuant to Section 111550.
(d) The manufacturer, or the sponsor of the investigation, require experts using the drugs or devices for investigational purposes to certify to the manufacturer or sponsor that they will comply with the requirements of Article 4 (commencing with Section 111515).
(e) Any other conditions as the department shall adopt as regulations necessary for the protection of the public health. The federal regulations adopted pursuant to Section 505(i) of the federal act (21 U.S.C. Sec. 355(i)) or Section 520(g) thereof (21 U.S.C. Secs. 352 and 360) shall be the regulations for exemptions from Section 111550 in this state. However, the department may prescribe, by regulation, any condition for exemption from Section 111550 whether or not the condition is in accordance with regulations adopted under the federal act.
(a) The submission to the department, before any clinical testing of a drug or device is undertaken, of reports, by the manufacturer or the sponsor of the investigation of the drug or device, of preclinical tests including tests on animals, of the drug or device adequate to justify the proposed clinical testing.
(b) The manufacturer or the sponsor of the investigation of a drug or a device proposed to be distributed to investigators for clinical testing obtaining a signed, notarized agreement from each of the investigators that patients to whom the drug or device is administered will be under his or her personal supervision, or under the supervision of investigators responsible to him or her, and that he or she will not supply the drug or device to any other investigator, or to clinics, for administration to human beings.
(c) The establishment and maintenance of the records, and the making of the reports to the department, by the manufacturer or the sponsor of the investigation of the drug or device, of data, including but not limited to, analytical reports by investigators, obtained as a result of the investigational use of the drug or device, as the department finds will enable it to evaluate the safety and effectiveness of the drug or device in the event of the filing of an application pursuant to Section 111550.
(d) The manufacturer, or the sponsor of the investigation, require experts using the drugs or devices for investigational purposes to certify to the manufacturer or sponsor that they will comply with the requirements of Article 4 (commencing with Section 111515).
(e) Any other conditions as the department shall adopt as regulations necessary for the protection of the public health. The federal regulations adopted pursuant to Section 505(i) of the federal act (21 U.S.C. Sec. 355(i)) or Section 520(g) thereof (21 U.S.C. Secs. 352 and 360) shall be the regulations for exemptions from Section 111550 in this state. However, the department may prescribe, by regulation, any condition for exemption from Section 111550 whether or not the condition is in accordance with regulations adopted under the federal act.
(a) In making determinations on requests for approval of
AIDS-related drugs, as defined in subdivision (b), in accordance with
Section 111550, or for exemptions from these requirements, for
purposes of investigations of these drugs, pursuant to Section
111595, the department shall employ persons to conduct reviews of
requests for drug marketing approval for AIDS-related drugs, or
exemptions from the approval requirements as specified in that
section. The AIDS Vaccine Research and Development Advisory Committee
shall review and advise the department in its actions under this
section.
Where necessary, the department shall enter into contracts with
appropriate and qualified persons or entities for the review of these
requests, including persons with significant experience in
conducting or reviewing clinical trials of drugs or physicians with
significant experience in treating AIDS patients.
No person may contract with the department for the review of a
request under this subdivision if the person has a financial interest
or a conflict of interest involving the drug being evaluated.
(b) "AIDS-related drug" means either of the following:
(1) A vaccine to protect against human immunodeficiency virus (HIV) infection.
(2) Antiviral agent, immune modulator, or other agent to be administered to persons who have been infected with HIV, to counteract the effects of this infection, or any drug to treat opportunistic infections associated with AIDS.
(c) The immunities provided for in Sections 818.4 and 821.6 of the Government Code shall apply whenever the department grants approval pursuant to Section 111550 or an exemption from the approval requirements pursuant to Section 111595, for an AIDS-related drug.
(b) "AIDS-related drug" means either of the following:
(1) A vaccine to protect against human immunodeficiency virus (HIV) infection.
(2) Antiviral agent, immune modulator, or other agent to be administered to persons who have been infected with HIV, to counteract the effects of this infection, or any drug to treat opportunistic infections associated with AIDS.
(c) The immunities provided for in Sections 818.4 and 821.6 of the Government Code shall apply whenever the department grants approval pursuant to Section 111550 or an exemption from the approval requirements pursuant to Section 111595, for an AIDS-related drug.
Section 111550 does not apply to any of the following:
(a) A drug or device that is sold in this state, or introduced into interstate commerce, at any time prior to the enactment of the federal act, if its labeling and advertising contained the same representations concerning the conditions of its use.
(b) Any drug that is licensed under the Public Health Service Act of July 1, 1944 (58 Stats. 682, as amended; 42 U.S.C. Sec. 201 et seq.) or under the eighth paragraph of the heading of Bureau of Animal Industry of the act of March 4, 1913 (37 Stat. 832-833; 21 U.S.C. Sec. 151 et seq.), commonly known as the "Virus-Serum-Toxin Act."
(a) A drug or device that is sold in this state, or introduced into interstate commerce, at any time prior to the enactment of the federal act, if its labeling and advertising contained the same representations concerning the conditions of its use.
(b) Any drug that is licensed under the Public Health Service Act of July 1, 1944 (58 Stats. 682, as amended; 42 U.S.C. Sec. 201 et seq.) or under the eighth paragraph of the heading of Bureau of Animal Industry of the act of March 4, 1913 (37 Stat. 832-833; 21 U.S.C. Sec. 151 et seq.), commonly known as the "Virus-Serum-Toxin Act."
