111550. No person shall sell, deliver, or give away any new drug or
new device unless it satisfies either of the following:
(a) It is 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for it and that approval has not been withdrawn, terminated, or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);
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been approved, and that approval has not been withdrawn, terminated,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withdrawn, terminated, or suspended.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.
111555. 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.
111560. 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.
111565. 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.
111570. 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.
111575. 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.
111580. When the department finds that there is an imminent hazard
to the public health, it may suspend the approval for the application
immediately.
111585. 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.
111590. 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.
111595. 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.
111605. (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.
111610. 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."
111550. No person shall sell, deliver, or give away any new drug or
new device unless it satisfies either of the following:
(a) It is 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);
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.
111555. 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.
111560. 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.
111565. 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.
111570. 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.
111575. 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.
111580. When the department finds that there is an imminent hazard
to the public health, it may suspend the approval for the application
immediately.
111585. 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.
111590. 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.
111595. 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.
111605. (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.
111610. 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."
111550. No person shall sell, deliver, or give away any new drug or
new device unless it satisfies either of the following:
(a) It is 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);
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.
111555. 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.
111560. 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.
111565. 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.
111570. 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.
111575. 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.
111580. When the department finds that there is an imminent hazard
to the public health, it may suspend the approval for the application
immediately.
111585. 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.
111590. 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.
111595. 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.
111605. (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.
111610. 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."
