109300-109395

HEALTH AND SAFETY CODE
SECTION 109300-109395




109300.  The sale, offering for sale, holding for sale, delivering,
giving away, prescribing or administering of any drug, medicine,
compound, or device to be used in the diagnosis, treatment,
alleviation, or cure of cancer is unlawful and prohibited unless (1)
an application with respect thereto has been approved under Section
505 of the federal Food, Drug and Cosmetic Act, or (2) there has been
approved an application filed with the board setting forth:
   (a) Full reports of investigations that have been made to show
whether or not the drug, medicine, compound, or device is safe for
the use, and whether the drug, medicine, compound, or device is
effective in the use;
   (b) A full list of the articles used as components of the drug,
medicine, compound, or device;
   (c) A full statement of the composition of the drug, medicine,
compound, or device;
   (d) A full description of the methods used in, and the facilities
and controls used for, the manufacture, processing, and packing of
the drug, medicine, or compound or in the case of a device, a full
statement of its composition, properties, and construction and the
principle or principles of its operation;
   (e) Such samples of the drug, medicine, compound, or device and of
the articles used as components of the drug, medicine, compound, or
device as the board may require; and
   (f) Specimens of the labeling and advertising proposed to be used
for the drug, medicine, compound, or device.



109305.  Within 180 days after the filing of an application provided
for in subdivision (2) of Section 109300 or an additional period as
may be agreed upon by the board and the applicant, the board shall
either:
   (a) Approve the application if it finds that none of the grounds
for denying approval specified in Section 109315 applies.
   (b) Give the applicant notice for an opportunity for a hearing
before the board on the question 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 board and the applicant otherwise agree. Any
hearing shall thereafter be conducted on an expedited basis and the
board order thereon shall be issued within 90 days after the date
fixed by the board for filing final briefs.
   Prior to approving the application or giving the applicant notice
for an opportunity for a hearing, the board shall have received a
written report from the Cancer Advisory Council setting forth its
recommendations on the action the board should take. The report shall
be signed by a majority of the members of the council.



109310.  In the case of any drug, medicine, compound or device for
that an approval of an application filed pursuant to this article and
Article 1 (commencing with Section 109250) is in effect, the
applicant shall establish and maintain the records, and make the
reports to the board, of data relating to clinical experience and
other data or information, received or otherwise obtained by the
applicant with respect to the drug, medicine, compound, or device, as
the board may prescribe on the basis of a finding that the records
and reports are necessary in order to enable the board to determine,
or facilitate a determination, whether there is or may be ground for
suspension of the application.
   Every person required under this section to maintain records, and
every person in charge of custody thereof, shall, upon request of an
agent of the board, permit the agent at all reasonable times to have
access to and copy and verify the records.



109315.  The board shall issue an order refusing to permit the
application to become effective, if, after due notice to the
applicant and opportunity for a hearing, the board finds any of the
following:
   (a) The investigations, reports that are required to be submitted
to the board pursuant to subdivision (2) of Section 109300 do not
include adequate tests by all methods reasonably applicable to show
whether or not a drug, medicine, compound, or device is safe for use
in the diagnosis, treatment, alleviation, or cure of cancer.
   (b) The results of tests specified in subdivision (a) show that a
drug, medicine, compound or device is unsafe for use under the
conditions specified in subdivision (a) or do not show that the drug,
medicine, compound, or device is safe for use under the conditions.
   (c) The methods used in, and the facilities and controls used for,
the manufacture, processing, and packing of a drug, medicine,
compound, or device are inadequate to preserve its identity,
strength, quality, and purity and with respect to a device are
inadequate to preserve its safety or effectiveness.
   (d) Upon the basis of the information submitted to it as part of
the application, or upon the basis of any other information before it
with respect to a drug, medicine, compound, or device, it has
insufficient evidence to determine whether the drug, medicine,
compound, or device is safe for use under the conditions specified in
subdivision (a).
   (e) Evaluated on the basis of the information submitted to it as
part of the application and any other information before it with
respect to the drug, medicine, compound, or device, there is a
reasonable doubt that the drug, medicine, compound, 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 advertising thereof.
   (f) The application contains any untrue statement of a material
fact.


109320.  (a) The board shall issue an order withdrawing approval of
an application concerning any drug, medicine, compound, or device if,
after due notice to the applicant and opportunity for a hearing, the
board finds any of the following:
   (1) That clinical or other experience, tests, or other scientific
data show that the drug, medicine, compound, or device is unsafe for
use under the conditions of use upon the basis that the application
was approved;
   (2) That new evidence of clinical experience, not contained in the
application or not available to the board 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 board
when the application was approved, shows that the drug, medicine,
compound, or device is not shown to be safe for use under conditions
of use upon the basis that the application was approved; or
   (3) On the basis of new information with respect to the drug,
medicine, compound, or device, evaluated together with the evidence
available to the board when the application was approved, that there
is a lack of substantial evidence that the drug, medicine, compound,
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 thereof; or
   (4) That the application contains any untrue statement of a
material fact.
   (b) If the board finds that there is an imminent hazard to the
public health, it may suspend the approval of the application
immediately.
   (c) The board may also, after due notice and opportunity for
hearing, withdraw the approval of an application with respect to any
drug, medicine, compound, or device under this section if the board
finds any of the following:
   (1) 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.
   (2) That on the basis of new information before the board,
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, maintenance, processing, and packing of
the drug, medicine, compound, or device are inadequate to assure and
preserve its identity, strength, quality, and purity and with respect
to a device are inadequate to preserve its safety or effectiveness
and were not made adequate within a reasonable time after receipt of
written notice from the board specifying the matter complained of.
   (3) That on the basis of new information before it, evaluated
together with the evidence before it when the application was
approved, the labeling of the drug, medicine, compound, or device,
based on a fair evaluation of all material facts, is false or
misleading in any particular and was not corrected within a
reasonable time after receipt of written notice from the board
specifying the matter complained of.
   (d) Any order under this section shall state the findings upon
which it is based.


109325.  This article and Article 1 (commencing with Section 109250)
shall not apply to the use of any drug, medicine, compound, or
device intended solely for legitimate and bona fide investigational
purposes by experts qualified by scientific training and experience
to investigate the safety and therapeutic value thereof unless the
department shall find that the drug, medicine, compound, or device is
being used in diagnosis or treatment for compensation and profit. In
order to qualify for an exemption under this section there shall be
on file with the federal Department of Health, Education, and Welfare
a current and unrevoked investigational new drug application issued
pursuant to subdivision (i) of Section 505 of the federal Food, Drug,
and Cosmetic Act (21 U.S.C. Sec. 355(i)), or the following
conditions shall be complied with:
   (a) The label of the drug, medicine, compound, or device shall
bear the statement "Caution: New drug (or medicine or compound or
device). Use in the diagnosis, treatment, alleviation, or cure of
cancer limited by law to investigational use."
   (b) The drug, medicine, compound, or device has had adequate
testing on appropriate experimental animals to demonstrate a lack of
toxicity and hazard sufficient to permit its use in or on human
beings and to establish with clarity the margins of safety ordinarily
recognized by experts qualified by scientific training and
experience to investigate the safety and effectiveness of the drugs,
substances, or devices.
   (c) The drug, medicine, compound, or device is to be used solely
for investigational use by, or under the direction of, an expert
qualified by scientific training and experience to investigate the
safety and effectiveness of the drug, medicine, compound, or device.
   (d) A written statement signed by the expert has been filed with
the board. The statement shall show what facilities the expert will
use for the investigation to be conducted by him or her, and that the
drug, medicine, compound, or device will be used solely by him or
her or under his or her direction for the investigation. The
statement shall contain information identifying any assistant or
agent of the expert who uses the drug, medicine, compound, or device
under the direction of the expert.
   (e) Complete records of the investigation shall be kept by the
expert and all records shall be made available by the expert for
inspection upon the request of any agent of the board at any
reasonable hour as long as the expert desires exemption.
   (f) The expert shall inform any persons who participate in the
investigation as patients, that the drug, medicine, compound, or
device is being used for investigational purposes and shall obtain
the consent of the persons or their representatives.



109330.  Section 109300 does not apply to any device used within the
scope of his or her license privileges by a physician and surgeon or
dentist licensed as such in this state.



109335.  The failure of any individual, person, firm, association,
or other entity representing himself, or itself, as engaged in the
diagnosis, treatment, alleviation, or cure of cancer to comply with
any of the regulations adopted under this article and Article 1
(commencing with Section 109250) is a misdemeanor. A third, and
subsequent violations, of this section is a felony.
   This article and Article 1 (commencing with Section 109250) shall
not apply to any person who depends exclusively upon prayer for
healing in accordance with the teachings of a bona fide religious
sect, denomination, or organization, nor practitioner thereof.




109340.  The investigation or testing of any product shall not be
deemed to imply or indicate any endorsement of the qualifications or
value of any product. No person shall make any representation that
investigation or testing hereunder constitutes any approval or
endorsement of his or her, or its, activities by the Cancer Advisory
Council or the department. The investigation or testing of any
product shall not be deemed to imply or indicate that the product is
useless or harmful and during testing no person shall make any
representation, except to the department or Cancer Advisory Council,
that the product under test is discredited or that it has been found
useless or harmful.



109345.  Following an investigation or testing of the content or
composition of any drug, medicine, compound, or device used by any
individual, person, firm, association, or other entity in the
diagnosis, treatment, alleviation, or cure of cancer, and after
hearing as provided in Section 109270, the department, upon
recommendation of the Cancer Advisory Council, may direct that any
individual, person, firm, association, or other entity shall cease
and desist any further prescribing, recommending, or use of any drug,
medicine, compound, or device, or any substantially similar drug,
medicine, compound, or device, in the diagnosis or treatment of
cancer.
   In the investigation or testing required by this article and
Article 1 (commencing with Section 109250) to determine the value or
lack thereof of any drug, medicine, compound or device in the
diagnosis, treatment, or cure of cancer, the department shall, as it
deems necessary or advisable, utilize the facilities and findings of
its own laboratories or other appropriate laboratories, clinics,
hospitals, and nonprofit cancer research institutes recognized by the
National Cancer Institute, within this State or the facilities and
findings of the Federal Government, including the National Cancer
Institute. Upon a recommendation by the Cancer Advisory Council, the
department shall arrange, by contract, for investigation by and
submission to it of findings, conclusions, or opinions of trained
scientists in the appropriate departments of universities, medical
schools, clinics, hospitals, and nonprofit cancer research institutes
recognized by the National Cancer Institute, and the submission to
it of findings, conclusions, or opinions of other qualified
scientists. Prior to the issuance of a cease and desist order under
this section, the Cancer Advisory Council, by the affirmative vote of
at least 11 of its members, at least one of whom shall not be a
physician and surgeon, shall make a written finding of fact based on
the investigation that the drug, medicine, compound, or device so
investigated has been found to be either definitely harmful or of no
value in the diagnosis, treatment, alleviation, or cure of cancer and
the department must be satisfied beyond a reasonable doubt that the
written findings of the fact are true.



109350.  The department may direct that any individual, person,
firm, association, or other entity shall cease and desist any further
prescribing, recommending, or use of any drug, medicine, compound,
or device for which no application has been approved under this
article and Article 1 (commencing with Section 109250) unless its use
is exempt under Section 109325 or 109330.



109355.  (a) Any violation of this article and Article 1 (commencing
with Section 109250), of the regulations adopted thereunder or of a
cease and desist order issued by the department under Section 109345
or 109350 may be enjoined by the superior court in any county, on
application of the department.
   (b) Proceedings under this section shall be governed by Chapter 3
(commencing with Section 525) of Title 7 of Part 2 of the Code of
Civil Procedure.


109360.  Any person against whom an injunction or cease and desist
order has been issued, under this article and Article 1 (commencing
with Section 109250), may not undertake to use in the diagnosis,
treatment, alleviation, or cure of cancer any new, experimental,
untested, or secret drug, medicine, compound, or device for which
there is no approved application on file or that does not qualify for
an exemption, without first submitting an application to the
department.


109365.  It is unlawful for any person, with the intent to defraud,
to falsely represent and provide for compensation a device,
substance, method or treatment as effective to diagnose, arrest,
prevent, or cure cancer. Nothing in this section shall abridge the
existent rights of the press.



109370.  Except as provided in Section 109335, a violation of this
article and Article 1 (commencing with Section 109250) is punishable
by imprisonment in the county jail for a period not exceeding one
year, or in the state prison, or by a fine not exceeding ten thousand
dollars ($10,000), or by both the imprisonment and fine.




109375.  The director shall investigate possible violations of this
article and Article 1 (commencing with Section 109250) and report
violations to the appropriate enforcement authority.



109380.  County health officers, district attorneys and the Attorney
General shall cooperate with the director in the enforcement of this
article and Article 1 (commencing with Section 109250).



109385.  The department, upon recommendation of the Cancer Advisory
Council, may from time to time publish reports based on its
investigation or testing of any drug, medicine, compound, or device
prescribed, recommended, or used by any individual, person, firm,
association, or other entity, and when, in the opinion of a majority
of the members of the Cancer Advisory Council, the use of any drug,
medicine, compound, or device in the diagnosis, treatment or cure of
cancer constitutes an imminent danger to health or a gross deception
of the public, the department may take appropriate steps to publicize
the same.


109390.  All hearings authorized by this article and Article 1
(commencing with Section 109250) shall be conducted in accordance
with Chapter 5 (commencing with Section 11500) of Part 1, Division 3,
Title 2 of the Government Code.


109395.  No provision of this article and Article 1 (commencing with
Section 109250) shall preclude reconsideration of an application for
use of any drug, medicine, compound or device for the diagnosis,
treatment, alleviation or cure of cancer if new evidence or matter is
presented to the department and the reconsideration is predicated
upon compliance with the applicable sections of the law, and
presentation of data developed subsequent to the applicable ruling of
the board.