BILL NUMBER: AB 1277 AMENDED
BILL TEXT
AMENDED IN ASSEMBLY APRIL 13, 2011
AMENDED IN ASSEMBLY MARCH 31, 2011
INTRODUCED BY Assembly Members Hill and Perea
FEBRUARY 18, 2011
An act to amend Sections 111550 and 111630
111635 of the Health and Safety Code, relating to public
health.
LEGISLATIVE COUNSEL'S DIGEST
AB 1277, as amended, Hill. Sherman Food, Drug, and Cosmetic Law.
(1) The
The Sherman Food, Drug, and Cosmetic Law regulates the
packaging, labeling, and advertising of drugs and devices, and is
administered by the State Department of Public Health. The law
prohibits the sale, delivery, or giving away of any new drug or new
device unless either 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not been withdrawn, terminated, or suspended or a new drug
application has been approved for it and that approval has not been
withdrawn, terminated, or suspended under specified provisions of the
federal Food, Drug, and Cosmetic Act, 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approval has not been withdrawn, terminated, or suspended under the
federal act.
(2) The
The Sherman Food, Drug, and Cosmetic Law requires the
department to adopt regulations to establish the application form and
set the fee for licensure and renewal of a drug or device license.
This bill would revise the above described
above-described prohibition , as specified, and
require the department to waive the fee for the issuance and renew of
a license for a person who has paid the most recent annual fees
required pursuant to the federal act to also apply to
a new biologic product for which a license has been issued under
federal law .
Existing law also requires the department to inspect the place of
business of each licensed person once every 2 years, unless the
United States Food and Drug Administration inspected the place of
business within the previous 2 years.
This bill would require inspections once every 4 years, unless the
United States Food and Drug Administration inspected the place of
business within the previous 4 years.
Vote: majority. Appropriation: no. Fiscal committee: yes.
State-mandated local program: no.
THE PEOPLE OF THE STATE OF CALIFORNIA DO ENACT AS FOLLOWS:
SECTION 1. Section 111550 of the Health and Safety Code is amended
to read:
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 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); it is a 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), or it is a
262).
(3) A new device that is reported
under Section 510(k) of the federal act (21 U.S.C. Sec. 360)
and or 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.
(c) It is the intent of the Legislature to preclude the department
from requiring a person who intends to sell, deliver, or give away
any new drug or device that meets the federal requirements described
in subdivision (a) to also obtain an approval pursuant to subdivision
(b), except to the extent that the department requires documentation
that the federal requirements are met.
SEC. 2. Section 111630 of the Health and Safety
Code is amended to read:
111630. (a) The department shall by regulation establish the
application form and set the fee for licensure and renewal of a
license. The penalty for failure to apply for renewal of a license
within 30 days after its expiration is ten dollars ($10) and shall be
added to the renewal fee and be paid by the applicant before the
renewal license may be issued. All moneys collected as fees shall be
expended when appropriated by the Legislature in the carrying out of
this part and the regulations adopted pursuant to this part.
(b) Notwithstanding subdivision (a), the department shall waive
the fee for the issuance and renew of a license for a person licensed
pursuant to this section who has paid the most recent annual fees
required pursuant to the federal act.
(c) A person licensed pursuant to this section shall immediately
notify the department of any change in the information reported in
the license application.
SEC. 2. Section 111635 of the Health
and Safety Code is amended to read:
111635. (a) Prior to issuing a license required by Section
111615, the department shall inspect each place of business.
(b) The department shall subsequently inspect the place of
business of each person licensed under Section 111615 once every
two four years. The department shall
conduct these inspections to determine ownership, adequacy of
facilities, and personnel qualifications. Where the United States
Food and Drug Administration has conducted an inspection of the place
of business within the previous two four
years, the department shall use the information contained in
the written documentation pertaining to that inspection rather than
conducting its own inspection pursuant to this subdivision. The
department may, if necessary, inspect to obtain information not
included or not sufficiently clear in the United States Food and Drug
Administration written documentation pertaining to the inspection
and needed to determine ownership, adequacy of facilities,
personnel qualifications, and compliance with this part
protect the health and safety of the public .
(c) The department may, in lieu of all or part of any inspection
required under this section, use information from audits conducted
pursuant to the provisions of the International Standards
Organization (ISO) 9000 series or European (EN) 46000 series quality
system standards, or other information identified by the department
by regulation.