BILL NUMBER: AB 1277 AMENDED
BILL TEXT
AMENDED IN SENATE JUNE 29, 2011
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 111635
, 111635, and 111640 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.
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that new drug or new device and that approval has not been withdrawn,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for it and that approval has not been withdrawn, terminated, or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withdrawn, terminated, or suspended under the federal act.
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 prohibition 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 , instead, require inspections
once every 4 years, unless each place of business to
submit to the department written documentation pertaining to an
inspection of the place of business by the United
States Food and Drug Administration inspected the place of
business within the previous 4 years prior to the
department issuing the place of business a license. This bill would
authorize the business to request specified written verification from
the department that its place of business was approved by the
department and require the department to provide a prescribed written
response .
Existing law authorizes any authorized agent of the department to
enter and inspect specified locations, as prescribed, for purposes of
enforcement of the Sherman Food, Drug, and Cosmetic Law.
This bill would require the department to make these
investigations or inspections when notification has been sent by the
United States Food and Drug Administration of a recall action or when
the United States Food and Drug Administration has requested
assistance for enforcement activities.
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 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 new device that is reported under Section 510(k) of the
federal act (21 U.S.C. Sec. 360) 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 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 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 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
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.
111615, the department shall receive from each place
of business written documentation pertaining to an inspection of the
place of business by the United States Food and Drug Administration.
(b) A business licensed under Section 111615 may request written
verification from the department that its place of business was
approved by the department where the United States Food and Drug
Administration's inspection was utilized as the basis for license
approval. The department shall provide the business with a written
response that its place of business has been approved for a license
under state law based on its passage of a federal inspection.
SEC. 3. Section 111640 of the Health
and Safety Code is amended to read:
111640. The department shall make investigations or inspections
authorized by Article 2 (commencing with Section 110410)
110140) of Chapter 2 as it deems
necessary to carry out this chapter when notification
has been sent by the United States Food and Drug Administration of a
recall action or when the United States Food and Drug Administration
has requested assistance for enforcement activities including, but
not limited to, embargoes, seizures, or injunctions
.