BILL NUMBER: AB 1277 AMENDED
BILL TEXT
AMENDED IN SENATE JANUARY 4, 2012
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
( Coauthors: Assembly Members
Alejo, Fletcher, Pan, and Smyth
)
( Coauthors: Senators
Blakeslee and Padilla )
FEBRUARY 18, 2011
An act to amend Sections 111550, 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that new drug or new device and that approval has not been withdrawn,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for it and that approval has not been withdrawn, terminated, or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
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approved, and that approval has not been withdrawn, terminated, or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 prior to issuance of the
license and, thereafter, 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 each place of business to submit
to the department written documentation
pertaining to an inspection of that evidences that
the place of business is operating pursuant to a valid
establishment registration issued by the United States Food and
Drug Administration , as prescribed, or is in compliance with
audits conducted pursuant to specified standards ,
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 based upon specified information
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 , instead, require the department to
make these investigations or inspections when
only under specified circumstances, including when the department
makes a determination that the health and safety of the public is at
risk, 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) (21 U.S.C.
Sec. 360(k)), or exempted therefrom pursuant to 21 U.S.C. Sec. 360
(m), 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
to any place of business , 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 documentation that evidences
that the place of business is operating pursuant to a valid
establishment registration issued by the United States Food and Drug
Administration in compliance with Section 351 of the
federal Public Health Service Act (42 U.S.C. Sec. 262) and Section
704 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. Sec. 374),
or is operating in compliance with audits conducted pursuant to the
International Standards Organization (ISO) 9000:2005, ISO 13485:2003
quality management systems standards, ISO 15378:2006 quality
management systems standards, or similar standards identified
by the department by regulation .
(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.
(b) Upon request by a place of business licensed under Section
111615, the department shall provide written verification that the
department issued the license based on documentation that evidences
that the place of business is operating pursuant to a valid
establishment registration issued by the United States Food and Drug
Administration in compliance with Section 351 of the federal Public
Health Service Act (42 U.S.C. Sec. 262) and Section 704 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. Sec. 374), or is
operating in compliance with audits conducted pursuant to the
International Standards Organization (ISO) 9000:2005, ISO 13485:2003
quality management systems standards, ISO 15378:2006 quality
management systems standards, or similar standards identified by the
department by regulation.
SEC. 3. Section 111640 of the Health and Safety Code is amended to
read:
111640. The With respect to drugs and
devices, the department shall make investigations or
inspections authorized by Article 2 (commencing with Section 110140)
of Chapter 2 when notification has been sent by the United
States Food and Drug Administration of a recall action or when the
only when any of the following occur:
(a) The department makes a determination that the health and
safety of the public is at risk.
(b) A complaint has been registered with the department and the
department makes a determination that the public health and safety is
at risk.
(c) A notification has been sent by the United States Food and
Drug Administration of any recall action memorandum.
(d) The United States Food and
Drug Administration has requested assistance for enforcement
activities, including, but not limited to, embargoes, seizures, or
injunctions.