BILL NUMBER: AB 1277	AMENDED
	BILL TEXT

	AMENDED IN SENATE  JUNE 20, 2012
	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that new drug or new device and that approval has not been withdrawn,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for it and that approval has not been withdrawn, terminated, or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 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withdrawn, terminated, or suspended under the federal act.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   exempt  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   manufacturer
of a drug or device in the state  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 documentation that evidences  ownership and
 that the place of business is operating pursuant to a valid
 biologics license,  establishment registration  , or
approved investigational new drug or investigational device exemption
 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.  If the business does not provide this
documentation, the bill would require the department to inspect the
place of business prior to licensure.  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   an
official copy of the valid license  .
   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 only under specified circumstances,
including when the department makes a determination that the health
and safety of the public is at  serious  risk, notification
has been sent by the United States Food and Drug Administration
 of   to the department requesting assistance
regarding  a  specified  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(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.
  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  where a drug or device is manufactured
 , the department shall receive from each place of business
documentation that evidences  that the  
ownership and any of the following: 
    (1)     The  place of business is
operating pursuant to a valid  establishment registration
  biologics license  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   . This documentation shall include an
attestation from the place of business that a federal inspection was
completed within the past two years from the date of the attestation
  . 
    (2)     The place of business is operating
with a valid establishment registration pursuant to Section 510 of
the federal act (21 U.S.C. Sec. 360). 
    (3)     The place of business  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   pursuant to
Parts 210 and 211 of Title 21 of the Code of Federal Regulations, or
pursuant to Part 820 of Title 21 of the Code of Federal Regulations
 . 
   (4) The place of business is operating pursuant to an approved
investigational new drug issued by the federal Food and Drug
Administration pursuant to Sections 312.22 and 312.23 of Title 21 of
the Code of Federal Regulations or pursuant to an approved
investigational device exemption issued by the federal Food and Drug
Administration pursuant to Part 812 of Title 21 of the Code of
Federal Regulations.  
   (b) If the department receives documentation that satisfies the
requirements of subdivision (a), the department shall not inspect the
place of business prior to issuing a license required by Section
111615. If the department does not receive the documentation
required, the department shall inspect the place of business prior to
issuing a license required by Section 111615.  
   (b) 
    (c)  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   an official copy of
the valid license to the place of business in accordance with
Sections 110230 and 110235  .
  SEC. 3.  Section 111640 of the Health and Safety Code is amended to
read:
   111640.  With respect to drugs and devices, the department shall
make investigations or inspections authorized by Article 2
(commencing with Section 110140) of Chapter 2 only when any of the
following occur:
   (a) The department makes a determination that the health and
safety of the public is at  serious  risk.
   (b) A complaint has been registered with the department and the
department makes a determination that the public health and safety is
at  serious  risk.
   (c) A notification has been sent by the United States Food and
Drug Administration  of   to the department that
requests assistance regarding  any  Class I or II 
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.