110190-110241

HEALTH AND SAFETY CODE
SECTION 110190-110241




110190.  Any person who ships to another state or country a food,
drug, device, or cosmetic manufactured or produced in this state may
request the department to issue an export document to reference the
shipment of the food, drug, device, or cosmetic. The food, drug,
device, or cosmetic shall be manufactured or produced in this state
by a person who has a valid registration, license, certificate, or
permit issued by the department under this part or the Miscellaneous
Food, Food Facility, and Hazardous Substances Act (Section 27). For
each request, the requesting person shall submit to the department
all of the following:
   (a) All original labels, labeling, and advertising affixed to,
accompanying, or relating to the food, drug, device, or cosmetic. The
department may accept copies if submission of original labels,
labeling, or advertising is impractical.
   (b) If not clearly evident from the materials submitted pursuant
to subdivision (a), the requester shall submit both of the following:
   (1) The name, place of business, and the type and number of the
registration, license, certificate, or permit issued by the
department to the manufacturer or producer of the food, drug, device,
or cosmetic.
   (2) The identity of the food, drug, device, or cosmetic being
shipped.
   (c) The name of the state or country to which the food, drug,
device, or cosmetic is being shipped.
   (d) The approximate date of shipment of the food, drug, device, or
cosmetic.
   (e) Additional statements the requesting person wishes to have
incorporated into the export document.
   (f) The name and telephone number of the requesting person to whom
the department may refer questions or requests for additional
information.
   (g) The one-time fee required by paragraph (1) of subdivision (a)
of Section 110210, if the fee has not yet been paid, and the minimum
charge required by paragraph (2) of subdivision (a) of Section
110210.



110200.  (a) Each export document issued by the department shall do
all of the following:
   (1) Identify either or both of the following:
   (A) The name and place of business of the manufacturer or producer
of the food, drug, device, or cosmetic.
   (B) The name and place of business of the distributor of the food,
drug, device, or cosmetic.
   (2) Identify the food, drug, device, or cosmetic being shipped.
   (3) Identify the state or country to which the food, drug, device,
or cosmetic is being shipped.
   (4) Identify the approximate date of shipment.
   (5) Describe the department's authority over the food, drug,
device, or cosmetic to be shipped and its manufacturer or producer.
   (6) State that the department does not object to the sale of the
food, drug, device, or cosmetic in this state or the shipment of the
food, drug, device, or cosmetic to any other state or country.
   (b) Each export document issued by the department may, in the
department's sole discretion, include additional statements requested
by the person who requested the export document.
   (c) Each export document issued by the department shall be issued
by the Chief of the Food and Drug Branch of the department, or his or
her designee. The chief or his or her designee may issue an export
document prepared by the department or by the requesting person.
   (d) The export document shall expire 180 days after its issue
date.


110210.  (a)  Each person requesting the department to issue an
export document shall pay nonreturnable fees as follows:
   (1) A one-time fee of one hundred dollars ($100).
   (2) A fee for service charge at the rate of eighty dollars ($80)
per hour, at a minimum of twenty-five dollars ($25) per request.
   (3) Any attendant costs incurred by the department, including, but
not limited to, the costs of additional inspection, priority
mailing, or notary service necessitated by the request.
   (b) The fee amounts shall be adjusted annually pursuant to Section
100425.
   (c) In no case shall the fees exceed the reasonable costs of the
department in administering this article.
   (d) The department shall provide to the person who pays the fees a
statement or invoice that describes the costs paid from the fees.




110220.  (a) The department may refuse to accept any request where
the information required to be submitted by this article is
incomplete.
   (b) The department may refuse to issue an export document, or may
invalidate an export document, if it finds, or has probable cause to
believe, any of the following:
   (1) The food, drug, device, or cosmetic, or requesting person
violated any provision of this part, the Miscellaneous Food, Food
Facility, and Hazardous Substances Act (Section 27), or any
regulation adopted pursuant to this part or that act.
   (2) Any information required to be submitted by this article is
incomplete or false.
   (3) The requesting person has not paid all outstanding fees
required by this article.
   (4) The food, drug, device, or cosmetic is not manufactured or
produced in this state.
   (5) The food, drug, device, or cosmetic is intended to be exported
under Section 110655, 110790, 111315, 111460, 111720, or 111785.
   (6) The food is a raw agricultural commodity or dairy product
regulated by the Department of Food and Agriculture or a poultry or
meat product regulated by the United States Department of
Agriculture.
   (c) If the department refuses to issue an export document, or
invalidates an export document, the department shall inform the
requesting person in writing of the reasons for the refusal or
invalidation. The requesting person may request reconsideration by
forwarding a written request to the Chief of the Division of
Environmental Health of the department. The request for
reconsideration must be postmarked or received by the department no
later than 30 days after the date of the department's refusal or
invalidation, and shall include a complete statement of all arguments
and evidence that support the request for reconsideration. The Chief
of the Division of Environmental Health shall notify the requesting
person of his or her decision within 30 days. The decision of the
Chief of the Division of Environmental Health shall be final.
   (d) It is the intent of the Legislature that the department shall
respond to each request for issuance of an export document within
five working days of receipt of the request by the Food and Drug
Branch of the department.


110225.  It is unlawful for any person to knowingly supply the
department with false material facts in a request for an export
document or to falsely represent that the department has issued an
export document.


110230.  Any person who has a valid registration, license,
certificate, or permit issued by the department to manufacture or
produce a food, drug, device, or cosmetic in this state may request
the department to issue an official copy of the valid registration,
license, certificate, or permit.



110235.  (a) Each person requesting the department to issue an
official copy of a valid registration, license, certificate, or
permit shall pay nonreturnable fees as follows:
   (1) Fifteen dollars ($15) per official copy.
   (2) Any attendant costs incurred by the department, including, but
not limited to, the costs of additional inspection, priority
mailing, or notary service necessitated by the request.
   (b) The fee amount shall be adjusted annually pursuant to Section
100425.
   (c) The department shall provide to the person who pays the fees a
statement or invoice that describes the costs paid from the fees.



110240.  There is established an Export Document Program Fund within
the General Fund. All fees collected pursuant to Sections 110210 and
110235 shall be deposited into the Export Document Program Fund and,
upon appropriation, shall be expended by the department for the
purpose of administering this article.


110241.  All fees collected by the department pursuant to requests
to conduct a voluntary medical device review shall be deposited into
the Export Document Program Fund and, upon appropriation, shall be
expended for the purpose of determining if the device is a new device
or is substantially equivalent to a current or previously marked
device.