SECTIONS 4080-4086 - California Statutes

BUSINESS AND PROFESSIONS CODE

SECTION 4080-4086

4080. All stock of any dangerous drug or dangerous device or of
shipments through a customs broker or carrier shall be, at all times
during business hours, open to inspection by authorized officers of
the law.

4081. (a) All records of manufacture and of sale, acquisition, or
disposition of dangerous drugs or dangerous devices shall be at all
times during business hours open to inspection by authorized officers
of the law, and shall be preserved for at least three years from the
date of making. A current inventory shall be kept by every
manufacturer, wholesaler, pharmacy, veterinary food-animal drug
retailer, physician, dentist, podiatrist, veterinarian, laboratory,
clinic, hospital, institution, or establishment holding a currently
valid and unrevoked certificate, license, permit, registration, or
exemption under Division 2 (commencing with Section 1200) of the
Health and Safety Code or under Part 4 (commencing with Section
16000) of Division 9 of the Welfare and Institutions Code who
maintains a stock of dangerous drugs or dangerous devices.
(b) The owner, officer, and partner of a pharmacy, wholesaler, or
veterinary food-animal drug retailer shall be jointly responsible,
with the pharmacist-in-charge or designated representative-in-charge,
for maintaining the records and inventory described in this section.
(c) The pharmacist-in-charge or designated
representative-in-charge shall not be criminally responsible for acts
of the owner, officer, partner, or employee that violate this
section and of which the pharmacist-in-charge or designated
representative-in-charge had no knowledge, or in which he or she did
not knowingly participate.

4082. When called upon by an inspector, the owner or manager of any
entity licensed by the board, or other store, shop, building, or
premises retailing, wholesaling, or storing drugs or devices shall
furnish the inspector with the names of the owner or owners, manager
or managers, and employees together with a brief statement of the
capacity in which these persons are employed on the premises.

4083. (a) An inspector may issue an order of correction to a
licensee directing the licensee to comply with this chapter or
regulations adopted pursuant to this chapter.
(b) The order of correction shall be in writing and shall describe
in detail the nature and facts of the violation, including a
reference to the statute or regulations violated.
(c) The order of correction shall inform the licensee that within
30 days of service of the order of correction, the licensee may do
either of the following:
(1) Submit a written request for an office conference with the
board's executive officer to contest the order of correction.
(A) Upon a timely request, the executive officer, or his or her
designee, shall hold an office conference with the licensee or the
licensee's legal counsel or authorized representative. Unless so
authorized by the executive officer, or his or her designee, no
individual other than the licensee's legal counsel or authorized
representative may accompany the licensee to the office conference.
(B) Prior to or at the office conference, the licensee may submit
to the executive officer declarations and documents pertinent to the
subject matter of the order of correction.
(C) The office conference is intended to be an informal proceeding
and shall not be subject to the provisions of the Administrative
Procedure Act (Chapter 3.5 (commencing with Section 11340), Chapter 4
(commencing with Section 11370), Chapter 4.5 (commencing with
Section 11400), and Chapter 5 (commencing with Section 11500) of Part
1 of Division 3 of Title 2 of the Government Code).
(D) The executive officer, or his or her designee, may affirm,
modify, or withdraw the order of correction. Within 14 calendar days
from the date of the office conference, the executive officer, or his
or her designee, shall personally serve or send by certified mail to
the licensee's address of record with the board a written decision.
This decision shall be deemed the final administrative decision
concerning the order of correction.
(E) Judicial review of the decision may be had by filing a
petition for a writ of mandate in accordance with the provisions of
Section 1094.5 of the Code of Civil Procedure within 30 days of the
date the decision was personally served or sent by certified mail.
The judicial review shall extend to the question of whether or not
there was a prejudicial abuse of discretion in the issuance of the
order of correction.
(2) Comply with the order of correction and submit a written
corrective action plan to the inspector documenting compliance. If an
office conference is not requested pursuant to this section,
compliance with the order of correction shall not constitute an
admission of the violation noted in the order of correction.
(d) The order of correction shall be served upon the licensee
personally or by certified mail at the licensee's address of record
with the board. If the licensee is served by certified mail, service
shall be effective upon deposit in the United States mail.
(e) The licensee shall maintain and have readily available on the
pharmacy premises a copy of the order of correction and corrective
action plan for at least three years from the date of issuance of the
order of correction.
(f) Nothing in this section shall in any way limit the board's
authority or ability to do any of the following:
(1) Issue a citation pursuant to Section 125.9, 148, or 4067 or
pursuant to Section 1775, 1775.15, 1777, or 1778 of Title 16 of the
California Code of Regulations.
(2) Issue a letter of admonishment pursuant to Section 4315.
(3) Institute disciplinary proceedings pursuant to Article 19
(commencing with Section 4300).
(g) Unless a writ of mandate is filed, a citation issued, a letter
of admonishment issued, or a disciplinary proceeding instituted, an
order of correction shall not be considered a public record and shall
not be disclosed pursuant to a request under the California Public
Records Act (Chapter 3.5 (commencing with Section 6250) of Division 7
of Title 1 of the Government Code).

4084. (a) When a board inspector finds, or has probable cause to
believe, that any dangerous drug or dangerous device is adulterated,
misbranded, or counterfeit, the board inspector shall affix a tag or
other marking to that dangerous drug or dangerous device. The board
inspector shall give notice to the person that the dangerous drug or
dangerous device bearing the tag or marking has been embargoed.
(b) When a board inspector has found that an embargoed dangerous
drug or dangerous device is not adulterated, misbranded, or
counterfeit, a board inspector shall remove the tag or other marking.
(c) A board inspector may secure a sample or specimen of a
dangerous drug or dangerous device. If the board inspector obtains a
sample prior to leaving the premises, the board inspector shall leave
a receipt describing the sample.
(d) For the purposes of this article, "counterfeit" shall have the
meaning defined in Section 109905 of the Health and Safety Code.
(e) For the purposes of this article, "adulterated" shall have the
meaning defined in Article 2 (commencing with Section 111250) of
Chapter 6 of Part 5 of Division 104 of the Health and Safety Code.
(f) For the purposes of this article, "misbranded" shall have the
meaning defined in Article 3 (commencing with Section 111330) of
Chapter 6 of Part 5 of Division 104 of the Health and Safety Code.

4085. (a) It is unlawful for any person to remove, sell, or dispose
of an embargoed dangerous drug or dangerous device without
permission of the board.
(b) When a board inspector has reasonable cause to believe, that
the embargo will be violated, a board inspector may remove the
embargoed dangerous drug or dangerous device from the premises.

4086. (a) If a dangerous drug or dangerous device is alleged to be
adulterated or counterfeit, the board shall commence proceedings in
the superior court in whose jurisdiction the dangerous drug or
dangerous device is located, for condemnation of the dangerous drug
or dangerous device.
(b) If the court finds that an embargoed dangerous drug or
dangerous device is adulterated or counterfeit, the dangerous drug or
dangerous device shall, after entry of the judgment, be destroyed at
the expense of the claimant or owner, under the supervision of the
board. All court costs and fees and all reasonable costs incurred by
the board in investigating and prosecuting the action, including, but
not limited to, the costs of storage and testing, shall be paid by
the claimant or owner of the dangerous drug or dangerous device.
(c) A superior court of this state may condemn any dangerous drug
or dangerous device pursuant to this article. In the absence of an
order, the dangerous drug or dangerous device may be destroyed under
the supervision of the board who has the written consent of the
owner, his or her attorney, or authorized representative. If the
board cannot ascertain ownership of the dangerous drug or dangerous
device within 30 days of establishing an embargo, the board may
destroy the dangerous drug or dangerous device.