Statutory Changes to Pharmacy Law
The below provisions take effect January 1, 2017 unless otherwise noted.
Business and Professions Code Changes
Section 4001 of the Business and Professions Code is amended to read:
(a) There is in the Department of Consumer Affairs a California State Board of Pharmacy in which the
administration and enforcement of this chapter is vested. The board consists of 13 members.
(b) The Governor shall appoint seven competent pharmacists who reside in different parts of the state
to serve as members of the board. The Governor shall appoint four public members, and the Senate
Committee on Rules and the Speaker of the Assembly shall each appoint a public member who shall not
be a licensee of the board, any other board under this division, or any board referred to in Section 1000
or 3600.
(c) At least five of the seven pharmacist appointees to the board shall be pharmacists who are actively
engaged in the practice of pharmacy. Additionally, the membership of the board shall include at least
one pharmacist representative from each of the following practice settings: an acute care hospital, an
independent community pharmacy, a chain community pharmacy, and a long‐term health care or skilled
nursing facility. The pharmacist appointees shall also include a pharmacist who is a member of a labor
union that represents pharmacists. For the purposes of this subdivision, a “chain community pharmacy”
means a chain of 75 or more stores in California under the same ownership, and an “independent
community pharmacy” means a pharmacy owned by a person or entity who owns no more than four
pharmacies in California.
(d) Members of the board shall be appointed for a term of four years. No person shall serve as a
member of the board for more than two consecutive terms. Each member shall hold office until the
appointment and qualification of his or her successor or until one year shall have elapsed since the
expiration of the term for which the member was appointed, whichever first occurs. Vacancies occurring
shall be filled by appointment for the unexpired term.
(e) Each member of the board shall receive a per diem and expenses as provided in Section 103.
(f) This section shall remain in effect only until January 1, 2017, 2021, and as of that date is repealed,
unless a later enacted statute, that is enacted before January 1, 2017, deletes or extends that
date. repealed. Notwithstanding any other provision of law, the repeal of this section renders the
board subject to review by the appropriate policy committees of the Legislature.
Section 4003 of the Business and Professions Code is amended to read:
(a) The board, with the approval of the director, may appoint a person exempt from civil service who
shall be designated as an executive officer and who shall exercise the powers and perform the duties
delegated by the board and vested in him or her by this chapter. The executive officer may or may not
be a member of the board as the board may determine. Page 2 of 46
(b) The executive officer shall receive the compensation as established by the board with the approval of
the Director of Finance. The executive officer shall also be entitled to travel and other expenses
necessary in the performance of his or her duties.
(c) The executive officer shall maintain and update in a timely fashion records containing the names,
titles, qualifications, and places of business of all persons subject to this chapter.
(d) The executive officer shall give receipts for all money received by him or her and pay it to the
department, taking its receipt therefor. Besides the duties required by this chapter, the executive officer
shall perform other duties pertaining to the office as may be required of him or her by the board.
(e) This section shall remain in effect only until January 1, 2017, 2021, and as of that date is repealed,
unless a later enacted statute, that is enacted before January 1, 2017, deletes or extends that
date. repealed.
Section 4013 of the Business and Professions Code is amended to read:
(a) Any facility licensed by the board shall join the board’s e‐mail email notification list within 60 days of
obtaining a license or at the time of license renewal.
(b) Any facility licensed by the board shall update its e‐mail email address with the board’s e‐
mail email notification list within 30 days of a change in the facility’s e‐mail email address.
(c) An owner of two or more facilities licensed by the board may comply with subdivisions (a) and (b) by
subscribing a single e‐mail email address to the board’s e‐mail email notification list, where the owner
maintains an electronic notice system within all of its licensed facilities that, upon receipt of an e‐
mail email notification from the board, immediately transmits electronic notice of the same notification
to all of its licensed facilities. If an owner chooses to comply with this section by using such an electronic
notice system, the owner shall register the electronic notice system with the board by July 1, 2011, or
within 60 days of initial licensure, whichever is later, informing the board of the single e‐
mail email address to be utilized by the owner, describing the electronic notice system, and listing all
facilities to which immediate notice will be provided. The owner shall update its e‐mail email address
with the board’s e‐mail email notification list within 30 days of any change in the owner’s e‐
mail email address.
(d) (1) Each pharmacist, intern pharmacist, pharmacy technician, designated representative‐3PL licensed
in this state shall join the board’s email notification list within 60 days of obtaining a license or at the
time of license renewal.
(2) Each pharmacist, intern pharmacist, pharmacy technician, designated representative, and designated
representative‐3PL licensed in this state shall update his or her email address with the board’s email
notification list within 30 days of a change in the licensee’s email address.
(3) The email address provided by a licensee shall not be posted on the board’s online license
verification system.
(4) The board shall, with each renewal application, remind licensees of their obligation to report and
keep current their email address with the board’s email notification list.
(d) (5) This section subdivision shall become operative on July 1, 2010. 2017. Page 3 of 46
Section 4034 is added to the Business and Professions Code, to read:
“Outsourcing facility” means a facility that meets all of the following:
(a) Is located within the United States of America at one address that is engaged in the compounding of
sterile drugs and nonsterile drugs.
(b) Has registered as an outsourcing facility with the federal Food and Drug Administration under
Section 503B of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. Sec. 353b).
(c) Is doing business within or into California.
(d) Is licensed with the board as an outsourcing facility pursuant to Article 7.7 (commencing with Section
4129).
Section 4035 of the Business and Professions Code is amended to read:
“Person” includes includes, but is not limited to, firm, association, partnership, corporation, limited
liability company, state governmental agency, trust, or political subdivision.
Section 4081 of the Business and Professions Code is amended to read:
(a) All records of manufacture and of sale, acquisition, receipt, shipment, 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, third‐party logistics provider, pharmacy,
veterinary food‐animal drug retailer, outsourcing facility, 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, third‐party logistics provider, or
veterinary food‐animal drug retailer shall be jointly responsible, with the pharmacist‐in‐charge,
responsible manager, or designated representative‐in‐charge, for maintaining the records and inventory
described in this section.
(c) The pharmacist‐in‐charge, responsible manager, 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, responsible manager, or designated representative‐in‐charge had no
knowledge, or in which he or she did not knowingly participate.
Section 4105.5 is added to the Business and Professions Code, to read:
(a) For purposes of this section, an “automated drug delivery system” has the same meaning as that
term is defined in paragraph (1) of subdivision (a) of Section 1261.6 of the Health and Safety Code. Page 4 of 46
(b) Except as provided by subdivision (e), a pharmacy that owns or provides dangerous drugs dispensed
through an automated drug delivery system shall register the automated drug delivery system by
providing the board in writing with the location of each device within 30 days of installation of the
device, and on an annual basis as part of the license renewal pursuant to subdivision (a) of Section 4110.
The pharmacy shall also advise the board in writing within 30 days if the pharmacy discontinues
operating an automated drug delivery system.
(c) A pharmacy may only use an automated drug delivery system if all of the following conditions are
satisfied:
(1) Use of the automated drug delivery system is consistent with legal requirements.
(2) The pharmacy’s policies and procedures related to the automated drug delivery system to include
appropriate security measures and monitoring of the inventory to prevent theft and diversion.
(3) The pharmacy reports drug losses from the automated drug delivery system to the board as required
by law.
(4) The pharmacy license is unexpired and not subject to disciplinary conditions.
(d) The board may prohibit a pharmacy from using an automated drug delivery system if the board
determines that the conditions provided in subdivision (c) are not satisfied. If such a determination is
made, the board shall provide the pharmacy with written notice including the basis for the
determination. The pharmacy may request an office conference to appeal the board’s decision within 30
days of receipt of the written notice. The executive officer or designee may affirm or overturn the
prohibition as a result of the office conference.
(e) An automated drug delivery system operated by a licensed hospital pharmacy as defined in Section
4029 for doses administered in a facility operated under a consolidated license under Section 1250.8 of
the Health and Safety Code shall be exempt from the requirements of subdivision (b).
Section 4107 of the Business and Professions Code is amended to read:
(a) The board may shall not issue more than one site license to a single premises except as follows:
(1) To issue a veterinary food‐animal drug retailer license to a wholesaler pursuant to Section 4196.
(2) To issue a license to compound sterile injectable drugs to a pharmacy pursuant to Section
4127.1. 4127.1 or 4127.
