Bill Text: CA SB600 | 2013-2014 | Regular Session | Amended

NOTE: There are more recent revisions of this legislation. Read Latest Draft

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Bill Title: Drugs.

Spectrum: Partisan Bill (Democrat 1-0)

Status: (Passed) 2014-09-20 - Chaptered by Secretary of State. Chapter 492, Statutes of 2014. [SB600 Detail]

Download: California-2013-SB600-Amended.html

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BILL NUMBER: SB 600	AMENDED
	BILL TEXT

	AMENDED IN ASSEMBLY  JUNE 10, 2014
	AMENDED IN SENATE  MAY 28, 2013
	AMENDED IN SENATE  APRIL 23, 2013
	AMENDED IN SENATE  APRIL 8, 2013

INTRODUCED BY   Senator Lieu

                        FEBRUARY 22, 2013

    An act to add Section 43006.5 to the Health and Safety
Code, relating to vehicular air pollution.   An act to
amend Sections 4033 and 4045 of, to add Section 2245 to, to repeal
Sections 4034, 4034.1, 4163.1, 4163.2, 4163.3, 4163.4, and 4163.5 of,
and to repeal and add Section 4163 of, the Business and Professions
Code, and to amend Section 111825 of, and to add Section 111397 to,
the Health and Safety Code, relating to pharmacy. 


	LEGISLATIVE COUNSEL'S DIGEST


   SB 600, as amended, Lieu.  Vehicles: alternative fuel.
  Drugs.  
   (1) Existing federal law, the Federal Food, Drug, and Cosmetic
Act, regulates, among other matters, the manufacture, distribution,
and sale of prescription drugs in interstate commerce and is
administered by the United States Food and Drug Administration. 

   Existing law, the Medical Practice Act, provides for the licensure
and regulation of physicians and surgeons by the Medical Board of
California. The act provides that it is unprofessional conduct for a
licensee under the act to prescribe, dispense, or furnish dangerous
drugs, as defined, under specified circumstances and requires the
board to take action against a licensee who is charged with
unprofessional conduct. Under existing law, a violation of any of the
enforcement provisions of the act is punishable as a misdemeanor.
 
   This bill would provide that purchasing a foreign dangerous drug
or device, illegitimate product, or suspect product that is not
approved by the United States Food and Drug Administration or that is
obtained outside of the licensed supply chain regulated by the
United States Food and Drug Administration, California State Board of
Pharmacy, or State Department of Public Health constitutes
unprofessional conduct. Because a violation of this provision would
be a crime, the bill would impose a state-mandated local program.
 
   (2) Existing law, the federal Drug Supply Chain Security Act
establishes the development of a system that will require, among
other things, manufacturers, wholesale drug distributors,
repackagers, and dispensers in the drug supply chain to provide
specified transaction information about a drug product, and prohibits
a state or political subdivision of a state from continuing in
effect any requirements for tracing products through the distribution
system, including any requirements with respect to electronic
pedigree systems, that are inconsistent with, more stringent than, or
in addition to, any requirements of federal law.  
   Existing law, the Pharmacy Law, provides for the licensure and
regulation of the practice of pharmacy and the sale of dangerous
drugs or dangerous devices by the California State Board of Pharmacy.
Existing law, commencing July 1, 2016, prohibits a wholesaler or
repackager from selling, trading, or transferring a dangerous drug at
wholesale without providing a pedigree, as defined, and from
acquiring a dangerous drug without receiving a pedigree. Existing law
imposes parallel requirements with respect to pharmacies commencing
July 1, 2017. Existing law makes these pedigree requirements
inoperative upon the effective date of federal law addressing
pedigree or serialization measures for dangerous drugs, or as
otherwise specified in the event of a conflict with federal law.
 
   This bill would repeal the pedigree requirements and make related
conforming changes.  
   (3) Existing 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.
Existing law makes it unlawful to manufacture, sell, deliver, hold,
or offer for sale, any drug that is misbranded, and provides that a
drug or device is misbranded if its labeling is false or misleading
in any particular. A violation of this law is a misdemeanor. 

   This bill would provide that any foreign dangerous drug that is
not approved by the United States Food and Drug Administration or
that is obtained outside of the licensed supply chain regulated by
the United States Food and Drug Administration, California State
Board of Pharmacy, or State Department of Public Health is
misbranded. Because a violation of this provision would be a crime,
the bill would impose a state-mandated local program. 
   The bill would provide that any person who purchases a foreign
dangerous drug or medical device, or an illegitimate product or
suspect product, as those terms are defined pursuant to federal law,
that is not approved by the United States Food and Drug
Administration or that is obtained outside of the licensed supply
chain regulated by the United States Food and Drug Administration,
California State Board of Pharmacy, or State Department of Public
Health is guilty of a misdemeanor and subject to imprisonment for not
more than one year in the county jail, a fine of not more that
$10,000 per occurrence, or both the imprisonment and fine. By
creating new crimes, the bill would impose a state-mandated local
program.  
   (4) The California Constitution requires the state to reimburse
local agencies and school districts for certain costs mandated by the
state. Statutory provisions establish procedures for making that
reimbursement.  
   This bill would provide that no reimbursement is required by this
act for a specified reason.  
   Existing law generally designates the State Air Resources Board as
the state agency with the primary responsibility for the control of
vehicular air pollution. Existing law authorizes the State Air
Resources Board to certify the fuel system of any motor vehicle
powered by a fuel other than gasoline or diesel if it meets certain
standards and to adopt test procedures for that certification.
 
   This bill, commencing January 1, 2014, would require the state
board to use specified procedures for small volume manufacturers of
vehicles seeking to have alternative fuel conversion systems
certified by the state board. The bill would require the state board,
commencing January 1, 2014, to extend the life of a new vehicle or
engine certification until December 31 of the year following a given
vehicle model year. 
   Vote: majority. Appropriation: no. Fiscal committee: yes.
State-mandated local program:  no   yes  .


THE PEOPLE OF THE STATE OF CALIFORNIA DO ENACT AS FOLLOWS:

   SECTION 1.    Section 2245 is added to the  
Business and Professions Code   , to read:  
   2245.  Purchasing a foreign dangerous drug or device, illegitimate
product, as defined in Section 360eee(8) of Title 21 of the United
States Code, or suspect product, as defined in Section 360eee(21) of
Title 21 of the United States Code, that is not approved by the
United States Food and Drug Administration or that is obtained
outside of the licensed supply chain regulated by the United States
Food and Drug Administration, California State Board of Pharmacy, or
State Department of Public Health constitutes unprofessional conduct.

   SEC. 2.    Section 4033 of the   Business
and Professions Code   is amended to read: 
   4033.  (a) (1) "Manufacturer" means and includes every person who
prepares, derives, produces, compounds, or repackages any drug or
device except a pharmacy that manufactures on the immediate premises
where the drug or device is sold to the ultimate consumer.
   (2) Notwithstanding paragraph (1), "manufacturer" shall not mean a
pharmacy compounding a drug for parenteral therapy, pursuant to a
prescription, for delivery to another pharmacy for the purpose of
delivering or administering the drug to the patient or patients named
in the prescription, provided that neither the components for the
drug nor the drug are compounded, fabricated, packaged, or otherwise
prepared prior to receipt of the prescription.
   (3) Notwithstanding paragraph (1), "manufacturer" shall not mean a
pharmacy that, at a patient's request, repackages a drug previously
dispensed to the patient, or to the patient's agent, pursuant to a
prescription.
   (b) Notwithstanding subdivision (a),  as used in Sections
4034, 4163, 4163.1, 4163.2, 4163.3, 4163.4, and 4163.5, 
"manufacturer"  also  means a person who prepares, derives,
manufactures, produces, or repackages a dangerous drug, as defined in
Section 4022, device, or cosmetic. Manufacturer also means the
holder or holders of a New Drug Application (NDA), an Abbreviated New
Drug Application (ANDA), or a Biologics License Application (BLA),
provided that such application has been approved; a manufacturer's
third party logistics provider; a private label distributor
(including colicensed partners) for whom the private label
distributor's prescription drugs are originally manufactured and
labeled for the distributor and have not been repackaged; or the
distributor agent for the manufacturer, contract manufacturer, or
private label distributor, whether the establishment is a member of
the manufacturer's affiliated group (regardless of whether the member
takes title to the drug) or is a contract distributor site.
   SEC. 3.    Section 4034 of the   Business
and Professions Code   is repealed.  
   4034.  (a) "Pedigree" means a record, in electronic form,
containing information regarding each transaction resulting in a
change of ownership of a given dangerous drug, from sale by a
manufacturer, through acquisition and sale by one or more
wholesalers, manufacturers, repackagers, or pharmacies, until final
sale to a pharmacy or other person furnishing, administering, or
dispensing the dangerous drug. The pedigree shall be created and
maintained in an interoperable electronic system, ensuring
compatibility throughout all stages of distribution.
   (b) A pedigree shall include all of the following information:
   (1) The source of the dangerous drug, including the name, the
federal manufacturer's registration number or a state license number
as determined by the board, and principal address of the source.
   (2) The trade or generic name of the dangerous drug, the quantity
of the dangerous drug, its dosage form and strength, the date of the
transaction, the sales invoice number or, if not immediately
available, a customer-specific shipping reference number linked to
the sales invoice number, the container size, the number of
containers, the expiration dates, and the lot numbers.
   (3) The business name, address, and the federal manufacturer's
registration number or a state license number as determined by the
board, of each owner of the dangerous drug, and the dangerous drug
shipping information, including the name and address of each person
certifying delivery or receipt of the dangerous drug.
   (4) A certification under penalty of perjury from a responsible
party of the source of the dangerous drug that the information
contained in the pedigree is true and accurate.
   (5) The unique identification number described in subdivision (i).

   (c) A single pedigree shall include every change of ownership of a
given dangerous drug from its initial manufacture through to its
final transaction to a pharmacy or other person for furnishing,
administering, or dispensing the drug, regardless of repackaging or
assignment of another National Drug Code (NDC) Directory number.
Dangerous drugs that are repackaged shall be serialized by the
repackager and a pedigree shall be provided that references the
pedigree of the original package or packages provided by the
manufacturer.
   (d) A pedigree shall track each dangerous drug at the smallest
package or immediate container distributed by the manufacturer,
received and distributed by the wholesaler or repackager, and
received by the pharmacy or another person furnishing, administering,
or dispensing the dangerous drug. For purposes of this section, the
"smallest package or immediate container" of a dangerous drug shall
include any dangerous drug package or container made available to a
repackager, wholesaler, pharmacy, or other entity for repackaging or
redistribution, as well as the smallest unit made by the manufacturer
for sale to the pharmacy or other person furnishing, administering,
or dispensing the drug.
   (e) Any return of a dangerous drug to a wholesaler or manufacturer
shall be documented on the same pedigree as the transaction that
resulted in the receipt of the drug by the party returning it.
   (f) If a licensed health care service plan, hospital organization,
and one or more physician organizations have exclusive contractual
relationships to provide health care services, drugs distributed
between these persons shall be deemed not to have changed ownership.
   (g) The following transactions are exempt from the pedigree
requirement created by this section:
   (1) An intracompany sale or transfer of a dangerous drug. For
purposes of this section, "intracompany sale or transfer" means any
transaction for any valid business purpose between a division,
subsidiary, parent, or affiliated or related company under the common
ownership and control of the same corporate or legal entity.
   (2) Dangerous drugs received by the state or a local government
entity from a department or agency of the federal government or an
agent of the federal government specifically authorized to deliver
dangerous drugs to the state or local government entity.
   (3) The provision of samples of dangerous drugs by a manufacturer'
s employee to an authorized prescriber, provided the samples are
dispensed to a patient of the prescriber without charge.
   (4) (A) A sale, trade, or transfer of a radioactive drug, as
defined in Section 1708.3 of Title 16 of the California Code of
Regulations, between any two entities licensed by the Radiologic
Health Branch of the State Department of Public Health, the federal
Nuclear Regulatory Commission, or an Agreement state.
   (B) The exemption in this paragraph shall remain in effect unless
the board, no earlier than the date that is two years after the
compliance date for manufacturers set forth in subdivision (k) of
Section 4034 or Section 4163.5, determines after consultation with
the Radiologic Health Branch of the State Department of Public Health
that the risk of counterfeiting or diversion of a radioactive drug
is sufficient to require a pedigree. Two years following the date of
any such determination, this paragraph shall become inoperative.
   (5) The sale, trade, or transfer of a dangerous drug that is
labeled by the manufacturer as "for veterinary use only."
   (6) The sale, trade, or transfer of compressed medical gas. For
purposes of this section, "compressed medical gas" means any
substance in its gaseous or cryogenic liquid form that meets medical
purity standards and has application in a medical or homecare
environment, including, but not limited to, oxygen and nitrous oxide.

   (7) The sale, trade, or transfer of solutions. For purposes of
this section, "solutions" means any of the following:
   (A) Those intravenous products that, by their formulation, are
intended for the replenishment of fluids and electrolytes, such as
sodium, chloride, and potassium, calories, such as dextrose and amino
acids, or both.
   (B) Those intravenous products used to maintain the equilibrium of
water and minerals in the body, such as dialysis solutions.
   (C) Products that are intended for irrigation or reconstitution,
as well as sterile water, whether intended for those purposes or for
injection.
   (8) Dangerous drugs that are placed in a sealed package with a
medical device or medical supplies at the point of first shipment
into commerce by the manufacturer and the package remains sealed
until the drug and device are used, provided that the package is only
used for surgical purposes.
   (9) A product that meets either of the following criteria:
   (A) A product comprised of two or more regulated components, such
as a drug/device, biologic/device, or drug/device/biologic, that are
physically, chemically, or otherwise combined or mixed and produced
as a single entity.
   (B) Two or more separate products packaged together in a single
package or as a unit and comprised of drug and device products or
device and biological products.
   (h) If a manufacturer, wholesaler, or pharmacy has reasonable
cause to believe that a dangerous drug in, or having been in, its
possession is counterfeit or the subject of a fraudulent transaction,
the manufacturer, wholesaler, or pharmacy shall notify the board
within 72 hours of obtaining that knowledge. This subdivision shall
apply to any dangerous drug that has been sold or distributed in or
through this state.
   (i) "Interoperable electronic system" as used in this chapter
means an electronic track and trace system for dangerous drugs that
uses a unique identification number, established at the point of
manufacture and supplemented by a linked unique identification number
in the event that drug is repackaged, contained within a
standardized nonproprietary data format and architecture, that is
uniformly used by manufacturers, wholesalers, repackagers, and
pharmacies for the pedigree of a dangerous drug. No particular data
carrier or other technology is mandated to accomplish the attachment
of the unique identification number described in this subdivision.
   (j) The application of the pedigree requirement shall be subject
to review during the board's evaluation pursuant to Section 473.4.
   (k) This section shall become operative on January 1, 2015.

   SEC. 4.    Section 4034.1 of the   Business
and Professions Code   is repealed.  
   4034.1.  (a) (1) Upon the effective date of federal legislation or
adoption of a federal regulation addressing pedigree or
serialization measures for dangerous drugs, Sections 4034, 4163,
4163.1, 4163.2, 4163.4, and 4163.5 shall become inoperative.
   (2) Within 90 days of the enactment of federal legislation or
adoption of a regulation addressing pedigree or serialization
measures for dangerous drugs, the board shall publish a notice that
Sections 4034, 4163, 4163.1, 4163.2, 4163.4, and 4163.5 are
inoperative.
   (3) Within 90 days of the enactment of federal legislation or
adoption of a regulation that is inconsistent with any provision of
California law governing the application of any pedigree or
serialization requirement or standard, the board shall adopt
emergency regulations necessary to reflect the inoperation of state
law.
   (b) (1) If the Food and Drug Administration (FDA) enacts any rule,
standard, or takes any other action that is inconsistent with any
provision of California law governing application of a pedigree to a
dangerous drug, that provision of California law shall be
inoperative.
   (2) Within 90 days of the FDA enacting any rule, standard, or
taking any other action that is inconsistent with any provision of
California law governing application of a pedigree to a dangerous
drug, the board shall publish a notice that the provision is
inoperative.
   (3) Within 90 days of the FDA enacting any rule, standard, or
taking any other action that is inconsistent with any provision of
California law governing application of a pedigree to a dangerous
drug, the board shall adopt emergency regulations necessary to
reflect the inoperation of state law.
   (c) If the board fails to recognize the inoperation within 90 days
pursuant to this section, nothing in this section shall preclude a
party from filing an action in state or federal court for declaratory
or injunctive relief as an alternative to filing a petition with the
board. 
   SEC. 5.    Section 4045 of the   Business
and Professions Code   is amended to read: 
   4045.  "Third-party logistics provider" or "reverse third-party
logistic provider" means an entity licensed as a wholesaler that
contracts with a dangerous drug manufacturer to provide or coordinate
warehousing, distribution, or other similar services on behalf of a
manufacturer, but for which there is no change of ownership in the
dangerous drugs.  For purposes of Sections 4034, 4163,
4163.1, 4163.2, 4163.3, 4163.4, and 4163.5, a third-party logistics
provider shall not be responsible for generating or updating pedigree
documentation, but shall maintain copies of the pedigree. To be
exempt from documentation for pedigrees, a reverse third-party
logistic provider may only accept decommissioned drugs from
pharmacies or wholesalers. 
   SEC. 6.    Section 4163 of the   Business
and Professions Code   is repealed.  
   4163.  (a) A manufacturer, wholesaler, repackager, or pharmacy may
not furnish a dangerous drug or dangerous device to an unauthorized
person.
   (b) Dangerous drugs or dangerous devices shall be acquired from a
person authorized by law to possess or furnish dangerous drugs or
dangerous devices. When the person acquiring the dangerous drugs or
dangerous devices is a wholesaler, the obligation of the wholesaler
shall be limited to obtaining confirmation of licensure of those
sources from whom it has not previously acquired dangerous drugs or
dangerous devices.
   (c) Except as otherwise provided in Section 4163.5, commencing on
July 1, 2016, a wholesaler or repackager may not sell, trade, or
transfer a dangerous drug at wholesale without providing a pedigree.
   (d) Except as otherwise provided in Section 4163.5, commencing on
July 1, 2016, a wholesaler or repackager may not acquire a dangerous
drug without receiving a pedigree.
   (e) Except as otherwise provided in Section 4163.5, commencing on
July 1, 2017, a pharmacy may not sell, trade, or transfer a dangerous
drug at wholesale without providing a pedigree.
   (f) Except as otherwise provided in Section 4163.5, commencing on
July 1, 2017, a pharmacy may not acquire a dangerous drug without
receiving a pedigree.
   (g) Except as otherwise provided in Section 4163.5, commencing on
July 1, 2017, a pharmacy warehouse may not acquire a dangerous drug
without receiving a pedigree. For purposes of this section and
Section 4034, a "pharmacy warehouse" means a physical location
licensed as a wholesaler for prescription drugs that acts as a
central warehouse and performs intracompany sales or transfers of
those drugs to a group of pharmacies under common ownership and
control. 
   SEC. 7.    Section 4163 is added to the  
Business and Professions Code   , to read:  
   4163.  (a) A manufacturer, wholesaler, repackager, or pharmacy may
not furnish a dangerous drug or dangerous device to an unauthorized
person.
   (b) Dangerous drugs or dangerous devices shall be acquired from a
person authorized by law to possess or furnish dangerous drugs or
dangerous devices. When the person acquiring the dangerous drugs or
dangerous devices is a wholesaler, the obligation of the wholesaler
shall be limited to obtaining confirmation of licensure of those
sources from whom it has not previously acquired dangerous drugs or
dangerous devices. 
   SEC. 8.    Section 4163.1 of the   Business
and Professions Code   , as added by Section 68 of Chapter
658 of the Statutes of 2006, is repealed.  
   4163.1.  It is the intent of the Legislature that commencing on
January 1, 2007, and continuing through the full implementation of
the pedigree requirements specified by Section 4163, manufacturers
and wholesalers shall use best efforts to provide in the most readily
accessible form possible, information regarding the manufacturer's
specific relationships in the distribution of dangerous drugs with
wholesalers. 
   SEC. 9.    Section 4163.1 of the   Business
and Professions Code   , as added by Section 9 of Chapter
713 of the Statutes of 2008, is repealed.  
   4163.1.  (a) For purposes of Sections 4034 and 4163, "drop
shipment" means a sale of a dangerous drug by the manufacturer of the
dangerous drug whereby all of the following occur:
   (1) The pharmacy, or other person authorized by law to dispense or
administer the drug, receives delivery of the dangerous drug
directly from the manufacturer.
   (2) The wholesale distributor takes ownership of, but not physical
possession of, the dangerous drug.
   (3) The wholesale distributor invoices the pharmacy or other
person authorized by law to dispense or administer the drug in place
of the manufacturer.
   (b) The board may develop regulations to establish an alternative
process to convey the pedigree information required in Section 4034
for dangerous drugs that are sold by drop shipment. 
   SEC. 10.    Section 4163.2 of the   Business
and Professions Code   is repealed.  
   4163.2.  (a) (1) A manufacturer, wholesaler, or pharmacy lawfully
possessing or owning dangerous drugs manufactured or distributed
prior to the operative date of the pedigree requirements, specified
in Sections 4034 and 4163, may designate these dangerous drugs as not
subject to the pedigree requirements by preparing a written
declaration made under penalty of perjury that lists those dangerous
drugs.
   (2) The written declaration shall include the National Drug Code
Directory lot number for each dangerous drug designated. The written
declaration shall be submitted to and received by the board no later
than 30 days after the operative date of the pedigree requirements.
The entity or person submitting the written declaration shall also
retain for a period of three years and make available for inspection
by the board a copy of each written declaration submitted.
   (3) The board may, by regulation, further specify the requirements
and procedures for the creation and submission of these written
declarations. Information contained in these declarations shall be
considered trade secrets and kept confidential by the board.
   (b) Any dangerous drugs designated on a written declaration timely
created and submitted to the board may be purchased, sold, acquired,
returned, or otherwise transferred without meeting the pedigree
requirements, if the transfer complies with the other requirements of
this chapter. 
   SEC. 11.    Section 4163.3 of the   Business
and Professions Code   is repealed.  
   4163.3.  (a) It is the intent of the Legislature that participants
in the distribution chain for dangerous drugs, including
manufacturers, wholesalers, or pharmacies furnishing, administering,
or dispensing dangerous drugs, distribute and receive electronic
pedigrees, and verify and validate the delivery and receipt of
dangerous drugs against those pedigrees at the unit level, in a
manner that maintains the integrity of the pedigree system without an
unacceptable increase in the risk of diversion or counterfeiting.
   (b) To meet this goal, and to facilitate efficiency and safety in
the distribution chain, the board shall, by regulation, define the
circumstances under which participants in the distribution chain may
infer the contents of a case, pallet, or other aggregate of
individual units, packages, or containers of dangerous drugs, from a
unique identifier associated with the case, pallet, or other
aggregate, without opening each case, pallet, or other aggregate or
otherwise individually validating each unit.
   (c) Manufacturers, wholesalers, and pharmacies opting to employ
the use of inference as authorized by the board to comply with the
pedigree requirements shall document their processes and procedures
in their standard operating procedures (SOPs) and shall make those
SOPs available for board review.
   (d) SOPs regarding inference shall include a process for
statistically sampling the accuracy of information sent with inbound
product.
   (e) Liability associated with accuracy of product information and
pedigree using inference shall be specified in the board's
regulations. 
   SEC. 12.    Section 4163.4 of the   Business
and Professions Code   is repealed.  
   4163.4.  (a) All units of dangerous drug in the possession of a
wholesaler or pharmacy, for which the manufacturer does not hold
legal title on the effective date of the pedigree requirement set
forth in Section 4163.5, shall not be subject to the pedigree
requirements set forth in Sections 4034 and 4163. However, if any
units of those drugs are subsequently returned to the manufacturer,
they shall be subject to the pedigree requirements if the
manufacturer distributes those units in California.
   (b) All units of dangerous drug manufactured in California but
distributed outside the state for dispensing outside the state shall
not be subject to the pedigree requirements set forth in Sections
4034 and 4163 at either the time of initial distribution or in the
event that any of those units are subsequently returned to the
manufacturer. 
   SEC. 13.    Section 4163.5 of the   Business
and Professions Code   is repealed.  
   4163.5.  (a) The Legislature hereby finds and declares that:
   (1) The electronic pedigree system required by Sections 4034 and
4163 will provide tremendous benefits to the public and to all
participants in the distribution chain. Those benefits should be made
available as quickly as possible through the full cooperation of
prescription drug supply chain participants. To this end, all drug
manufacturers and repackagers are strongly encouraged to serialize
drug products and initiate electronic pedigrees as soon as possible,
and all participants in the supply chain are encouraged to
immediately ready themselves to receive and pass electronic
pedigrees.
   (2) At the same time, it is recognized that the process of
implementing serialized electronic pedigree for all prescription
drugs in the entire chain of distribution is a complicated
technological and logistical undertaking for manufacturers,
wholesalers, repackagers, pharmacies, and other supply chain
participants. The Legislature seeks to ensure continued availability
of prescription drugs in California while participants implement
these requirements.
   (b) Before January 1, 2015, each manufacturer of a dangerous drug
distributed in California shall designate those dangerous drugs
representing a minimum of 50 percent of its drugs, generic or single
source, distributed in California, for which it is listed as the
manufacturer by the federal Food and Drug Administration, which shall
be the subject of its
initial phase of compliance with the January 1, 2015, deadline of the
state's serialized electronic pedigree requirements set forth in
Sections 4034 and 4163. Each manufacturer shall notify the Board of
Pharmacy of the drugs so designated and the measure or measures used
in designating its drugs to be serialized, and shall include in the
notification the technology to be used to meet the serialized
electronic pedigree requirements. The notification process for these
specific actions may be specified by the board.
   (c) Before January 1, 2016, each manufacturer of a dangerous drug
distributed in California shall designate the final 50 percent of its
drugs, generic or single source, distributed in California for which
it is listed as the manufacturer by the federal Food and Drug
Administration that are subject to the state's serialized electronic
pedigree requirements set forth in Sections 4034 and 4163, which
shall comply with the state's serialized electronic pedigree
requirement by January 1, 2016. Each manufacturer shall notify the
Board of Pharmacy of the drugs so designated and the measure or
measures used in designating its drugs to be serialized, and shall
include in the notification the technology to be used to meet the
serialized electronic pedigree requirements. The notification process
for these specific actions may be specified by the board.
   (d) For purposes of designating drugs to be serialized as required
by subdivisions (b) and (c), manufacturers shall select from any of
the following measures:
   (1) Unit volume.
   (2) Product package (SKU) type.
   (3) Drug product family.
   (e) Drugs not subject to compliance with the pedigree requirements
set forth in Sections 4034 and 4163 under this section shall not be
subject to the provisions of subdivisions (c), (d), (e), and (f) of
Section 4163. 
   SEC. 14.    Section 111397 is added to the  
Health and Safety Code   , to read:  
   111397.  Any foreign dangerous drug that is not approved by the
United States Food and Drug Administration or that is obtained
outside of the licensed supply chain regulated by the United States
Food and Drug Administration, California State Board of Pharmacy, or
State Department of Public Health is misbranded. 
   SEC. 15.    Section 111825 of the   Health
and Safety Code   is amended to read: 
   111825.  (a) Any person who violates any provision of this part or
any regulation adopted pursuant to this part shall, if convicted, be
subject to imprisonment for not more than one year in the county
jail or a fine of not more than one thousand dollars ($1,000), or
both the imprisonment and fine.
   (b) Notwithstanding subdivision (a), any person who violates
Section 111865 by removing, selling, or disposing of an embargoed
food, drug, device, or cosmetic without the permission of an
authorized agent of the department or court shall, if convicted, be
subject to imprisonment for not more than one year in the county jail
or a fine of not more than ten thousand dollars ($10,000), or both
the fine and imprisonment. 
   (c) Notwithstanding subdivision (a), any person who purchases a
foreign dangerous drug or medical device, illegitimate product, as
defined in Section 360eee(8) of Title 21 of the United States Code,
or suspect product, as defined in Section 360eee(21) of Title 21 of
the United States Code, that is not approved by the United States
Food and Drug Administration or that is obtained outside of the
licensed supply chain regulated by the United States Food and Drug
Administration, California State Board of Pharmacy, or State
Department of Public Health is guilty of a misdemeanor and subject to
imprisonment for not more than one year in the county jail, a fine
of not more that ten thousand dollars ($10,000) per occurrence, or
both the imprisonment and fine.  
   (c) 
    (   d)  If the violation is committed after a
previous conviction under this section that has become final, or if
the violation is committed with intent to defraud or mislead, or if
the person committed a violation of Section 110625 or 111300 that was
intentional or that was intended to cause injury, the person shall
be subject to imprisonment for not more than one year in the county
jail, imprisonment in state prison, or a fine of not more than ten
thousand dollars ($10,000), or both the imprisonment and fine.
   SEC. 16.    No reimbursement is required by this act
pursuant to Section 6 of Article XIII B of the California
Constitution because the only costs that may be incurred by a local
agency or school district will be incurred because this act creates a
new crime or infraction, eliminates a crime or infraction, or
changes the penalty for a crime or infraction, within the meaning of
Section 17556 of the Government Code, or changes the definition of a
crime within the meaning of Section 6 of Article XIII B of the
California Constitution.  
  SECTION 1.    Section 43006.5 is added to the
Health and Safety Code, to read:
   43006.5.  (a) Commencing January 1, 2014, for purposes of small
volume manufacturers of vehicles seeking to have alternative fuel
conversion systems certified by the state board, the state board
shall do all of the following:
   (1) Automatically qualify new vehicle alternative fuel conversion
certifications for aftermarket certifications if requested. Requests
may be made with a one-page letter and additional documentation
necessary for labeling and warranty.
   (2) Use commercially available fuel for all required emissions
testing.
   (3) Conduct evaporative emissions testing only on the added
alternative fuel system when seeking to certify a dual-fuel vehicle
conversion.
   (b) Commencing January 1, 2014, the state board shall extend the
life of a new vehicle or engine certification until December 31 of
the year following a given vehicle model year.