Amended in Assembly June 10, 2014

Amended in Senate May 28, 2013

Amended in Senate April 23, 2013

Amended in Senate April 8, 2013

Senate BillNo. 600


Introduced by Senator Lieu

February 22, 2013


begin deleteAn act to add Section 43006.5 to the Health and Safety Code, relating to vehicular air pollution. end deletebegin insertAn 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.end insert

LEGISLATIVE COUNSEL’S DIGEST

SB 600, as amended, Lieu. begin deleteVehicles: alternative fuel. end deletebegin insertDrugs.end insert

begin insert

(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.

end insert
begin insert

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.

end insert
begin insert

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.

end insert
begin insert

(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.

end insert
begin insert

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.

end insert
begin insert

This bill would repeal the pedigree requirements and make related conforming changes.

end insert
begin insert

(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.

end insert
begin insert

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.

end insert
begin insert

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.

end insert
begin insert

(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.

end insert
begin insert

This bill would provide that no reimbursement is required by this act for a specified reason.

end insert
begin delete

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.

end delete
begin delete

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.

end delete

Vote: majority. Appropriation: no. Fiscal committee: yes. State-mandated local program: begin deleteno end deletebegin insertyesend insert.

The people of the State of California do enact as follows:

P4    1begin insert

begin insertSECTION 1.end insert  

end insert

begin insertSection 2245 is added to the end insertbegin insertBusiness and
2Professions Code
end insert
begin insert, to read:end insert

begin insert
3

begin insert2245.end insert  

Purchasing a foreign dangerous drug or device,
4illegitimate product, as defined in Section 360eee(8) of Title 21 of
5the United States Code, or suspect product, as defined in Section
6360eee(21) of Title 21 of the United States Code, that is not
7approved by the United States Food and Drug Administration or
8that is obtained outside of the licensed supply chain regulated by
9the United States Food and Drug Administration, California State
10Board of Pharmacy, or State Department of Public Health
11constitutes unprofessional conduct.

end insert
12begin insert

begin insertSEC. 2.end insert  

end insert

begin insertSection 4033 of the end insertbegin insertBusiness and Professions Codeend insertbegin insert is
13amended to read:end insert

14

4033.  

(a) (1) “Manufacturer” means and includes every person
15who prepares, derives, produces, compounds, or repackages any
16drug or device except a pharmacy that manufactures on the
17immediate premises where the drug or device is sold to the ultimate
18consumer.

19(2) Notwithstanding paragraph (1), “manufacturer” shall not
20mean a pharmacy compounding a drug for parenteral therapy,
21pursuant to a prescription, for delivery to another pharmacy for
22the purpose of delivering or administering the drug to the patient
23or patients named in the prescription, provided that neither the
24components for the drug nor the drug are compounded, fabricated,
25packaged, or otherwise prepared prior to receipt of the prescription.

26(3) Notwithstanding paragraph (1), “manufacturer” shall not
27mean a pharmacy that, at a patient’s request, repackages a drug
28previously dispensed to the patient, or to the patient’s agent,
29pursuant to a prescription.

30(b) Notwithstanding subdivision (a),begin delete as used in Sections 4034,
314163, 4163.1, 4163.2, 4163.3, 4163.4, and 4163.5,end delete
“manufacturer”
32begin insert alsoend insert means a person who prepares, derives, manufactures,
33produces, or repackages a dangerous drug, as defined in Section
344022, device, or cosmetic. Manufacturer also means the holder or
35holders of a New Drug Application (NDA), an Abbreviated New
36Drug Application (ANDA), or a Biologics License Application
37(BLA), provided that such application has been approved; a
38manufacturer’s third party logistics provider; a private label
P5    1distributor (including colicensed partners) for whom the private
2label distributor’s prescription drugs are originally manufactured
3and labeled for the distributor and have not been repackaged; or
4the distributor agent for the manufacturer, contract manufacturer,
5or private label distributor, whether the establishment is a member
6of the manufacturer’s affiliated group (regardless of whether the
7member takes title to the drug) or is a contract distributor site.

8begin insert

begin insertSEC. 3.end insert  

end insert

begin insertSection 4034 of the end insertbegin insertBusiness and Professions Codeend insertbegin insert is
9repealed.end insert

begin delete
10

4034.  

(a) “Pedigree” means a record, in electronic form,
11containing information regarding each transaction resulting in a
12change of ownership of a given dangerous drug, from sale by a
13manufacturer, through acquisition and sale by one or more
14wholesalers, manufacturers, repackagers, or pharmacies, until final
15sale to a pharmacy or other person furnishing, administering, or
16dispensing the dangerous drug. The pedigree shall be created and
17maintained in an interoperable electronic system, ensuring
18compatibility throughout all stages of distribution.

19(b) A pedigree shall include all of the following information:

20(1) The source of the dangerous drug, including the name, the
21federal manufacturer’s registration number or a state license
22number as determined by the board, and principal address of the
23source.

24(2) The trade or generic name of the dangerous drug, the quantity
25of the dangerous drug, its dosage form and strength, the date of
26the transaction, the sales invoice number or, if not immediately
27available, a customer-specific shipping reference number linked
28to the sales invoice number, the container size, the number of
29containers, the expiration dates, and the lot numbers.

30(3) The business name, address, and the federal manufacturer’s
31registration number or a state license number as determined by the
32board, of each owner of the dangerous drug, and the dangerous
33drug shipping information, including the name and address of each
34person certifying delivery or receipt of the dangerous drug.

35(4) A certification under penalty of perjury from a responsible
36party of the source of the dangerous drug that the information
37contained in the pedigree is true and accurate.

38(5) The unique identification number described in subdivision
39(i).

P6    1(c) A single pedigree shall include every change of ownership
2of a given dangerous drug from its initial manufacture through to
3its final transaction to a pharmacy or other person for furnishing,
4administering, or dispensing the drug, regardless of repackaging
5or assignment of another National Drug Code (NDC) Directory
6number. Dangerous drugs that are repackaged shall be serialized
7by the repackager and a pedigree shall be provided that references
8the pedigree of the original package or packages provided by the
9manufacturer.

10(d) A pedigree shall track each dangerous drug at the smallest
11package or immediate container distributed by the manufacturer,
12received and distributed by the wholesaler or repackager, and
13received by the pharmacy or another person furnishing,
14administering, or dispensing the dangerous drug. For purposes of
15this section, the “smallest package or immediate container” of a
16dangerous drug shall include any dangerous drug package or
17container made available to a repackager, wholesaler, pharmacy,
18or other entity for repackaging or redistribution, as well as the
19smallest unit made by the manufacturer for sale to the pharmacy
20or other person furnishing, administering, or dispensing the drug.

21(e) Any return of a dangerous drug to a wholesaler or
22manufacturer shall be documented on the same pedigree as the
23transaction that resulted in the receipt of the drug by the party
24returning it.

25(f) If a licensed health care service plan, hospital organization,
26and one or more physician organizations have exclusive contractual
27relationships to provide health care services, drugs distributed
28between these persons shall be deemed not to have changed
29ownership.

30(g) The following transactions are exempt from the pedigree
31requirement created by this section:

32(1) An intracompany sale or transfer of a dangerous drug. For
33purposes of this section, “intracompany sale or transfer” means
34any transaction for any valid business purpose between a division,
35subsidiary, parent, or affiliated or related company under the
36common ownership and control of the same corporate or legal
37entity.

38(2) Dangerous drugs received by the state or a local government
39entity from a department or agency of the federal government or
P7    1an agent of the federal government specifically authorized to
2deliver dangerous drugs to the state or local government entity.

3(3) The provision of samples of dangerous drugs by a
4manufacturer’s employee to an authorized prescriber, provided
5the samples are dispensed to a patient of the prescriber without
6charge.

7(4) (A) A sale, trade, or transfer of a radioactive drug, as defined
8in Section 1708.3 of Title 16 of the California Code of Regulations,
9between any two entities licensed by the Radiologic Health Branch
10of the State Department of Public Health, the federal Nuclear
11Regulatory Commission, or an Agreement state.

12(B) The exemption in this paragraph shall remain in effect unless
13the board, no earlier than the date that is two years after the
14compliance date for manufacturers set forth in subdivision (k) of
15Section 4034 or Section 4163.5, determines after consultation with
16the Radiologic Health Branch of the State Department of Public
17Health that the risk of counterfeiting or diversion of a radioactive
18drug is sufficient to require a pedigree. Two years following the
19date of any such determination, this paragraph shall become
20inoperative.

21(5) The sale, trade, or transfer of a dangerous drug that is labeled
22by the manufacturer as “for veterinary use only.”

23(6) The sale, trade, or transfer of compressed medical gas. For
24purposes of this section, “compressed medical gas” means any
25substance in its gaseous or cryogenic liquid form that meets
26medical purity standards and has application in a medical or
27homecare environment, including, but not limited to, oxygen and
28nitrous oxide.

29(7) The sale, trade, or transfer of solutions. For purposes of this
30section, “solutions” means any of the following:

31(A) Those intravenous products that, by their formulation, are
32intended for the replenishment of fluids and electrolytes, such as
33sodium, chloride, and potassium, calories, such as dextrose and
34amino acids, or both.

35(B) Those intravenous products used to maintain the equilibrium
36of water and minerals in the body, such as dialysis solutions.

37(C) Products that are intended for irrigation or reconstitution,
38as well as sterile water, whether intended for those purposes or for
39injection.

P8    1(8) Dangerous drugs that are placed in a sealed package with a
2medical device or medical supplies at the point of first shipment
3into commerce by the manufacturer and the package remains sealed
4until the drug and device are used, provided that the package is
5only used for surgical purposes.

6(9) A product that meets either of the following criteria:

7(A) A product comprised of two or more regulated components,
8such as a drug/device, biologic/device, or drug/device/biologic,
9that are physically, chemically, or otherwise combined or mixed
10and produced as a single entity.

11(B) Two or more separate products packaged together in a single
12package or as a unit and comprised of drug and device products
13or device and biological products.

14(h) If a manufacturer, wholesaler, or pharmacy has reasonable
15cause to believe that a dangerous drug in, or having been in, its
16possession is counterfeit or the subject of a fraudulent transaction,
17the manufacturer, wholesaler, or pharmacy shall notify the board
18within 72 hours of obtaining that knowledge. This subdivision
19shall apply to any dangerous drug that has been sold or distributed
20in or through this state.

21(i) “Interoperable electronic system” as used in this chapter
22means an electronic track and trace system for dangerous drugs
23that uses a unique identification number, established at the point
24of manufacture and supplemented by a linked unique identification
25number in the event that drug is repackaged, contained within a
26standardized nonproprietary data format and architecture, that is
27uniformly used by manufacturers, wholesalers, repackagers, and
28pharmacies for the pedigree of a dangerous drug. No particular
29data carrier or other technology is mandated to accomplish the
30attachment of the unique identification number described in this
31subdivision.

32(j) The application of the pedigree requirement shall be subject
33to review during the board’s evaluation pursuant to Section 473.4.

34(k) This section shall become operative on January 1, 2015.

end delete
35begin insert

begin insertSEC. 4.end insert  

end insert

begin insertSection 4034.1 of the end insertbegin insertBusiness and Professions Codeend insert
36begin insert is repealed.end insert

begin delete
37

4034.1.  

(a) (1) Upon the effective date of federal legislation
38or adoption of a federal regulation addressing pedigree or
39serialization measures for dangerous drugs, Sections 4034, 4163,
404163.1, 4163.2, 4163.4, and 4163.5 shall become inoperative.

P9    1(2) Within 90 days of the enactment of federal legislation or
2adoption of a regulation addressing pedigree or serialization
3measures for dangerous drugs, the board shall publish a notice that
4Sections 4034, 4163, 4163.1, 4163.2, 4163.4, and 4163.5 are
5inoperative.

6(3) Within 90 days of the enactment of federal legislation or
7adoption of a regulation that is inconsistent with any provision of
8California law governing the application of any pedigree or
9serialization requirement or standard, the board shall adopt
10emergency regulations necessary to reflect the inoperation of state
11law.

12(b) (1) If the Food and Drug Administration (FDA) enacts any
13rule, standard, or takes any other action that is inconsistent with
14any provision of California law governing application of a pedigree
15to a dangerous drug, that provision of California law shall be
16inoperative.

17(2) Within 90 days of the FDA enacting any rule, standard, or
18taking any other action that is inconsistent with any provision of
19California law governing application of a pedigree to a dangerous
20drug, the board shall publish a notice that the provision is
21inoperative.

22(3) Within 90 days of the FDA enacting any rule, standard, or
23taking any other action that is inconsistent with any provision of
24California law governing application of a pedigree to a dangerous
25drug, the board shall adopt emergency regulations necessary to
26reflect the inoperation of state law.

27(c) If the board fails to recognize the inoperation within 90 days
28pursuant to this section, nothing in this section shall preclude a
29party from filing an action in state or federal court for declaratory
30or injunctive relief as an alternative to filing a petition with the
31board.

end delete
32begin insert

begin insertSEC. 5.end insert  

end insert

begin insertSection 4045 of the end insertbegin insertBusiness and Professions Codeend insertbegin insert is
33amended to read:end insert

34

4045.  

“Third-party logistics provider” or “reverse third-party
35logistic provider” means an entity licensed as a wholesaler that
36contracts with a dangerous drug manufacturer to provide or
37coordinate warehousing, distribution, or other similar services on
38behalf of a manufacturer, but for which there is no change of
39ownership in the dangerous drugs.begin delete For purposes of Sections 4034,
404163, 4163.1, 4163.2, 4163.3, 4163.4, and 4163.5, a third-party
P10   1logistics provider shall not be responsible for generating or
2updating pedigree documentation, but shall maintain copies of the
3pedigree. To be exempt from documentation for pedigrees, a
4reverse third-party logistic provider may only accept
5decommissioned drugs from pharmacies or wholesalers.end delete

6begin insert

begin insertSEC. 6.end insert  

end insert

begin insertSection 4163 of the end insertbegin insertBusiness and Professions Codeend insertbegin insert is
7repealed.end insert

begin delete
8

4163.  

(a) A manufacturer, wholesaler, repackager, or pharmacy
9may not furnish a dangerous drug or dangerous device to an
10unauthorized person.

11(b) Dangerous drugs or dangerous devices shall be acquired
12from a person authorized by law to possess or furnish dangerous
13drugs or dangerous devices. When the person acquiring the
14dangerous drugs or dangerous devices is a wholesaler, the
15obligation of the wholesaler shall be limited to obtaining
16confirmation of licensure of those sources from whom it has not
17previously acquired dangerous drugs or dangerous devices.

18(c) Except as otherwise provided in Section 4163.5, commencing
19on July 1, 2016, a wholesaler or repackager may not sell, trade, or
20transfer a dangerous drug at wholesale without providing a
21pedigree.

22(d) Except as otherwise provided in Section 4163.5, commencing
23on July 1, 2016, a wholesaler or repackager may not acquire a
24dangerous drug without receiving a pedigree.

25(e) Except as otherwise provided in Section 4163.5, commencing
26on July 1, 2017, a pharmacy may not sell, trade, or transfer a
27dangerous drug at wholesale without providing a pedigree.

28(f) Except as otherwise provided in Section 4163.5, commencing
29on July 1, 2017, a pharmacy may not acquire a dangerous drug
30without receiving a pedigree.

31(g) Except as otherwise provided in Section 4163.5, commencing
32on July 1, 2017, a pharmacy warehouse may not acquire a
33dangerous drug without receiving a pedigree. For purposes of this
34section and Section 4034, a “pharmacy warehouse” means a
35physical location licensed as a wholesaler for prescription drugs
36that acts as a central warehouse and performs intracompany sales
37or transfers of those drugs to a group of pharmacies under common
38ownership and control.

end delete
39begin insert

begin insertSEC. 7.end insert  

end insert

begin insertSection 4163 is added to the end insertbegin insertBusiness and Professions
40Code
end insert
begin insert, to read:end insert

begin insert
P11   1

begin insert4163.end insert  

(a) A manufacturer, wholesaler, repackager, or
2pharmacy may not furnish a dangerous drug or dangerous device
3to an unauthorized person.

4(b) Dangerous drugs or dangerous devices shall be acquired
5from a person authorized by law to possess or furnish dangerous
6drugs or dangerous devices. When the person acquiring the
7dangerous drugs or dangerous devices is a wholesaler, the
8obligation of the wholesaler shall be limited to obtaining
9confirmation of licensure of those sources from whom it has not
10previously acquired dangerous drugs or dangerous devices.

end insert
11begin insert

begin insertSEC. 8.end insert  

end insert

begin insertSection 4163.1 of the end insertbegin insertBusiness and Professions Codeend insertbegin insert,
12as added by Section 68 of Chapter 658 of the Statutes of 2006, is
13repealed.end insert

begin delete
14

4163.1.  

It is the intent of the Legislature that commencing on
15January 1, 2007, and continuing through the full implementation
16of the pedigree requirements specified by Section 4163,
17manufacturers and wholesalers shall use best efforts to provide in
18the most readily accessible form possible, information regarding
19the manufacturer’s specific relationships in the distribution of
20dangerous drugs with wholesalers.

end delete
21begin insert

begin insertSEC. 9.end insert  

end insert

begin insertSection 4163.1 of the end insertbegin insertBusiness and Professions Codeend insertbegin insert,
22as added by Section 9 of Chapter 713 of the Statutes of 2008, is
23repealed.end insert

begin delete
24

4163.1.  

(a) For purposes of Sections 4034 and 4163, “drop
25shipment” means a sale of a dangerous drug by the manufacturer
26of the dangerous drug whereby all of the following occur:

27(1) The pharmacy, or other person authorized by law to dispense
28or administer the drug, receives delivery of the dangerous drug
29directly from the manufacturer.

30(2) The wholesale distributor takes ownership of, but not
31physical possession of, the dangerous drug.

32(3) The wholesale distributor invoices the pharmacy or other
33person authorized by law to dispense or administer the drug in
34place of the manufacturer.

35(b) The board may develop regulations to establish an alternative
36process to convey the pedigree information required in Section
374034 for dangerous drugs that are sold by drop shipment.

end delete
38begin insert

begin insertSEC. 10.end insert  

end insert

begin insertSection 4163.2 of the end insertbegin insertBusiness and Professions Codeend insert
39begin insert is repealed.end insert

begin delete
P12   1

4163.2.  

(a) (1) A manufacturer, wholesaler, or pharmacy
2lawfully possessing or owning dangerous drugs manufactured or
3distributed prior to the operative date of the pedigree requirements,
4specified in Sections 4034 and 4163, may designate these
5dangerous drugs as not subject to the pedigree requirements by
6preparing a written declaration made under penalty of perjury that
7lists those dangerous drugs.

8(2) The written declaration shall include the National Drug Code
9Directory lot number for each dangerous drug designated. The
10written declaration shall be submitted to and received by the board
11no later than 30 days after the operative date of the pedigree
12requirements. The entity or person submitting the written
13declaration shall also retain for a period of three years and make
14available for inspection by the board a copy of each written
15declaration submitted.

16(3) The board may, by regulation, further specify the
17requirements and procedures for the creation and submission of
18these written declarations. Information contained in these
19declarations shall be considered trade secrets and kept confidential
20by the board.

21(b) Any dangerous drugs designated on a written declaration
22timely created and submitted to the board may be purchased, sold,
23acquired, returned, or otherwise transferred without meeting the
24pedigree requirements, if the transfer complies with the other
25requirements of this chapter.

end delete
26begin insert

begin insertSEC. 11.end insert  

end insert

begin insertSection 4163.3 of the end insertbegin insertBusiness and Professions Codeend insert
27begin insert is repealed.end insert

begin delete
28

4163.3.  

(a) It is the intent of the Legislature that participants
29in the distribution chain for dangerous drugs, including
30manufacturers, wholesalers, or pharmacies furnishing,
31administering, or dispensing dangerous drugs, distribute and
32receive electronic pedigrees, and verify and validate the delivery
33and receipt of dangerous drugs against those pedigrees at the unit
34level, in a manner that maintains the integrity of the pedigree
35system without an unacceptable increase in the risk of diversion
36or counterfeiting.

37(b) To meet this goal, and to facilitate efficiency and safety in
38the distribution chain, the board shall, by regulation, define the
39circumstances under which participants in the distribution chain
40may infer the contents of a case, pallet, or other aggregate of
P13   1individual units, packages, or containers of dangerous drugs, from
2a unique identifier associated with the case, pallet, or other
3aggregate, without opening each case, pallet, or other aggregate
4or otherwise individually validating each unit.

5(c) Manufacturers, wholesalers, and pharmacies opting to
6employ the use of inference as authorized by the board to comply
7with the pedigree requirements shall document their processes and
8procedures in their standard operating procedures (SOPs) and shall
9make those SOPs available for board review.

10(d) SOPs regarding inference shall include a process for
11 statistically sampling the accuracy of information sent with inbound
12product.

13(e) Liability associated with accuracy of product information
14and pedigree using inference shall be specified in the board’s
15regulations.

end delete
16begin insert

begin insertSEC. 12.end insert  

end insert

begin insertSection 4163.4 of the end insertbegin insertBusiness and Professions Codeend insert
17begin insert is repealed.end insert

begin delete
18

4163.4.  

(a) All units of dangerous drug in the possession of a
19wholesaler or pharmacy, for which the manufacturer does not hold
20legal title on the effective date of the pedigree requirement set
21forth in Section 4163.5, shall not be subject to the pedigree
22requirements set forth in Sections 4034 and 4163. However, if any
23units of those drugs are subsequently returned to the manufacturer,
24they shall be subject to the pedigree requirements if the
25manufacturer distributes those units in California.

26(b) All units of dangerous drug manufactured in California but
27distributed outside the state for dispensing outside the state shall
28not be subject to the pedigree requirements set forth in Sections
294034 and 4163 at either the time of initial distribution or in the
30event that any of those units are subsequently returned to the
31manufacturer.

end delete
32begin insert

begin insertSEC. 13.end insert  

end insert

begin insertSection 4163.5 of the end insertbegin insertBusiness and Professions Codeend insert
33begin insert is repealed.end insert

begin delete
34

4163.5.  

(a) The Legislature hereby finds and declares that:

35(1) The electronic pedigree system required by Sections 4034
36and 4163 will provide tremendous benefits to the public and to all
37participants in the distribution chain. Those benefits should be
38made available as quickly as possible through the full cooperation
39of prescription drug supply chain participants. To this end, all drug
40manufacturers and repackagers are strongly encouraged to serialize
P14   1drug products and initiate electronic pedigrees as soon as possible,
2and all participants in the supply chain are encouraged to
3immediately ready themselves to receive and pass electronic
4pedigrees.

5(2) At the same time, it is recognized that the process of
6implementing serialized electronic pedigree for all prescription
7drugs in the entire chain of distribution is a complicated
8technological and logistical undertaking for manufacturers,
9wholesalers, repackagers, pharmacies, and other supply chain
10participants. The Legislature seeks to ensure continued availability
11of prescription drugs in California while participants implement
12these requirements.

13(b) Before January 1, 2015, each manufacturer of a dangerous
14drug distributed in California shall designate those dangerous drugs
15representing a minimum of 50 percent of its drugs, generic or
16single source, distributed in California, for which it is listed as the
17manufacturer by the federal Food and Drug Administration, which
18shall be the subject of its initial phase of compliance with the
19January 1, 2015, deadline of the state’s serialized electronic
20pedigree requirements set forth in Sections 4034 and 4163. Each
21manufacturer shall notify the Board of Pharmacy of the drugs so
22designated and the measure or measures used in designating its
23drugs to be serialized, and shall include in the notification the
24technology to be used to meet the serialized electronic pedigree
25requirements. The notification process for these specific actions
26may be specified by the board.

27(c) Before January 1, 2016, each manufacturer of a dangerous
28drug distributed in California shall designate the final 50 percent
29of its drugs, generic or single source, distributed in California for
30which it is listed as the manufacturer by the federal Food and Drug
31Administration that are subject to the state’s serialized electronic
32pedigree requirements set forth in Sections 4034 and 4163, which
33shall comply with the state’s serialized electronic pedigree
34requirement by January 1, 2016. Each manufacturer shall notify
35the Board of Pharmacy of the drugs so designated and the measure
36or measures used in designating its drugs to be serialized, and shall
37include in the notification the technology to be used to meet the
38serialized electronic pedigree requirements. The notification
39process for these specific actions may be specified by the board.

P15   1(d) For purposes of designating drugs to be serialized as required
2by subdivisions (b) and (c), manufacturers shall select from any
3of the following measures:

4(1) Unit volume.

5(2) Product package (SKU) type.

6(3) Drug product family.

7(e) Drugs not subject to compliance with the pedigree
8requirements set forth in Sections 4034 and 4163 under this section
9shall not be subject to the provisions of subdivisions (c), (d), (e),
10and (f) of Section 4163.

end delete
11begin insert

begin insertSEC. 14.end insert  

end insert

begin insertSection 111397 is added to the end insertbegin insertHealth and Safety
12Code
end insert
begin insert, to read:end insert

begin insert
13

begin insert111397.end insert  

Any foreign dangerous drug that is not approved by
14the United States Food and Drug Administration or that is obtained
15outside of the licensed supply chain regulated by the United States
16Food and Drug Administration, California State Board of
17Pharmacy, or State Department of Public Health is misbranded.

end insert
18begin insert

begin insertSEC. 15.end insert  

end insert

begin insertSection 111825 of the end insertbegin insertHealth and Safety Codeend insertbegin insert is
19amended to read:end insert

20

111825.  

(a) Any person who violates any provision of this
21part or any regulation adopted pursuant to this part shall, if
22convicted, be subject to imprisonment for not more than one year
23in the county jail or a fine of not more than one thousand dollars
24($1,000), or both the imprisonment and fine.

25(b) Notwithstanding subdivision (a), any person who violates
26Section 111865 by removing, selling, or disposing of an embargoed
27food, drug, device, or cosmetic without the permission of an
28authorized agent of the department or court shall, if convicted, be
29subject to imprisonment for not more than one year in the county
30jail or a fine of not more than ten thousand dollars ($10,000), or
31both the fine and imprisonment.

begin insert

32(c) Notwithstanding subdivision (a), any person who purchases
33a foreign dangerous drug or medical device, illegitimate product,
34as defined in Section 360eee(8) of Title 21 of the United States
35Code, or suspect product, as defined in Section 360eee(21) of Title
3621 of the United States Code, that is not approved by the United
37States Food and Drug Administration or that is obtained outside
38of the licensed supply chain regulated by the United States Food
39and Drug Administration, California State Board of Pharmacy,
40or State Department of Public Health is guilty of a misdemeanor
P16   1and subject to imprisonment for not more than one year in the
2county jail, a fine of not more that ten thousand dollars ($10,000)
3per occurrence, or both the imprisonment and fine.

end insert
begin delete

4(c)

end delete

5begin insert(end insertbegin insertd)end insert If the violation is committed after a previous conviction
6under this section that has become final, or if the violation is
7committed with intent to defraud or mislead, or if the person
8committed a violation of Section 110625 or 111300 that was
9intentional or that was intended to cause injury, the person shall
10be subject to imprisonment for not more than one year in the county
11jail, imprisonment in state prison, or a fine of not more than ten
12thousand dollars ($10,000), or both the imprisonment and fine.

13begin insert

begin insertSEC. 16.end insert  

end insert
begin insert

No reimbursement is required by this act pursuant
14to Section 6 of Article XIII B of the California Constitution because
15the only costs that may be incurred by a local agency or school
16district will be incurred because this act creates a new crime or
17infraction, eliminates a crime or infraction, or changes the penalty
18for a crime or infraction, within the meaning of Section 17556 of
19the Government Code, or changes the definition of a crime within
20the meaning of Section 6 of Article XIII B of the California
21Constitution.

end insert
begin delete
22

SECTION 1.  

Section 43006.5 is added to the Health and Safety
23Code
, to read:

24

43006.5.  

(a) Commencing January 1, 2014, for purposes of
25small volume manufacturers of vehicles seeking to have alternative
26fuel conversion systems certified by the state board, the state board
27shall do all of the following:

28(1) Automatically qualify new vehicle alternative fuel
29conversion certifications for aftermarket certifications if requested.
30Requests may be made with a one-page letter and additional
31documentation necessary for labeling and warranty.

32(2) Use commercially available fuel for all required emissions
33testing.

34(3) Conduct evaporative emissions testing only on the added
35alternative fuel system when seeking to certify a dual-fuel vehicle
36conversion.

37(b) Commencing January 1, 2014, the state board shall extend
38the life of a new vehicle or engine certification until December 31
39of the year following a given vehicle model year.

end delete


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