Amended in Assembly June 12, 2014

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


An act to amend Sections 4033 and 4045 of,begin delete to add Section 2245 to,end delete 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. 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.

begin delete

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 delete
begin delete

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 delete
begin delete

(2) Existing

end delete

begin insertExistingend insert 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.

begin delete

(3)

end delete

begin insert(2)end insert 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.

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(4)

end delete

begin insert(3)end insert 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.

Vote: majority. Appropriation: no. Fiscal committee: yes. State-mandated local program: yes.

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

begin deleteP3    1

SECTION 1.  

Section 2245 is added to the Business and
2Professions Code
, to read:

3

2245.  

Purchasing a foreign dangerous drug or device,
4illegitimate product, as defined in Section 360eee(8) of Title 21
5of the 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
P4    1Board of Pharmacy, or State Department of Public Health
2constitutes unprofessional conduct.

end delete
3

begin deleteSEC. 2.end delete
4begin insertSECTION 1.end insert  

Section 4033 of the Business and Professions
5Code
is amended to read:

6

4033.  

(a) (1) “Manufacturer” means and includes every person
7who prepares, derives, produces, compounds, or repackages any
8drug or device except a pharmacy that manufactures on the
9immediate premises where the drug or device is sold to the ultimate
10consumer.

11(2) Notwithstanding paragraph (1), “manufacturer” shall not
12mean a pharmacy compounding a drug for parenteral therapy,
13pursuant to a prescription, for delivery to another pharmacy for
14the purpose of delivering or administering the drug to the patient
15or patients named in the prescription, provided that neither the
16components for the drug nor the drug are compounded, fabricated,
17packaged, or otherwise prepared prior to receipt of the prescription.

18(3) Notwithstanding paragraph (1), “manufacturer” shall not
19mean a pharmacy that, at a patient’s request, repackages a drug
20previously dispensed to the patient, or to the patient’s agent,
21pursuant to a prescription.

22(b) Notwithstanding subdivision (a), “manufacturer” also means
23a person who prepares, derives, manufactures, produces, or
24repackages a dangerous drug, as defined in Section 4022, device,
25or cosmetic. Manufacturer also means the holder or holders of a
26New Drug Application (NDA), an Abbreviated New Drug
27Application (ANDA), or a Biologics License Application (BLA),
28provided that such application has been approved; a manufacturer’s
29third party logistics provider; a private label distributor (including
30colicensed partners) for whom the private label distributor’s
31prescription drugs are originally manufactured and labeled for the
32distributor and have not been repackaged; or the distributor agent
33for the manufacturer, contract manufacturer, or private label
34distributor, whether the establishment is a member of the
35manufacturer’s affiliated group (regardless of whether the member
36takes title to the drug) or is a contract distributor site.

37

begin deleteSEC. 3.end delete
38begin insertSEC. 2.end insert  

Section 4034 of the Business and Professions Code is
39repealed.

P5    1

begin deleteSEC. 4.end delete
2begin insertSEC. 3.end insert  

Section 4034.1 of the Business and Professions Code
3 is repealed.

4

begin deleteSEC. 5.end delete
5begin insertSEC. 4.end insert  

Section 4045 of the Business and Professions Code is
6amended to read:

7

4045.  

“Third-party logistics provider” or “reverse third-party
8logistic provider” means an entity licensed as a wholesaler that
9contracts with a dangerous drug manufacturer to provide or
10coordinate warehousing, distribution, or other similar services on
11behalf of a manufacturer, but for which there is no change of
12ownership in the dangerous drugs.

13

begin deleteSEC. 6.end delete
14begin insertSEC. 5.end insert  

Section 4163 of the Business and Professions Code is
15repealed.

16

begin deleteSEC. 7.end delete
17begin insertSEC. 6.end insert  

Section 4163 is added to the Business and Professions
18Code
, to read:

19

4163.  

(a) A manufacturer, wholesaler, repackager, or pharmacy
20may not furnish a dangerous drug or dangerous device to an
21unauthorized person.

22(b) Dangerous drugs or dangerous devices shall be acquired
23from a person authorized by law to possess or furnish dangerous
24drugs or dangerous devices. When the person acquiring the
25dangerous drugs or dangerous devices is a wholesaler, the
26obligation of the wholesaler shall be limited to obtaining
27confirmation of licensure of those sources from whom it has not
28previously acquired dangerous drugs or dangerous devices.

29

begin deleteSEC. 8.end delete
30begin insertSEC. 7.end insert  

Section 4163.1 of the Business and Professions Code,
31as added by Section 68 of Chapter 658 of the Statutes of 2006, is
32repealed.

33

begin deleteSEC. 9.end delete
34begin insertSEC. 8.end insert  

Section 4163.1 of the Business and Professions Code,
35as added by Section 9 of Chapter 713 of the Statutes of 2008, is
36repealed.

37

begin deleteSEC. 10.end delete
38begin insertSEC. 9.end insert  

Section 4163.2 of the Business and Professions Code
39 is repealed.

P6    1

begin deleteSEC. 11.end delete
2begin insertSEC. 10.end insert  

Section 4163.3 of the Business and Professions Code
3 is repealed.

4

begin deleteSEC. 12.end delete
5begin insertSEC. 11.end insert  

Section 4163.4 of the Business and Professions Code
6 is repealed.

7

begin deleteSEC. 13.end delete
8begin insertSEC. 12.end insert  

Section 4163.5 of the Business and Professions Code
9 is repealed.

10

begin deleteSEC. 14.end delete
11begin insertSEC. 13.end insert  

Section 111397 is added to the Health and Safety
12Code
, to read:

13

111397.  

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.

18

begin deleteSEC. 15.end delete
19begin insertSEC. 14.end insert  

Section 111825 of the Health and Safety Code is
20amended to read:

21

111825.  

(a) Any person who violates any provision of this
22part or any regulation adopted pursuant to this part shall, if
23convicted, be subject to imprisonment for not more than one year
24in the county jail or a fine of not more than one thousand dollars
25($1,000), or both the imprisonment and fine.

26(b) Notwithstanding subdivision (a), any person who violates
27Section 111865 by removing, selling, or disposing of an embargoed
28food, drug, device, or cosmetic without the permission of an
29authorized agent of the department or court shall, if convicted, be
30subject to imprisonment for not more than one year in the county
31jail or a fine of not more than ten thousand dollars ($10,000), or
32both the fine and imprisonment.

33(c) Notwithstanding subdivision (a), any person who purchases
34a foreign dangerous drug or medical device, illegitimate product,
35as defined in Section 360eee(8) of Title 21 of the United States
36Code, or suspect product, as defined in Section 360eee(21) of Title
3721 of the United States Code, that is not approved by the United
38States Food and Drug Administration or that is obtained outside
39of the licensed supply chain regulated by the United States Food
40and Drug Administration, California State Board of Pharmacy, or
P7    1State Department of Public Health is guilty of a misdemeanor and
2subject to imprisonment for not more than one year in the county
3jail, a fine of not more that ten thousand dollars ($10,000) per
4occurrence, or both the imprisonment and fine.

5(d) 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.

13

begin deleteSEC. 16.end delete
14begin insertSEC. 15.end insert  

No reimbursement is required by this act pursuant to
15Section 6 of Article XIII B of the California Constitution because
16the only costs that may be incurred by a local agency or school
17district will be incurred because this act creates a new crime or
18infraction, eliminates a crime or infraction, or changes the penalty
19for a crime or infraction, within the meaning of Section 17556 of
20the Government Code, or changes the definition of a crime within
21the meaning of Section 6 of Article XIII B of the California
22Constitution.



O

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