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

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

---

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

---

BILL NUMBER: SB 600	AMENDED
	BILL TEXT

	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

INTRODUCED BY   Senator Lieu

                        FEBRUARY 22, 2013

   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. 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 
    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) 
    (2)  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) 
    (3)  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:
   
  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 1.   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), "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.   SEC. 2.   Section 4034 of the
Business and Professions Code is repealed.
   SEC. 4.   SEC. 3.   Section 4034.1 of
the Business and Professions Code is repealed.
   SEC. 5.   SEC. 4.   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.
   SEC. 6.   SEC. 5.   Section 4163 of the
Business and Professions Code is repealed.
   SEC. 7.   SEC. 6.   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.   SEC. 7.   Section 4163.1 of
the Business and Professions Code, as added by Section 68 of Chapter
658 of the Statutes of 2006, is repealed.
   SEC. 9.   SEC. 8.   Section 4163.1 of
the Business and Professions Code, as added by Section 9 of Chapter
713 of the Statutes of 2008, is repealed.
   SEC. 10.   SEC. 9.   Section 4163.2 of
the Business and Professions Code is repealed.
   SEC. 11.   SEC. 10.   Section 4163.3 of
the Business and Professions Code is repealed.
   SEC. 12.   SEC. 11.   Section 4163.4 of
the Business and Professions Code is repealed.
   SEC. 13.   SEC. 12.   Section 4163.5 of
the Business and Professions Code is repealed.
   SEC. 14.   SEC. 13.   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.   SEC. 14.   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.
   (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.   SEC. 15.   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.