Bill Text: CA SB600 | 2013-2014 | Regular Session | Chaptered
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-Chaptered.html
BILL NUMBER: SB 600 CHAPTERED
BILL TEXT
CHAPTER 492
FILED WITH SECRETARY OF STATE SEPTEMBER 20, 2014
APPROVED BY GOVERNOR SEPTEMBER 20, 2014
PASSED THE SENATE AUGUST 29, 2014
PASSED THE ASSEMBLY AUGUST 26, 2014
AMENDED IN ASSEMBLY AUGUST 22, 2014
AMENDED IN ASSEMBLY JUNE 30, 2014
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 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, 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 federal Drug Supply Chain Security Act, provides
for 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.
(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, except as specified. 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, except as specified, who
purchases or sells 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 or otherwise authorized
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
a county jail, a fine of not more than $10,000 per occurrence, or
both the imprisonment and fine. By creating new crimes, the bill
would impose a state-mandated local program.
(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.
THE PEOPLE OF THE STATE OF CALIFORNIA DO ENACT AS FOLLOWS:
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 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. 2. Section 4034 of the Business and Professions Code is
repealed.
SEC. 3. Section 4034.1 of the Business and Professions Code is
repealed.
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. 5. Section 4163 of the Business and Professions Code is
repealed.
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. If 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. 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. 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. 9. Section 4163.2 of the Business and Professions Code is
repealed.
SEC. 10. Section 4163.3 of the Business and Professions Code is
repealed.
SEC. 11. Section 4163.4 of the Business and Professions Code is
repealed.
SEC. 12. Section 4163.5 of the Business and Professions Code is
repealed.
SEC. 13. Section 111397 is added to the Health and Safety Code, to
read:
111397. (a) 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.
(b) Any foreign dangerous drug that is imported lawfully under the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. Sec. 301 et seq.) or
pursuant to an announcement by the United States Food and Drug
Administration of the exercise of enforcement discretion for
instances including, but not limited to, clinical research purposes,
drug shortages, development of countermeasures against chemical,
biological, radiological, and nuclear terrorism agents, or pandemic
influenza preparedness and response is not misbranded.
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 a 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 a county jail
or a fine of not more than ten thousand dollars ($10,000), or both
the fine and imprisonment.
(c) (1) Notwithstanding subdivision (a), any person who purchases
or sells a foreign dangerous drug or medical device, an 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 or otherwise
authorized 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
a county jail, a fine of not more than ten thousand dollars
($10,000) per occurrence, or both the imprisonment and fine.
(2) This subdivision does not apply to those individuals
determined by the United States Food and Drug Administration to have
acted in compliance with the requirements under Part H (commencing
with Section 360eee) of Subchapter V of Chapter 9 of Title 21 of the
United States Code with regard to the illegitimate or suspect
products.
(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 a county jail,
imprisonment in the state prison, or a fine of not more than ten
thousand dollars ($10,000), or both the imprisonment and fine.
(e) This section does not preclude punishment under any other law
that provides for a greater punishment.
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.
