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 federal Drug Supply Chain Security Actbegin delete establishesend deletebegin insert, provides forend insert 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. 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 inbegin delete theend deletebegin insert aend insert county jail, a fine of not morebegin delete thatend deletebegin insert
thanend insert
$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.
Vote: majority. Appropriation: no. Fiscal committee: yes. State-mandated local program: yes.
The people of the State of California do enact as follows:
Section 4033 of the Business and Professions
2Code is amended to read:
(a) (1) “Manufacturer” means and includes every person
4who prepares, derives, produces, compounds, or repackages any
5drug or device except a pharmacy that manufactures on the
6immediate premises where the drug or device is sold to the ultimate
7consumer.
8(2) Notwithstanding paragraph (1), “manufacturer” shall not
9mean a pharmacy compounding a drug for parenteral therapy,
10pursuant to a prescription, for delivery to another pharmacy for
11the purpose of delivering or administering the drug to the patient
12or patients named in the prescription, provided that neither the
13components for the drug nor the drug are compounded, fabricated,
14packaged,
or otherwise prepared prior to receipt of the prescription.
15(3) Notwithstanding paragraph (1), “manufacturer” shall not
16mean a pharmacy that, at a patient’s request, repackages a drug
17previously dispensed to the patient, or to the patient’s agent,
18pursuant to a prescription.
19(b) Notwithstanding subdivision (a), “manufacturer” also means
20a person who prepares, derives, manufactures, produces, or
21repackages a dangerous drug, as defined in Section 4022, device,
22or cosmetic. Manufacturer also means the holder or holders of a
23New Drug Application (NDA), an Abbreviated New Drug
24Application (ANDA), or a Biologics License Application (BLA),
25provided that such application has been approved; a manufacturer’s
26third party logistics provider; a private label distributor (including
P4 1colicensed
partners) for whom the private label distributor’s
2prescription drugs are originally manufactured and labeled for the
3distributor and have not been repackaged; or the distributor agent
4for the manufacturer, contract manufacturer, or private label
5distributor, whether the establishment is a member of the
6manufacturer’s affiliated group (regardless of whether the member
7takes title to the drug) or is a contract distributor site.
Section 4034 of the Business and Professions Code is
9repealed.
Section 4034.1 of the Business and Professions Code
11 is repealed.
Section 4045 of the Business and Professions Code is
13amended to read:
“Third-party logistics provider” or “reverse third-party
15logistic provider” means an entity licensed as a wholesaler that
16contracts with a dangerous drug manufacturer to provide or
17coordinate warehousing, distribution, or other similar services on
18behalf of a manufacturer, but for which there is no change of
19ownership in the dangerous drugs.
Section 4163 of the Business and Professions Code is
21repealed.
Section 4163 is added to the Business and Professions
23Code, to read:
(a) A manufacturer, wholesaler, repackager, or pharmacy
25may not furnish a dangerous drug or dangerous device to an
26unauthorized person.
27(b) Dangerous drugs or dangerous devices shall be acquired
28from a person authorized by law to possess or furnish dangerous
29drugs or dangerous devices.begin delete Whenend deletebegin insert Ifend insert the person acquiring the
30dangerous drugs or dangerous devices is a wholesaler, the
31obligation of the wholesaler shall be limited to obtaining
32confirmation of licensure of those sources from whom it has not
33previously
acquired dangerous drugs or dangerous devices.
Section 4163.1 of the Business and Professions Code,
35as added by Section 68 of Chapter 658 of the Statutes of 2006, is
36repealed.
Section 4163.1 of the Business and Professions Code,
38as added by Section 9 of Chapter 713 of the Statutes of 2008, is
39repealed.
Section 4163.2 of the Business and Professions Code
2 is repealed.
Section 4163.3 of the Business and Professions Code
4 is repealed.
Section 4163.4 of the Business and Professions Code
6 is repealed.
Section 4163.5 of the Business and Professions Code
8 is repealed.
Section 111397 is added to the Health and Safety
10Code, to read:
Any foreign dangerous drug that is not approved by
12the United States Food and Drug Administration or that is obtained
13outside of the licensed supply chain regulated by the United States
14Food and Drug Administration, California State Board of
15Pharmacy, or State Department of Public Health is misbranded.
Section 111825 of the Health and Safety Code is
17amended to read:
(a) Any person who violates any provision of this
19part or any regulation adopted pursuant to this part shall, if
20convicted, be subject to imprisonment for not more than one year
21in begin deletethe end deletebegin inserta end insertcounty jail or a fine of not more than one thousand dollars
22($1,000), or both the imprisonment and fine.
23(b) Notwithstanding subdivision (a), any person who violates
24Section 111865 by removing, selling, or disposing of an embargoed
25food, drug, device, or cosmetic without the permission of an
26authorized
agent of the department or court shall, if convicted, be
27subject to imprisonment for not more than one year inbegin delete theend deletebegin insert aend insert county
28jail or a fine of not more than ten thousand dollars ($10,000), or
29both the fine and imprisonment.
30(c) Notwithstanding subdivision (a), any person who purchases
31a foreign dangerous drug or medical device, illegitimate product,
32as defined in Section 360eee(8) of Title 21 of the United States
33Code, or suspect product, as defined in Section 360eee(21) of Title
3421 of the United States Code, that is not approved by the United
35States Food and Drug Administration or that is obtained outside
36of the licensed supply chain regulated by the United States Food
37and
Drug Administration, California State Board of Pharmacy, or
38State Department of Public Health is guilty of a misdemeanor and
39subject to imprisonment for not more than one year inbegin delete theend deletebegin insert aend insert county
P6 1jail, a fine of not morebegin delete thatend deletebegin insert thanend insert ten thousand dollars ($10,000)
2per occurrence, or both the imprisonment and fine.
3(d) If the violation is committed after a previous conviction
4under this section that has become final, or if the violation is
5committed with intent to defraud or mislead, or if the person
6committed a
violation of Section 110625 or 111300 that was
7intentional or that was intended to cause injury, the person shall
8be subject to imprisonment for not more than one year inbegin delete theend deletebegin insert aend insert
9
county jail, imprisonment inbegin insert theend insert state prison, or a fine of not more
10than ten thousand dollars ($10,000), or both the imprisonment and
11fine.
No reimbursement is required by this act pursuant to
13Section 6 of Article XIII B of the California Constitution because
14the only costs that may be incurred by a local agency or school
15district will be incurred because this act creates a new crime or
16infraction, eliminates a crime or infraction, or changes the penalty
17for a crime or infraction, within the meaning of Section 17556 of
18the Government Code, or changes the definition of a crime within
19the meaning of Section 6 of Article XIII B of the California
20Constitution.
O
93