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 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 misbrandedbegin insert, except as specifiedend insert. 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 personbegin insert, except as specified,end insert who purchasesbegin insert or sellsend insert 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 approvedbegin insert or otherwise authorizedend insert 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.
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;begin delete a manufacturer’s
a private label distributor (including
P4 1third party logistics provider;end delete
2colicensed partners) for whom the private label distributor’s
3prescription drugs are originally manufactured and labeled for the
4distributor and have not been repackaged; or the distributor agent
5for the manufacturer, contract manufacturer, or private label
6distributor, whether the establishment is a member of the
7manufacturer’s affiliated group (regardless of whether the member
8takes title to the drug) or is a contract distributor site.
Section 4034 of the Business and Professions Code is
10repealed.
Section 4034.1 of the Business and Professions Code
12 is repealed.
Section 4045 of the Business and Professions Code is
14amended to read:
“Third-party logistics provider” or “reverse third-party
16logistic provider” means an entity licensed as a wholesaler that
17contracts with a dangerous drug manufacturer to provide or
18coordinate warehousing, distribution, or other similar services on
19behalf of a manufacturer, but for which there is no change of
20ownership in the dangerous drugs.
Section 4163 of the Business and Professions Code is
22repealed.
Section 4163 is added to the Business and Professions
24Code, to read:
(a) A manufacturer, wholesaler, repackager, or pharmacy
26may not furnish a dangerous drug or dangerous device to an
27unauthorized person.
28(b) Dangerous drugs or dangerous devices shall be acquired
29from a person authorized by law to possess or furnish dangerous
30drugs or dangerous devices. If the person acquiring the dangerous
31drugs or dangerous devices is a wholesaler, the obligation of the
32wholesaler shall be limited to obtaining confirmation of licensure
33of those sources from whom it has not previously acquired
34dangerous drugs or dangerous devices.
Section 4163.1 of the Business and Professions Code,
36as added by Section 68 of Chapter 658 of the Statutes of 2006, is
37repealed.
Section 4163.1 of the Business and Professions Code,
39as added by Section 9 of Chapter 713 of the Statutes of 2008, is
40repealed.
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:
begin insert(a)end insertbegin insert end insert Any foreign dangerous drug that is not approved
12by the United States Food and Drug Administration or that is
13obtained outside of the licensed supply chain regulated by the
14United States Food and Drug Administration, California State
15Board of Pharmacy, or State Department of Public Health is
16misbranded.
17(b) Any foreign dangerous drug that is imported lawfully under
18the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
Sec. 301 et
19seq.) or pursuant to an announcement by the United States Food
20and Drug Administration of the exercise of enforcement discretion
21for instances including, but not limited to, clinical research
22purposes, drug shortages, development of countermeasures against
23chemical, biological, radiological, and nuclear terrorism agents,
24or pandemic influenza preparedness and response is not
25misbranded.
Section 111825 of the Health and Safety Code is
27amended to read:
(a) Any person who violates any provision of this
29part or any regulation adopted pursuant to this part shall, if
30convicted, be subject to imprisonment for not more than one year
31in a county jail or a fine of not more than one thousand dollars
32($1,000), or both the imprisonment and fine.
33(b) Notwithstanding subdivision (a), any person who violates
34Section 111865 by removing, selling, or disposing of an embargoed
35food, drug, device, or cosmetic without the permission of an
36authorized agent of the department or court shall, if convicted, be
37subject to imprisonment for not more than one year in a county
38jail or a fine of not more than ten thousand
dollars ($10,000), or
39both the fine and imprisonment.
P6 1(c) begin insert(1)end insertbegin insert end insert Notwithstanding subdivision (a), any person who
2 purchasesbegin insert or sellsend insert a foreign dangerous drug or medical device,begin insert anend insert
3 illegitimate product, as defined in Section 360eee(8) of Title 21
4of the United States Code, or suspect product, as defined in Section
5360eee(21) of Title 21 of the United States Code, that is not
6approvedbegin insert
or otherwise authorizedend insert by the United States Food and
7Drug Administration or that is obtained outside of the licensed
8supply chain regulated by the United States Food and Drug
9Administration, California State Board of Pharmacy, or State
10Department of Public Health is guilty of a misdemeanor and subject
11to imprisonment for not more than one year in a county jail, a fine
12of not more than ten thousand dollars ($10,000) per occurrence,
13or both the imprisonment and fine.
14(2) This subdivision does not apply to those individuals
15determined by the United States Food and Drug Administration
16to have acted in compliance with the requirements under Part H
17(commencing with Section 360eee) of Subchapter V of Chapter 9
18of Title 21 of the United States Code with regard to the
illegitimate
19or suspect products.
20(d) If the violation is committed after a previous conviction
21under this section that has become final, or if the violation is
22committed with intent to defraud or mislead, or if the person
23committed a violation of Section 110625 or 111300 that was
24intentional or that was intended to cause injury, the person shall
25be subject to imprisonment for not more than one year in a
county
26jail, imprisonment in the state prison, or a fine of not more than
27ten thousand dollars ($10,000), or both the imprisonment and fine.
28(e) This section does not preclude punishment under any other
29law that provides for a greater punishment.
No reimbursement is required by this act pursuant to
31Section 6 of Article XIII B of the California Constitution because
32the only costs that may be incurred by a local agency or school
33district will be incurred because this act creates a new crime or
34infraction, eliminates a crime or infraction, or changes the penalty
35for a crime or infraction, within the meaning of Section 17556 of
36the Government Code, or changes the definition of a crime within
37the meaning of Section 6 of Article XIII B of the California
38Constitution.
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