Ted Lieu
- Democratic
Author
(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.
Chaptered by Secretary of State. Chapter 492, Statutes of 2014.
Approved by the Governor.
Enrolled and presented to the Governor at 3 p.m.
Assembly amendments concurred in. (Ayes 35. Noes 0. Page 4978.) Ordered to engrossing and enrolling.
From committee: That the Assembly amendments be concurred in. (Ayes 9. Noes 0. Page 5014.)
Set for hearing August 28.
From committee: Be re-referred to Com. on B., P. & E.D. pursuant to Senate Rule 29.10. (Ayes 5. Noes 0. Page 4888.) Re-referred to Com. on B., P. & E.D.
Re-referred to Com. on RLS. pursuant to Senate Rule 29.10.
In Senate. Concurrence in Assembly amendments pending.
Read third time. Passed. (Ayes 77. Noes 0. Page 6453.) Ordered to the Senate.
Ordered to third reading.
Read third time and amended. (Page 6340.)
Read second time. Ordered to consent calendar.
Ordered to third reading.
From consent calendar.
From committee: Do pass. Ordered to consent calendar. (Ayes 17. Noes 0.) (August 6).
Read second time and amended. Re-referred to Com. on APPR.
From committee: Do pass as amended and re-refer to Com. on APPR. (Ayes 12. Noes 0.) (June 24).
From committee: Be re-referred to Com. on B.,P. & C.P. (Ayes 10. Noes 0.) (June 12). Re-referred to Com. on B.,P. & C.P.
Re-referred to Com. on RLS. pursuant to Assembly Rule 96(a).
From committee with author's amendments. Read second time and amended. Re-referred to Com. on B.,P. & C.P.
From committee with author's amendments. Read second time and amended. Re-referred to Com. on TRANS.
Set, first hearing. Hearing canceled at the request of author.
In Assembly. Read first time. Held at Desk.
Read third time. Passed. (Ayes 39. Noes 0. Page 1180.) Ordered to the Assembly.
Read second time and amended. Ordered to third reading.
From committee: Do pass as amended. (Ayes 7. Noes 0. Page 1017.) (May 23).
Set for hearing May 23.
Placed on APPR. suspense file.
Set for hearing May 13.
From committee: Do pass and re-refer to Com. on APPR. (Ayes 11. Noes 0. Page 759.) (April 30). Re-referred to Com. on APPR.
From committee with author's amendments. Read second time and amended. Re-referred to Com. on T. & H.
Set for hearing April 30.
From committee with author's amendments. Read second time and amended. Re-referred to Com. on RLS.
Read first time.
From printer. May be acted upon on or after March 26.
Introduced. To Com. on RLS. for assignment. To print.
| Bill Text Versions | Format |
|---|---|
| SB600 | HTML |
| 02/22/13 - Introduced | |
| 04/08/13 - Amended Senate | |
| 04/23/13 - Amended Senate | |
| 05/28/13 - Amended Senate | |
| 06/10/14 - Amended Assembly | |
| 06/12/14 - Amended Assembly | |
| 06/30/14 - Amended Assembly | |
| 08/22/14 - Amended Assembly | |
| 09/03/14 - Enrolled | |
| 09/20/14 - Chaptered |
| Document | Format |
|---|---|
| No related documents. |
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