---
type: "Bill"
title: "Investigational drugs, biological products, and devices."
description: "Existing law, the federal Food, Drug, and Cosmetic Act, prohibits a person from introducing into interstate commerce any new drug unless the drug has been approved by the United States Food and Drug Administration (FDA) . Existing law requires the sponsor of a new drug to submit to the FDA an investigational new drug application and to then conduct a series of clinical trials to establish the safety and efficacy of the drug in human populations and submit the results to the FDA in a new drug application."
jurisdiction: "us/states/ca"
legislature: "California Legislature"
session: "20152016"
identifier: "AB 1668"
citation: "California AB 1668 (20152016)"
classification: ["bill"]
subjects: ["Investigational drugs", "biological products", "and devices."]
status: "enacted"
primary_sponsors: ["Calderon"]
version_count: 6
action_count: 24
vote_count: 10
first_action: "2016-01-15"
last_action: "2016-09-27"
source: "openstates"
source_identifier: "ocd-bill/2d82af8c-6ec5-47b8-949d-8e9fec1ea823"
source_url: "http://leginfo.legislature.ca.gov/faces/billNavClient.xhtml?bill_id=201520160AB1668"
source_hash: "8926919f59b9fc0c2e1551d257bf454eff80d7a407f086ee5e10d8c991e7d6dd"
vintage: "2026-07-01"
source_snapshot: "https://data.openstates.org/daily/2026-07-01/public.pgdump"
retrieved_at: "2026-07-06"
confidence: "reported"
tags: ["legislation", "bill", "us-ca"]
---

# California AB 1668 (20152016) — Investigational drugs, biological products, and devices.

Existing law, the federal Food, Drug, and Cosmetic Act, prohibits a person from introducing into interstate commerce any new drug unless the drug has been approved by the United States Food and Drug Administration (FDA) . Existing law requires the sponsor of a new drug to submit to the FDA an investigational new drug application and to then conduct a series of clinical trials to establish the safety and efficacy of the drug in human populations and submit the results to the FDA in a new drug application.

## Version chain

The bill's text revisions, in order — the diff chain from filing to enrollment.

1. **01/15/16 - Introduced** (filed) — [source](https://leginfo.legislature.ca.gov/faces/billPdf.xhtml?bill_id=201520160AB1668&version=20150AB166899INT)
2. **03/07/16 - Amended Assembly** (committee substitute) — [source](https://leginfo.legislature.ca.gov/faces/billPdf.xhtml?bill_id=201520160AB1668&version=20150AB166898AMD)
3. **08/15/16 - Amended Senate** (committee substitute) — [source](https://leginfo.legislature.ca.gov/faces/billPdf.xhtml?bill_id=201520160AB1668&version=20150AB166897AMD)
4. **09/27/16 - Chaptered** (committee substitute) — [source](https://leginfo.legislature.ca.gov/faces/billPdf.xhtml?bill_id=201520160AB1668&version=20150AB166895CHP)
5. **AB1668** (committee substitute) — [source](http://leginfo.legislature.ca.gov/faces/billNavClient.xhtml?bill_id=201520160AB1668)
6. **08/25/16 - Enrolled** (enrolled) — [source](https://leginfo.legislature.ca.gov/faces/billPdf.xhtml?bill_id=201520160AB1668&version=20150AB166896ENR)

## Votes

- AB 1668 CALDERON Concurrence in Senate Amendments — **77–2** (pass) · lower
- Do pass, but first be re-referred to the Committee on [Appropriations] — **9–0** (pass) · upper
- 3rd Reading AB1668 Calderon By Stone — **38–0** (pass) · upper
- Do pass. — **20–0** (pass) · lower
- Do pass as amended — **7–0** (pass) · upper
- AB 1668 CALDERON Assembly Third Reading — **77–2** (pass) · lower
- Do pass and be re-referred to the Committee on [Business and Professions] — **18–0** (pass) · lower
- Do pass, but first be re-referred to the Committee on [Business, Professions and Economic Development] — **9–0** (pass) · upper
- Do pass and be re-referred to the Committee on [Appropriations] — **14–0** (pass) · lower
- Placed on suspense file — **7–0** (pass) · upper

## Sponsors

- Calderon — primary (person)
- Alejo — coauthor (person)
- Allen — coauthor (person)
- Bonta — coauthor (person)
- Brown — coauthor (person)
- Campos — coauthor (person)
- Chu — coauthor (person)
- Dababneh — coauthor (person)
- Daly — coauthor (person)
- Frazier — coauthor (person)
- Galgiani — coauthor (person)
- Gatto — coauthor (person)
- Gipson — coauthor (person)
- Gonzalez — coauthor (person)
- Gray — coauthor (person)
- Hadley — coauthor (person)
- Jones-Sawyer — coauthor (person)
- Lackey — coauthor (person)
- Linder — coauthor (person)
- Low — coauthor (person)
- Mark Stone — coauthor (person)
- McCarty — coauthor (person)
- Medina — coauthor (person)
- O'Donnell — coauthor (person)
- Obernolte — coauthor (person)
- Olsen — coauthor (person)
- Rendon — coauthor (person)
- Rodriguez — coauthor (person)
- Roger Hernández — coauthor (person)
- Runner — coauthor (person)
- Salas — coauthor (person)
- Stone — coauthor (person)
- Waldron — coauthor (person)
- Williams — coauthor (person)

## Timeline

The legislative action history — every referral, reading, and vote.

- **2016-01-15** Read first time. To print. `reading-1`
- **2016-01-19** From printer. May be heard in committee February 18.
- **2016-02-04** Referred to Coms. on HEALTH and B. & P. `referral-committee`
- **2016-03-07** From committee chair, with author's amendments: Amend, and re-refer to Com. on HEALTH. Read second time and amended. `reading-2, amendment-introduction, amendment-passage, reading-1`
- **2016-03-08** Re-referred to Com. on HEALTH. `referral-committee`
- **2016-03-16** From committee: Do pass and re-refer to Com. on B. & P. (Ayes 18. Noes 0.) (March 15). Re-referred to Com. on B. & P. `referral-committee, committee-passage-favorable, committee-passage`
- **2016-03-29** From committee: Do pass and re-refer to Com. on APPR. (Ayes 14. Noes 0.) (March 29). Re-referred to Com. on APPR. `referral-committee, committee-passage-favorable, committee-passage`
- **2016-04-06** In committee: Set, first hearing. Referred to APPR. suspense file. `referral-committee`
- **2016-05-27** From committee: Do pass. (Ayes 20. Noes 0.) (May 27). `committee-passage-favorable, committee-passage`
- **2016-05-27** Read second time. Ordered to third reading. `reading-2, reading-1`
- **2016-05-31** Read third time. Passed. Ordered to the Senate. (Ayes 77. Noes 2. Page 5020.) `reading-3, passage, reading-1`
- **2016-06-01** In Senate. Read first time. To Com. on RLS. for assignment. `reading-1`
- **2016-06-09** Referred to Coms. on HEALTH and B., P. & E.D. `referral-committee`
- **2016-06-23** From committee: Do pass and re-refer to Com. on B., P. & E.D. (Ayes 9. Noes 0.) (June 22). Re-referred to Com. on B., P. & E.D. `referral-committee, committee-passage-favorable, committee-passage`
- **2016-06-28** From committee: Do pass and re-refer to Com. on APPR. (Ayes 9. Noes 0.) (June 27). Re-referred to Com. on APPR. `referral-committee, committee-passage-favorable, committee-passage`
- **2016-08-01** In committee: Referred to APPR. suspense file. `referral-committee`
- **2016-08-11** From committee: Amend, and do pass as amended. (Ayes 7. Noes 0.) (August 11). `amendment-introduction, committee-passage, amendment-passage`
- **2016-08-15** Read second time and amended. Ordered to third reading. `amendment-passage, reading-2, reading-1`
- **2016-08-18** Read third time. Passed. Ordered to the Assembly. (Ayes 38. Noes 0. Page 5117.). `reading-3, passage, reading-1`
- **2016-08-19** In Assembly. Concurrence in Senate amendments pending. May be considered on or after August 21 pursuant to Assembly Rule 77.
- **2016-08-23** Senate amendments concurred in. To Engrossing and Enrolling. (Ayes 77. Noes 2. Page 6157.). `committee-passage-favorable, amendment-passage`
- **2016-08-30** Enrolled and presented to the Governor at 4 p.m.
- **2016-09-27** Approved by the Governor. `executive-signature`
- **2016-09-27** Chaptered by Secretary of State - Chapter 684, Statutes of 2016.

## Source

OpenStates / OpenCivicData bulk snapshot [2026-07-01](https://data.openstates.org/daily/2026-07-01/public.pgdump); origin `ocd-bill/2d82af8c-6ec5-47b8-949d-8e9fec1ea823`. Confidence: reported (aggregated from official California legislature records).