BILL NUMBER: SB 1014 AMENDED
BILL TEXT
AMENDED IN ASSEMBLY AUGUST 6, 2014
AMENDED IN ASSEMBLY JUNE 30, 2014
AMENDED IN ASSEMBLY JUNE 18, 2014
AMENDED IN ASSEMBLY JUNE 10, 2014
AMENDED IN SENATE MAY 27, 2014
AMENDED IN SENATE APRIL 21, 2014
AMENDED IN SENATE APRIL 1, 2014
INTRODUCED BY Senator Jackson
(Principal coauthor: Senator Leno)
(Coauthors: Senators Evans, Hancock, Liu, and Pavley)
(Coauthors: Assembly Members Ammiano, Skinner, and Williams)
FEBRUARY 13, 2014
An act to add Section 4068.1 to the Business and
Professions Code, to amend Section 117700 of, and to add Section
117670.1 to, the Health and Safety Code, and to add Article 3.4
(commencing with Section 47120) to Chapter 1 of Part 7 of Division 30
of the Public Resources Sections 4027.5 and 4108 to
the Business and Professions Code, relating to pharmaceutical
waste.
LEGISLATIVE COUNSEL'S DIGEST
SB 1014, as amended, Jackson. Pharmaceutical waste: home
generated: collection.
The Pharmacy Law provides for the licensure and regulation of
pharmacists and pharmacy establishments by the California State Board
of Pharmacy. Existing law required the Department of Resources
Recycling and Recovery, pursuant to provisions repealed on January 1,
2013, to develop, in consultation with appropriate state, local, and
federal agencies, model programs for the collection and proper
disposal of drug waste. The Medical Waste Management Act,
administered by the State Department of Public Health, regulates the
management and handling of medical waste, including pharmaceutical
waste, as defined.
This bill would, upon the enactment of federal regulations,
require the California State Board of Pharmacy, in consultation with
the Department of Resources Recycling and Recovery and the State
Department of Public Health, to adopt regulations to implement
California drug takeback programs for the collection and destruction
of home-generated pharmaceutical waste, as defined. The bill would
provide that the regulations adopted pursuant to these provisions
only apply to licensees of the board.
(1) The Department of Resources Recycling and Recovery was
required, pursuant to provisions repealed on January 1, 2013, to
develop, in consultation with appropriate state, local, and federal
agencies, model programs for the collection and proper disposal of
drug waste.
This bill would require the department and the California State
Board of Pharmacy, on or before January 1, 2016, to jointly develop
and adopt regulations to authorize a participant to establish a
program to collect and properly dispose of home-generated
pharmaceutical waste, based upon the model guidelines developed by
the department pursuant to those repealed provisions and to include
specified provisions in those regulations. The bill would deem a
participant operating a program in accordance with those regulations
to be in compliance with all state laws and regulations concerning
the handling, management, and disposal of home-generated
pharmaceutical waste.
(2) The Medical Waste Management Act, administered by the State
Department of Public Health, regulates the management and handling of
medical waste, including pharmaceutical waste, as defined. Existing
law defines the term medical waste and excludes certain types of
waste from that definition.
This bill would define the term "home-generated pharmaceutical
waste" for purposes of that act. The bill would exclude, from the
definition of medical waste, home-generated pharmaceutical waste that
is handled by a collection and disposal program operating in
accordance with the regulations specified above.
(3) The Pharmacy Law provides for the licensure and regulation of
pharmacists and pharmacy establishments by the California State Board
of Pharmacy, and makes a knowing violation of that law a
misdemeanor.
The bill would also authorize a pharmacy to accept the return of
home-generated pharmaceutical waste from a consumer, consistent with
specified federal laws. Because a knowing violation of this provision
would be a crime, the bill would impose a state-mandated local
program.
(4) 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 no .
THE PEOPLE OF THE STATE OF CALIFORNIA DO ENACT AS FOLLOWS:
SECTION 1. Section 4027.5 is added to the
Business and Professions Code , to read:
4027.5. "Home-generated pharmaceutical waste" means a
prescription or over-the-counter human or veterinary home-generated
pharmaceutical drug, as defined in Section 4022 or 4025.1, that is a
waste generated by a household or households. "Home-generated
pharmaceutical waste" shall not include waste generated by a
business, corporation, limited partnership, or an entity involved in
a wholesale transaction between a distributor and retailer.
SEC. 2. Section 4108 is added to the
Business and Professions Code , to read:
4108. (a) Within 18 months of the enactment of federal
regulations regarding the collection of unwanted or expired
controlled substances from the public, the board, in consultation
with the Department of Resources Recycling and Recovery and the State
Department of Public Health, shall adopt regulations to implement
California drug takeback programs for the collection and destruction
of home-generated pharmaceutical waste.
(b) The regulations promulgated pursuant to this section shall
require a participant in a program to take all of the following
actions:
(1) Provide, at no additional cost to the consumer, for the safe
take back and proper disposal of home-generated pharmaceutical waste.
(2) Ensure the protection of the public health and safety, the
environment, and the health and safety of consumers and employees.
(3) Report annually to the board and the State Department of
Public Health for purposes of evaluating the safety, efficiency, and
effectiveness of the implemented program on an annual basis. The
report shall contain both qualitative and quantitative measures, as
determined by the board and the State Department of Public Health.
(4) Protect against the potential for the diversion of
home-generated pharmaceutical waste included in a program for
unlawful use or sale.
(c) The regulations adopted pursuant to this section shall only
apply to licensees of the board.
SECTION 1. Section 4068.1 is added to the
Business and Professions Code, to read:
4068.1. A pharmacy may accept the return of home-generated
pharmaceutical waste, as defined in Section 117670.1 of the Health
and Safety Code, from a consumer, consistent with the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. Sec. 301 et seq.) and the federal
Controlled Substances Act (21 U.S.C. Sec. 801 et seq.).
SEC. 2. Section 117670.1 is added to the Health
and Safety Code, to read:
117670.1. "Home-generated pharmaceutical waste" means a
prescription or over-the-counter human or veterinary home-generated
pharmaceutical, including, but not limited to, a drug as defined in
Section 109925 or in Section 321(g)(1) of Title 21 of the United
States Code, that is a waste, as defined in Section 25124, derived
from a household, including, but not limited to, a multifamily
residence or household.
SEC. 3. Section 117700 of the Health and Safety
Code is amended to read:
117700. Medical waste does not include any of the following:
(a) Waste generated in food processing or biotechnology that does
not contain an infectious agent as defined in Section 117675.
(b) Waste generated in biotechnology that does not contain human
blood or blood products or animal blood or blood products suspected
of being contaminated with infectious agents known to be communicable
to humans.
(c) Urine, feces, saliva, sputum, nasal secretions, sweat, tears,
or vomitus, unless it contains fluid blood, as provided in
subdivision (d) of Section 117635.
(d) Waste that is not biohazardous, such as paper towels, paper
products, articles containing nonfluid blood, and other medical solid
waste products commonly found in the facilities of medical waste
generators.
(e) Hazardous waste, radioactive waste, or household waste,
including, but not limited to, home-generated sharps waste, as
defined in Section 117671.
(f) Waste generated from normal and legal veterinarian,
agricultural, and animal livestock management practices on a farm or
ranch.
(g) Home-generated pharmaceutical waste, including, but not
limited to, consolidated home-generated pharmaceutical waste, that is
handled by a collection and disposal program operating in accordance
with the regulations adopted by the Department of Resources
Recycling and Recovery and the California State Board of Pharmacy
pursuant to Article 3.4 (commencing with Section 47120) of Chapter 1
of Part 7 of Division 30 of the Public Resources Code.
SEC. 4. Article 3.4 (commencing with Section
47120) is added to Chapter 1 of Part 7 of Division 30 of the Public
Resources Code, to read:
Article 3.4. Home-Generated Pharmaceutical Waste Collection
and Disposal
47120. For the purposes of this article, the following terms have
the following meanings, unless the context clearly requires
otherwise:
(a) "Consumer" means an individual purchaser or owner of a
pharmaceutical. "Consumer" does not include a business, corporation,
limited partnership, or an entity involved in a wholesale transaction
between a distributor and retailer.
(b) "Entity" means a state or local public agency, pharmacy,
veterinarian clinic, or other office or facility.
(c) "Home-generated pharmaceutical waste" has the same meaning as
defined in Section 117670.1 of the Health and Safety Code, and
includes all of the following:
(1) Articles recognized in the official United States
Pharmacopoeia, the official National Formulary, the official
Homeopathic Pharmacopoeia of the United States, or any supplement of
the formulary or those pharmacopoeias.
(2) Articles intended for use in the diagnosis, cure, mitigation,
treatment, or prevention of disease in humans or other animals.
(3) Articles, excluding food, intended to affect the structure or
function of the body of humans or other animals.
(4) Articles intended for use as a component of an article
specified in paragraph (1), (2), or (3).
(d) "Participant" means an entity that the department and the
California State Board of Pharmacy deems appropriate for implementing
and evaluating a program in accordance with the regulations adopted
pursuant to this article and that chooses to participate.
(e) "Sale" includes, but is not limited to, transactions conducted
through sales outlets, catalogs, or the Internet, or any other
similar electronic means, but does not include a sale that is a
wholesale transaction with a distributor or retailer.
47121. On or before January 1, 2016, the department and the
California State Board of Pharmacy shall jointly develop regulations,
to be approved by both agencies before adoption, authorizing a
participant to establish a program to collect and properly dispose of
home-generated pharmaceutical waste. The regulations shall be based
upon the model guidelines developed by the department pursuant to
former Section 47122, as that section read on January 1, 2012, and
shall include both of the following:
(a) Provisions that do all of the following:
(1) Specify the types of participants authorized to maintain
permanent collection locations.
(2) Specify any requirements for obtaining state permits or
approvals.
(3) Specify which home-generated pharmaceutical wastes may be
included in a program, including requirements for the collection of a
controlled substance, as defined in Section 11007 of the Health and
Safety Code.
(4) Require participants to enter into arrangements with medical
or hazardous waste haulers, including ensuring that all
home-generated pharmaceutical waste included in a program is
appropriately picked up and transported by registered waste haulers.
(5) Specify methods for handling wastes commingled in containers
with other household waste or hazardous waste.
(6) Provide methods for collecting and storing home-generated
pharmaceutical waste included in a program, including the use of
secured containers, and ensure that collected home-generated
pharmaceutical waste is not resold, reused, sold, donated, or
provided to anyone other than a registered medical or hazardous waste
hauler.
(7) Provide that a facility that collects home-generated
pharmaceutical waste included in a program is responsible for
ensuring that the storage, removal, and transportation of containers
and the disposal of the waste are in compliance with state laws and
regulations.
(8) Require the collection and retention of detailed information
and invoices for each collection site.
(9) Impose requirements for one-time or periodic collection
events.
(10) Impose requirements for mail-back collection and disposal
programs.
(11) Impose requirements for the appropriate public education and
management of consolidated home-generated pharmaceutical waste
included in a program to ensure the public health and safety.
(b) Provisions requiring a participant to take all of the
following actions:
(1) Provide, at no additional cost to the consumer, for the safe
take back and proper disposal of pharmaceuticals.
(2) Ensure the protection of the public health and safety, the
environment, and the health and safety of consumers and employees.
(3) Report annually to the department, for purposes of evaluating
the safety, efficiency, and effectiveness of the implemented program
on an annual basis. The report shall contain both qualitative and
quantitative measures, as determined by the department and the
California State Board of Pharmacy.
(4) Protect against the potential for the diversion of
pharmaceutical waste included in a program for unlawful use or sale.
47122. A participant operating a program in accordance with the
regulations adopted pursuant to this article shall be deemed in
compliance with all state laws and regulations concerning the
handling, management, and disposal of home-generated pharmaceutical
waste.
47123. Regulations adopted pursuant to this article shall conform
to any requirements of a federal drug take-back program.
SEC. 5. 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.