BILL NUMBER: SB 1014 AMENDED
BILL TEXT
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 Code, relating to pharmaceutical waste.
LEGISLATIVE COUNSEL'S DIGEST
SB 1014, as amended, Jackson. Pharmaceutical waste: home
generated: collection.
(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required, pursuant to provisions repealed on January 1, 2013, to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the department pursuant to those repealed provisions and to include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 requirements and 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. The bill
would, however, allow an entity with a home-generated pharmaceutical
waste program, existing as of January 1, 2015, to continue operating
that program.
(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.
THE PEOPLE OF THE STATE OF CALIFORNIA DO ENACT AS FOLLOWS:
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 which 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. (a) 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, shall
include the requirements specified in subdivision (b), and
shall include the provisions specified in subdivisions (c)
and (d). 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) The regulations adopted pursuant to this section
shall require 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
evaluation, 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.
(5) Provide notices and materials to consumers that provide
information about the potential impacts of improper disposal of
home-generated pharmaceutical waste and the return opportunities for
the proper disposal of home-generated pharmaceutical waste. Those
materials shall include, but are not limited to, all of the
following:
(A) Internet Web site links.
(B) Telephone numbers placed on an invoice or purchase order, or
packaged with a pharmaceutical.
(C) Information about the opportunities and locations for no-cost
home-generated pharmaceutical waste disposal.
(D) Signage that is prominently displayed and easily visible to
the consumer.
(E) Written materials provided to the consumer at the time of
purchase or delivery.
(F) Reference to the home-generated pharmaceutical waste take back
opportunity in advertising or other promotional materials.
(G) Direct communications with the consumer at the time of
purchase.
(c) The regulations adopted pursuant to this section shall include
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) Require participants to enter into arrangements with medical
or hazardous waste haulers, including ensuring that all
home-generated pharmaceutical waste is appropriately picked up and
transported by registered waste haulers.
(4) 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.
(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, 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 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.
(d) The department shall include, in the regulations adopted
pursuant to this section, provisions for the appropriate management
of consolidated home-generated pharmaceutical waste to ensure the
public health and safety.
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. Nothing in this article shall prohibit an entity with a
home-generated pharmaceutical waste program, existing as of January
1, 2015, from continuing to operate that program.
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.