BILL NUMBER: SB 1014 AMENDED
BILL TEXT
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 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.
(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required, pursuant to provisions repealed on January 1, 2013, to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 enact the Home-Generated Pharmaceutical Waste
Collection Disposal Act and would define terms for purposes of the
act. The bill would require a producer of covered pharmaceuticals to
submit to the Department of Resources Recycling and Recovery, by July
1, 2015, except as specified, a product stewardship plan and would
authorize one or more producers to submit a plan or designate a
stewardship organization to act as an agent on behalf of the
producers to submit a plan. The bill would require the stewardship
plan to contain specified elements with regard to the collection and
disposal of home-generated pharmaceutical waste, including provisions
for the payment of all administrative and operational fees
associated with the product stewardship program.
The bill would specify procedures for the approval of the plan by
the department and would require a producer, group of producers, or
stewardship organization operating a stewardship program to take
specified actions with regard to the disposal of home-generated
pharmaceutical waste and promoting product stewardship programs to
consumers, pharmacists, retailers of covered pharmaceuticals, and
health care practitioners.
The bill would require a producer, group of producers, or
stewardship organization operating a product stewardship program to
prepare and submit to the department an annual written report
describing the program's activities during the previous calendar year
by July 1, 2016, or at a later date as approved by the department,
and on or before July 1 annually thereafter.
The bill would authorize the department to adopt regulations to
implement the act and would require the department to adopt
regulations to provide for the appropriate management of consolidated
home-generated pharmaceutical waste, to establish a schedule of fees
to be charged to cover the department's costs of administering and
enforcing the act, and to adopt a schedule setting the amounts of
administrative civil penalties that the department would be
authorized to impose. The bill would require a producer, group of
producers, or a stewardship organization submitting a plan to the
department to pay the fees set by the department and would require
the department to deposit the fees into the Home-Generated
Pharmaceutical Waste Program Account, which the bill would create in
the Integrated Waste Management Fund. The department would be
authorized to expend the fees, upon appropriation by the Legislature,
to administer and enforce the act.
The bill would authorize the department to issue an administrative
order to, or impose a civil penalty upon, a producer who is in
violation of the act or a regulation adopted pursuant to the act. The
bill would require the department to deposit the penalties into the
Home-Generated Pharmaceutical Waste Penalty Account, which the bill
would create in the Integrated Waste Management Fund, and would
authorize the department to expend the moneys in that account, upon
appropriation by the Legislature, to enforce the act.
This bill would require the department to 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 require an entity
that elects to implement a home-generated pharmaceutical waste
collection program to comply with the requirements specified in those
regulations and 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 act regulations
specified above. This exclusion would not become operative
until the Secretary of State posts a notice regarding the effective
date of the regulations that the department is required to adopt
pursuant to that act.
(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 home-generated
pharmaceutical 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 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 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 that provides
medical services.
(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 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) The department shall adopt regulations 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).
(b) The regulations adopted pursuant to this section shall require
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 the type or brand of pharmaceuticals
that the participant sells or previously sold.
(2) Ensure the protection of the public health and safety, the
environment, and the health and safety of consumers and employees.
(3) Report to the department, for purposes of evaluation, the
safety, efficiency, effectiveness, and funding sustainability of the
implemented program.
(4) Protect against the potential for the diversion of
pharmaceutical waste 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 provide
for all of the following:
(1) Specify the types of participants authorized to maintain
permanent collection locations.
(2) Establish requirements for obtaining local or 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 becomes the generator of the pharmaceutical
waste, and 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.
(e) The department may revise the regulations adopted pursuant to
this article, as deemed necessary by the department, if the revision
provides an equivalent or greater level of safety.
47122. (a) An entity that elects to implement a home-generated
pharmaceutical waste program shall comply with the regulations
adopted pursuant to this article.
(b) 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.
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. All matter omitted in this version of
the bill appears in the bill as amended in the Senate, April 1, 2014.
(JR11)