BILL NUMBER: SB 1014 AMENDED
BILL TEXT
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. 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required, pursuant to provisions repealed on January 1, 2013, to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 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repealed provisions and to include specified requirements and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 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
home-generated pharmaceutical 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 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 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 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
pharmaceuticals .
(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 and effectiveness of the
implemented program on an annual basis. The report shall contain
both qualitative and quantitative measures, as determined by the
department .
(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 include provisions that do
all of the following:
(1) Specify the types of participants authorized to maintain
permanent collection locations.
(2) Establish Specify any
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)
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.
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.