Amended in Senate May 27, 2014

Amended in Senate April 21, 2014

Amended in Senate April 1, 2014

Senate Bill No. 1014

Introduced by Senator Jackson

(Principal coauthor: Senator Leno)

(Coauthors: Senators Evans, Hancock, Liu, and Pavley)

(Coauthors: Assembly Members Ammiano begin insert , Skinner, end insert 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 begin delete generated. end delete begin insert generated: collection. end insert

(1) The Department of Resources Recycling and Recovery was required, pursuant to provisions repealed on January 1, 2013, to develop, in consultation with appropriate state, local, and federal agencies, model programs for the collection and proper disposal of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of home-generated pharmaceutical waste, based upon the model guidelines developed by the department pursuant to those repealed provisions and to include specified requirements and provisions in those regulations.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 begin delete 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 end delete 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
begin delete home-generated pharmaceutical end delete begin insert drug end insert 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 begin delete facility that provides medical
services end delete begin insert facility end insert .

(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 begin delete the type or brand of
pharmaceuticals that the participant sells or previously sold end delete
begin insert pharmaceuticals end insert .

(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, begin delete effectiveness, and funding sustainability end delete begin insert and
effectiveness end insert of the implemented program begin insert on an annual basis. The
report shall contain both qualitative and quantitative measures,
as determined by the department end insert .

(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 begin delete provide
for end delete begin insert include provisions that do end insert all of the following:

(1) Specify the types of participants authorized to maintain
permanent collection locations.

(2)  begin delete Establish end delete begin insert Specify any end insert requirements for obtaining begin delete local or end delete
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 begin delete becomes the generator of the pharmaceutical
waste, and end delete 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.

begin delete

(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.

end delete

begin delete

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) 

end delete

begin insert

begin insert 47122. end insert   

end insert

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.