Senate Bill No. 727

Introduced by Senator Jackson

February 22, 2013

An act to add Section 117647 to, and to add Chapter 12 (commencing with Section 118365) to Part 14 of Division 104 of, the Health and Safety Code, relating to public health.

LEGISLATIVE COUNSEL’S DIGEST

SB 727, as introduced, Jackson. Medical waste: pharmaceutical product stewardship program.

The existing 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 requires, among other things, that all medical waste be hauled by either a registered hazardous waste hauler or by a person with an approved limited-quantity exemption granted pursuant to specified provisions of law. Under the law, an enforcement agency may bring an action to enjoin the violation or threatened violation of those provisions or issue a specified order to a person who is responsible for a violation or threatened violation. A violation of that order, and other provisions of law, is a crime.

This bill would, effective January 1, 2015, prohibit a producer of a pharmaceutical that is a cover drug, as defined, from selling or distributing that pharmaceutical in the state unless it is included in a product stewardship plan that is approved by the department. This bill would require each producer to operate, individually or jointly with other producers, an approved product stewardship program or to enter into an agreement with a stewardship organization, as defined, to operate that program on the producer’s behalf. This bill would require a producer, group of producers, or stewardship organization, if applicable, to pay all associated costs with its product stewardship program, as specified, including the costs incurred by the state for administration and enforcement of the program. The bill would prohibit the producer from charging specified fees to recover the costs of its program.

This bill would require a producer, individually or jointly with other producers, in consultation with specified entities, to develop a product stewardship plan that includes, among other things, certification that the product stewardship program will accept all unwanted products, except as specified, contact information for the individual or entity submitting the plan and for each producer participating in the program, and a description of the methods by which unwanted products will be collected in the state. This bill would require the producer, group of producers, or stewardship organization operating the program to prepare and submit a written report to the department, as prescribed. This bill would require the department to administer any penalties under those provisions. By expanding the definition of a crime, this bill would impose a state-mandated local program.

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 117647 is added to the Health and Safety
Code, to read:

117647.  

(a) “Covered drugs” means all drugs as defined in
Section 201 of the Federal Food, Drug, and Cosmetic Act (FFDCA)
(21 U.S.C. 321(g)(1)), and covered under Section 503 of the act
(21 U.S.C. Section 353(b)(1)), including both brand name and
generic drugs.

(b) Covered drugs do not include any of the following:

(1) Vitamins or supplements.

(2) Herbal-based remedies, or homeopathic drugs, products, or
remedies.

(3) Cosmetics, soap, with or without germicidal agents, laundry
detergent, bleach, household cleaning products, shampoo,
sunscreen, toothpaste, lip balm, antiperspirants, or other personal
care products that are regulated as both cosmetics and
nonprescription drugs under the FFDCA.

(4) Drugs for which a producer provides a take-back program
as part of an FFDCA managed risk evaluation and mitigation
strategy.

(5) Drugs that are biological products, as defined in Section
262(i) of Title 42 of the United States Code, if the producer already
provides a take-back program

(6) Pet pesticide products contained in pet collars, powders,
shampoos, topical applications, or other delivery systems.

(7) Nonprescription drugs.

SEC. 2.  

Chapter 12 (commencing with Section 118365) is
added to Part 14 of Division 104 of the Health and Safety Code,
to read:

 

Chapter  12. Pharmaceutical Product Stewardship
Program

 

118365.  

For purposes of this chapter, “stewardship
organization” means a nonprofit organization created by a producer
to implement the pharmaceutical product stewardship program
described in Section 118365.1.

118365.1.  

(a) Effective January 1, 2015, a producer of a
pharmaceutical that is a covered drug shall not sell or distribute
that pharmaceutical in the state unless it is included in a product
stewardship plan approved by the department.

(b) Each producer shall do one of the following:

(1) Operate, individually or jointly with other producers, a
product stewardship program approved by the department.

(2) Enter into an agreement with a stewardship organization to
operate, on the producer’s behalf, a product stewardship program
approved by the department.

(c) (1) A producer, group of producers, or stewardship
organization shall pay all administrative and operational fees
associated with its product stewardship program, including the
costs of collecting, transporting, and disposing of unwanted
products collected from residential generators and the recycling
or disposal, or both, of packaging collected with the unwanted
product.

(2) A producer, group of producers, or stewardship organization
shall pay for all fees associated with obtaining compliance with
the California Environmental Quality Act (Division 13
(commencing with Section 21000) of the Public Resources Code),
if required, for a product stewardship program and product
stewardship plan.

(3) A person or producer shall not charge a specific point-of-sale
fee to a consumer to recover the costs of its product stewardship
program, and shall not charge a specific point-of-collection fee at
the time the unwanted products are collected from residential
generators or delivered for disposal.

(4) A producer, group of producers, or stewardship organization
shall pay all costs incurred by the state, including, but not limited
to, the department’s costs, for the administration and enforcement
of its pharmaceutical product stewardship program. Exclusive of
any fines, the state shall only recover the actual costs of
administration and enforcement under this chapter, and shall not
charge any amounts under this chapter in excess of the actual
administrative and enforcement costs.

118365.2.  

In consultation with local governments, water
districts, sanitation districts, pharmacies, waste haulers,
environmental health officers, and all interested stakeholders, the
producers, individually or jointly with other producers, shall
develop a product stewardship plan.

(a) Each product stewardship plan required under Section
118365.1 shall contain all of the following:

(1) Certification that the product stewardship program will
accept all unwanted products, regardless of who produced them
under a joint plan, unless excused from this requirement by the
department as part of its approval of the plan.

(2) Contact information for the individual and the entity
submitting the plan and for each of the producers participating in
the product stewardship program.

(3) A description of the methods by which unwanted products
from residential generators will be collected in the state and an
explanation of how the collection system will be convenient and
adequate to serve the needs of all California residents.

(4) A description of how the product stewardship plan will
provide collection services for unwanted products in all areas of
California that are convenient to the public and adequate to meet
the needs of the population in the area being served.

(5) If applicable, the location of each collection site and
locations where envelopes for a mail-back program are available.

(6) A list containing the name, location, permit status, and record
of any penalties, violations, or regulatory orders received in the
previous five years by each person that will be involved in
transporting unwanted products and each medical waste or
hazardous disposal facility proposed to participate in the product
stewardship program.

(7) A description of how the unwanted products will be safely
and securely tracked and handled from collection through final
disposal, and the policies and procedures to be followed to ensure
security and adherence to highest management standards.

(8) A description of public education and outreach activities
that are consistent with this chapter, and how the effectiveness of
those programs and activities will be evaluated.

(9) A description of how the scope and extent of the product
stewardship program is reasonably related to the amount of covered
drugs that are sold in the state by the producer, or group of
producers.

(10) A starting date for the collection of unwanted products.

(11) If applicable, a description of how support will be provided
to any law enforcement agencies within the state that operate, or
later agree to operate, a collection program for controlled
substances, including the provision of a collection kiosk with
appropriate accessories and signage, the ability to accept controlled
substances and other covered drugs, and technical support, up to
and including an appropriate person to provide on-site assistance
with the sorting and separation of controlled substances at no cost
to a participating law enforcement agency. Otherwise, controlled
substances are expressly excluded from this chapter,
notwithstanding any other provision.

(12) A description of how collection sites for unwanted products
may be placed at appropriate retail stores in the state, including a
description of the involvement of the retail store. Retailers are not
required or mandated to host collection sites, and nothing in this
chapter shall be interpreted as requiring that participation.

(13) If more than one producer will be involved in a proposed
product stewardship program, the plan for that program shall
include a fair and reasonable manner for allocating the costs of
the program among the participants in that program, so that the
portion of costs paid by each producer is reasonably related to the
amount of covered drugs that producer sells in the state.

118365.3.  

On or before January 1, 2016, or at a later date as
approved in writing by the department, and in each subsequent
year, each producer, group of producers, or stewardship
organization operating a product stewardship program shall prepare
and submit to the department an annual written report describing
the program’s activities during the previous reporting period.

118365.4.  

The department shall administer the penalty
provisions for this chapter.

SEC. 3.  

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.