Amended in Senate June 3, 2015

Senate Bill No. 423

Introduced by Senator Bates

February 25, 2015

An act to amend Section 117690 of the Health and Safety Code, relating to medical begin delete waste. end delete begin insert waste, and declaring the urgency thereof, to take effect immediately. end insert

LEGISLATIVE COUNSEL’S DIGEST

SB 423, as amended, Bates. Pharmaceutical waste: over-the-counter drugs and nutritional supplements.

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The existing

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begin insert Existing end insert law, the Medical Waste Management Act, administered by the State Department of Public Health, regulates the management, handling, and disposal of medical waste, as defined, including pharmaceutical waste. For purposes of that act, “pharmaceutical waste” is defined as a prescription or over-the counter human or veterinary drug, as specified, that is waste, as defined, but excludes from that definition certain pharmaceuticals being sent out of state to a reverse distributor, or being sent by a reverse distributor offsite for treatment and disposal, as prescribed.

This bill would additionally exclude from the definition of “pharmaceutical waste,” for purposes of regulation under the act, any over-the-counter human or veterinary drug or dietary supplement that is, among other things, characterized and managed as a hazardous or solid waste and, with respect to an over-the-counter human or veterinary drug, is not disposed of on land within the state.

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This bill would declare that it is to take effect immediately as an urgency statute.

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Vote:  begin delete majority end delete begin insert ²⁄₃ end insert . Appropriation: no. Fiscal committee: yes. State-mandated local program: no.

The people of the State of California do enact as follows:

SECTION 1.  

Section 117690 of the Health and Safety Code
is amended to read:

117690.  

(a) “Medical waste” means any biohazardous,
pathology, pharmaceutical, or trace chemotherapy waste not
regulated by the federal Resource Conservation and Recovery Act
of 1976 (Public Law 94-580), as amended; sharps and trace
chemotherapy wastes generated in a health care setting in the
diagnosis, treatment, immunization, or care of humans or animals;
waste generated in autopsy or necropsy; waste generated during
preparation of a body for final disposition such as cremation or
interment; waste generated in research pertaining to the production
or testing of microbiologicals; waste generated in research using
human or animal pathogens; sharps and laboratory waste that poses
a potential risk of infection to humans generated in the inoculation
of animals in commercial farming operations; waste generated
from the consolidation of home-generated sharps; and waste
generated in the cleanup of trauma scenes. Biohazardous,
pathology, pharmaceutical, sharps, and trace chemotherapy wastes
that meet the conditions of this section are not subject to any of
the hazardous waste requirements found in Chapter 6.5
(commencing with Section 25100) of Division 20.

(b) For purposes of this part the following definitions apply:

(1) “Biohazardous waste” includes all of the following:

(A) (i) Regulated medical waste, clinical waste, or biomedical
waste that is a waste or reusable material derived from the medical
treatment of a human or from an animal that is suspected by the
attending veterinarian of being infected with a pathogen that is
also infectious to humans, which includes diagnosis and
immunization; or from biomedical research, which includes the
production and testing of biological products.

(ii) Regulated medical waste or clinical waste or biomedical
waste suspected of containing a highly communicable disease.

(B) Laboratory waste such as human specimen cultures or
animal specimen cultures that are infected with pathogens that are
also infectious to humans; cultures and stocks of infectious agents
from research; wastes from the production of bacteria, viruses,
spores, discarded live and attenuated vaccines used in human health
care or research, discarded animal vaccines, including Brucellosis
and Contagious Ecthyma, as defined by the department; culture
dishes, devices used to transfer, inoculate, and mix cultures; and
wastes identified by Section 173.134 of Title 49 of the Code of
Federal Regulations as Category B “once wasted” for laboratory
wastes.

(C) Waste that, at the point of transport from the generator’s
site or at the point of disposal contains recognizable fluid human
blood, fluid human blood products, containers, or equipment
containing human blood that is fluid, or blood from animals
suspected by the attending veterinarian of being contaminated with
infectious agents known to be contagious to humans.

(D) Waste containing discarded materials contaminated with
excretion, exudate, or secretions from humans or animals that are
required to be isolated by the infection control staff, the attending
physician and surgeon, the attending veterinarian, or the local
health officer, to protect others from highly communicable diseases
or diseases of animals that are communicable to humans.

(2) Pathology waste includes both of the following:

(A) Human body parts, with the exception of teeth, removed at
surgery and surgery specimens or tissues removed at surgery or
autopsy that are suspected by the health care professional of being
contaminated with infectious agents known to be contagious to
humans or having been fixed in formaldehyde or another fixative.

(B) Animal parts, tissues, fluids, or carcasses suspected by the
attending veterinarian of being contaminated with infectious agents
known to be contagious to humans.

(3) “Pharmaceutical waste” means a pharmaceutical, as defined
in Section 117747, including trace chemotherapy waste, that is a
waste, as defined in Section 25124. For purposes of this part,
“pharmaceutical waste” does not include a pharmaceutical that
meets any of the following criteria:

(A) The pharmaceutical is being sent out of the state to a reverse
distributor, as defined in Section 4040.5 of the Business and
Professions Code, that is licensed as a wholesaler of dangerous
drugs by the California State Board of Pharmacy pursuant to
Section 4161 of the Business and Professions Code.

(B) The pharmaceutical is being sent by a reverse distributor,
as defined in Section 4040.5 of the Business and Professions Code,
offsite for treatment and disposal in accordance with applicable
laws, or to a reverse distributor that is licensed as a wholesaler of
dangerous drugs by the California State Board of Pharmacy
pursuant to Section 4160 of the Business and Professions Code
and as a permitted transfer station if the reverse distributor is
located within the state.

(C) The pharmaceutical is an over-the-counter human or
veterinary drug or dietary supplement that meets all of the
following requirements:

(i) Is offered for sale without a prescription.

(ii) Is labeled with information entitled “Drug Facts” or
“Supplement Facts,” in accordance with the requirements of the
Federal Food, Drug, and Cosmetic Act, as amended, (21 U.S.C.A.
Sec. 321 et seq.).

(iii) Is characterized and managed as either a hazardous waste
pursuant to Chapter 6.5 (commencing with Section 25100) of
Division 20, or a solid waste pursuant to Division 30 (commencing
with Section 40000) of the Public Resources Code.

(iv) With respect to an over-the-counter human or veterinary
drug, is not disposed of on land within the state.

(4) “Sharps waste” means a device that has acute rigid corners,
edges, or protuberances capable of cutting or piercing, including,
but not limited to, hypodermic needles, hypodermic needles with
syringes, blades, needles with attached tubing, acupuncture needles,
root canal files, broken glass items used in health care such as
Pasteur pipettes and blood vials contaminated with biohazardous
waste, and any item capable of cutting or piercing from trauma
scene waste.

(5) “Trace chemotherapeutic waste” means waste that is
contaminated through contact with, or having previously contained,
chemotherapeutic agents, including, but not limited to, gloves,
disposable gowns, towels, and intravenous solution bags and
attached tubing that are empty. A biohazardous waste that meets
the conditions of this paragraph is not subject to the hazardous
waste requirements of Chapter 6.5 (commencing with Section
25100) of Division 20.

(6) “Trauma scene waste” means waste that is a regulated waste,
as defined in Section 5193 of Title 8 of the California Code of
Regulations, and that has been removed, is to be removed, or is in
the process of being removed, from a trauma scene by a trauma
scene waste management practitioner.

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This act is an urgency statute necessary for the
immediate preservation of the public peace, health, or safety within
the meaning of Article IV of the Constitution and shall go into
immediate effect. The facts constituting the necessity are:

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In order to make statutory changes needed to exempt
over-the-counter human or veterinary drugs or dietary supplements
from laws regulating the management, handling, and disposal of
medical waste, as soon as possible, it is necessary that this act
take effect immediately.

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