BILL NUMBER: SB 423	INTRODUCED
	BILL TEXT


INTRODUCED BY   Senator Bates

                        FEBRUARY 25, 2015

   An act to amend Section 117690 of the Health and Safety Code,
relating to medical waste.


	LEGISLATIVE COUNSEL'S DIGEST


   SB 423, as introduced, Bates. Pharmaceutical waste:
over-the-counter drugs and nutritional supplements.
   The existing 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.
   Vote: majority. 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
 either   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.