Senate BillNo. 423


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:

P2    1

SECTION 1.  

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

3

117690.  

(a) “Medical waste” means any biohazardous,
4pathology, pharmaceutical, or trace chemotherapy waste not
5regulated by the federal Resource Conservation and Recovery Act
6of 1976 (Public Law 94-580), as amended; sharps and trace
7chemotherapy wastes generated in a health care setting in the
8diagnosis, treatment, immunization, or care of humans or animals;
9 waste generated in autopsy or necropsy; waste generated during
10preparation of a body for final disposition such as cremation or
11interment; waste generated in research pertaining to the production
12or testing of microbiologicals; waste generated in research using
13human or animal pathogens; sharps and laboratory waste that poses
14a potential risk of infection to humans generated in the inoculation
15of animals in commercial farming operations; waste generated
16from the consolidation of home-generated sharps; and waste
17generated in the cleanup of trauma scenes. Biohazardous,
18pathology, pharmaceutical, sharps, and trace chemotherapy wastes
19that meet the conditions of this section are not subject to any of
20the hazardous waste requirements found in Chapter 6.5
21(commencing with Section 25100) of Division 20.

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

23(1) “Biohazardous waste” includes all of the following:

24(A) (i) Regulated medical waste, clinical waste, or biomedical
25waste that is a waste or reusable material derived from the medical
26treatment of a human or from an animal that is suspected by the
27attending veterinarian of being infected with a pathogen that is
28also infectious to humans, which includes diagnosis and
29immunization; or from biomedical research, which includes the
30production and testing of biological products.

31(ii) Regulated medical waste or clinical waste or biomedical
32waste suspected of containing a highly communicable disease.

33(B) Laboratory waste such as human specimen cultures or
34animal specimen cultures that are infected with pathogens that are
35also infectious to humans; cultures and stocks of infectious agents
36from research; wastes from the production of bacteria, viruses,
37spores, discarded live and attenuated vaccines used in human health
38care or research, discarded animal vaccines, including Brucellosis
P3    1and Contagious Ecthyma, as defined by the department; culture
2dishes, devices used to transfer, inoculate, and mix cultures; and
3wastes identified by Section 173.134 of Title 49 of the Code of
4Federal Regulations as Category B “once wasted” for laboratory
5wastes.

6(C) Waste that, at the point of transport from the generator’s
7site or at the point of disposal contains recognizable fluid human
8blood, fluid human blood products, containers, or equipment
9containing human blood that is fluid, or blood from animals
10suspected by the attending veterinarian of being contaminated with
11infectious agents known to be contagious to humans.

12(D) Waste containing discarded materials contaminated with
13excretion, exudate, or secretions from humans or animals that are
14required to be isolated by the infection control staff, the attending
15physician and surgeon, the attending veterinarian, or the local
16health officer, to protect others from highly communicable diseases
17or diseases of animals that are communicable to humans.

18(2) Pathology waste includes both of the following:

19(A) Human body parts, with the exception of teeth, removed at
20surgery and surgery specimens or tissues removed at surgery or
21autopsy that are suspected by the health care professional of being
22contaminated with infectious agents known to be contagious to
23humans or having been fixed in formaldehyde or another fixative.

24(B) Animal parts, tissues, fluids, or carcasses suspected by the
25attending veterinarian of being contaminated with infectious agents
26known to be contagious to humans.

27(3) “Pharmaceutical waste” means a pharmaceutical, as defined
28in Section 117747, including trace chemotherapy waste, that is a
29waste, as defined in Section 25124. For purposes of this part,
30“pharmaceutical waste” does not include a pharmaceutical that
31meetsbegin delete eitherend deletebegin insert anyend insert of the following criteria:

32(A) The pharmaceutical is being sent out of the state to a reverse
33distributor, as defined in Section 4040.5 of the Business and
34Professions Code, that is licensed as a wholesaler of dangerous
35drugs by the California State Board of Pharmacy pursuant to
36Section 4161 of the Business and Professions Code.

37(B) The pharmaceutical is being sent by a reverse distributor,
38as defined in Section 4040.5 of the Business and Professions Code,
39offsite for treatment and disposal in accordance with applicable
40laws, or to a reverse distributor that is licensed as a wholesaler of
P4    1dangerous drugs by the California State Board of Pharmacy
2pursuant to Section 4160 of the Business and Professions Code
3and as a permitted transfer station if the reverse distributor is
4located within the state.

begin insert

5(C) The pharmaceutical is an over-the-counter human or
6veterinary drug or dietary supplement that meets all of the
7following requirements:

end insert
begin insert

8(i) Is offered for sale without a prescription.

end insert
begin insert

9(ii) Is labeled with information entitled “Drug Facts” or
10“Supplement Facts,” in accordance with the requirements of the
11Federal Food, Drug, and Cosmetic Act, as amended, (21 U.S.C.A.
12Sec. 321 et seq.).

end insert
begin insert

13(iii) Is characterized and managed as either a hazardous waste
14pursuant to Chapter 6.5 (commencing with Section 25100) of
15Division 20, or a solid waste pursuant to Division 30 (commencing
16with Section 40000) of the Public Resources Code.

end insert
begin insert

17(iv) With respect to an over-the-counter human or veterinary
18drug, is not disposed of on land within the state.

end insert

19(4) “Sharps waste” means a device that has acute rigid corners,
20edges, or protuberances capable of cutting or piercing, including,
21but not limited to, hypodermic needles, hypodermic needles with
22syringes, blades, needles with attached tubing, acupuncture needles,
23root canal files, broken glass items used in health care such as
24Pasteur pipettes and blood vials contaminated with biohazardous
25waste, and any item capable of cutting or piercing from trauma
26 scene waste.

27(5) “Trace chemotherapeutic waste” means waste that is
28contaminated through contact with, or having previously contained,
29chemotherapeutic agents, including, but not limited to, gloves,
30disposable gowns, towels, and intravenous solution bags and
31attached tubing that are empty. A biohazardous waste that meets
32the conditions of this paragraph is not subject to the hazardous
33waste requirements of Chapter 6.5 (commencing with Section
3425100) of Division 20.

35(6) “Trauma scene waste” means waste that is a regulated waste,
36as defined in Section 5193 of Title 8 of the California Code of
37Regulations, and that has been removed, is to be removed, or is in
P5    1the process of being removed, from a trauma scene by a trauma
2scene waste management practitioner.



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