Amended in Senate June 3, 2015

Senate BillNo. 423

Introduced by Senator Bates

February 25, 2015

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


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 insertExistingend 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 deletemajority end deletebegin insert23end insert. Appropriation: no. Fiscal committee: yes. State-mandated local program: no.

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

P2    1


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



(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;
9waste 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
P3    1from research; wastes from the production of bacteria, viruses,
2spores, discarded live and attenuated vaccines used in human health
3care or research, discarded animal vaccines, including Brucellosis
4and Contagious Ecthyma, as defined by the department; culture
5dishes, devices used to transfer, inoculate, and mix cultures; and
6wastes identified by Section 173.134 of Title 49 of the Code of
7Federal Regulations as Category B “once wasted” for laboratory

9(C) Waste that, at the point of transport from the generator’s
10site or at the point of disposal contains recognizable fluid human
11blood, fluid human blood products, containers, or equipment
12containing human blood that is fluid, or blood from animals
13suspected by the attending veterinarian of being contaminated with
14infectious agents known to be contagious to humans.

15(D) Waste containing discarded materials contaminated with
16excretion, exudate, or secretions from humans or animals that are
17required to be isolated by the infection control staff, the attending
18physician and surgeon, the attending veterinarian, or the local
19health officer, to protect others from highly communicable diseases
20or diseases of animals that are communicable to humans.

21(2) Pathology waste includes both of the following:

22(A) Human body parts, with the exception of teeth, removed at
23surgery and surgery specimens or tissues removed at surgery or
24autopsy that are suspected by the health care professional of being
25contaminated with infectious agents known to be contagious to
26humans or having been fixed in formaldehyde or another fixative.

27(B) Animal parts, tissues, fluids, or carcasses suspected by the
28attending veterinarian of being contaminated with infectious agents
29known to be contagious to humans.

30(3) “Pharmaceutical waste” means a pharmaceutical, as defined
31in Section 117747, including trace chemotherapy waste, that is a
32waste, as defined in Section 25124. For purposes of this part,
33“pharmaceutical waste” does not include a pharmaceutical that
34meets any of the following criteria:

35(A) The pharmaceutical is being sent out of the state to a reverse
36distributor, as defined in Section 4040.5 of the Business and
37Professions Code, that is licensed as a wholesaler of dangerous
38drugs by the California State Board of Pharmacy pursuant to
39Section 4161 of the Business and Professions Code.

P4    1(B) The pharmaceutical is being sent by a reverse distributor,
2as defined in Section 4040.5 of the Business and Professions Code,
3offsite for treatment and disposal in accordance with applicable
4laws, or to a reverse distributor that is licensed as a wholesaler of
5dangerous drugs by the California State Board of Pharmacy
6pursuant to Section 4160 of the Business and Professions Code
7and as a permitted transfer station if the reverse distributor is
8located within the state.

9(C) The pharmaceutical is an over-the-counter human or
10veterinary drug or dietary supplement that meets all of the
11following requirements:

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

13(ii) Is labeled with information entitled “Drug Facts” or
14“Supplement Facts,” in accordance with the requirements of the
15Federal Food, Drug, and Cosmetic Act, as amended, (21 U.S.C.A.
16Sec. 321 et seq.).

17(iii) Is characterized and managed as either a hazardous waste
18pursuant to Chapter 6.5 (commencing with Section 25100) of
19Division 20, or a solid waste pursuant to Division 30 (commencing
20with Section 40000) of the Public Resources Code.

21(iv) With respect to an over-the-counter human or veterinary
22drug, is not disposed of on land within the state.

23(4) “Sharps waste” means a device that has acute rigid corners,
24edges, or protuberances capable of cutting or piercing, including,
25but not limited to, hypodermic needles, hypodermic needles with
26syringes, blades, needles with attached tubing, acupuncture needles,
27root canal files, broken glass items used in health care such as
28Pasteur pipettes and blood vials contaminated with biohazardous
29waste, and any item capable of cutting or piercing from trauma
30 scene waste.

31(5) “Trace chemotherapeutic waste” means waste that is
32contaminated through contact with, or having previously contained,
33chemotherapeutic agents, including, but not limited to, gloves,
34disposable gowns, towels, and intravenous solution bags and
35attached tubing that are empty. A biohazardous waste that meets
36the conditions of this paragraph is not subject to the hazardous
37waste requirements of Chapter 6.5 (commencing with Section
3825100) of Division 20.

39(6) “Trauma scene waste” means waste that is a regulated waste,
40as defined in Section 5193 of Title 8 of the California Code of
P5    1Regulations, and that has been removed, is to be removed, or is in
2the process of being removed, from a trauma scene by a trauma
3scene waste management practitioner.

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This act is an urgency statute necessary for the
5immediate preservation of the public peace, health, or safety within
6the meaning of Article IV of the Constitution and shall go into
7immediate effect. The facts constituting the necessity are:

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8In order to make statutory changes needed to exempt
9over-the-counter human or veterinary drugs or dietary supplements
10from laws regulating the management, handling, and disposal of
11medical waste, as soon as possible, it is necessary that this act
12take effect immediately.

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