Amended in Senate July 6, 2015

Amended in Senate June 3, 2015

Senate BillNo. 423


Introduced by Senator Bates

February 25, 2015


An act tobegin delete amend Section 117690 ofend deletebegin insert add and repeal Article 11.2 (commencing with Section 25230) of Chapter 6.5 of Division 20 ofend insert the Health and Safety Code, relating tobegin delete medicalend deletebegin insert hazardousend insert waste, and declaring the urgency thereof, to take effect immediately.

LEGISLATIVE COUNSEL’S DIGEST

SB 423, as amended, Bates. begin deletePharmaceutical waste: over-the-counter drugs and nutritional supplements. end deletebegin insertRetail nonprescription surplus products: determinations for reuse.end insert

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.begin delete 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.end deletebegin insert Existing law also provides for the disposition of hazardous waste. A violation of these provisions is a crime.end insert

begin delete

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.

end delete
begin insert

This bill, until January 1, 2022, would establish criteria to be followed for the handling and management of retail nonprescription pharmaceutical surplus products, as defined, if a reasonable determination for reuse has been made or when a reasonable determination for reuse cannot be made but the product has been recalled as required by law. The bill would authorize the State Department of Public Health to adopt regulations as deemed necessary to establish standards for the proper and safe handling of retail nonprescription pharmaceutical surplus products.

end insert
begin insert

Because a violation of these provisions would be a crime, this bill would impose a state-mandated local program.

end insert
begin insert

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.

end insert
begin insert

This bill would provide that no reimbursement is required by this act for a specified reason.

end insert

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

Vote: 23. Appropriation: no. Fiscal committee: yes. State-mandated local program: begin deleteno end deletebegin insertyesend insert.

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

P2    1begin insert

begin insertSECTION 1.end insert  

end insert

begin insertArticle 11.2 (commencing with Section 25230) is
2added to Chapter 6.5 of Division 20 of the end insert
begin insertHealth and Safety Codeend insertbegin insert,
3to read:end insert

begin insert

4 

5Article begin insert11.2.end insert  Nonprescription Pharmaceutical Surplus Products
6

 

7

begin insert25230.end insert  

(a) The Legislature finds and declares that this section
8is intended to address the unique circumstances associated with
9the management of retail nonprescription pharmaceutical surplus
10products that potentially can be safely diverted from the waste
11stream for reuse, if appropriate. The Legislature further declares
12that this section shall not be construed to set a precedent applicable
13to the management, including disposal, of other hazardous or
14medical wastes.

P3    1(b) For purposes of this section, the following definitions shall
2apply:

3(1) “Retail nonprescription pharmaceutical surplus product”
4means a pharmaceutical, as that term is defined in Section 117747,
5that may be sold without a prescription and that is labeled for use
6by the consumer in accordance with the requirements of the laws
7and rules of this state and the federal government, defined as a
8nonprescription drug in Article 2 (commencing with Section 4015)
9of Chapter 9 of Division 2 of the Business and Professions Code,
10in which a waste generator has made a reasonable determination
11for reuse. A retail nonprescription pharmaceutical surplus product
12does not include waste that is subject to regulation as a hazardous
13waste under the federal Resource Conservation and Recovery Act
14of 1976, as amended (42 U.S.C. Sec. 6901 et seq.).

15(2) “Reasonable determination for reuse” means, upon removal
16of a retail nonprescription pharmaceutical surplus product from
17sale, a generator who has evaluated the product and makes a
18finding that the product meets all of the following criteria:

19(A) The product is in unadulterated packaging.

20(B) The product and packaging are in a condition that is suitable
21for resale.

22(C) The product is not designated for disposal by the
23manufacturer or the manufacturer’s agent.

24(D) The product is otherwise eligible for liquidation or donation.

25(3) “Reverse distributor” or “reverse distribution center” has
26the same meaning as set forth in Section 4040.5 of the Business
27and Professions Code that satisfies all of the following:

28(A) Is licensed as a wholesaler of dangerous drugs by the
29California State Board of Pharmacy pursuant to Section 4160 of
30the Business and Professions Code.

31(B) Is permitted by the department as a transfer station, if the
32reverse distributor is located within the State of California.

33(C) Is registered with the Department of Toxic Substances
34Control and any other appropriate state and local agencies as a
35hazardous waste generator, transfer facility, or storage facility.

36(D) Complies with handling, storage, training, emergency
37response, and recordkeeping requirements, and any other
38applicable requirements.

39(c) Notwithstanding Sections 25189.5, 25201, and 117747, if a
40reasonable determination for reuse has been made, a retail
P4    1nonprescription pharmaceutical surplus product may be handled
2in accordance with all of the following:

3(1) The retail nonprescription pharmaceutical surplus product
4shall be transported to a reverse distributor or reverse distribution
5center for any of the following purposes:

6(A) Evaluating the manufacturer’s or supplier’s credit or other
7financial reconciliation.

8(B) Liquidation.

9(C) Donation.

10(D) Transferring back to a manufacturer, distributor, or
11supplier, or its respective agent.

12(2) The retail nonprescription pharmaceutical surplus product
13shall be transported with a tracking document that identifies all
14of the following information:

15(A) The product, the UPC label, and the lot number.

16(B) Name, address, and telephone number of the generator of
17the waste.

18(C) Name, address, and telephone number of the reverse
19distributor or reverse distribution center receiving the shipment.

20(D) The purpose for which the retail nonprescription
21pharmaceutical surplus product is being shipped to the reverse
22distributor or reverse distribution center.

23(3) Shipments of retail nonprescription pharmaceutical surplus
24products to a reverse distributor or a reverse distribution center
25shall be made via a transporter registered with the United States
26Department of Transportation Federal Motor Carrier Safety
27Administration. Transporters shall use due diligence to ensure
28safe handling, which includes, but is not limited to, ensuring that
29the packaging does not become damaged or adulterated during
30shipment and that the shipment is handled in appropriate moisture
31and temperature conditions.

32(4) The reverse distributor or reverse distribution center shall
33do all of the following:

34(A) Maintain the specified tracking documents for a period of
35three years following receipt date of a shipment and shall make
36those documents available for inspection by any applicable
37enforcement agencies.

38(B) Submit a hazardous materials business plan to the
39appropriate state and local agencies, as required by Article 1
40(commencing with Section 25500) of Chapter 6.95 and any
P5    1regulations promulgated by either the department or any certified
2unified program agency.

3(d) A retail nonprescription pharmaceutical surplus product
4that has been transported to a reverse distributor or reverse
5distribution center for any of the purposes listed in paragraph (1)
6of subdivision (c) shall not be stored or held at the reverse
7distributor or reverse distribution center for more than 364
8calendar days. A retail nonprescription pharmaceutical surplus
9product held or stored for 365 or more days shall immediately be
10considered waste and, if hazardous, managed in accordance with
11applicable federal and state hazardous waste management laws
12and regulations.

13(e) Notwithstanding Sections 25189.5, 25201, and 117747, the
14provisions of subdivision (c) may be used for a retail
15nonprescription pharmaceutical surplus product for which a
16reasonable determination for reuse cannot be made if the product
17has been recalled as required by law, including safety recalls for
18secure destruction.

19(f) The department may adopt regulations as deemed necessary
20to establish standards for the proper and safe handling of retail
21nonprescription pharmaceutical surplus products.

22(g) This article shall remain in effect only until January 1, 2022,
23and as of that date is repealed, unless a later enacted statute, that
24is enacted before January 1, 2022, deletes or extends that date.

end insert
25begin insert

begin insertSEC. 2.end insert  

end insert
begin insert

No reimbursement is required by this act pursuant to
26Section 6 of Article XIII B of the California Constitution because
27the only costs that may be incurred by a local agency or school
28district will be incurred because this act creates a new crime or
29infraction, eliminates a crime or infraction, or changes the penalty
30for a crime or infraction, within the meaning of Section 17556 of
31the Government Code, or changes the definition of a crime within
32the meaning of Section 6 of Article XIII B of the California
33Constitution.

end insert
34begin insert

begin insertSEC. 3.end insert  

end insert
begin insert

This act is an urgency statute necessary for the
35immediate preservation of the public peace, health, or safety within
36the meaning of Article IV of the Constitution and shall go into
37immediate effect. The facts constituting the necessity are:

end insert
begin insert

38In order to make statutory changes needed to address the unique
39circumstances associated with the management, handling, and
40reasonable determination of reuse or retail nonprescription
P6    1pharmaceutical surplus products as soon as possible, it is
2necessary that this act take effect immediately.

end insert
begin delete
3

SECTION 1.  

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

5

117690.  

(a) “Medical waste” means any biohazardous,
6pathology, pharmaceutical, or trace chemotherapy waste not
7regulated by the federal Resource Conservation and Recovery Act
8of 1976 (Public Law 94-580), as amended; sharps and trace
9chemotherapy wastes generated in a health care setting in the
10diagnosis, treatment, immunization, or care of humans or animals;
11waste generated in autopsy or necropsy; waste generated during
12preparation of a body for final disposition such as cremation or
13interment; waste generated in research pertaining to the production
14or testing of microbiologicals; waste generated in research using
15human or animal pathogens; sharps and laboratory waste that poses
16a potential risk of infection to humans generated in the inoculation
17of animals in commercial farming operations; waste generated
18from the consolidation of home-generated sharps; and waste
19generated in the cleanup of trauma scenes. Biohazardous,
20pathology, pharmaceutical, sharps, and trace chemotherapy wastes
21that meet the conditions of this section are not subject to any of
22the hazardous waste requirements found in Chapter 6.5
23(commencing with Section 25100) of Division 20.

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

25(1) “Biohazardous waste” includes all of the following:

26(A) (i) Regulated medical waste, clinical waste, or biomedical
27waste that is a waste or reusable material derived from the medical
28treatment of a human or from an animal that is suspected by the
29attending veterinarian of being infected with a pathogen that is
30also infectious to humans, which includes diagnosis and
31immunization; or from biomedical research, which includes the
32production and testing of biological products.

33(ii) Regulated medical waste or clinical waste or biomedical
34waste suspected of containing a highly communicable disease.

35(B) Laboratory waste such as human specimen cultures or
36animal specimen cultures that are infected with pathogens that are
37also infectious to humans; cultures and stocks of infectious agents
38from research; wastes from the production of bacteria, viruses,
39spores, discarded live and attenuated vaccines used in human health
40care or research, discarded animal vaccines, including Brucellosis
P7    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
31meets any 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
P8    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.

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

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

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.).

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.

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

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
38the process of being removed, from a trauma scene by a trauma
39scene waste management practitioner.

P9    1

SEC. 2.  

This act is an urgency statute necessary for the
2immediate preservation of the public peace, health, or safety within
3the meaning of Article IV of the Constitution and shall go into
4immediate effect. The facts constituting the necessity are:

5In order to make statutory changes needed to exempt
6over-the-counter human or veterinary drugs or dietary supplements
7from laws regulating the management, handling, and disposal of
8medical waste, as soon as possible, it is necessary that this act take
9effect immediately.

end delete


O

    97