SB 1014, as amended, Jackson. Pharmaceutical waste: home generated: collection.
(1) The Department of Resources Recycling and Recovery was required, pursuant to provisions repealed on January 1, 2013, to develop, in consultation with appropriate state, local, and federal agencies, model programs for the collection and proper disposal of drug waste.
This bill would require the department and the California State Board of Pharmacy, on or before January 1, 2016, to jointly develop and adopt regulations to authorize a participant to establish a program to collect and properly dispose of home-generated pharmaceutical waste, based upon the model guidelines developed by the department pursuant to those repealed provisions and to include specifiedbegin delete requirements andend delete provisions in those regulations. The bill would deem a
participant operating a program in accordance with those regulations to be in compliance with all state laws and regulations concerning the handling, management, and disposal of home-generated pharmaceutical waste.begin deleteThe bill would, however, allow an entity with a home-generated pharmaceutical waste program, existing as of January 1, 2015, to continue operating that program.end delete
(2) The Medical Waste Management Act, administered by the State Department of Public Health, regulates the management and handling of medical waste, including pharmaceutical waste, as defined. Existing law defines the term medical waste and excludes certain types of waste from that definition.
This bill would define the term “home-generated pharmaceutical waste” for purposes of that act. The bill would exclude, from the definition of medical waste, home-generated pharmaceutical waste that is handled by a collection and disposal program operating in accordance with the regulations specified above.
(3) The Pharmacy Law provides for the licensure and regulation of pharmacists and pharmacy establishments by the California State Board of Pharmacy, and makes a knowing violation of that law a misdemeanor.
The bill would also authorize a pharmacy to accept the return of home-generated pharmaceutical waste from a consumer, consistent with specified federal laws. Because a knowing violation of this provision would be a crime, the bill would impose a state-mandated local program.
(4) 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.
This bill would provide that no reimbursement is required by this act for a specified reason.
Vote: majority. Appropriation: no. Fiscal committee: yes. State-mandated local program: yes.
The people of the State of California do enact as follows:
Section 4068.1 is added to the Business and
2Professions Code, to read:
A pharmacy may accept the return of home-generated
4pharmaceutical waste, as defined in Section 117670.1 of the Health
5and Safety Code, from a consumer, consistent with the Federal
6Food, Drug, and Cosmetic Act (21 U.S.C. Sec. 301 et seq.) and
7the federal Controlled Substances Act (21 U.S.C. Sec. 801 et seq.).
Section 117670.1 is added to the Health and Safety
9Code, to read:
“Home-generated pharmaceutical waste” means a
11prescription or over-the-counter human or veterinary
12home-generated pharmaceutical, including, but not limited to, a
13drug as defined in Section 109925 or in Section 321(g)(1) of Title
1421 of the United States Code, that is a waste, as defined in Section
1525124, derived from a household, including, but not limited to, a
16multifamily residence or household.
Section 117700 of the Health and Safety Code is
18amended to read:
Medical waste does not include any of the following:
20(a) Waste generated in food processing or biotechnology that
21does not contain an infectious agent as defined in Section 117675.
22(b) Waste generated in biotechnology that does not contain
23human blood or blood products or animal blood or blood products
24suspected of being contaminated with infectious agents known to
25be communicable to humans.
26(c) Urine, feces, saliva, sputum, nasal secretions, sweat, tears,
27or vomitus, unless it contains fluid blood, as provided in
28subdivision (d) of Section
117635.
29(d) Wastebegin delete whichend deletebegin insert thatend insert is not biohazardous, such as paper towels,
30paper products, articles containing nonfluid blood, and other
31medical solid waste products commonly found in the facilities of
32medical waste generators.
33(e) Hazardous waste, radioactive waste, or household waste,
34including, but not limited to, home-generated sharps waste, as
35defined in Section 117671.
36(f) Waste generated from normal and legal veterinarian,
37agricultural, and animal livestock management practices on a farm
38or ranch.
P4 1(g) Home-generated pharmaceutical waste, including, but not
2limited to, consolidated home-generated pharmaceutical waste,
3that is handled by a collection and disposal program operating in
4accordance with the regulations adopted by the Department of
5Resources Recycling and Recoverybegin insert and the California State Board
6of Pharmacyend insert pursuant to Article 3.4 (commencing with Section
747120) of Chapter 1 of Part 7 of Division 30 of the Public
8Resources Code.
Article 3.4 (commencing with Section 47120) is added
10to Chapter 1 of Part 7 of Division 30 of the Public Resources Code,
11to read:
12
For the purposes of this article, the following terms
17have the following meanings, unless the context clearly requires
18otherwise:
19(a) “Consumer” means an individual purchaser or owner of a
20pharmaceutical. “Consumer” does not include a business,
21corporation, limited partnership, or an entity involved in a
22wholesale transaction between a distributor and retailer.
23(b) “Entity” means a state or local public agency, pharmacy,
24veterinarian clinic, or other office or facility.
25(c) “Home-generated pharmaceutical waste” has the same
26meaning as defined in Section 117670.1
of the Health and Safety
27Code, and includes all of the following:
28(1) Articles recognized in the official United States
29Pharmacopoeia, the official National Formulary, the official
30Homeopathic Pharmacopoeia of the United States, or any
31supplement of the formulary or those pharmacopoeias.
32(2) Articles intended for use in the diagnosis, cure, mitigation,
33treatment, or prevention of disease in humans or other animals.
34(3) Articles, excluding food, intended to affect the structure or
35function of the body of humans or other animals.
36(4) Articles intended for use as a component of an article
37specified in paragraph (1), (2), or (3).
38(d) “Participant” means an entity that the departmentbegin insert and the
39California State Board of Pharmacyend insert deems appropriate for
40implementing and evaluating a program in accordance with the
P5 1regulations adopted pursuant to this article and that chooses to
2participate.
3(e) “Sale” includes, but is not limited to, transactions conducted
4through sales outlets, catalogs, or the Internet, or any other similar
5electronic means, but does not include a sale that is a wholesale
6transaction with a distributor or retailer.
begin delete(a)end deletebegin delete end deleteOn or before January 1, 2016, the department and
8the California State Board of Pharmacy shall jointly develop
9regulations, to be approved by both agencies before adoption,
10authorizing a participant to establish a program to collect and
11properly dispose of home-generated pharmaceutical waste. The
12regulations shall be based upon the model guidelines developed
13by the department pursuant to former Section 47122, as that section
14read on January 1, 2012,begin delete shall include the requirements specified
15
in subdivision (b),end deletebegin delete the provisions specified in begin insert both of the following:end insert
16subdivisions (c) and (d).end delete
17(a) Provisions that do all of the following:
end insertbegin insert
18(1) Specify the types of participants authorized to maintain
19permanent collection locations.
20(2) Specify any requirements for obtaining state permits or
21approvals.
22(3) Specify which home-generated pharmaceutical wastes may
23be included in a program, including requirements for the collection
24of a controlled substance, as defined in Section 11007 of the Health
25and Safety Code.
26(4) Require participants to
enter into arrangements with medical
27or hazardous waste haulers, including ensuring that all
28home-generated pharmaceutical waste included in a program is
29appropriately picked up and transported by registered waste
30haulers.
31(5) Specify methods for handling wastes commingled in
32containers with other household waste or hazardous waste.
33(6) Provide methods for collecting and storing home-generated
34pharmaceutical waste included in a program, including the use of
35secured containers, and ensure that collected home-generated
36pharmaceutical waste is not resold, reused, sold, donated, or
37provided to anyone other than a registered medical or hazardous
38waste hauler.
39(7) Provide that a facility that collects home-generated
40pharmaceutical waste included in a program is responsible for
P6 1ensuring that the storage, removal, and transportation of
2containers and the disposal of the waste are in compliance with
3state laws and regulations.
4(8) Require the collection and retention of detailed information
5and invoices for each collection site.
6(9) Impose requirements for one-time or periodic collection
7events.
8(10) Impose requirements for mail-back collection and disposal
9programs.
10(11) Impose requirements for the appropriate public education
11and management of consolidated home-generated pharmaceutical
12waste included in a program to ensure the public health and safety.
13(b) begin deleteThe regulations adopted pursuant to this section shall require end delete
14begin insertProvisions requiring end inserta participant to take all of the following
15actions:
16(1) Provide, at no additional cost to the consumer, for the safe
17take back and proper disposal of pharmaceuticals.
18(2) Ensure the protection of the public health and safety, the
19environment, and the health and safety of consumers and
20employees.
21(3) Reportbegin insert
annuallyend insert
to the department, for purposes of
22begin delete evaluation,end deletebegin insert evaluatingend insert the safety, efficiency, and effectiveness of
23the implemented program on an annual basis. The report shall
24contain both qualitative and quantitative measures, as determined
25by the departmentbegin insert and the California State Board of Pharmacyend insert.
26(4) Protect against the potential for the diversion of
27pharmaceutical wastebegin insert included in a programend insert for unlawful use or
28sale.
29(5) Provide notices and materials to consumers that provide
30information about the potential impacts of improper disposal of
31home-generated pharmaceutical waste and the return opportunities
32for the proper disposal of home-generated pharmaceutical waste.
33Those materials shall include, but are not limited to, all of the
34following:
35(A) Internet Web site links.
36(B) Telephone numbers placed on an invoice or purchase order,
37or packaged with a pharmaceutical.
38(C) Information about the opportunities and locations for no-cost
39home-generated pharmaceutical waste disposal.
P7 1(D) Signage that is prominently displayed and easily visible to
2the consumer.
3(E) Written materials provided to the consumer at the time of
4purchase or delivery.
5(F) Reference to the home-generated pharmaceutical waste take
6back opportunity in advertising or other promotional materials.
7(G) Direct communications with the consumer at the time of
8purchase.
9(c) The regulations adopted pursuant to this section shall include
10provisions that do all of the following:
11(1) Specify the types of participants authorized to maintain
12permanent collection locations.
13(2) Specify any requirements for obtaining state permits or
14approvals.
15(3) Require participants to enter into arrangements with medical
16or
hazardous waste haulers, including ensuring that all
17home-generated pharmaceutical waste is appropriately picked up
18and transported by registered waste haulers.
19(4) Specify which home-generated pharmaceutical wastes may
20be included in a program, including requirements for the collection
21of a controlled substance, as defined in Section 11007 of the Health
22and Safety Code.
23(5) Specify methods for handling wastes commingled in
24containers with other household waste or hazardous waste.
25(6) Provide methods for collecting and storing home-generated
26pharmaceutical waste, including the use of secured containers, and
27ensure that collected home-generated pharmaceutical waste is not
28resold, reused, sold, donated, or provided to anyone other than a
29registered medical or hazardous waste hauler.
30(7) Provide that a facility that collects home-generated
31pharmaceutical waste is responsible for ensuring that the storage,
32removal, and transportation of containers and the disposal of the
33waste are in compliance with state laws and regulations.
34(8) Require the collection and retention of detailed information
35and invoices for each collection site.
36(9) Impose requirements for one-time or periodic collection
37events.
38(10) Impose requirements for mail-back collection and disposal
39programs.
P8 1(d) The department shall include, in the regulations adopted
2pursuant to this section, provisions for the appropriate management
3of consolidated home-generated pharmaceutical waste to ensure
4the public health and safety.
A participant operating a program in accordance with
6the regulations adopted pursuant to this article shall be deemed in
7compliance with all state laws and regulations concerning the
8handling, management, and disposal of home-generated
9pharmaceutical waste.
Nothing in this article shall prohibit an entity with a
11home-generated pharmaceutical waste program, existing as of
12January 1, 2015, from continuing to operate that program.
Regulations adopted pursuant to this article shall
14conform to any requirements of a federal drug take-back program.
No reimbursement is required by this act pursuant to
16Section 6 of Article XIII B of the California Constitution because
17the only costs that may be incurred by a local agency or school
18district will be incurred because this act creates a new crime or
19infraction, eliminates a crime or infraction, or changes the penalty
20for a crime or infraction, within the meaning of Section 17556 of
21the Government Code, or changes the definition of a crime within
22the meaning of Section 6 of Article XIII B of the California
23Constitution.
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