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(1) The Department of Resources Recycling and Recovery was required, pursuant to provisions repealed on January 1, 2013, to develop, in consultation with appropriate state, local, and federal agencies, model programs for the collection and proper disposal of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of home-generated pharmaceutical waste, based upon the model guidelines developed by the department pursuant to those repealed provisions and to include specified requirements and provisions in those regulations.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 insertThe 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 insert
(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
2pharmaceutical waste, as defined in Section 117670.1 of the Health
3and Safety Code, from a consumer, consistent with the Federal
4Food, Drug, and Cosmetic Act (21 U.S.C. Sec. 301 et seq.) and
5the federal Controlled Substances Act (21 U.S.C. Sec. 801 et seq.).
Section 117670.1 is added to the Health and Safety
7Code, to read:
“Home-generated pharmaceutical waste” means a
9prescription or over-the-counter human or veterinary
10home-generated pharmaceutical, including, but not limited to, a
11drug as defined in Section 109925 or in Section 321(g)(1) of Title
1221 of the United States Code, that is a waste, as defined in Section
1325124, derived from a household, including, but not limited to, a
14multifamily residence or household.
Section 117700 of the Health and Safety Code is
16amended to read:
Medical waste does not include any of the following:
18(a) Waste generated in food processing or biotechnology that
19does not contain an infectious agent as defined in Section 117675.
20(b) Waste generated in biotechnology that does not contain
21human blood or blood products or animal blood or blood products
22suspected of being contaminated with infectious agents known to
23be communicable to humans.
24(c) Urine, feces, saliva, sputum, nasal secretions, sweat, tears,
25or vomitus, unless it contains fluid blood, as provided in
26subdivision (d) of Section
117635.
27(d) Waste which is not biohazardous, such as paper towels,
28paper products, articles containing nonfluid blood, and other
29medical solid waste products commonly found in the facilities of
30medical waste generators.
31(e) Hazardous waste, radioactive waste, or household waste,
32including, but not limited to, home-generated sharps waste, as
33defined in Section 117671.
34(f) Waste generated from normal and legal veterinarian,
35agricultural, and animal livestock management practices on a farm
36or ranch.
37(g) Home-generated pharmaceutical waste, including, but not
38limited to, consolidated home-generated pharmaceutical waste,
39that is handled by a collection and
disposal program operating in
40accordance with the regulations adopted by the Department of
P4 1Resources Recycling and Recovery pursuant to Article 3.4
2(commencing with Section 47120) of Chapter 1 of Part 7 of
3Division 30 of the Public Resources Code.
Article 3.4 (commencing with Section 47120) is added
5to Chapter 1 of Part 7 of Division 30 of the Public Resources Code,
6to read:
7
For the purposes of this article, the following terms
12have the following meanings, unless the context clearly requires
13otherwise:
14(a) “Consumer” means an individual purchaser or owner of a
15pharmaceutical. “Consumer” does not include a business,
16corporation, limited partnership, or an entity involved in a
17wholesale transaction between a distributor and retailer.
18(b) “Entity” means a state or local public agency, pharmacy,
19veterinarian clinic, or other office or facility.
20(c) “Home-generated pharmaceutical waste” has the same
21meaning as defined in Section 117670.1 of
the Health and Safety
22Code, and includes all of the following:
23(1) Articles recognized in the official United States
24Pharmacopoeia, the official National Formulary, the official
25Homeopathic Pharmacopoeia of the United States, or any
26supplement of the formulary or those pharmacopoeias.
27(2) Articles intended for use in the diagnosis, cure, mitigation,
28treatment, or prevention of disease in humans or other animals.
29(3) Articles, excluding food, intended to affect the structure or
30function of the body of humans or other animals.
31(4) Articles intended for use as a component of an article
32specified in paragraph (1), (2), or (3).
33(d) “Participant” means an entity that the department deems
34appropriate for implementing and evaluating a program in
35accordance with the regulations adopted pursuant to this article
36and that chooses to participate.
37(e) “Sale” includes, but is not limited to, transactions conducted
38through sales outlets, catalogs, or the Internet, or any other similar
39electronic means, but does not include a sale that is a wholesale
40transaction with a distributor or retailer.
(a) On or before January 1, 2016, the department and
2the California State Board of Pharmacy shall jointly develop
3regulations, to be approved by both agencies before adoption,
4authorizing a participant to establish a program to collect and
5properly dispose of home-generated pharmaceutical waste. The
6regulations shall be based upon the model guidelines developed
7by the department pursuant to former Section 47122, as that section
8read on January 1, 2012, shall include the requirements specified
9in subdivision (b), and shall include the provisions specified in
10subdivisions (c) and (d).
11(b) The regulations adopted pursuant to this section shall require
12a participant
to take all of the following actions:
13(1) Provide, at no additional cost to the consumer, for the safe
14take back and proper disposal of pharmaceuticals.
15(2) Ensure the protection of the public health and safety, the
16environment, and the health and safety of consumers and
17employees.
18(3) Report to the department, for purposes of evaluation, the
19safety, efficiency, and effectiveness of the implemented program
20on an annual basis. The report shall contain both qualitative and
21quantitative measures, as determined by the department.
22(4) Protect against the potential for the diversion of
23pharmaceutical waste for unlawful use or sale.
24(5) Provide notices and materials to consumers that provide
25information about the potential impacts of improper disposal of
26home-generated pharmaceutical waste and the return opportunities
27for the proper disposal of home-generated pharmaceutical waste.
28Those materials shall include, but are not limited to, all of the
29following:
30(A) Internet Web site links.
31(B) Telephone numbers placed on an invoice or purchase order,
32or packaged with a pharmaceutical.
33(C) Information about the opportunities and locations for no-cost
34home-generated pharmaceutical waste disposal.
35(D) Signage that is prominently
displayed and easily visible to
36the consumer.
37(E) Written materials provided to the consumer at the time of
38purchase or delivery.
39(F) Reference to the home-generated pharmaceutical waste take
40back opportunity in advertising or other promotional materials.
P6 1(G) Direct communications with the consumer at the time of
2purchase.
3(c) The regulations adopted pursuant to this section shall include
4provisions that do all of the following:
5(1) Specify the types of participants authorized to maintain
6permanent collection locations.
7(2) Specify any requirements for obtaining state permits or
8approvals.
9(3) Require participants to enter into arrangements with medical
10or hazardous waste haulers, including ensuring that all
11home-generated pharmaceutical waste is appropriately picked up
12and transported by registered waste haulers.
13(4) Specify which home-generated pharmaceutical wastes may
14be included in a program, including requirements for the collection
15of a controlled substance, as defined in Section 11007 of the Health
16and Safety Code.
17(5) Specify methods for handling wastes commingled in
18containers with other household waste or hazardous waste.
19(6) Provide methods for
collecting and storing home-generated
20pharmaceutical waste, including the use of secured containers, and
21ensure that collected home-generated pharmaceutical waste is not
22resold, reused, sold, donated, or provided to anyone other than a
23registered medical or hazardous waste hauler.
24(7) Provide that a facility that collects home-generated
25pharmaceutical waste is responsible for ensuring that the storage,
26removal, and transportation of containers and the disposal of the
27waste are in compliance with state laws and regulations.
28(8) Require the collection and retention of detailed information
29and invoices for each collection site.
30(9) Impose requirements for one-time or periodic collection
31events.
32(10) Impose requirements for mail-back collection and disposal
33programs.
34(d) The department shall include, in the regulations adopted
35pursuant to this section, provisions for the appropriate management
36of consolidated home-generated pharmaceutical waste to ensure
37the public health and safety.
A participant operating a program in accordance with
39the regulations adopted pursuant to this article shall be deemed in
40compliance with all state laws and regulations concerning the
P7 1handling, management, and disposal of home-generated
2pharmaceutical waste.
Nothing in this article shall prohibit an entity with a
4home-generated pharmaceutical waste program, existing as of
5January 1, 2015, from continuing to operate that program.
No reimbursement is required by this act pursuant to
7Section 6 of Article XIII B of the California Constitution because
8the only costs that may be incurred by a local agency or school
9district will be incurred because this act creates a new crime or
10infraction, eliminates a crime or infraction, or changes the penalty
11for a crime or infraction, within the meaning of Section 17556 of
12the Government Code, or changes the definition of a crime within
13the meaning of Section 6 of Article XIII B of the California
14Constitution.
O
94