SB 1014, as amended, Jackson. Pharmaceutical waste: home generated: collection.
begin insertThe Pharmacy Law provides for the licensure and regulation of pharmacists and pharmacy establishments by the California State Board of Pharmacy. Existing law required the Department of Resources Recycling and Recovery, pursuant to provisions repealed on January 1, 2013, to develop, in consultation with appropriate state, local, and federal agencies, model programs for the collection and proper disposal of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. 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.
end insertbegin insertThis bill would, upon the enactment of federal regulations, require the California State Board of Pharmacy, in consultation with the Department of Resources Recycling and Recovery and the State Department of Public Health, to adopt regulations to implement California drug takeback programs for the collection and destruction of home-generated pharmaceutical waste, as defined. The bill would provide that the regulations adopted pursuant to these provisions only apply to licensees of the board.
end insert(1) The Department of Resources Recycling and Recovery was required, pursuant to provisions repealed on January 1, 2013, to develop, in consultation with appropriate state, local, and federal agencies, model programs for the collection and proper disposal of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.
end deleteThis 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of home-generated pharmaceutical waste, based upon the model guidelines developed by the department pursuant to those repealed provisions and to include specified provisions in those regulations.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.
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.
end deleteThis 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.
end delete(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.
end deleteThe 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.
end delete(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.
end deleteThis bill would provide that no reimbursement is required by this act for a specified reason.
end deleteVote: majority.
Appropriation: no.
Fiscal committee: yes.
State-mandated local program: begin deleteyes end deletebegin insertnoend insert.
The people of the State of California do enact as follows:
begin insertSection 4027.5 is added to the end insertbegin insertBusiness and
2Professions Codeend insertbegin insert, to read:end insert
“Home-generated pharmaceutical waste” means a
4prescription or over-the-counter human or veterinary
5home-generated pharmaceutical drug, as defined in Section 4022
6or 4025.1, that is a waste generated by a household or households.
7“Home-generated pharmaceutical waste” shall not include waste
8generated by a business, corporation, limited partnership, or an
9entity involved in a wholesale transaction between a distributor
10and retailer.
begin insertSection 4108 is added to the end insertbegin insertBusiness and Professions
12Codeend insertbegin insert, to read:end insert
(a) Within 18 months of the enactment of federal
14regulations regarding the collection of unwanted or expired
15controlled substances from the public, the board, in consultation
16with the Department of Resources Recycling and Recovery and
17the State Department of Public Health, shall adopt regulations to
18implement California drug takeback programs for the collection
19and destruction of home-generated pharmaceutical waste.
20(b) The regulations promulgated pursuant to this section shall
21require a participant in a program to take all of the following
22actions:
P4 1(1) Provide, at no additional cost to the consumer, for the safe
2take back and proper disposal of home-generated pharmaceutical
3
waste.
4(2) Ensure the protection of the public health and safety, the
5environment, and the health and safety of consumers and
6employees.
7(3) Report annually to the board and the State Department of
8Public Health for purposes of evaluating the safety, efficiency, and
9effectiveness of the implemented program on an annual basis. The
10report shall contain both qualitative and quantitative measures,
11as determined by the board and the State Department of Public
12Health.
13(4) Protect against the potential for the diversion of
14home-generated pharmaceutical waste included in a program for
15unlawful use or sale.
16(c) The regulations adopted pursuant to this section shall only
17apply to licensees of the board.
Section 4068.1 is added to the Business and
19Professions Code, to read:
A pharmacy may accept the return of home-generated
21pharmaceutical waste, as defined in Section 117670.1 of the Health
22and Safety Code, from a consumer, consistent with the Federal
23Food, Drug, and Cosmetic Act (21 U.S.C. Sec. 301 et seq.) and
24the federal Controlled Substances Act (21 U.S.C. Sec. 801 et seq.).
Section 117670.1 is added to the Health and Safety
26Code, to read:
“Home-generated pharmaceutical waste” means a
28prescription or over-the-counter human or veterinary
29home-generated pharmaceutical, including, but not limited to, a
30drug as defined in Section 109925 or in Section 321(g)(1) of Title
3121 of the United States Code, that is a waste, as defined in Section
3225124, derived from a household, including, but not limited to, a
33multifamily residence or household.
Section 117700 of the Health and Safety Code is
35amended to read:
Medical waste does not include any of the following:
37(a) Waste generated in food processing or biotechnology that
38does not contain an infectious agent as defined in Section 117675.
39(b) Waste generated in biotechnology that does not contain
40human blood or blood products or animal blood or blood products
P5 1suspected of being contaminated with infectious agents known to
2be communicable to humans.
3(c) Urine, feces, saliva, sputum, nasal secretions, sweat, tears,
4or vomitus, unless it contains fluid blood, as provided in
5subdivision (d) of Section
117635.
6(d) Waste that is not biohazardous, such as paper towels, paper
7products, articles containing nonfluid blood, and other medical
8solid waste products commonly found in the facilities of medical
9waste generators.
10(e) Hazardous waste, radioactive waste, or household waste,
11including, but not limited to, home-generated sharps waste, as
12defined in Section 117671.
13(f) Waste generated from normal and legal veterinarian,
14agricultural, and animal livestock management practices on a farm
15or ranch.
16(g) Home-generated pharmaceutical waste, including, but not
17limited to, consolidated home-generated pharmaceutical waste,
18that is handled by a collection and disposal program operating in
19accordance with the regulations adopted by the Department of
20Resources Recycling and Recovery and the California State Board
21of Pharmacy pursuant to Article 3.4 (commencing with Section
2247120) of Chapter 1 of Part 7 of Division 30 of the Public
23Resources Code.
Article 3.4 (commencing with Section 47120) is added
25to Chapter 1 of Part 7 of Division 30 of the Public Resources Code,
26to read:
27
For the purposes of this article, the following terms
32have the following meanings, unless the context clearly requires
33otherwise:
34(a) “Consumer” means an individual purchaser or owner of a
35pharmaceutical. “Consumer” does not include a business,
36corporation, limited partnership, or an entity involved in a
37wholesale transaction between a distributor and retailer.
38(b) “Entity” means a state or local public agency, pharmacy,
39veterinarian clinic, or other office or facility.
P6 1(c) “Home-generated pharmaceutical waste” has the same
2meaning as defined in Section 117670.1
of the Health and Safety
3Code, and includes all of the following:
4(1) Articles recognized in the official United States
5Pharmacopoeia, the official National Formulary, the official
6Homeopathic Pharmacopoeia of the United States, or any
7supplement of the formulary or those pharmacopoeias.
8(2) Articles intended for use in the diagnosis, cure, mitigation,
9treatment, or prevention of disease in humans or other animals.
10(3) Articles, excluding food, intended to affect the structure or
11function of the body of humans or other animals.
12(4) Articles intended for use as a component of an article
13specified in paragraph (1), (2), or (3).
14(d) “Participant” means an entity that the department and the
15California State Board of Pharmacy deems appropriate for
16implementing and evaluating a program in accordance with the
17regulations adopted pursuant to this article and that chooses to
18participate.
19(e) “Sale” includes, but is not limited to, transactions conducted
20through sales outlets, catalogs, or the Internet, or any other similar
21electronic means, but does not include a sale that is a wholesale
22transaction with a distributor or retailer.
On or before January 1, 2016, the department and the
24California State Board of Pharmacy shall jointly develop
25regulations, to be approved by both agencies before adoption,
26authorizing a participant to establish a program to collect and
27properly dispose of home-generated pharmaceutical waste. The
28regulations shall be based upon the model guidelines developed
29by the department pursuant to former Section 47122, as that section
30read on January 1, 2012, and shall include both of the following:
31(a) Provisions that do all of the following:
32(1) Specify the types of participants authorized to maintain
33permanent collection locations.
34(2) Specify any requirements for obtaining state permits or
35approvals.
36(3) Specify which home-generated pharmaceutical wastes may
37be included in a program, including requirements for the collection
38of a controlled substance, as defined in Section 11007 of the Health
39and Safety Code.
P7 1(4) Require participants to
enter into arrangements with medical
2or hazardous waste haulers, including ensuring that all
3home-generated pharmaceutical waste included in a program is
4appropriately picked up and transported by registered waste haulers.
5(5) Specify methods for handling wastes commingled in
6containers with other household waste or hazardous waste.
7(6) Provide methods for collecting and storing home-generated
8pharmaceutical waste included in a program, including the use of
9secured containers, and ensure that collected home-generated
10pharmaceutical waste is not resold, reused, sold, donated, or
11provided to anyone other than a registered medical or hazardous
12waste hauler.
13(7) Provide that a facility that collects home-generated
14pharmaceutical waste included in a program is responsible for
15ensuring that the storage, removal, and transportation of containers
16and the disposal of the waste are in compliance with state laws
17and regulations.
18(8) Require the collection and retention of detailed information
19and invoices for each collection site.
20(9) Impose requirements for one-time or periodic collection
21events.
22(10) Impose requirements for mail-back collection and disposal
23programs.
24(11) Impose requirements for the appropriate public education
25and management of consolidated home-generated pharmaceutical
26waste included in a program to ensure the public health and safety.
27(b) Provisions requiring a participant to take all of the following
28actions:
29(1) Provide, at no additional cost to the consumer, for the safe
30take back and proper disposal of pharmaceuticals.
31(2) Ensure the protection of the public health and safety, the
32environment, and the health and safety of consumers and
33employees.
34(3) Report
annually
to the department, for purposes of evaluating
35the safety, efficiency, and effectiveness of the implemented
36program on an annual basis. The report shall contain both
37qualitative and quantitative measures, as determined by the
38department and the California State Board of Pharmacy.
P8 1(4) Protect against the potential for the diversion of
2pharmaceutical waste included in a program for unlawful use or
3sale.
A participant operating a program in accordance with
5the regulations adopted pursuant to this article shall be deemed in
6compliance with all state laws and regulations concerning the
7handling, management, and disposal of home-generated
8pharmaceutical waste.
Regulations adopted pursuant to this article shall
10conform to any requirements of a federal drug take-back program.
No reimbursement is required by this act pursuant to
12Section 6 of Article XIII B of the California Constitution because
13the only costs that may be incurred by a local agency or school
14district will be incurred because this act creates a new crime or
15infraction, eliminates a crime or infraction, or changes the penalty
16for a crime or infraction, within the meaning of Section 17556 of
17the Government Code, or changes the definition of a crime within
18the meaning of Section 6 of Article XIII B of the California
19Constitution.
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