On September 30, 2018, Governor Brown active SB 212, an act alteration the California Integrated Decay Administration Act to actualize a statewide takeback affairs for pharmaceuticals and sharps (the “Act”) from households. California joins Washington and New York in implementing statewide biologic takeback programs. By assuming SB 212, California additionally adds to absolute producer-funded administration programs operating in the Accompaniment for articles alignment from acrylic to mattresses.
The Act requires manufacturers of “covered products” to actualize and accomplish a administration affairs that provides for the takeback of covered drugs and home-generated sharps decay from households. The Act additionally imposes assorted requirements on a covered article or administration alignment that operates a administration program, including appointment a proposed administration plan, an antecedent administration affairs budget, an anniversary budget, anniversary report, and added authentic advice to the California Department of Resources Recycling and Accretion (“CalRecycle”). CalRecycle is appropriate to accept implementing regulations no afterwards than January 1, 2021. Cal. Pub. Resc. Code § 42031.2(a). “Program operators” allegation abide their proposed programs aural six months of CalRecycle adopting accordant implementing regulations.
Under the Act, “covered product” bureau a covered biologic or home-generated sharps waste. § 42030(g). A “covered drug” is authentic as a drug, including a cast name or all-encompassing drug, sold, offered for sale, or dispensed in the State. § 42030(e)(1). Covered drugs additionally board a biologic in a medical device, or a aggregate artefact absolute a biologic and a medical device. Id. Covered drugs exclude vitamins, supplements, herbal-based remedies, cosmetics, domiciliary charwoman products, drugs that are acclimated for beastly medicines, and medical devices, or basic genitalia or accessories of medical devices, if they do not board a covered drug. § 42030(e)(2).
Home-generated sharps decay bureau hypodermic needles, pen needles, intravenous needles, lancets and added accessories that are acclimated to access the bark for the commitment of medications. § 42030(l) (incorporating Health and Assurance Code § 117671).
A “covered entity” is the architect of covered drugs or sharps that are awash in or into the state. § 42030(f)(1)(A). If no article meets this “manufacturer” definition, the Act again identifies four added abeyant elements of the accumulation alternation as “covered entities”, alignment from the benefactor of covered articles that is accountant as a wholesaler, to a repackager, to the buyer or licensee of a cast or cast beneath which the covered articles are awash in or into the state, to ensure that an article is amenable for managing all covered products. § 42030(f)(1)(B)-(E).
A “stewardship organization” is a non-profit organization, which allegation be a 501(c)(3) article beneath the federal Internal Revenue Code, that is accustomed by a accumulation of covered entities to develop, implement, and administrate a administration affairs for covered drugs and/or home-generated sharps waste. § 42030(w). A “program operator” bureau a covered entity, or administration alignment acting on account of a accumulation of covered entities, that is amenable for operating a administration program. § 42030(q).
An “authorized collector” bureau a being or article that has entered into an acceding with a affairs abettor to aggregate covered drugs, which can board a law administration agency, a retail pharmacy, or added beneficiary registered with the U.S. Biologic Administration Bureau (“DEA”) that is accustomed to aggregate controlled substances for the purpose of destruction. § 42030(b). An “authorized accumulating site” bureau a area area an accustomed beneficiary operates a defended accumulating bowl for accession covered products. § 42030(a).
A “retail pharmacy” is a pharmacy possessing a authorization from the California Board of Pharmacy to accomplish a pharmacy. § 42030(s). A “retail pharmacy chain” bureau a retail pharmacy with bristles or added food in the state. § 42030(t). As discussed below, the Act places assertive accumulating obligations on retail pharmacy chains.
Within 90 canicule of the Act’s able date, a covered article allegation analyze all covered products, and analyze any drugs or sharps that are not covered products, that it sells or offers for auction in the state. § 42031(a)(1). A covered entity, or the administration alignment on account of covered entities, allegation amend this account by January 15th of anniversary year. § 42031(a)(2).
Within 90 canicule of the Act’s able date, a retail pharmacy that sells a covered artefact beneath its own characterization allegation analyze the covered article from which the retail pharmacy obtains a covered artefact that the retail pharmacy sells beneath its abundance label. § 42031(b). The California Board of Pharmacy shall verify the advice calm pursuant to this and the above-mentioned paragraph, and accomplish it accessible to CalRecycle. § 42031(c).
If an article receives a letter of analysis as to what drugs and sharps it distributes in California from the California Board of Pharmacy, it allegation acknowledge aural 60 days. § 42031(d). If the article does not accept it is a covered entity, it allegation accompaniment the base for that belief, a account of any drugs and sharps it sells, distributes, repackages, or contrarily offers for auction in California, and analyze the name and acquaintance advice of the architect for anniversary biologic identified. Id. Advice provided pursuant to this claim may be aggregate with CalRecycle, but is contrarily accounted proprietary and absolved from disclosure. Id.
Within six months of the acceptance date of regulations, a affairs abettor allegation abide a complete administration plan for the enactment and accomplishing of a administration affairs to CalRecycle for approval. § 42032(a)(1). Above-mentioned to appointment a administration plan to CalRecycle, a affairs abettor allegation abide its proposed administration plan for analysis to the California Board of Pharmacy and additionally to any added accompaniment bureau with areas of ascendancy about to the administration plan. § 42032(b)(1).
An bureau that receives a plan shall analysis the plan for acquiescence with accompaniment and federal laws and regulations accompanying to the agency’s corresponding authority. § 42032(b)(2). The bureau shall actuate acquiescence or contravention with those laws and regulations aural 90 canicule of cancellation of the plan, and board to the affairs abettor that assurance and an account for any award of noncompliance. Id.
CalRecycle allegation analysis the submitted plan and actuate if it is complete aural 30 canicule of receipt, and acquaint the affairs operator. § 42032(c)(1). If CalRecycle determines that a plan is incomplete, it shall analyze for the affairs abettor the appropriate added information, and the affairs abettor shall resubmit the plan aural 30 days. § 42032(c)(3).
CalRecycle allegation analysis the plan and approve, disapprove, or conditionally accept the plan aural 90 canicule of cancellation of a complete plan. § 42032(d)(1). This timeline shall be continued if CalRecycle consults with or submits a plan to accession accompaniment agency. § 42032(d)(2). If CalRecycle disapproves a submitted administration plan, it allegation explain in autograph how the plan does not accede with the Act aural 30 canicule of accusatory the plan. § 42032(f)(1).
A affairs abettor is appropriate to absolutely apparatus the operation of an accustomed administration affairs no afterwards than 270 canicule afterwards CalRecycle approves the administration plan. § 42032(g).
The law identifies the advice appropriate for plan proposals, including advice about anniversary accommodating covered entity, anniversary covered drug, the adjustment for handling, transporting, and administration of calm products, and a affirmation of able funding. § 42032.2. All handling, transport, and auctioning undertaken as a allotment of a administration affairs allegation accede with all applicative accompaniment and federal laws, including, but not bound to, regulations adopted by the DEA. § 42035.8.
A administration plan for covered drugs allegation board for a accumulating arrangement affair the “convenience standard,” which is authentic as accouterment in anniversary canton in which the plan shall be implemented: (i) a minimum of bristles accustomed accumulating sites or one accustomed accumulating armpit per 50,000 residents, whichever is greater; (ii) a “reasonable geographic spread” of accustomed accumulating sites and an account for the geographic spread; and (iii) a mail-back affairs accoutrement any counties area there is not an accustomed retail pharmacy operating as an accustomed accumulating site. § 42032.2(a)(1)(F).
In addition, a plan allegation admittance homeless, homebound, or disabled individuals to appeal prepaid, preaddressed, commitment envelopes or another forms of a accumulating and auctioning arrangement that would cede a covered biologic inert. § 42032.2(a)(1)(G)(i). Moreover, a plan allegation board another methods of accumulating for any covered drugs, added than controlled substances, that cannot be accustomed or commingled with added covered drugs in defended accumulating receptacles or through a mailback program, to the admeasurement technically achievable and permissible beneath accompaniment and federal law. § 42032.2(a)(1)(G)(ii).
At atomic 120 canicule afore appointment a administration plan for covered drugs, the affairs abettor shall acquaint abeyant accustomed collectors in the canton or counties in which it operates of the befalling to serve as an accustomed beneficiary for the proposed administration program. § 42032.2(b)(1). If a abeyant accustomed beneficiary expresses absorption in accommodating in a administration program, the affairs abettor shall arise acceptable acceptance negotiations with the abeyant accustomed beneficiary aural 30 days. Id.
After a administration plan for covered drugs has been approved, the affairs abettor may supplement service, if accustomed by CalRecycle, for a canton in which it operates that does not accept the minimum cardinal of accustomed accumulating sites due to affairs above the affairs operator’s control, by establishing (1) a mail aback program, which may board accouterment advice on area and how to accept mail-back abstracts or accouterment the area at which it distributes prepaid, preaddressed commitment envelopes (locations shall be proposed as allotment of the administration plan) (note that prepaid commitment envelopes may be mailed to an “ultimate user” aloft request), and/or (2) an another anatomy of accumulating and auctioning of covered drugs that complies with applicative accompaniment and federal laws, including DEA regulations. § 42032.2(c).
A administration plan for home-generated sharps decay allegation board for a mail aback handling, transport, and auctioning system, at no bulk to the end-user, that complies with applicative accompaniment and federal laws. § 42032.2(d)(1). The affairs allegation board or admit administration of a sharps decay alembic and mail-back abstracts at the point of sale, to the admeasurement acceptable by law. § 42032.2(d)(1)(F). The affairs abettor shall baddest and administer a alembic and mail-back abstracts acceptable to board the aggregate of sharps purchased by an ultimate user over a called time period, and all sharps decay containers shall board prepaid postage added to the alembic or to the mail-back packaging. § 42032.2(d)(1)(F). All sharps decay containers shall board the affairs operator’s website abode and toll-free blast cardinal added to a characterization on the alembic or packaging, or on a abstracted admit included in the alembic or packaging. § 42032.2(d)(1)(F)(i)(II). The affairs allegation additionally authenticate able allotment for all authoritative and operational costs of the sharps decay administration program. § 42032.2(d)(1)(C).
Upon request, a administration plan allegation board for agreement to bounded agencies for absolute costs of carriage and auctioning accompanying to home-generated sharps waste, unless the affairs abettor provides for the abatement of the home-generated sharps decay from the bounded domiciliary chancy decay facility. § 42032.2(d)(1)(F)(ii). When a bounded administration requests abatement of home-generated sharps waste, bulk recovery, or agreement for abatement of home-generated sharps, the bounded administration allegation board advice on home-generated sharps decay to the covered article or affairs operator, aural a reasonable time aloft appeal by the covered article or affairs operator. § 42033.5. A bounded bureau shall not advisedly appeal agreement for costs for auctioning costs consistent from a borough aggravate barter affairs or a medical decay generator. § 42032.2(d)(1)(F)(ii)(I). Any appeal for agreement shall be submitted with a acknowledgment beneath amends of canard that the bounded bureau has not advisedly requested agreement for banned expenses. § 42032.2(d)(1)(F)(ii)(III).
A retail pharmacy allegation accomplish a reasonable accomplishment to serve as an accustomed beneficiary as allotment of a administration affairs in the canton in which it is located. § 42032.2(b)(2). If the “convenience standard” acute a minimum of bristles accustomed accumulating sites or one accustomed accumulating armpit per 50,000 bodies is not met in a canton in which a retail pharmacy alternation has abundance locations, the retail pharmacy alternation allegation accept at atomic one area or 15 percent of its abundance locations, whichever is greater, in that canton serve as accustomed collectors in the administration program. § 42032.2(b)(2).
On or afore March 31, 2022, and annually thereafter, a affairs abettor allegation abide a accounting abode anecdotic the administration affairs activities during the antecedent advertisement period. § 42033.2(a)(1). This anniversary abode allegation board a account of covered entities accommodating in the administration organization; the adapted and absolute account of covered articles that anniversary covered article accountable to the administration plan sells or offers for sale; the amount, by weight, of covered articles calm from ultimate users at anniversary accustomed accumulating site; the name and area of accustomed accumulating sites at which covered drugs were collected; advice about the home-generated sharps decay mail-back program; a description of any noncomliance with behavior and procedures for collecting, transporting, and administration of covered products, as accustomed in the administration plan; whether any assurance or aegis problems occurred during collection, transportation, or auctioning of calm covered articles during the advertisement aeon and what changes accept been fabricated to allay the botheration and to advance assurance and security; and any added advice CalRecycle analytic requires. § 42033.2(b).
In addition, on or afore March 31, 2022, and annually thereafter, a affairs abettor allegation abide to CalRecycle a accounting affairs account for administration affairs accomplishing for the accessible agenda year. § 42033.2(a)(2). This anniversary affairs account allegation board an absolute banking analysis of the administration program, adjourned by the administration alignment from the allegation paid from its affiliate covered entities. § 42033.2(c)(1). The anniversary affairs account allegation additionally board advancing costs and the recommended allotment akin all-important to apparatus the administration program, including costs to awning the administration plan’s approaching costs and to accomplish the administration affairs over a multiyear aeon in a “prudent and amenable manner.” § 42033.2(c)(2).
CalRecycle has 30 canicule to actuate whether an anniversary abode and affairs account are complete and to acquaint the affairs abettor of its determination. § 42033.2(d)(1). If complete, CalRecycle has 90 canicule for review. § 42033.2(d)(2). If they are not complete, CalRecycle allegation analyze the appropriate added advice in 30 days, and the affairs abettor has 30 canicule from that date to resubmit. § 42033.2(d)(3). At that point, CalRecycle can conditionally accept the anniversary abode and budget, and alarm for added resubmissions. § 42033.2(e)(2).
A affairs abettor allegation advance minutes, books, and annal that acutely reflect the activities and affairs of the affairs operator’s administration plan. § 42033.4(a). The minutes, books, and annal of a affairs abettor allegation be audited by an absolute certified accessible accountant at atomic already annually at the affairs operator’s expense. § 42033.4(b)(1).
Proprietary advice submitted to CalRecycle shall be able by all parties as arcane and shall be absolved from accessible acknowledgment beneath the California Accessible Annal Act. § 42036.4.
Covered entities are appropriate to pay all authoritative and operational costs associated with establishing and implementing the administration affairs in which it participates, including the bulk of collecting, transporting, and administration of covered products. § 42034. On or afore the end of the 2022-2023 budgetary year, and already every three months thereafter, a affairs abettor shall pay CalRecycle an authoritative fee, set by CalRecycle, which is able to awning CalRecycle’s and added accompaniment agencies’ costs of administrating and administration this chapter. § 42034.2(a)(1). These costs may board the absolute and reasonable costs associated with authoritative activities afore acquiescence of administration plans. § 42034.2(a)(1). The authoritative fees shall be deposited into a Biologic and Sharps Administration Fund. § 42034.2(b).
Each affairs abettor allegation conduct a absolute apprenticeship and beat affairs advised to advance accord in the administration program. § 42031.6(a). The law requires anniversary affairs to, at a minimum: advance its administration affairs to ultimate users by accouterment signage for hospitals, pharmacies, and added locations; board educational and beat abstracts for bodies accustomed to appoint drugs, pharmacies, pharmacists, ultimate user, and others, as necessary; authorize a website that publicizes the area of accustomed collectors and provides added advice advised to advance the use of the administration program; adapt and board added abstracts to advance the accumulating and able administration of covered products; and animate ultimate users to abstracted abstracts that are not covered articles afore administration of the covered products. § 42031.6(a).
Drugs and sharps take-back ordinances already abide in a cardinal of California counties, including Alameda (drugs and sharps), Contra Costa, Marin, San Francisco, San Mateo, Santa Barbara, Santa Clara (drugs and sharps), and Santa Cruz (drugs and sharps). This Act does not administer to a biologic or aciculate aural a administration that is accountable to a bounded administration affairs pursuant to an authorization that took aftereffect afore April 18, 2018. § 42036.2(a). If that authorization is repealed in the jurisdiction, the biologic or aciculate shall be accountable to this statewide law aural 270 canicule afterwards the date on which the authorization is repealed. Id. This Act preempts a bounded administration affairs for drugs or sharps allowable by an authorization with an able date of April 18, 2018 or later. § 42036.2(b).
A bounded administration affairs for covered articles allowable by a bounded authorization that has an able date afore April 18, 2018 may abide in operation, but such affairs and its participants cannot accept or account from moneys from the Biologic and Sharps Administration Fund or the Biologic and Sharps Administration Amends Account accustomed pursuant to the Act, including funds calm as authoritative fees or administration costs. § 42036.2(c).
CalRecycle may appoint penalties on any covered entity, affairs operator, administration organization, or accustomed beneficiary that sells, offers for sale, or provides a covered artefact in abuse of the law. § 42035.2(a)(1). The bulk of the authoritative amends cannot beat $10,000 per day unless the abuse is intentional, knowing, or reckless, in which case the amends shall not beat $50,000 per day. § 42035.2(a)(2). Any penalties calm pursuant to these authorities shall be deposited in the Biologic and Sharps Administration Amends Account. § 42035.2(c).
Upon a accounting award that a covered entity, affairs operator, administration alignment or accustomed beneficiary has not met a actual claim of the Act, CalRecycle may, afterwards affording the covered entity, affairs operator, administration alignment or accustomed beneficiary a reasonable befalling to acknowledge to, or rebut, the finding, abjure a affairs operator’s approval or crave the affairs abettor to resubmit a plan, or to crave added advertisement apropos to acquiescence with the actual claim of the Act that was not met. § 42035.4.
 All citations to the California Accessible Resources Code.
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