For purposes of this chapter, the following terms have the following meanings:
(a)
“Authorized collection site” means a location where an authorized collector operates a secure collection receptacle for collecting covered products.
(b)
“Authorized collector” means a person or entity that has entered into an agreement with a program operator to collect covered drugs, including, but not limited to, any of the following:
(1)
A person or entity that is registered with the United States Drug Enforcement Administration and that qualifies under federal law to modify that registration to collect controlled substances for the purpose of destruction.
(2)
A law enforcement agency.
(3)
A retail pharmacy that offers drug take-back services in compliance with Article 9.1 (commencing with Section 1776) of Title 16 of the California Code of Regulations.
(c)
“Controlled substance” means a substance listed under Sections 11053 to 11058, inclusive, of the Health and Safety Code or Section 812 or 813 of Title 21 of the United States Code, or any successor section.
(d)
“Cosmetic” means an article, or a component of an article, intended to be rubbed, poured, sprinkled, sprayed, introduced into, or otherwise applied to the human body for cleansing, beautifying, promoting attractiveness, or altering the appearance. “Cosmetic” includes articles with or without expiration dates.
(e)
(1)
“Covered drug” means a drug, including a brand name or generic drug, sold, offered for sale, or dispensed in the State of California in any form, including, but not limited to, any of the following:
(A)
Prescription and nonprescription drugs approved by the United States Food and Drug Administration pursuant to Section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. Sec. 355) or Section 351 of the federal Public Health Service Act (42 U.S.C. Sec. 262).
(B)
A drug marketed pursuant to an over-the-counter drug monograph.
(C)
A drug in a medical device, or a combination product containing a drug and a medical device.
(2)
“Covered drug” does not include
any of the following:
(A)
Vitamins or supplements.
(B)
Herbal-based remedies and homeopathic drugs, products, or remedies.
(C)
Cosmetics, soap, with or without germicidal agents, laundry detergent, bleach, household cleaning products, shampoos, sunscreens, toothpaste, lip balm, antiperspirants, or any other personal care product that is regulated as both a cosmetic and a nonprescription drug under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. Sec. 301 et seq.).
(D)
A drug for which a pharmaceutical product stewardship program or drug takeback program is provided in the state as part of a United States Food and Drug Administration managed risk evaluation and mitigation strategy under 21 U.S.C. Sec. 355-1.
(E)
Biological drug products, as defined by 42 U.S.C. Sec. 262(i)(1), including those products currently approved in the state under a new drug application that will be deemed to be licensed under Section 351 of the Public Health Service Act (42 U.S.C. Sec. 262) pursuant to Section 7002(e) of the federal Biologics Price Competition and Innovation Act of 2009 (Public Law 111-148).
(F)
A medical device, or a component part or accessory of a medical device, if it does not contain a covered drug.
(G)
Drugs that are used for animal medicines, including, but not limited to, parasiticide products for animals.
(H)
Dialysate drugs or other saline solutions required to perform kidney dialysis.
(f)
(1)
(A)
“Covered entity” means the manufacturer of covered products that are sold in or into the state.
(B)
If no entity that meets the definition in subparagraph (A) is in the state, “covered entity” means the distributor of covered products that are sold in or into the state that is licensed as a wholesaler, as defined in Section 4043 of the Business and Professions Code, but does not include a warehouse of a retail pharmacy chain that is licensed as a wholesaler if it engages only in intracompany transfers between any division, affiliate, subsidiary, parent, or other entity under complete common ownership and control.
(C)
If no entity that meets the definition in subparagraph (A) or (B) is in the state, “covered entity” means a repackager, as defined in Section 4044 of the Business and Professions Code, of covered
products that are sold in or into the state.
(D)
If no entity that meets the definition in subparagraph (A), (B), or (C) is in the state, “covered entity” means the owner or licensee of a trademark or brand under which covered products are sold in or into the state, regardless of whether the trademark is registered.
(E)
If no entity that meets the definition in subparagraph (A), (B), (C), or (D) is in the state, “covered entity” means the importer of the covered products that are sold in or into the state.
(2)
The department shall adopt regulations on the process for determining what entity is a covered entity following the priority order set forth in paragraph (1).
(g)
“Covered product” means a covered drug or home-generated sharps waste.
(h)
“Department” means the Department of Resources Recycling and Recovery, and any successor agency.
(i)
“Distributor” means a wholesaler, as that term is defined in Section 4043 of the Business and Professions Code.
(j)
“Drug” means any of the following:
(1)
An article recognized in the official United States Pharmacopoeia, the official National Formulary, the official Homeopathic Pharmacopoeia of the United States, or any supplement of the formulary or those pharmacopoeias.
(2)
A substance intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in humans or other animals.
(3)
A substance, other
than food, intended to affect the structure or any function of the body of humans or other animals.
(4)
A substance intended for use as a component of any substance specified in this subdivision.
(k)
“Generic drug” means a drug that is chemically identical or bioequivalent to a brand name drug in dosage form, safety, strengths, route of administration, quality, performance, characteristics, and intended use, though inactive ingredients may vary.
(l)
(1)
“Home-generated sharps waste” has the same meaning as defined in Section 117671 of the Health and Safety Code.
(2)
“Home-generated sharps waste” does not include either of the following:
(A)
Components manufactured for
use with external ambulatory insulin pump therapy systems or continuous glucose monitoring systems, including, but not limited to, insulin infusion sets, glucose sensors that are sterile goods indicated for single subcutaneous use, sterile drug delivery channels indicated for single subcutaneous use, and injection ports.
(B)
A biological product, as defined in Section 262(i)(1) of Title 42 of the United States Code, including a combination product, as defined in Section 3.2(e) of Title 21 of the Code of Federal Regulations.
(m)
“Mail-back program” means a method of collecting covered products from ultimate users by using prepaid, preaddressed mailing envelopes as described in Section 1776.2 of Article 9.1 of Division 17 of Title 16 of the California Code of Regulations.
(n)
“Nonprescription drug” means any drug that
may be lawfully sold without a prescription.
(o)
“Pharmacy” has the same meaning as defined in Section 4037 of the Business and Professions Code.
(p)
“Prescription drug” means a drug, including, but not limited to, a controlled substance, that is required under federal or state law to be dispensed with a prescription, or is restricted to use by practitioners only.
(q)
“Program operator” means a covered entity, or stewardship organization on behalf of a group of covered entities, that is responsible for operating a stewardship program in accordance with this chapter.
(r)
“Proprietary information” means information that is all of the following:
(1)
Submitted pursuant to this chapter.
(2)
A trade secret, or commercial or financial information, that is privileged or confidential, and is identified as such by the entity providing the information to the department.
(3)
Not required to be disclosed under any other law or any regulation affecting a covered product or covered entity.
(s)
“Retail pharmacy” means an independent pharmacy, a supermarket pharmacy, a chain pharmacy, or a mass merchandiser pharmacy possessing a license from the state board to operate a pharmacy.
(t)
“Retail pharmacy chain” means a retail pharmacy with five or more stores in the state.
(u)
“Sharps” means hypodermic needles, pen needles, intravenous needles, lancets, and other devices that are used to
penetrate the skin for the delivery of medications.
(v)
“State board” means the California State Board of Pharmacy.
(w)
“Stewardship organization” means an organization exempt from taxation under Section 501(c)(3) of the federal Internal Revenue Code of 1986 (21 U.S.C. Sec. 501(c)(3)) that is established by a group of covered entities in accordance with this chapter to develop, implement, and administer a stewardship program established pursuant to this chapter.
(x)
“Stewardship plan,” or “plan” means the plan for collecting and properly managing covered products that is developed by a covered entity or stewardship organization pursuant to this chapter.
(y)
“Stewardship program” means a stewardship program for the collection, transportation, and
disposal of covered products.
(z)
“Ultimate user” means a state resident or other nonbusiness entity and includes a person who has lawfully obtained, and who possesses, a covered product, including a controlled substance, for the person’s own use or for the use of a member of the person’s household. “Ultimate user” does not include a needle exchange program established under Section 121349 of the Health and Safety Code, or a medical waste generator, as defined in Section 117705 of the Health and Safety Code.