Code Section Group

Public Resources Code - PRC

DIVISION 30. WASTE MANAGEMENT [40000 - 49620]

  ( Division 30 added by Stats. 1989, Ch. 1096, Sec. 2. )

PART 3. STATE PROGRAMS [42000 - 42999]

  ( Part 3 added by Stats. 1989, Ch. 1096, Sec. 2. )

CHAPTER 2. Pharmaceutical and Sharps Waste Stewardship [42030 - 42036.4]

  ( Chapter 2 added by Stats. 2018, Ch. 1004, Sec. 1. )

ARTICLE 6. Enforcement [42035 - 42035.8]
  ( Article 6 added by Stats. 2018, Ch. 1004, Sec. 1. )

42035.
  

(a) (1) On or before June 30, 2022, and at least annually thereafter, the department shall post on its Internet Web site a list of stewardship organizations, including entities with an approved stewardship plan, and covered entities, authorized collection sites, retail pharmacies, and retail pharmacy chains provided in the stewardship plans that are in compliance with this chapter.

(2) The state board shall coordinate with the department to verify that the list posted pursuant to paragraph (1) is consistent with the information submitted to each agency pursuant to Section 42031.

(b) A covered entity or stewardship organization that is not listed on the department’s Internet Web site pursuant to subdivision (a), but demonstrates compliance with this chapter before the department is required to post the following year’s list pursuant to subdivision (a), may request a certification letter from the department stating that the covered entity or stewardship organization is in compliance with this chapter. A covered entity or stewardship organization that receives a certification letter shall be deemed to be in compliance with this chapter.

(c) A distributor or wholesaler of covered products, and a pharmacy or other retailer that sells or offers for sale a covered product, shall monitor the department’s Internet Web site to determine which covered entities and stewardship organizations are in compliance with this chapter. The distributor or wholesaler and the pharmacy or other retailer shall notify the department if it determines that a covered product that it sells or offers for sale is from a covered entity that is not listed on the department’s Internet Web site.

(d) The sale, distribution, or offering for sale of any inventory that was in stock before the commencement of a stewardship program is exempt from this chapter and not required to be subject to a stewardship plan.

(e) If the department determines a covered entity or stewardship organization is not in compliance with this chapter, the department shall remove the entity from the list maintained on the department’s Internet Web site pursuant to subdivision (a).

(Added by Stats. 2018, Ch. 1004, Sec. 1. (SB 212) Effective January 1, 2019.)

42035.2.
  

(a) (1) The department may impose an administrative penalty on any covered entity, program operator, stewardship organization, or authorized collector that sells, offers for sale, or provides a covered product in violation of this chapter.

(2) The amount of the administrative penalty imposed pursuant to this subdivision shall not exceed ten thousand dollars ($10,000) per day unless the violation is intentional, knowing, or reckless, in which case the administrative penalty shall not exceed fifty thousand dollars ($50,000) per day.

(b) The department shall not impose a penalty on a program operator pursuant to this section for failure to comply with this chapter if the program operator demonstrates it received false or misleading information that contributed to its failure to comply, including, for a stewardship organization, from a participating covered entity.

(c) The department shall deposit all penalties collected pursuant to this section in the Pharmaceutical and Sharps Stewardship Penalty Account, which is hereby created in the Pharmaceutical and Sharps Stewardship Fund established in Section 42034.2. Upon appropriation by the Legislature, moneys in the Pharmaceutical and Sharps Stewardship Penalty Account may be expended by the department on activities including, but not limited to, the promotion of safe handling and disposal of covered products, grants for related purposes, and the administration and enforcement of this chapter.

(Amended by Stats. 2019, Ch. 497, Sec. 232. (AB 991) Effective January 1, 2020.)

42035.4.
  

Upon a written finding that a covered entity, program operator, stewardship organization, or authorized collector has not met a material requirement of this chapter, in addition to any other penalties authorized under this chapter, the department may take one or both of the following actions to ensure compliance with the requirements of this chapter, after affording the covered entity, stewardship organization, or authorized collector a reasonable opportunity to respond to, or rebut, the finding:

(a) Revoke the program operator’s stewardship plan approval or require the program operator to resubmit the plan.

(b) Require additional reporting relating to compliance with the material requirement of this chapter that was not met.

(Added by Stats. 2018, Ch. 1004, Sec. 1. (SB 212) Effective January 1, 2019.)

42035.6.
  

(a) A covered entity, stewardship organization, program operator, retail pharmacy, or retail pharmacy chain shall do both of the following:

(1) Upon request, provide the department with reasonable and timely access, as determined by the department, to its facilities and operations, as necessary to determine compliance with this chapter.

(2) Upon request, provide the department with relevant records necessary to determine compliance with this chapter.

(b) A covered entity, stewardship organization, program operator, retail pharmacy, or retail pharmacy chain shall maintain and keep accessible all records required to be kept or submitted pursuant to this chapter for a minimum of three years.

(c) All reports and records provided to the department pursuant to this chapter shall be provided under penalty of perjury.

(d) The department may take disciplinary action against a covered entity, stewardship organization, program operator, pharmacy, retail pharmacy, or retail pharmacy chain that fails to provide the department with the access to information required pursuant to this section, including one or both of the following:

(1) Imposing an administrative penalty pursuant to Section 42035.2.

(2) Posting a notice on the department’s Internet Web site, in association with the list that the department maintains pursuant to paragraph (1) of subdivision (a) of Section 42035, that the covered entity, stewardship organization, program operator, pharmacy, retail pharmacy, or retail pharmacy chain is no longer in compliance with this chapter.

(e) The department shall not prohibit as a disciplinary action a covered entity, stewardship organization, program operator, pharmacy, retail pharmacy, or retail pharmacy chain from selling a covered product.

(Added by Stats. 2018, Ch. 1004, Sec. 1. (SB 212) Effective January 1, 2019.)

42035.8.
  

All handling, transport, and disposal undertaken as part of a stewardship program under this chapter shall comply with applicable state and federal laws, including, but not limited to, regulations adopted by the United States Drug Enforcement Administration.

(Added by Stats. 2018, Ch. 1004, Sec. 1. (SB 212) Effective January 1, 2019.)

PRCPublic Resources Code - PRC6