Senate BillNo. 482


Introduced by Senator Lara

February 26, 2015


An act to amend Section 11165 of the Health and Safety Code, relating to controlled substances.

LEGISLATIVE COUNSEL’S DIGEST

SB 482, as introduced, Lara. Controlled substances: reporting.

Existing law classifies certain controlled substances into designated schedules. Existing law requires the Department of Justice to maintain the Controlled Substance Utilization Review and Evaluation System (CURES) for the electronic monitoring of the prescribing and dispensing of Schedule II, Schedule III, and Schedule IV controlled substances by all practitioners authorized to prescribe or dispense these controlled substances. Existing law requires dispensing pharmacies and clinics to report specified information for each prescription of a Schedule II, Schedule III, or Schedule IV controlled substance to the department, no more than 7 days after the controlled substance was dispensed.

This bill would specify that the dispensing pharmacies and clinics are required to report the specified information to the department no more than 7 business days after the controlled substance was dispensed.

Vote: majority. Appropriation: no. Fiscal committee: no. State-mandated local program: no.

The people of the State of California do enact as follows:

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SECTION 1.  

Section 11165 of the Health and Safety Code is
2amended to read:

3

11165.  

(a) To assist health care practitioners in their efforts
4to ensure appropriate prescribing, ordering, administering,
P2    1furnishing, and dispensing of controlled substances, law
2enforcement and regulatory agencies in their efforts to control the
3diversion and resultant abuse of Schedule II, Schedule III, and
4Schedule IV controlled substances, and for statistical analysis,
5education, and research, the Department of Justice shall, contingent
6upon the availability of adequate funds in the CURES Fund,
7maintain the Controlled Substance Utilization Review and
8Evaluation System (CURES) for the electronic monitoring of, and
9Internet access to information regarding, the prescribing and
10dispensing of Schedule II, Schedule III, and Schedule IV controlled
11substances by all practitioners authorized to prescribe, order,
12administer, furnish, or dispense these controlled substances.

13(b) The Department of Justice may seek and use grant funds to
14pay the costs incurred by the operation and maintenance of
15CURES. The department shall annually report to the Legislature
16and make available to the public the amount and source of funds
17it receives for support of CURES.

18(c) (1) The operation of CURES shall comply with all
19applicable federal and state privacy and security laws and
20regulations.

21(2) CURES shall operate under existingbegin delete provisions ofend delete law to
22safeguard the privacy and confidentiality of patients. Data obtained
23from CURES shall only be provided to appropriate state, local,
24and federal public agencies for disciplinary, civil, or criminal
25purposes and to other agencies or entities, as determined by the
26Department of Justice, for the purpose of educating practitioners
27and others in lieu of disciplinary, civil, or criminal actions. Data
28may be provided to public or private entities, as approved by the
29Department of Justice, for educational, peer review, statistical, or
30research purposes, provided that patient information, including
31any information that may identify the patient, is not compromised.
32Further, data disclosed tobegin delete anyend deletebegin insert anend insert individual or agency as described
33in this subdivision shall not be disclosed, sold, or transferred to
34begin delete anyend deletebegin insert aend insert third party. The Department of Justice shall establish policies,
35procedures, and regulations regarding the use, access, evaluation,
36management, implementation, operation, storage, disclosure, and
37security of the information within CURES, consistent with this
38subdivision.

39(d) For each prescription for a Schedule II, Schedule III, or
40Schedule IV controlled substance, as defined in the controlled
P3    1substances schedules in federal law and regulations, specifically
2Sections 1308.12, 1308.13, and 1308.14, respectively, of Title 21
3of the Code of Federal Regulations, the dispensing pharmacy,
4clinic, or other dispenser shall report the following information to
5the Department of Justice as soon as reasonably possible, but not
6more than sevenbegin insert businessend insert days after the date a controlled substance
7is dispensed, in a format specified by the Department of Justice:

8(1) Full name, address, and, if available, telephone number of
9the ultimate user or research subject, or contact information as
10determined by the Secretary of the United States Department of
11Health and Human Services, and the gender, and date of birth of
12the ultimate user.

13(2) The prescriber’s category of licensure, license number,
14national provider identifier (NPI) number, if applicable, the federal
15controlled substance registration number, and the state medical
16license number of any prescriber using the federal controlled
17substance registration number of a government-exempt facility.

18(3) Pharmacy prescription number, license number, NPI number,
19and federal controlled substance registration number.

20(4) National Drug Code (NDC) number of the controlled
21 substance dispensed.

22(5) Quantity of the controlled substance dispensed.

23(6) International Statistical Classification of Diseases, 9th
24revision (ICD-9) or 10th revision (ICD-10) Code, if available.

25(7) Number of refills ordered.

26(8) Whether the drug was dispensed as a refill of a prescription
27or as a first-time request.

28(9) Date of origin of the prescription.

29(10) Date of dispensing of the prescription.

30(e) The Department of Justice may invite stakeholders to assist,
31advise, and make recommendations on the establishment of rules
32and regulations necessary to ensure the proper administration and
33enforcement of the CURES database. All prescriber and dispenser
34invitees shall be licensed by one of the boards or committees
35identified in subdivision (d) of Section 208 of the Business and
36Professions Code, in active practice in California, and a regular
37user of CURES.

38(f) The Department of Justice shall, prior to upgrading CURES,
39consult with prescribers licensed by one of the boards or
40committees identified in subdivision (d) of Section 208 of the
P4    1Business and Professions Code, one or more of the boards or
2committees identified in subdivision (d) of Section 208 of the
3Business and Professions Code, and any other stakeholder
4identified by the department, for the purpose of identifying
5desirable capabilities and upgrades to the CURES Prescription
6Drug Monitoring Program (PDMP).

7(g) The Department of Justice may establish a process to educate
8 authorized subscribers of the CURES PDMP on how to access and
9use the CURES PDMP.



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