BILL ANALYSIS                                                                                                                                                                                                    Ó







                      SENATE COMMITTEE ON PUBLIC SAFETY
                            Senator Loni Hancock, Chair              S
                             2011-2012 Regular Session               B

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          SB 360 (DeSaulnier)                                         
          As Amended April 14, 2011 
          Hearing date:  May 3, 2011
          Family; Health & Safety Codes
          JM:dl


                                 CONTROLLED SUBSTANCES

                                           
                                       HISTORY

          Source:  Attorney General

          Prior Legislation: AB 2986 (Mullin) - Ch. 286, Stats.  2006
                       SB 1366 (Aanestad) - 2005-06, held in Senate Public 
          Safety
                       SB 734 (Torlakson) - Ch. 487, Stats. 2005
                       SB 151 (Burton) - Ch. 406, Stats. 2004

          Support: California Statewide Law Enforcement Association; 
                   Consumer Attorneys of California; California State 
                   Sheriffs' Association; Peace Officers Research 
                   Association of California; California Narcotic Officers 
                   Association; California Police Chiefs Association

          Opposition:None known




                                      KEY ISSUES
           




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          SHOULD SCHEDULES I, II, III and IV FOR CONTROLLED SUBSTANCES IN 
          CURRENT LAW BE EXPANDED TO INCLUDE ADDITIONAL SUBSTANCES, AS 
          SPECIFIED?

                                                                (CONTINUED)







           
          
          SHOULD SPECIFIED CHANGES BE MADE TO THE LAW REGARDING SECURITY 
          PRINTERS FOR PRESCRIPTION FORMS FOR CONTROLLED SUBSTANCE 
          PRESCRIPTIONS, AS SPECIFIED?

          SHOULD THE CURES PRESCRIPTION DRUG MONITORING PROGRAM (PDMP) BE 
          REVISED TO ALLOW PARTICIPATING CONTROLLED SUBSTANCE PRESCRIBERS 
          AND PHARMACISTS TO ACCESS OVER THE INTERNET THE HISTORY OF 
          CONTROLLED SUBSTANCE PRESCRIPTIONS OF PERSONS UNDER THEIR CARE, 
          AS SPECIFIED?



                                       PURPOSE

          The purposes of this bill are to 1) add additional substances to 
          schedules I and IV for controlled substances, as specified; 2) 
          make certain changes to the law regarding security printers for 
          prescription forms for controlled substance prescriptions, as 
          specified; and 3) establish the CURES revise Prescription Drug 
          Monitoring Program to allow controlled substance subscribers and 
          pharmacists to have Internet access to the controlled substance 
          prescription history of persons under their care, as specified.  
           

           Existing law  classifies controlled substances in five schedules 
          according to their danger and potential for abuse.  Schedule I 




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          controlled substances have the greatest restrictions and 
          penalties, including prohibiting the prescribing of a Schedule I 
          controlled substance.  (Health & Saf. Code §§ 11054-11058.)  
            
           Existing law  provides penalties for sale, possession for sale or 
          distribution, sale or distribution, and manufacturing of 
          controlled substances.  (Health & Saf. Code §§ 11350-11401.)

           Existing law  , with numerous exceptions, includes the following 
          penalties:

                 Heroin, cocaine and other specified drugs (section 
               references are to the Health and Safety Code):

                       §              § 11350 possession straight felony - 
                         prison term of 16 months, 2 years or 3 years<1>
                       §              § 11351 possession for sale or 
                         distribution - prison for 2, 3 or 4 years
                       §              § 11351.5 possession of cocaine base 
                         (crack) for sale - prison for 3, 4, 5 years
                       §              § 11352 sale or distribution - 3, 6 
                         or 9 years

                 Marijuana:

                       §              § 11357 possession - misdemeanor
                       §              § 11358 cultivation or processing - 
                         felony
                       §              § 11359 possession for sale - felony
                       §              § 11360 sale or distribution - 
                         felony, 2, 3 or 4 years

                 Methamphetamine and other specified drugs:

          § § 11377 possession - alternate felony-misdemeanor
          § § 11378 possession for sale or distribution - felony
          ---------------------------
          <1>  Hereinafter, a description of a crime as a "felony," 
          without an additional explanation or description of the 
          applicable prison sentence, means that the crime is punishable 
          by imprisonment for 16 months, 2 years or 3 years.



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          § § 11379 sale or distribution - felony, 2, 3 or 4 years

           Existing law  includes numerous enhancement provisions for 
          controlled substance crimes.  These include enhancements based 
          on the weight and volume of controlled substances and sale 
          within a certain distance from a school.  Examples of 
          enhancements include the following: enhancement for weight of 
          controlled substances involved in sale or distribution (Health & 
          Safety Code § 11370.4, subdivision (b)); enhancement for weight 
          or volume of controlled substance involved in manufacturing 
          (Health & Saf. Code § 11379.8); and enhancement where person 
          dies or suffers great bodily injury in the manufacturing of 
          methamphetamine.

           Existing law  provides that any person who manufactures, 
          compounds, converts, produces, derives, processes, or prepares 
          either directly or indirectly by chemical extraction or 
          independently by means of chemical synthesis any controlled 
          substance is guilty of a felony, punishable by imprisonment in 
          the state prison for three, five or seven years, and by a fine 
          of up to $50,000.  (Health & Saf. Code § 11379.6.)

           Existing law  provides that any person who possesses specified 
          chemicals with the intent to manufacture a controlled substance 
          is guilty of a felony and shall be punished by imprisonment in 
          the state  prison for two, four or six years.  (Health & Saf. 
          Code § 11383.)

           Existing law  includes enhancements for controlled substance 
          crimes that occur in specified places.  For example, the 
          enhancement triad for involving a minor in specified controlled 
          substance crimes is three, six or nine years.  (Health & Saf. 
          Code § 11353.)  There are a myriad other special penalty 
          provisions.

           This bill  would add additional substances to these schedules, as 
          specified.
           
          Existing law  includes the CURES (Controlled Substance 
          Utilization Review and Evaluation System) system of electronic 




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          monitoring of Schedule II, III and IV controlled substance 
          prescriptions.  CURES provides for the electronic transmission 
          of Schedule II, III and IV prescription data to the Department 
          of Justice (DOJ) at the time prescriptions are dispensed.  
          (Health & Saf. Code § 11165.)

           Existing law  states that the purpose of CURES is to assist law 
          enforcement and regulatory agencies in controlling diversion and 
          abuse of Schedule II, III and IV controlled substances and for 
          statistical analysis, education and research.  (Health & Saf. 
          Code § 11165, subd. (a).)

           Existing law  provides that pharmacists, in filling a controlled 
          substance prescription, shall provide to DOJ the patient's name, 
          date of birth, the name, form, strength and quantity of the 
          drug, and the pharmacy name, pharmacy number and the prescribing 
          physician information.  (Health & Saf. Code § 11165, subd. (d).)

           Existing law  provides that a licensed health care practitioner 
          eligible to prescribe Schedule II, III or IV controlled 
          substances, or a pharmacist, may make a written request to the 
          DOJ for the history of controlled substances dispensed to an 
          individual based on the data in CURES.  (Health & Saf. Code § 
          11165.1, subd. (a).)

           Existing law  provides that the DOJ may initiate the referral of 
          the history controlled substances dispensed to an individual, 
          based on the CURES data, to licensed health care practitioners 
          and pharmacists, as specified.  (Health & Saf. Code § 11165.1, 
          subd. (b).)

           Existing law  provides that the history of controlled substances 
          dispensed to a patient based on CURES data that is received by a 
          practitioner or pharmacist shall be considered medical 
          information, as specified.  (Health & Saf. Code § 11165.1, subd. 
          (c).)

           Existing law  provides that CURES data "shall only be provided to 
          appropriate state, local and federal persons or public agencies 
          for disciplinary, civil or criminal purposes ?"  CURES data 




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          shall also only be provided, as determined by DOJ, to other 
          agencies or entities for educating practitioners and others, in 
          lieu of disciplinary, civil or criminal actions.  (Health & Saf. 
          Code § 11165 subd. (b).)

           Existing law  allows non-identifying CURES data to be provided to 
          public and private entities
          for education, research, peer review and statistical analysis.  
          (Health & Saf. Code § 11165,
          subd. (c).)

           Existing law  provides that prescriptions for controlled 
          substances must be made on special security forms to prevent 
          copying or forgery of prescriptions.  (Health & Saf. Code § 
          11162.1.)

           Existing law  requires health practitioners who prescribe or 
          administer a controlled substance classified in Schedule II to 
          make a record containing the name and address of the patient, 
          date, and the character, name, strength, and quantity of the 
          controlled substance prescribed, as well as the pathology and 
          purpose for which the controlled substance was administered or 
          prescribed.  (Health & Saf. Code § 11190, subd. (a)-(b).)

           Existing law  requires prescribers who are authorized to dispense 
          Schedule II, III  or IV controlled substance in their office or 
          place of practice to record and maintain information for each 
          such prescription that includes the patient's name, address, 
          gender, and date of birth,  prescriber's license and license 
          number, federal controlled substance registration number, state 
          medical license number, NDC number of the controlled substance 
          dispensed, quantity dispensed, diagnosis code, if available, and 
          original date of dispensing.  This information shall be provided 
          to DOJ on a monthly basis.  (Health & Saf. Code § 11190 subd. 
          (c).)

           This bill  provides that any security prescription form printer 
          shall provide DOJ with the following information: the names and 
          addresses of an owner, partner, corporate officer, manager, 
          agent, representative, employee or subcontractor with direct 




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          access to, management of, or control over controlled substance 
          prescription forms.

           This bill  provides that a security printer shall inform DOJ if 
          any owner, partner, corporate officer, manager, agent, 
          representative, employee or subcontractor with direct access to, 
          management of, or control over controlled substance prescription 
          forms has been convicted of, or pleaded no contest, any crime.

           This bill  directs DOJ to inform any owner, partner, corporate 
          officer, manager, agent, representative, employee or 
          subcontractor with direct access to, management of, or control 
          over controlled substance prescription forms how to provide 
          fingerprints and other required information to DOJ for criminal 
          background checks.

           This bill  requires that controlled substance forms shall be 
          provided in person only to established customers.  The printer 
          shall obtain the customer's photo identification and log the 
          information.  Controlled substance forms shall only be mailed to 
          an address verified by the DEA or Medical Board of California.

           This bill  requires security printers to report theft of loss of 
          controlled substance prescription forms to DOJ by fax or e-mail 
          within 24 hours.

           This bill  requires DOJ to impose sanctions on security printers 
          who violate applicable statutes and regulations, as specified.  

           This bill  provides that the following security printer 
          violations are subject to a fine of up to $1,000 for a first 
          violation, a fine of up to $2,500 for each subsequent violation; 
          a printer who violates these rules for a third time is subject 
          to disciplinary proceeding for suspension or revocation of 
          security printer status:

                 failure to comply with guidelines;
                 failure to take reasonable precautions to prevent 
               dishonest or illegal actions concerning control of 
               controlled substance forms; and




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                 theft or fraudulent use of a prescriber's identity to 
               obtain forms.

           This bill  establishes the Prescription Drug Monitoring Program 
          (PDMP), with the following features:

                 Any practitioner licensed to prescribe Schedules II 
               through IV controlled substances or pharmacist may apply to 
               participate in the PMDP, as specified.
                 Under the PMDP the participating practitioner or 
               pharmacist (subscriber) may access, using the Internet, the 
               electronic history of controlled substances dispensed to an 
               individual under his or her care based on data contained in 
               CURES.
                 A practitioner or pharmacist PDMP subscriber may access 
               through the PDMP the number, amount, and type of controlled 
               substances being dispensed to an individual under his or 
               her care, in order to control the diversion and resultant 
               abuse of, and to ensure the safe and lawful dispensing of, 
               Schedule II, Schedule III, and Schedule IV controlled 
               substances.
                 DOJ may release to the subscribing practitioner or 
               pharmacist the electronic history of controlled substances 
               dispensed to a person under the care of the practitioner or 
               pharmacist based on data in the CURES Prescription Drum 
               Monitoring Program (PDMP). 
           
          This bill  provides that an application may be denied, or a 
          subscriber suspended, for any of the following:

                 materially falsifying an application;
                 failing to maintain effective controls for access to the 
               patient activity report;
                 suspended or revoked DEA registration;
                 arrest of a subscriber for a controlled substance 
               offense; or
                 accessing information for any reason except patient 
               care.

           This bill  provides that an authorized subscriber shall notify 




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          DOJ within 10 days of any changes to the subscriber account.  

           This bill  allows, until July 12, 2012, a health care 
          practitioner or pharmacist to make a written request for 
          controlled substance history information about a person under 
          the care of the practitioner or pharmacist, in order to provide 
          sufficient time for subscribers to apply for access to PDMP.  

           This bill  provides that DOJ may audit the PDMP system and its 
          users.  

           This bill  provides that DOJ may establish, by regulation, a 
          system for issuing a citation to a PDMP subscriber.

           This bill  provides that the citation may contain an order or 
          abatement or to pay a fine if the subscriber is in violation of 
          the CURES-PDMP statutes or corresponding regulations:

                 Citations shall be written and particularly describe the 
               violation, including a specific citation of the statute or 
               regulation violated.
                 When appropriate, the citation shall include a 
               reasonable time for abatement of the violation.
                 An administrative fine shall not exceed $2,500 for each 
               violation and shall be based on the gravity of the 
               violation, the good faith of the subscriber and any 
               previous violations.
                 The citation shall inform the subscriber that he or she 
               may, within 30 days of receiving a citation, request a 
               hearing.  
                 A subscriber may, within 10 days of receiving a 
               citation, request in writing an informal conference with 
               DOJ.  DOJ may, pursuant to the conference, affirm, modify 
               or dismiss the citation. 
                 If the citation is affirmed, the subscriber may request 
               a formal hearing.
                 If the citation is modified, the original citation shall 
               be deemed withdrawn and a new citation issued.  The 
               subscriber may request a formal hearing on the subsequent 
               citation.




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                 Failure to pay a fine within 30 days, or to comply with 
               an order of abatement within the time prescribed to do so, 
               may result in disciplinary action by DOJ, unless the 
               citation is being appealed.
                 If the citation is not contested and the fine is not 
               paid, the subscriber's account will be terminated.
                 A citation may be issued without a fine.
                 Fines may be limited to particular violations.
                 If a fine is paid, payment shall represent satisfactory 
               resolution of the matter for public disclosure.
                 Administrative fines shall be deposited in the CURES 
               Program Special Fund and "shall provide support for costs 
               association with hearings, maintenance, and updates to the 
               ÝPDMP]."  
                 These sanctions shall be in separate form and in 
               addition to any other administrative, civil or criminal 
               remedies.
                 A criminal action may not be initiated for a specific 
               offense if a citation has been issued for that matter.  A 
               citation may not be issued for a specific offense, if a 
               criminal action has been filed for that violation.  
               However, nothing in the citation provisions shall prevent 
               DOJ from prosecuting a suspension or revocation of a 
               subscriber.


                    RECEIVERSHIP/OVERCROWDING CRISIS AGGRAVATION
          
          For the last several years, severe overcrowding in California's 
          prisons has been the focus of evolving and expensive litigation. 
           As these cases have progressed, prison conditions have 
          continued to be assailed, and the scrutiny of the federal courts 
          over California's prisons has intensified.  

          On June 30, 2005, in a class action lawsuit filed four years 
          earlier, the United States District Court for the Northern 
          District of California established a Receivership to take 
          control of the delivery of medical services to all California 
          state prisoners confined by the California Department of 
          Corrections and Rehabilitation ("CDCR").  In December of 2006, 




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          plaintiffs in two federal lawsuits against CDCR sought a 
          court-ordered limit on the prison population pursuant to the 
          federal Prison Litigation Reform Act.  On January 12, 2010, a 
          three-judge federal panel issued an order requiring California 
          to reduce its inmate population to 137.5 percent of design 
          capacity -- a reduction at that time of roughly 40,000 inmates 
          -- within two years.  The court stayed implementation of its 
          ruling pending the state's appeal to the U.S. Supreme Court.  

          On Monday, June 14, 2010, the U.S. Supreme Court agreed to hear 
          the state's appeal of this order and, on Tuesday, November 30, 
          2010, the Court heard oral arguments.  A decision is expected as 
          early as this spring.  

          In response to the unresolved prison capacity crisis, in early 
          2007 the Senate Committee on Public Safety began holding 
          legislative proposals which could further exacerbate prison 
          overcrowding through new or expanded felony prosecutions.     

           This bill  does appear to aggravate the prison overcrowding 
          crisis described above.


                                      COMMENTS

          1.  Need for This Bill  

          According to the author:

               Due to the rise in prescription drug abuse, controlled 
               drugs prescription history information is available 
               and maintained by the Department of Justice (DOJ) 
               CURES program.  In 2009, the DOJ launched an automated 
               Prescription Drug Monitoring Program (PDMP).  The 
               program allows licensed health care practitioners 
               eligible to prescribe controlled substances access to 
               patient controlled substance prescription information. 
                Prescribers and pharmacists can now make informed 
               decisions about patient care and detect patients who 
               may be abusing controlled substances by obtaining 




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               multiple prescriptions from various practitioners.  
               Current efforts at maintaining privacy and control of 
               CURES data are inadequate to protect confidential 
               patient information and to deter its misuse.

               The DOJ also manages the California Security 
               Prescription Printer Program.  While DOJ has 
               established guidelines for the security of 
               prescription forms, current law lacks sufficient 
               safeguards against theft and fraudulent use of 
               prescription pads.  The DOJ has seen an increase in 
               criminal enterprises involved in prescription theft 
               and fraud.

               The existing list of controlled substances in 
                                              Schedules II, III, and IV set forth in the California 
               Health and Safety Code is out of date and no longer in 
               conformity with the Federal controlled substances 
               list.  As a result, the CURES program is no longer 
               collecting all controlled substance information as 
               required by law.

          2.  Controlled Substance Schedules - Criteria for Listings  

          The Federal Government classifies drugs into five schedules.  
          (21 U.S.C. § 812.)  California law generally follows federal law 
          as to the assigned schedule, but does not set out the criteria 
          for the schedules that are included in federal law.  (Health and 
          Safety Code Section 11054.)

          21 U.S.C., Section 812 (b) includes the following explanations:

           Schedule I  drugs are drugs that have no currently accepted 
          medical use in treatment in the United States, have a high 
          potential for abuse, and there is a lack of accepted safety for 
          use of the drug or other substance under medical supervision.  
          Schedule I drugs include but are not limited to cannabis, 
          heroin, GHB, and ecstasy.  

           Schedule II  controlled substances have a currently accepted 




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          medical use in treatment, a high potential for abuse, which may 
          lead to severe psychological or physical dependence.  Schedule 
          II drugs include but are not limited to Cocaine, Ritalin, 
          oxdycodone, morphine, and amphetamines.

           Schedule III  controlled substances have a currently accepted 
          medical use in treatment, a potential for abuse that is less 
          than that for Schedule I and II drugs, and abuse may lead to 
          moderate or low physical dependence or high psychological 
          dependence.  Schedule III drugs include but are not limited to 
          anabolic steroids, prescriptions that combine codeine or 
          hydrocodone with aspirin or another non-narcotic ingredient, 
          ketamine, and testosterone.  

           Schedule IV  drugs have a currently accepted medical use in 
          treatment, have a low potential for abuse relative to the 
          substances in Schedule III, and abuse may lead to limited 
          physical dependence or psychological dependence.  Schedule IV 
          drugs include but are not limited to Xanax, Librium, Valium, 
          talwin and Phenobarbital.  

           Schedule V  drugs have a low potential for abuse, have a 
          currently accepted medical use in treatment, and abuse of the 
          drug may lead to limited physical dependence or psychological 
          dependence.  Schedule V drugs include but are not limited to 
          narcotic drugs containing active medicinal qualities other than 
          those possessed by narcotic drugs alone, such as cough 
          suppressants containing small amounts of codeine.  
           
           3.  The CURES Program: Electronic Monitoring of Controlled 
            Substance Prescriptions, Private Contractor 

          The CURES program was established in 1997 by AB 3042 (Takasugi) 
          in response to recommendations of the Controlled Substance 
          Prescription Advisory Council.  (SCR 74, 1992.)  A CURE 
          initially was intended to electronically monitor the prescribing 
          and dispensing of Schedule II controlled substances such as 
          oxycodone.  CURES provides for real-time electronic transmission 
          of specified prescription data to DOJ.  Essentially the data is 
          analyzed for indications that controlled substances are being 




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          improperly prescribed, or that drug abusers are obtaining 
          prescriptions from many doctors (doctor shopping).  Physicians 
          and pharmacists, in addition to DOJ, have access to CURES data 
          through PAR - patient activity reports.  A private contractor - 
          Atlantic Associates - collects CURES data for DOJ.  The previous 
          vendor was Infinite Solutions.

          4.  Confidentiality Concerns  

          According to a report issued by the General Accounting Office 
          (GAO) in May 2002:

               Both physicians who legitimately prescribe prescription 
               drugs and patients who legitimately use them are 
               concerned that the information collected, centrally 
               maintained, and monitored by state PDMP's may be used 
               inappropriately or compromised.  ÝP]DMP's, particularly 
               those with electronic databases, raise additional 
               confidentiality concerns, however, because their 
               databases contain complete dispensing records that can 
               more quickly identify individual patients, physicians 
               and pharmacies and provide an individual report on 
               their prescription drug history.  Physicians are 
               concerned that their prescribing decisions and patterns 
               may be questioned, and that they could be investigated 
               without sufficient cause.  Some physicians contend that 
               patients may suffer because physicians will be 
               reluctant to prescribe appropriate controlled 
               substances to manage a patient's pain or treat their 
               conditions?Patients are concerned that their personal 
               information may be used inappropriately by those with 
               authorized access or shared with unauthorized entities. 
                (U.S. Gen. Accounting Office, Prescription Drugs, 
               State Monitoring Programs Provide Useful Tool to Reduce 
               Diversion, (May, 2002) p. 18; 
               http://www.gao.gov/new.items/d02634.pdf.)








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          This appears to be a legitimate concern, given the number of 
          persons and entities with access to this information.  This bill 
          provides penalties for unauthorized use of CURES data by those 
          with PDMP access.  The question is raised as to whether privacy 
          may be better protected by preventive measures than penalties 
          imposed after misuse of CURES information.

          WHAT MEASURES COULD BE IMPLEMENTED TO PREVENT MISUSE OF CURES 
          DATA?

          WOULD PREVENTION OF MISUSE BE MORE EFFECTIVE THAN IMPOSING 
          SANCTIONS AFTER MISUSE OF THE DATA OR IMPROPER ACCESS?

          5.  Prior Legislation Amending the CURES System  

                 AB 2986 (Mullin), Chapter 286, Statutes of 2006, 
               required designated prescription forms  for controlled 
               substances and prescriptions for controlled substances to 
               contain additional information identifying the final 
               consumer and any refill information.  AB 2986 also added 
               Schedule IV drugs to the controlled substances subject to 
               electronic reporting and monitoring system under CURES.
                 SB 1366 (Aanestad), of the 2005-06 Legislative Session, 
               would have removed the requirement that authorized persons 
               write prescriptions for controlled substances on a 
               specialized secured prescription form and would have 
               allowed courts to issue an order prohibiting prescriber 
               from prescribing controlled substances when the prescriber 
               is charged with a specified felony offense.  SB 1366 was 
               held in the Senate Committee on Public Safety.
                 SB 734 (Torlakson), Chapter 487, Statutes of 2005, made 
               technical and clarifying changes to CURES.
                 SB 151 (Burton), Chapter 406, Statutes of 2004, made the 
               CURES reporting system permanent.  

          6.  Expansion of Existing Felonies; Potential ROCA Remedy
           
          As explained in detail above, under existing law the unlawful 
          possession of certain controlled substances (as well as other 
          conduct relating to controlled substances) can be a felony.  




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          Because this bill would include additional substances in the 
          schedules of controlled substances, it would violate ROCA.  The 
          Committee and the author may wish to consider the following 
          amendments, which would remedy the bill's ROCA implications:

          1)  Strike additions to the California controlled substance 
          schedules and related provisions.
          
          These amendments would strike SECTION 1 through SECTION 5 of the 
          bill.  (p. 3, line 1, through p. 22, line 24.)  These amendments 
          also would strike SECTION 13 through SECTION 24 of the bill.  
          (p. 34, line 37 through p. 40, line 32.)
          2)  Direct prescribers and pharmacists to report to CURES 
          prescriptions for controlled substances listed in Schedules II, 
          III and IV of the federal controlled substance schedules. 
          
          The bill could be amended to provide that prescribers and 
          pharmacists shall report prescriptions for controlled substances 
          to CURES that are listed in Schedules II, III and IV of the 
          federal controlled substance schedules set out in 21 U.S.C. § 
          812 and as updated in 21 Code of Federal Regulations, Sections 
          1308.12, 1308.13 and 1308.14.   


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