Bill Text: CA SB632 | 2011-2012 | Regular Session | Amended

NOTE: There are more recent revisions of this legislation. Read Latest Draft

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Bill Title: Marriage and family therapists.

Spectrum: Partisan Bill (Republican 1-0)

Status: (Passed) 2012-07-03 - Chaptered by Secretary of State. Chapter 50, Statutes of 2012. [SB632 Detail]

Download: California-2011-SB632-Amended.html

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BILL NUMBER: SB 632	AMENDED
	BILL TEXT

	AMENDED IN SENATE  MARCH 24, 2011

INTRODUCED BY   Senator Emmerson

                        FEBRUARY 18, 2011

    An act to amend Section 4037 of the Business and
Professions Code,   An act to add Section 4052.6 to the
Business and Professions Code,  relating to pharmacy.


	LEGISLATIVE COUNSEL'S DIGEST


   SB 632, as amended, Emmerson. Pharmacy.
   Existing law, the Pharmacy Law, provides for the licensure and
regulation of pharmacists and pharmacies by the California State
Board of Pharmacy.  Existing law defines the term "pharmacy"
for the purposes of these provisions.   A violation of
the law is a crime. Existing law authorizes a pharmacist filling a
prescription order for a drug product prescribed by the trade or
brand name to substitute a generic drug product, subject to specified
requirements. Existing law also authorizes a pharmacist filling a
prescription order for a drug product to select a different form of
medication with the same active chemical ingredients, as specified,
if certain requirements are met. 
   This bill would  make a technical, nonsubstantive change
to that provision.   prohibit a pharmacist from
interchanging or substituting an opioid analgesic drug, as defined,
for an opioid analgesic drug incorporating a tamper resistant
technology, as defined, unless the opioid analgesic drug to be
interchanged or substituted is described on a list to be prepared by
the board. In those situations where the drug is not on the board's
list, the bill would require the pharmacist to obtain consent from
the prescriber prior to an interchange or substitution. The bill
would make findings and declarations in that regard. Because a
violation of these requirements by a pharmacist would constitute a
crime, the bill would impose a state-mandated local program. 

   The California Constitution requires the state to reimburse local
agencies and school districts for certain costs mandated by the
state. Statutory provisions establish procedures for making that
reimbursement.  
   This bill would provide that no reimbursement is required by this
act for a specified reason. 
   Vote: majority. Appropriation: no. Fiscal committee:  no
  yes  . State-mandated local program:  no
  yes  .


THE PEOPLE OF THE STATE OF CALIFORNIA DO ENACT AS FOLLOWS:

   SECTION 1.    The Legislature finds and declares all
of the following:  
   (a) Opioid use and abuse has increased greatly in the United
States since the 1990s and continues to rise. While the benefits of
these products in treating and managing pain are widely recognized,
the potential for misuse and abuse of these products has long been a
concern of manufacturers, federal and state law enforcement, health
care providers, legislators, and regulators.  
   (b) Studies show that addicts tend to crush or otherwise break
down time-released products into a form that can be snorted or
injected for a more intense high. Thus, formulations that make it
more difficult to crush or otherwise manipulate those products may
mitigate the potential for abuse.  
   (c) Pharmaceutical manufacturers have invested enormous research
and development resources in both creating novel technologies that
may help deter the inappropriate use of opioid medications and
testing those products against other opioid formulations.  
   (d) The United States Food and Drug Administration (FDA) has
afforded priority review to new drug applications for opioids
incorporating tamper resistant technologies. However, the FDA has
been reluctant to permit claims that those products actually mitigate
the potential for abuse without additional research. Companies
continue to develop post approval data in the overall patient
population; however, that effort will take many years. Products
incorporating tamper resistant technologies can play an important
role today in offering health care providers the opportunity to
prescribe products incorporating tamper resistant technologies that
provide advantages in reducing the potential for misuse and abuse of
opioids.  
   (e) Given the critically important public health and law
enforcement goals of preventing the abuse and misuse of opioids, the
Legislature should approve policies that encourage manufacturers to
develop opioid products with tamper resistant technologies and
promote efficient use of scarce health care resources.  
   (f) Health care providers should have the ability to write
prescriptions for opioid products incorporating tamper resistant
technologies when, in their medical judgment, those prescriptions are
medically necessary. 
   SEC. 2.    Section 4052.6 is added to the  
Business and Professions Code   , to read:  
   4052.6.  (a) For the purposes of this section, the following
definitions shall apply:
   (1) "Opioid analgesic drug" means a drug in the opioid analgesic
drug class prescribed to treat moderate to severe pain or other
conditions, whether in immediate release or extended release form and
whether or not combined with other drug substances to form a single
tablet or other dosage form.
   (2) "Opioid analgesic drug incorporating a tamper resistant
technology" means an opioid analgesic drug listed as such by the
board pursuant to subdivision (b).
   (b) (1) For the purposes of carrying out the provisions described
in subdivision (c), the board shall create a list of opioid analgesic
drugs that incorporate a tamper resistant technology. A drug shall
not be included on the list unless the following requirements are
satisfied:
   (A)  The drug manufacturer or distributor submits evidence to the
board that the opioid analgesic drug incorporates a tamper resistant
technology.
   (B) The opioid analgesic drug has been approved by the United
States Food and Drug Administration (FDA) pursuant to an application
that includes at least one human tampering or abuse potential study
or a laboratory study comparing the tamper or abuse resistant
properties of the drug to one or more opioid analgesic drugs that
have been approved by the FDA and serve as a positive control.
   (2) The list shall include a determination by the board as to
which opioid analgesic drugs incorporating tamper resistant
technologies provide substantially similar tamper resistant
properties, based solely upon studies submitted by the drug
manufacturer.
   (3) Nothing in this subdivision shall be construed to require that
a drug included on the list bear a labeling claim with respect to
reduction of tampering, abuse, or abuse potential at the time of
listing.
   (c) (1) Notwithstanding Sections 4052.5 and 4073, a pharmacist
shall not interchange or substitute an opioid analgesic drug, brand,
or generic, for an opioid analgesic drug incorporating a tamper
resistant technology unless the opioid analgesic drug that is
interchanged or substituted is included on the list described in
subdivision (b).
   (2) If the opioid analgesic drug is not on the list described in
subdivision (b), the pharmacist shall obtain consent from the
prescribing physician and surgeon prior to an interchange or
substitution. The consent may be obtained by telephone or through any
other electronic communication. 
   SEC. 3.    No reimbursement is required by this act
pursuant to Section 6 of Article XIII B of the California
Constitution because the only costs that may be incurred by a local
agency or school district will be incurred because this act creates a
new crime or infraction, eliminates a crime or infraction, or
changes the penalty for a crime or infraction, within the meaning of
Section 17556 of the Government Code, or changes the definition of a
crime within the meaning of Section 6 of Article XIII B of the
California Constitution.  
  SECTION 1.    Section 4037 of the Business and
Professions Code is amended to read:
   4037.  (a) "Pharmacy" shall mean an area, place, or premises
licensed by the board in which the profession of pharmacy is
practiced and where prescriptions are compounded. "Pharmacy"
includes, but is not limited to, any area, place, or premises
described in a license issued by the board wherein controlled
substances, dangerous drugs, or dangerous devices are stored,
possessed, prepared, manufactured, derived, compounded, or
repackaged, and from which the controlled substances, dangerous
drugs, or dangerous devices are furnished, sold, or dispensed at
retail.
   (b) "Pharmacy" shall not include any area in a facility licensed
by the State Department of Public Health where floor supplies, ward
supplies, operating room supplies, or emergency room supplies of
dangerous drugs or dangerous devices are stored or possessed solely
for treatment of patients registered for treatment in the facility or
for treatment of patients receiving emergency care in the facility.