Showing posts with label California Proposed Legislation. Show all posts
Showing posts with label California Proposed Legislation. Show all posts

Thursday, February 21, 2013

Bill Deadline in California Legislature Promises a Few Insurance Issues By Don Jergler | February 20, 2013


Compounding drugs may be another workers’ comp-related issue that warrants a bill.
A report on compounding drugs released earlier this month reveals the effects of another workers’ comp-related law enacted at the beginning of 2012. Price controls were created via Assembly Bill 378, authored by lawmaker Jose Solorio, D-Santa Ana, to address a rise in the utilization and cost of compounded drugs in workers’ comp.
But while the law, which took effect at the beginning of 2012, may have helped push compounded drug prescriptions down from 3.1 percent in 2011 to 2 percent of California workers’ comp prescriptions in 2012, those compounders seemed to have more than made up for it.
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Sunday, February 17, 2013

More Proposed Legislation in California--Senate Bill No. 294

CALIFORNIA LEGISLATURE— 2013–2014 REGULAR SESSION

SENATE BILLNo. 294


Introduced  by  Senator Emmerson

February 15, 2013


An act to amend Sections 4127.1, 4127.2, and 4400 of, to amend the heading of Article 7.5 (commencing with Section 4127) of Chapter 9 of Division 2 of, and to repeal and add Section 4127 of, the Business and Professions Code, relating to pharmacy.


LEGISLATIVE COUNSEL'S DIGEST


SB 294, as introduced, Emmerson. Sterile drug products.

The Pharmacy Law provides for the licensure and regulation of pharmacists and pharmacy corporations in this state by the California State Board of Pharmacy. Existing law requires the board to adopt regulations establishing standards for compounding injectable sterile drug products in a pharmacy. Existing law requires pharmacies to obtain a license from the board, subject to annual renewal, in order to compound injectable sterile drug products. A similar licensing requirement applies to nonresident pharmacies compounding injectable sterile drug products for shipment into California. A violation of the Pharmacy Law is a crime.
This bill would expand these provisions to prohibit a pharmacy from compounding or dispensing, and a nonresident pharmacy from compounding for shipment into this state, sterile drug products for injection, administration into the eye, or inhalation, unless the pharmacy has obtained a sterile compounding pharmacy license from the board. The bill would specify requirements for the board for issuance or renewal of a license, and requirements for the pharmacy as a licensee. By adding additional requirements to the Pharmacy Law concerning sterile drug products, the violation of which is a crime, the bill would impose a state-mandated local program.
Existing law specifies the fee for issuance or renewal of a nongovernmental license to compound sterile drug products.
This bill would provide that the fee for a nonresident sterile compounding pharmacy license shall also require payment of the travel expenses incurred by the board in inspecting the pharmacy at least once annually.

Saturday, February 16, 2013

Proposed Legislation in California Relating to Nonresident Pharmacies


BILL NUMBER: AB 299 INTRODUCED
 BILL TEXT


INTRODUCED BY   Assembly Member Holden

                        FEBRUARY 12, 2013

   An act to amend Section 4112 of the Business and Professions Code,
relating to pharmacy.


 LEGISLATIVE COUNSEL'S DIGEST


   AB 299, as introduced, Holden. Pharmacy.
   The Pharmacy Law governs the business and practice of pharmacy in
this state. That law provides that any pharmacy located outside this
state that ships, mails, or delivers, in any manner, controlled
substances, dangerous drugs, or dangerous devices into this state is
considered a nonresident pharmacy. The law prohibits a person from
acting as a nonresident pharmacy unless he or she has obtained a
license, and imposes various disclosure and recordkeeping
requirements on nonresident pharmacies. Any person who knowingly
violates these provisions is guilty of a misdemeanor.
   This bill would prohibit a nonresident pharmacy or a pharmacy
located in this state that delivers prescriptions via mail from
entering into, or being a party to, an agreement with a health care
service plan or disability insurer that requires a plan enrollee or
insured to utilize mail order services or that requires a plan
enrollee or insured to opt out of a mail order process. By creating
new crimes, 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: yes.
State-mandated local program: yes.


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

  SECTION 1.  Section 4112 of the Business and Professions Code is
amended to read:
   4112.  (a) Any pharmacy located outside this state that ships,
mails, or delivers, in any manner, controlled substances, dangerous
drugs, or dangerous devices into this state shall be considered a
nonresident pharmacy.
   (b) A person may not act as a nonresident pharmacy unless he or
she has obtained a license from the board. The board may register a
nonresident pharmacy that is organized as a limited liability company
in the state in which it is licensed.
   (c) A nonresident pharmacy shall disclose to the board the
location, names, and titles of (1) its agent for service of process
in this state, (2) all principal corporate officers, if any, (3) all
general partners, if any, and (4) all pharmacists who are dispensing
controlled substances, dangerous drugs, or dangerous devices to
residents of this state. A report containing this information shall
be made on an annual basis and within 30 days after any change of
office, corporate officer, partner, or pharmacist.
   (d) All nonresident pharmacies shall comply with all lawful
directions and requests for information from the regulatory or
licensing agency of the state in which it is licensed as well as with
all requests for information made by the board pursuant to this
section. The nonresident pharmacy shall maintain, at all times, a
valid unexpired license, permit, or registration to conduct the
pharmacy in compliance with the laws of the state in which it is a
resident. As a prerequisite to registering with the board, the
nonresident pharmacy shall submit a copy of the most recent
inspection report resulting from an inspection conducted by the
regulatory or licensing agency of the state in which it is located.
   (e) All nonresident pharmacies shall maintain records of
controlled substances, dangerous drugs, or dangerous devices
dispensed to patients in this state so that the records are readily
retrievable from the records of other drugs dispensed.
   (f) Any pharmacy subject to this section shall, during its regular
hours of operation, but not less than six days per week, and for a
minimum of 40 hours per week, provide a toll-free telephone service
to facilitate communication between patients in this state and a
pharmacist at the pharmacy who has access to the patient's records.
This toll-free telephone number shall be disclosed on a label affixed
to each container of drugs dispensed to patients in this state.
   (g) A nonresident pharmacy shall not permit a pharmacist whose
license has been revoked by the board to manufacture, compound,
furnish, sell, dispense, or initiate the prescription of a dangerous
drug or dangerous device, or to provide any pharmacy-related service,
to a person residing in California. 
   (h) A nonresident pharmacy or a pharmacy located in this state
that delivers prescriptions via mail is prohibited from entering
into, or being a party to, an agreement with a health care service
plan or disability insurer that requires a plan enrollee or insured
to utilize mail order services or that requires a plan enrollee or
insured to opt out of a mail order process.  
   (h) 
    (i)  The board shall adopt regulations that apply the
same requirements or standards for oral consultation to a nonresident
pharmacy that operates pursuant to this section and ships, mails, or
delivers any controlled substances, dangerous drugs, or dangerous
devices to residents of this state, as are applied to an in-state
pharmacy that operates pursuant to Section 4037 when the pharmacy
ships, mails, or delivers any controlled substances, dangerous drugs,
or dangerous devices to residents of this state. The board shall not
adopt any regulations that require face-to-face consultation for a
prescription that is shipped, mailed, or delivered to the patient.
The regulations adopted pursuant to this subdivision shall not result
in any unnecessary delay in patients receiving their medication.

   (i) 
    (   j)  The registration fee shall be the fee
specified in subdivision (a) of Section 4400. 
   (j) 
    (   k)  The registration requirements of this
section shall apply only to a nonresident pharmacy that ships, mails,
or delivers controlled substances, dangerous drugs, and dangerous
devices into this state pursuant to a prescription. 
   (k) 
    (   l)  Nothing in this section shall be
construed to authorize the dispensing of contact lenses by
nonresident pharmacists except as provided by Section 4124.
  SEC. 2.  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.

Source found here