BILL ANALYSIS Ó
SENATE COMMITTEE ON APPROPRIATIONS
Senator Ricardo Lara, Chair
2015 - 2016 Regular Session
SB 1193 (Hill) - Pharmacy: outsourcing facilities
-----------------------------------------------------------------
| |
| |
| |
-----------------------------------------------------------------
|--------------------------------+--------------------------------|
| | |
|Version: April 13, 2016 |Policy Vote: B., P. & E.D. 9 - |
| | 0 |
| | |
|--------------------------------+--------------------------------|
| | |
|Urgency: No |Mandate: Yes |
| | |
|--------------------------------+--------------------------------|
| | |
|Hearing Date: May 2, 2016 |Consultant: Brendan McCarthy |
| | |
-----------------------------------------------------------------
This bill meets the criteria for referral to the Suspense File.
Bill
Summary: SB 1193 would extend the statutory sunset on the Board
of Pharmacy to January 1, 2021. The bill would also make several
changes to the authority and practice of the Board.
Fiscal
Impact:
Ongoing costs of $20 million per year for the continued
operation of the Board of Pharmacy (Pharmacy Board Contingent
Fund). The Board's operations are fully supported by licensing
fees.
One-time costs of $335,000 and ongoing costs of $320,000 per
year for licensing and inspection activities relating to
outsourcing facilities (Pharmacy Board Contingent Fund).
Background: Under current law, the Board of Pharmacy licenses pharmacists
as well as pharmacies, compounding pharmacies, wholesalers,
dispensaries, and related facilities. Current law requires
SB 1193 (Hill) Page 1 of
?
out-of-state pharmacies that sell prescription drugs in the
state to be licensed by the Board. The Board has a statutory
sunset of January 1, 2017.
Federal law has created a new category of pharmacy relating to
prescription drugs known as outsourcing facilities. Outsourcing
facilities are sterile facilities that compound prescription
drugs in large quantities, not for individual patients. (In
contrast to compounding pharmacies, which compound drugs to fill
specific prescriptions.) Current California law does not have a
license category specific to outsourcing facilities.
Proposed Law:
SB 1193 would extend the statutory sunset on the Board of
Pharmacy to January 1, 2021.
Specific provisions of the bill would:
Extend the operation of the Board and the authority to
employ an executive officer to January 1, 2021;
Require outsourcing facilities to be licensed by the
Board (whether or not they are located in California) and
impose specified regulatory requirements on outsourcing
facilities;
Establish a $780 licensing fee for outsourcing
facilities;
Require a pharmacy using an automated drug delivery
system to register its use with the Board;
Require the Board to issue a license to a clinic (or
incorporate any changes to a license) within 30 days;
Authorize the Board to issue a cease and desist letter
to an entity practicing activities without a license that
require licensure;
Authorize pharmacists to establish professional
corporations.
Related
Legislation: SB 619 (Morrell) would have required outsourcing
facilities to be licensed by the Board of Pharmacy. That bill
was held on this committee's Suspense File.
-- END --
SB 1193 (Hill) Page 2 of
?