BILL ANALYSIS Ó
SENATE COMMITTEE ON APPROPRIATIONS
Senator Ricardo Lara, Chair
2015 - 2016 Regular Session
SB 619 (Morrell) - Pharmacy: outsourcing facilities: licensure
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|Version: April 6, 2015 |Policy Vote: B., P. & E.D. 8 - |
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|Urgency: No |Mandate: No |
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|Hearing Date: May 11, 2015 |Consultant: Brendan McCarthy |
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This bill meets the criteria for referral to the Suspense File.
Bill
Summary: SB 619 would require outsourcing facilities to be
licensed by the Board of Pharmacy.
Fiscal
Impact: One-time costs of $177,000 for licensing and inspection
activities and computer system upgrades and ongoing costs of
$126,000 per year for licensing and inspections (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
out-of-state pharmacies that sell prescription drugs in the
SB 619 (Morrell) Page 1 of
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state to be licensed by the Board.
Federal law has created a new category 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.)
Proposed Law:
SB 619 would require outsourcing facilities to be licensed by
the Board of Pharmacy.
Specific provisions of the bill would:
Require an outsourcing facility to be licensed by the Board
of Pharmacy if it compounds medication, without a
patient-specific prescription, for patients or practitioners
inside or outside California;
Specify the activities that an outsourcing facility can and
cannot perform;
Apply the licensing requirement to out-of-state outsourcing
facilities that ship compounded prescription drugs into the
state;
Require the Board to report to the Legislature by January
1, 2018 on its licensing and regulatory efforts;
Authorize the Board to issue a cease and desist order to an
outsourcing facility if the Board determines that there is
an immediate threat to public health;
Specify the fees for issuance or renewal of a license for
an outsourcing facility, including a requirement that an
out-of-state outsourcing facility must also provide
reasonable funding to cover the costs for out-of-state
inspections.
Related Legislation:
SB 600 (Lieu, Statutes of 2014) made changes to state law
to conform to changes to federal law in the area of
pharmacy.
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AB 2605 (Bonilla, Statutes of 2014) requires third party
logistics providers to be licensed by the Board of Pharmacy.
SB 294 (Emmerson, Statutes of 2013) requires an inspection
by the Board of Pharmacy before licensing compounding
pharmacies, including out-of-state facilities.
Staff
Comments: As noted above, recent federal law created a new
category of facility relating to the distribution of
prescription drugs. This bill requires licensure by outsourcing
facilities by the Board of Pharmacy with requirements similar to
those imposed on compounding pharmacies.
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