BILL ANALYSIS Ó
AB 1045
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Date of Hearing: May 15, 2013
ASSEMBLY COMMITTEE ON APPROPRIATIONS
Mike Gatto, Chair
AB 1045 (Quirk-Silva) - As Amended: April 22, 2013
Policy Committee: Business,
Professions and Consumer Protection Vote: 13-0
Urgency: No State Mandated Local Program:
Yes Reimbursable: No
SUMMARY
This bill requires patients to be notified within 24 hours of a
recall notice for a sterile compounded drug, and requires the
automatic suspension or revocation of a nonresident pharmacy
license in this state if the nonresident pharmacy's home state
license is suspended or revoked.
FISCAL EFFECT
Minor and absorbable costs to the Board of Pharmacy (BOP).
COMMENTS
1)Rationale . This bill addresses gaps noted in existing federal
and state pharmacy regulation after a nationwide meningitis
outbreak killing 47 people was traced back to problems with a
Massachusetts compounding pharmacy. The Massachusetts
pharmacy's California license could not be revoked immediately
under existing law.
2)Background . A compounding pharmacy is a licensed pharmacy that
prepares, alters or combines drugs or drug ingredients by or
under the supervision of a licensed pharmacist pursuant to a
prescription. There are 286 licensed sterile injectable
compounding pharmacies in California and 93 nonresident
licensed sterile injectable compounding pharmacies that ship
to the state.
Sterile compounding is a specific sub-type of general
compounding in which the compounded drug product is sterile.
These products are often placed directly into the body through
AB 1045
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injection, via eye drops, or inhaled; these drugs must be
produced in the most sanitary, regulated environments and be
absolutely sterile to avoid infection.
Compounding pharmacies have been compounding greater volumes
of sterile drugs in recent years because these pharmacies are
increasingly requested by hospitals and health care providers
to help address drug shortages. According to the federal Food
and Drug Administration (FDA), there has been an almost 500%
increase in manufactured drug shortages since 2006, the
majority of which are for critical, medically necessary,
generic sterile injectable drugs.
In September 2012, the New England Compounding Center (NECC),
a compounding pharmacy in Massachusetts, was found to be
responsible for 47 meningitis deaths across 19 states due to
its sale of a contaminated injectable steroid. That pharmacy
was primarily regulated by the Massachusetts Board of
Pharmacy, with concurrent authority by the FDA. NECC
surrendered its license to the Massachusetts Board of
Pharmacy, but BOP lacked authority to immediately revoke
NECC's license.
3)Related legislation . SB 294 (Emmerson) eliminates the
exemption from BOP inspection for accredited sterile
compounding pharmacies, including nonresident pharmacies, and
requires nonresident sterile compounding pharmacies to pay
appropriate travel expenses for staff. It also requires
sterile compounding pharmacies to report additional safety
information to BOP and requires pharmacies to report any
adverse effects due to a pharmacy's sterile drug product to
the FDA's MedWatch program. SB 294 is currently pending on the
Senate Appropriations Committee Suspense File.
Analysis Prepared by : Debra Roth / APPR. / (916) 319-2081