BILL ANALYSIS Ó
AB 1045
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CONCURRENCE IN SENATE AMENDMENTS
AB 1045 (Quirk-Silva)
As Amended June 19, 2013
Majority vote
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|ASSEMBLY: |74-0 |(May 23, 2013) |SENATE: |37-0 |(August 19, |
| | | | | |2013) |
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Original Committee Reference: B.,P. & C.P.
SUMMARY : Requires a recipient pharmacy, prescriber, or patient
of a recalled drug and the California Board of Pharmacy (BOP) to
be notified within 12 hours of a recall notice for a sterile
compounded drug, and requires the automatic suspension,
cancellation, or revocation of a California pharmacy license if
an out-of-state pharmacy's home state license is suspended,
cancelled, or revoked.
The Senate amendments :
1)State that a pharmacy must notify a recipient pharmacy,
prescriber, or patient of a recalled drug and BOP as soon as
possible within 12 hours of notice of a recall, as specified;
and,
2)Authorize BOP to cancel a nonresident pharmacy registration if
the home state pharmacy license is cancelled.
3)Make technical changes.
FISCAL EFFECT : According to the Senate Appropriations
Committee, pursuant to Senate Rule 28.8, negligible state costs.
COMMENTS :
1)Sterile compounding pharmacy problems . 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.
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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
injection, via eye drops, or inhaled, and so it is exceedingly
important these drugs 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 asked by hospitals and health care providers to
help address drug shortages. According to the 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 was unable to immediately revoke NECC's
licensed based on its Massachusetts license.
2)Minimal federal regulation of compounding pharmacies . The FDA
regards traditional pharmacy compounding as the combining or
altering of ingredients by a licensed pharmacist, in response
to a licensed practitioner's prescription for an individual
patient. FDA regulates compounding only if it rises in scale
to the level of manufacturing, but that threshold is not
precisely defined.
Although compounding originated as patient-specific drug
modification, federal law does not prohibit anticipatory
compounding (compounding in advance of a prescription) or the
compounding of drugs that are essentially copies of
FDA-approved drugs. Doctors and hospitals are increasingly
turning to compounding pharmacies to meet their patients' drug
needs because of shortages caused by diminishing production of
generics and the lower prices charged by compounders. As a
result, some compounding pharmacies have been producing far
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larger quantities of products than the FDA guidelines might
permit. This occurs in large part because of a lack of
clarity as to how much production constitutes "manufacturing"
requiring federal oversight.
This ambiguity leaves primary regulation of small to medium
scale compounding pharmacies to the states.
3)California regulation of compounding pharmacies . California
currently has some of the most comprehensive laws and
regulations for compounding pharmacies in the nation. In the
last decade, BOP developed its own sterile injectable
compounding requirements and created a licensing system for
resident and nonresident (out-of-state) sterile injectable
compounding facilities. Even with these protections, however,
the NECC product contamination affected California because
California generally relies on the pharmacy's home regulator,
the FDA, and private accreditors to certify safety in
out-of-state pharmacies, none of which acted on multiple
warnings in the NECC case. The BOP issued a cease and desist
order to NECC on October 4, 2012, following notice of the
outbreak so NECC could no longer ship product into the state,
but BOP could not act immediately to revoke or suspend its
license.
Currently, BOP must go through an extensive process to suspend
or revoke a license. BOP is required to compile an
investigation report that substantiates serious violations of
law, and then transfer the report and evidence to Attorney
General's office, which prepares and serves an accusation on
the pharmacy. If the pharmacy does not respond, the license
is cancelled by a default decision. If a statement of defense
is filed, BOP will attempt to settle the case with a
stipulation that may include a cessation of shipping into the
state, or go to hearing to obtain a proposed decision from an
administrative law judge to stop shipments. The stipulation
or proposed decision must be approved by BOP. Once approved
by board vote, the decision generally takes effect in 30 days.
This entire process usually takes about two to three years.
This bill would immediately suspend, cancel, or revoke an
out-of-state pharmacy's California license by operation of law
based on the suspension, cancellation, or revocation of its
home state license.
4)Drug recalls . Recall is a voluntary process. Drug recalls
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for tainted products or inappropriate labeling may be
undertaken voluntarily and at any time by manufacturers,
compounders, or distributors, or at the FDA's request.
However, since a recall is voluntary, the FDA has no authority
to impose or seek sanctions for an entity's refusal to carry
out the recall. FDA may institute legal action respecting the
underlying violation that led to FDA's request, but this is
not usually necessary. There have been eight recalls of
sterile compounded drugs nationwide since the beginning of
2013.
FDA has issued industry guidelines for recalls, and in the
event of a recall works with the recalling entity to develop
an effective strategy. After an entity decides to recall its
product and notifies the FDA, it is the entity's own
responsibility to monitor the progress of the recall. In some
cases where it is more difficult for an entity to institute a
recall at the consumer level, the FDA, state and local
agencies will assist.
BOP currently requires pharmacies to subscribe to BOP's
mailing list, and BOP sends licensees notifications from FDA
on recalled drugs. BOP currently works with pharmacies to
appropriately notify and remove recalled products and alert
consumers. There are no California statutory provisions
guiding this process, however.
This bill aims to codify best practices for sterile compounded
drug recalls. This bill would require a California or
nonresident pharmacy that issues a recall notice for a sterile
compounded drug to contact the pharmacy, prescriber, or
patient who received the recalled drug and the BOP as soon as
possible within 12 hours of the recall notice if use of or
exposure to the recalled drug may cause serious adverse health
consequences or death. BOP has existing authority to develop
any regulations that may be necessary to implement this bill.
Analysis Prepared by : Sarah Huchel / B.,P. & C.P. / (916)
319-3301
FN: 0001665
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