BILL ANALYSIS Ó
AB 1045
Page 1
Date of Hearing: April 30, 2013
ASSEMBLY COMMITTEE ON BUSINESS, PROFESSIONS AND CONSUMER
PROTECTION
Richard S. Gordon, Chair
AB 1045 (Quirk-Silva) - As Amended: April 22, 2013
SUBJECT : Sterile compounding pharmacies.
SUMMARY : 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 California pharmacy
license if an out-of-state pharmacy's home state license is
suspended or revoked. Specifically, this bill :
1)Suspends or revokes by operation of law a nonresident pharmacy
license or a nonresident sterile compounding license if the
pharmacy's home state license is suspended or revoked for any
reason.
2)Requires a California or nonresident pharmacy that issues a
recall notice for a sterile compounded drug to contact the
recipient pharmacy, prescriber, or patient of the recalled
drug and the California Board of Pharmacy (BOP) within 24
hours of the recall notice if both of the following apply:
a) Use of or exposure to the recalled drug may cause
serious adverse health consequences or death; and,
b) The recalled drug was dispensed, or is intended for use,
in this state.
3)Requires the recall notice to be made as follows:
a) If the recalled drug was dispensed directly to the
patient, the notice shall be made to the patient;
b) If the recalled drug was dispensed directly to the
prescriber, the notice shall be made to the prescriber, who
shall ensure the patient is notified; or,
c) If the recalled drug was dispensed directly to a
pharmacy, the notice shall be made to the pharmacy, who
shall notify the prescriber or patient, as appropriate. If
the pharmacy notifies the prescriber, the prescriber shall
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ensure the patient is notified.
4)States that no reimbursement is required by this bill pursuant
to Section 6 of Article XIIIB 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 XIIIB of the California Constitution.
EXISTING STATE LAW :
1)Establishes BOP to regulate the Pharmacy Law. (Business and
Professions Code (BPC) Section 4000 et seq.)
2)Permits BOP to adopt rules and regulations as may be necessary
for the protection of the public. (BPC 4005 (a))
3)Requires a pharmacy outside California that ships, mails, or
delivers, in any manner, controlled substances, dangerous
drugs, or dangerous devices into this state to obtain a
nonresident pharmacy license from BOP. (BPC 4112)
4)Requires a nonresident pharmacy that compounds injectable
sterile drug products for shipment into California to obtain a
nonresident sterile compounding license from BOP. (BPC
4127.2)
5)Automatically suspends a pharmacist's California license if
the pharmacist's license is suspended or revoked by another
state or by an agency of the federal government. (BPC 4301.5)
6)States that if a dangerous drug is alleged to be adulterated
or counterfeit, BOP shall commence condemnation proceedings in
superior court. (BPC 4085)
EXISTING FEDERAL LAW :
1)Establishes guidelines for recalling drugs. (21 Code of
Federal Regulations (CFR) Part 7)
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2)States that recall is an effective method of removing or
correcting consumer products that are in violation of laws
administered by the Food and Drug Administration (FDA). Recall
is a voluntary action related to a manufacturer's duty to
protect the public from products that present a risk of
injury, gross deception, or are otherwise defective. (21 CFR
7.40(a))
3)States that a drug recall is an alternative to a FDA initiated
court action for removing or correcting violative products in
distribution by setting forth specific recall procedures to
monitor recalls and assess the adequacy of a firm's recall
efforts. (21 CFR 7.40(a))
FISCAL EFFECT : Unknown
COMMENTS :
1)Purpose of this bill . This bill automatically suspends or
revokes an out-of-state pharmacy's California license if its
home state license is revoked or suspended, and codifies
industry best practices by requiring 24 hour notice in the
event of a sterile compounded drug recall. These measures are
intended to address gaps in the existing system of federal and
state pharmacy regulation after a nationwide meningitis
outbreak killing 47 people was traced back to problems with a
Massachusetts compounding pharmacy. This bill is author
sponsored.
2)Author's statement . According to the author's office, "AB
1045 takes preventative measures to ensure patients are
immediately notified of any serious public health risks, or
safety recalls, of drugs being made at a compound pharmacy. In
light of the devastating deaths of 47 people across 19 states
due to the sale of a contaminated injectable steroid made at a
compounding pharmacy in Massachusetts, it is important that
these contaminations are contained and everything is properly
handled by everyone involved. With a state as large as
California, it is imperative that we take precautionary
measure to ensure that the 93 nonresident licensed sterile
injectable compounding pharmacies are also doing everything
they can to keep our citizens aware of any serious adverse
health consequences or deaths that can be caused by any drugs.
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This bill is a common sense measure that gives the state of
California the authority to protect the consumers that may be
harmed by receiving a drug made by a compounding pharmacy."
3)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.
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 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.
4)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.
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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
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.
5)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
AB 1045
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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 2-3 years. This bill
would immediately suspend or revoke an out-of-state pharmacy's
California license by operation of law based on the suspension
or revocation of its home state license.
6)Drug recalls . Recall is a voluntary process. Drug recalls 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 8 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 within 24
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.
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7)Related legislation . SB 294 (Emmerson) would eliminate the
exemption from BOP inspection for accredited sterile
compounding pharmacies, including for nonresident pharmacies,
and require nonresident sterile compounding pharmacies to pay
appropriate travel expenses for staff. It would also require
sterile compounding pharmacies to report additional safety
information to the Board and require 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 in
the Senate Appropriations Committee.
REGISTERED SUPPORT / OPPOSITION :
Support
None on file.
Opposition
None on file.
Analysis Prepared by : Sarah Huchel / B.,P. & C.P. / (916)
319-3301