BILL ANALYSIS Ó
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|SENATE RULES COMMITTEE | AB 1045|
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THIRD READING
Bill No: AB 1045
Author: Quirk-Silva (D)
Amended: 6/19/13 in Senate
Vote: 21
SENATE BUSINESS, PROF. & ECON. DEVELOP. COMM. : 10-0, 6/17/13
AYES: Lieu, Emmerson, Block, Corbett, Galgiani, Hernandez,
Hill, Padilla, Wyland, Yee
SENATE APPROPRIATIONS COMMITTEE : Senate Rule 28.8
ASSEMBLY FLOOR : 74-0, 5/23/13 (Consent) - See last page for
vote
SUBJECT : Sterile compounding and nonresident pharmacies
SOURCE : Author
DIGEST : This bill requires patients to be notified as soon as
possible within 12 hours of a recall notice for a sterile
compounded drug, and requires the automatic cancellation,
suspension, or revocation of a California pharmacy license if an
out-of-state pharmacy's home state license is canceled,
suspended, or revoked.
ANALYSIS :
Existing law:
1. Provides for the practice of pharmacy and the licensing and
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regulation of pharmacies and pharmacists by the Board of
Pharmacy (Board); and authorizes the Board inspectors to
inspect all pharmacies, wholesalers, dispensaries, stores or
places where drugs or devices are compounded, prepared,
furnished, dispensed or stored.
2. Defines "manufacturer" as every person who prepares, derives,
produces, compounds or repackages any drug or device except a
pharmacy that manufactures on the immediate premises where
the drug or device is sold to the ultimate consumer; and
specifies what "manufacturer" means and does not mean.
3. Prohibits an out-of-state pharmacy from selling or
distributing dangerous drugs or devices in California through
any other method than a Board-licensed wholesaler, unless the
out-of-state pharmacy is licensed by the Board.
4. States that any pharmacy that contracts to compound a drug
for parenteral therapy, pursuant to a prescription, for
delivery to another pharmacy, must report that contractual
arrangement to the Board within 30 days of commencing that
compounding.
5. Requires the Board to adopt regulations establishing
standards for compounding injectable sterile drug products
(sterile injectables) in a pharmacy; and clarifies that a
pharmacy cannot compound sterile injectables unless the
pharmacy is licensed by the Board.
6. Authorizes the Board to issue a cease and desist order to a
pharmacy compounding sterile injectables whenever the Board
has reasonable belief, based on information obtained through
an investigation or inspection, that there is an immediate
threat to public health or safety.
7. Allows a centralized hospital packaging pharmacy to prepare
medications for administration only to inpatients within its
own general acute care hospital, and one or more general
acute care hospitals, if the hospitals are under common
ownership and located within a 75-mile radius of each other.
Requires a centralized hospital packaging pharmacy to obtain
a specialty license from the Board. Clarifies that all
compounding functions shall only be performed in the licensed
centralized hospital pharmacy.
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8. Grants the Board certain enforcement abilities against
out-of-state pharmacies, authorizes the Board to report
actions against an out-of-state pharmacy and authorizes the
Board to take any action against an out-of-state pharmacy
that it would against a pharmacy in this state if the grounds
for action are also grounds for action in the state in which
the out-of-state pharmacy is permanently located.
This bill:
1. Provides that a pharmacy licensed by the Board to compound
injectable sterile drug products in this state, or an
out-of-state pharmacy that compounds sterile drug products
for shipment into the state of California and licensed by the
Board, which issues a recall notice regarding a sterile
compounded drug shall, in addition to any other duties,
contact the recipient pharmacy, prescriber or patient of the
recalled drug and the Board as soon as possible within 12
hours of the recall notice if both of the following apply:
A. Use or exposure to the recalled drug may cause
serious adverse health consequences or death.
B. The recalled drug was dispensed, or is intended for
use, in California.
2. Provides that the recall notice shall be made according to
the following:
A. If the recalled drug was dispensed directly to the
patient, the recall notice shall be made to the patient.
B. If the recalled drug product was dispensed directly
to the prescriber, the recall notice shall be made to
the prescriber who shall ensure the patient is notified.
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 ensure the patient is notified.
3. Provides that if the home state license of an out-of-state
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pharmacy also licensed by the Board is canceled, revoked, or
suspended for any reason, the license issued by the Board
shall be immediately canceled, revoked, or suspended by
operation of law.
Background
The current regulatory framework . Under the current regulatory
system, drug manufacturers are regulated by the federal Food and
Drug Administration (FDA). Compounding organizations are
regulated by their respective states of residence. Compounding
organizations also make drugs, but they are limited to producing
small amounts in response to a specific patient's prescription,
or to create a small supply for an identifiable patient
population to ensure continuity of treatment. The
state-by-state approach to regulating compounding organizations
yields inconsistent standards and varying levels of enforcement
on an industry that ships dangerous drugs across state lines.
FDA Oversight
The FDA's oversight authority is limited, and according to the
agency, is not the right fit to provide appropriate and
efficient oversight of the growing compounding industry. The
FDA is currently working with states to inspect certain
state-licensed pharmacies that produce sterile drug products
that the FDA believes may present the highest risk. However,
even during this time of heightened awareness, FDA inspectors
are being delayed in their work or denied full access to records
at some of the facilities they are inspecting.
It is possible that regulation may occur at the federal level,
pre-empting state law on this issue. The FDA has been working
with Congress to craft legislation authorizing increased federal
oversight of compounding pharmacies. The FDA asserts that there
should be minimum federal standards for firms that compound
sterile drug products in advance of or without a prescription
and ship them interstate. The FDA also wants clear authority to
proactively inspect pharmacies to determine the scope and nature
of their operations.
New regulations governing compounding took effect last summer.
According to the Board, a Workgroup on Compounding was formed in
2004 comprised of board members, board staff and industry
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representatives. The workgroup recognized that current pharmacy
regulations addressing compounding only govern the physical
circumstances, procedures and record keeping requirements for
general compounding and do not address quality, strength or
purity.
The Board adopted regulations in Article 7 of Division 17 of
Title 16 of the California Code of Regulations (commencing with
Section 1751) to implement provisions for pharmacies that
compound sterile injectable products as required in statute. As
there were no similar provisions in regulation for general
compounding, the Board approved the addition of language that
will establish parameters and provide uniformity for pharmacies
that carry out compounding in general (including sterile
injectable). Pharmacies that compound sterile injectable
products must now go above and beyond the requirements for
compounding in general.
Subsequent to that workgroup activity, in response to patient
deaths and recalls due to contaminated compounded drugs, the
Board recently formed a Compounding Sub-Committee to address the
issues unique to effectively regulating compounding pharmacies
located in or shipping into this state. The Sub-Committee's
first meeting occurred on March 15, 2013. The Compounding
Sub-Committee is responsible for shaping the Board's future
changes to its regulations on compounding pharmacies.
Comments
According to the author's office, this bill protects patients
from drugs made by compound pharmacies that may cause serious
adverse health consequences or death by codifying the proper
procedure to ensure patients are safe.
According to information provided by the author's office,
California requires pharmacies that compound sterile injectable
drug products to have a special license. Currently, there are
286 licensed sterile injectable compounding pharmacies in
California, and 93 licensed sterile injectable compounding
pharmacies operating in another state. The author's office
states that California has some of the most comprehensive laws
and regulations for compounding pharmacies in the nation, and in
the last decade, the Board developed its own sterile injectable
compounding requirements, and created a licensing system for
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sterile injectable compounding facilities in California and in
other states.
The author's office states that even with these protections, the
recent New England Compounding Center (NECC) product
contamination of 2012 affected California because California
relies on the pharmacy's home regulator, the FDA, and private
accreditors to certify safety in out-of-state pharmacies; none
of which acted after receiving multiple warnings.
Later on October 4, 2012, the Board issued a cease and desist
order to NECC following notice of the fungal outbreak so NECC
could no longer ship products into the state. However, if the
Board had the authority, the Board would have also revoked or
suspended the California license, in addition to obtaining the
cease and desist order.
FISCAL EFFECT : Appropriation: No Fiscal Com.: Yes
Local: Yes
SUPPORT : (Verified 7/2/13)
California Senior Legislature
California Society of Health-System Pharmacists
California State Board of Pharmacy
ARGUMENTS IN SUPPORT : According to supporters, this bill
takes preventive measures to ensure that patients are
immediately notified of any serious public health risks or
safety recalls of drugs from compounding pharmacies.
ASSEMBLY FLOOR : 74-0, 5/23/13
AYES: Achadjian, Alejo, Allen, Ammiano, Atkins, Bigelow, Bloom,
Blumenfield, Bocanegra, Bonilla, Bonta, Bradford, Brown,
Buchanan, Ian Calderon, Campos, Chau, Chávez, Chesbro, Conway,
Cooley, Dahle, Daly, Dickinson, Donnelly, Eggman, Fong, Fox,
Frazier, Beth Gaines, Garcia, Gatto, Gomez, Gordon, Gorell,
Gray, Hagman, Hall, Harkey, Roger Hernández, Jones-Sawyer,
Levine, Linder, Logue, Lowenthal, Maienschein, Mansoor,
Medina, Melendez, Mitchell, Morrell, Mullin, Muratsuchi,
Nazarian, Nestande, Olsen, Pan, Patterson, Perea, V. Manuel
Pérez, Quirk, Quirk-Silva, Rendon, Salas, Skinner, Stone,
Ting, Wagner, Weber, Wieckowski, Wilk, Williams, Yamada, John
A. Pérez
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NO VOTE RECORDED: Grove, Holden, Jones, Waldron, Vacancy,
Vacancy
MW:d 7/2/13 Senate Floor Analyses
SUPPORT/OPPOSITION: SEE ABOVE
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