BILL ANALYSIS
AB 2077
Page 1
ASSEMBLY THIRD READING
AB 2077 (Solorio)
As Amended May 10, 2010
Majority vote
BUSINESS & PROFESSIONS 9-1 APPROPRIATIONS 16-0
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|Ayes:|Hayashi, Emmerson, |Ayes:|Fuentes, Conway, |
| |Conway, Eng, | |Bradford, |
| |Hernandez, Hill, Ma, | |Charles Calderon, Coto, |
| |Niello, Smyth | |Davis, |
| | | |De Leon, Hall, Harkey, |
| | | |Miller, Nielsen, Norby, |
| | | |Skinner, Solorio, |
| | | |Torlakson, Torrico |
|-----+--------------------------+-----+--------------------------|
|Nays:|Ruskin | | |
| | | | |
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SUMMARY : Permits a hospital pharmacy to compound or repackage
drugs for other hospitals and pharmacies under common ownership.
Specifically, this bill :
1)Expands the definition of hospital pharmacy to include a
pharmacy not on the premises of a hospital, but regulated
under that hospital's license.
2)Creates an exemption from the definition of "manufacturer" for
a pharmacy compounding or repackaging a drug for parenteral
therapy or oral therapy in a hospital for delivery to another
pharmacy or hospital for the purpose of dispensing or
administering the drug, pursuant to a prescription or order,
to the patient or patients named in the prescription or order.
3)Makes legislative findings and declarations.
EXISTING LAW :
1)Provides for the licensure and regulation of pharmacies,
including hospital pharmacies, by the Board of Pharmacy (BOP).
AB 2077
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2)Prohibits the operation of a pharmacy without a license, and
requires a separate license for each pharmacy location.
3)Restricts a hospital pharmacy to providing pharmaceutical
services to registered hospital patients on the premises of
the same physical plant in which the pharmacy is located.
4)Provides that a knowing violation of the Pharmacy Law is a
crime.
FISCAL EFFECT : According to the Assembly Appropriations
Committee analysis, minor absorbable workload to the California
Board of Pharmacy to continue oversight of hospital-based
pharmacies.
COMMENTS : According to the author's office, "Current law
attempts to separate the regulation of pharmacies, on the one
hand, from drug manufacturers or repackagers, on the other. The
regulation of manufacturers and repackagers is based on the
premise of broad-scale commercial operations. Pharmacies, in
particular, hospitals pharmacies, are regulated on the basis of
the safe delivery of medication to inpatients. However, the
laws governing hospital pharmacies mandate that the pharmacy be
on the physical site of the hospital. In order to do the same
activity that can be performed by a hospital pharmacy now, but
in a location off the hospital campus, the laws governing
manufacturing and repackaging are impacted.
"Hospitals attempting to automate and use cutting edge
technology require an economy of scale in order to improve
patient safety and reduce medication errors. By allowing
hospitals under common ownership to use a centralized pharmacy
regulated like a pharmacy enables these hospitals to afford the
technology that will enhance patient safety by reducing errors."
Current law restricts a hospital pharmacy to providing
"pharmaceutical services only to registered hospital patients
who are on the premises of the same physical plant in which the
pharmacy is located." This bill would allow a single hospital
pharmacy to prepare compounded drugs, repackage and prepare unit
dose packages and compounded unit dose drugs for single
administration to patient populations of multiple hospitals
under common ownership.
AB 2077
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Repackaging, distribution, and compounding in advance of a
patient prescription are activities currently available only to
licensed manufacturers, which are regulated by the United States
Food and Drug Administration (FDA). This bill seeks an
exemption from federal regulation on account of the relatively
small scale of production. Communications from FDA indicate
they are comfortable allowing the state to regulate this level
of manufacturing. The FDA states "[the proposed health facility
pharmacy] system does not need to register as a
repacker/relabler as long as they are servicing their own
hospitals within the state of California and repackaged drugs
are not commercially distributed and used only within your
hospital facilities."
These hospital pharmacies would be regulated by the BOP and
subject to all applicable pharmacy laws and regulations, and
compounding and pedigree requirements.
Analysis Prepared by : Sarah Weaver / B.,P. & C.P. / (916)
319-3301
FN: 0004255