CONTINUEDCALIFORNIA STATE BOARD OF PHARMACY
• California took an aggressive leadership role in
requiring the pharmaceutical track-and-trace program
for all prescription medication provided to patients in
California, and passed E-pedigree. E-pedigree was
preempted by Federal legislation in late 2014 in favor
of the national system to be built over the next 10
years. E-pedigree had been in the works for 10 years
and requirements would have been effective starting
in 2015. The goal of track-and-trace programs is to
ensure the integrity of the pharmaceutical products
sold in the United States and protect consumers
against counterfeits, adulterated, misbranded, or
outdated drugs. The Board’s law was instrumental in
the enactment of the Federal requirements.
MAJOR NEW LEGISLATION OR REGULATIONS
• Senate Bill 294, Emmerson (Chapter 565, Statutes of
2013), helps ensure patients receive safe medications
by prohibiting a pharmacy from compounding sterile
drug products for injection, administration into the
eye, or inhalation unless the pharmacy has obtained
a sterile compounding pharmacy license from the
Board. Compounding pharmacies will also be subject
to random, annual inspections by the Board, and
be required to report to the Board any disciplinary
or regulatory action taken against the pharmacy by
another state within 10 days and any recall notice
within 12 hours.
• Assembly Bill 1045, Quirk-Silva (Chapter 302,
Statutes of 2013), requires a pharmacy issuing a
recall notice regarding a sterile compounded drug
to contact the recipient pharmacy, prescriber, or
patient and the Board about the recalled drug within
12 hours if use of or exposure to the recalled drug
may cause serious adverse health consequences
or death, and revokes the license of a nonresident
sterile compounding pharmacy if its license is
canceled, revoked, or suspended for any reason in its
home state.
• SB 493, Hernandez (Chapter 469, Statutes of 2013),
creates an advanced practice pharmacist classification
that will allow pharmacists, with proper training,
to greater assist in serving patients as healthcare
providers. The new law allows pharmacists who
receive training, are in a pharmacy setting, and meet
additional requirements, to administer biological
products that have been ordered by a prescriber;
provide self-administered hormonal contraceptives;
and provide training and education to patients about
drug therapy, disease management and prevention;
nicotine replacement products; non-diagnosis
requiring drugs for travelers going outside of the
United States. Pharmacist can also order and monitor
tests to manage the efficacy and toxicity of drug
therapies; perform physical assessments; order and
interpret medication-related tests; refer patients
to other providers; initiate, adjust, and discontinue
medications under physician protocol or as part of an
integrated system such as an ACO; and participate in
the evaluation and management of health conditions
in collaboration with other providers; to independently
initiate and administer vaccines listed on the routine
immunization; and initiate and administer epinephrine
or diphenhydramine by injection for the treatment of
severe allergic reaction.
• AB 1136, Levine (Chapter 304, Statutes of 2013),
requires a pharmacist to determine that if a drug,
when taken by itself or when combined with alcohol,
may impair a person’s ability to operate a vehicle or
vessel. If so, the pharmacist shall include a written
ancillary label on the prescription container indicating
that the drug may impair a person’s ability to operate
a vehicle or vessel.
• E-pedigree, the Board’s track-and-trace program
2013 / 14 ANNUAL REPORT
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