California Legislature—2015–16 Regular Session

Assembly Bill No. 1073

Introduced by Assembly Member Ting

February 27, 2015

An act to amend Section 4076.5 of the Business and Professions Code, relating to pharmacy.

LEGISLATIVE COUNSEL’S DIGEST

AB 1073, as introduced, Ting. Pharmacy: prescription drug labels.

The Pharmacy Law provides for the licensure and regulation of pharmacists by the California State Board of Pharmacy. That law requires the board to promulgate regulations that require, on or before January 1, 2011, a standardized, patient-centered, prescription drug label on all prescription medicine dispensed to patients in California. Existing regulations of the board implement that requirement.

This bill would remove that obsolete date.

Vote: majority. Appropriation: no. Fiscal committee: no. State-mandated local program: no.

The people of the State of California do enact as follows:

SECTION 1.  

Section 4076.5 of the Business and Professions
Code is amended to read:

4076.5.  

(a) The board shall promulgate regulations that begin delete require,
on or before January 1, 2011, end delete begin insert require end insert a standardized,
patient-centered, prescription drug label on all prescription
medicine dispensed to patients in California.

(b) To ensure maximum public comment, the board shall hold
public meetings statewide that are separate from its normally
scheduled hearings in order to seek information from groups
representing consumers, seniors, pharmacists or the practice of
pharmacy, other health care professionals, and other interested
parties.

(c) When developing the requirements for prescription drug
labels, the board shall consider all of the following factors:

(1) Medical literacy research that points to increased
understandability of labels.

(2) Improved directions for use.

(3) Improved font types and sizes.

(4) Placement of information that is patient-centered.

(5) The needs of patients with limited English proficiency.

(6) The needs of senior citizens.

(7) Technology requirements necessary to implement the
standards.

(d) The board may exempt from the begin delete requirements of end delete regulations
promulgated pursuant to subdivision (a) prescriptions dispensed
to a patient in a health facility, as defined in Section 1250 of the
Health and Safety Code, if the prescriptions are administered by
a licensed health care professional. Prescriptions dispensed to a
patient in a health facility that will not be administered by a
licensed health care professional or that are provided to the patient
upon discharge from the facility shall be subject to begin delete the requirements
of end delete this section and the regulations promulgated pursuant to
subdivision (a). Nothing in this subdivision shall alter or diminish
existing statutory and regulatory informed consent, patients’ rights,
or pharmaceutical labeling and storage requirements, including,
but not limited to, begin delete the requirements of end delete Section 1418.9 of the Health
and Safety Code or Section 72357, 72527, or 72528 of Title 22 of
the California Code of Regulations.

(e) (1) The board may exempt from the begin delete requirements of end delete
regulations promulgated pursuant to subdivision (a) a prescription
dispensed to a patient if all of the following apply:

(A) The drugs are dispensed by a JCAHO-accredited home
infusion or specialty pharmacy.

(B) The patient receives health-professional-directed education
begin delete prior to end delete begin insert before end insert the beginning of therapy by a nurse or pharmacist.

(C) The patient receives weekly or more frequent followup
contacts by a nurse or pharmacist.

(D) Care is provided under a formal plan of care based upon a
physician and surgeon’s orders.

(2) For purposes of paragraph (1), home infusion and specialty
therapies include parenteral therapy or other forms of
administration that require regular laboratory and patient
monitoring.