Rule Regarding Patient-Centered Labels for Prescription Drugs Now in Effect in California

The new rule in California provides:


1707.5. Patient-Centered Labels for Prescription Drug
Containers; Requirements
(a) Labels on drug containers dispensed to patients in California
shall conform to the following format:
(1) Each of the following items shall be clustered into one
area of the label that comprises at least 50 percent of the
label. Each item shall be printed in at least a 10-point
sans serif typeface or, if requested by the consumer, at
least a 12-pooint typeface, and listed in the following
order:
(A) Name of the patient
(B) Name of the drug and strength of the drug. For the
purposes of this section, “name of the drug” means
either the manufacturer’s trade name of the drug, or
the generic name and the name of the manufacturer.
(C) The directions for the use of the drug.
(D) The condition or purpose for which the drug was
prescribed if the condition or purpose is indicated
on the prescription.
(2) For added emphasis, the label shall also highlight in
bold typeface or color, or use blank space to set off the
items listed in subdivision (a)(1).
(3) The remaining required elements for the label specified
in section 4076 of the Business and Professions Code,
as well as any other items of information appearing on
the label or the container, shall be printed so as not to
interfere with the legibility or emphasis of the primary
elements specified in paragraph (1) of subdivision (a).
These additional elements may appear in any style, font,
and size typeface.

To read remainder of new rule, click here.