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New California Requirements on Labels for Prescription Drug Containers

Under regulation § 1707.5, California is making changes to its label requirements for prescription drug containers dispensed to patients in the state.

The amended rules state:

(a) Labels on drug containers dispensed to patients in California shall conform to the following format:

(1) Each of the following items, and only these four 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 12-point sans serif 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 statement “generic for _____” where the brand name is inserted, and the name of the manufacturer. In the professional judgment of the pharmacist,

(i) If the brand name is no longer widely used, the label may list only the generic name of the drug, and

(ii) The manufacturer’s name may be listed outside of the patient-centered area.

(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.

Assistance and Support: You can review the state’s complete Order of Adoption here. For questions about the regulations, go to http://www.pharmacy.ca.gov/about/contact_us.shtml for complete information on contacting the California Board of Pharmacy.

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