Cal. Code Regs. Tit. 16, § 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, 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.

(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.

(4) When applicable, directions for use shall use one of the following phrases:

(A) Take 1 [insert appropriate dosage form] at bedtime

(B) Take 2 [insert appropriate dosage form] at bedtime

(C) Take 3 [insert appropriate dosage form] at bedtime

(D) Take 1 [insert appropriate dosage form] in the morning

(E) Take 2 [insert appropriate dosage form] in the morning

(F) Take 3 [insert appropriate dosage form] in the morning

(G) Take 1 [insert appropriate dosage form] in the morning, and Take 1 [insert appropriate dosage form] at bedtime

(H) Take 2 [insert appropriate dosage form] in the morning, and Take 2 [insert appropriate dosage form] at bedtime

(I) Take 3 [insert appropriate dosage form] in the morning, and Take 3 [insert appropriate dosage form] at bedtime

(J) Take 1 [insert appropriate dosage form] in the morning, 1 [insert appropriate dosage form] at noon, and l [insert appropriate dosage form] in the evening

(K) Take 2 [insert appropriate dosage form] in the morning, 2 [insert appropriate dosage form] at noon, and 2 [insert appropriate dosage form] in the evening

(L) Take 3 [insert appropriate dosage form] in the morning, 3 [insert appropriate dosage form] at noon, and 3 [insert appropriate dosage form] in the evening

(M) Take 1 [insert appropriate dosage form] in the morning, 1 [insert appropriate dosage form] at noon, 1 [insert appropriate dosage form] in the evening, and 1 [insert appropriate dosage form] at bedtime

(N) Take 2 [insert appropriate dosage form] in the morning, 2 [insert appropriate dosage form] at noon, 2 [insert appropriate dosage form] in the evening, and 2 [insert appropriate dosage form] at bedtime

(O) Take 3 [insert appropriate dosage form] in the morning, 3 [insert appropriate dosage form] at noon, 3 [insert appropriate dosage form] in the evening, and 3 [insert appropriate dosage form] at bedtime

(P) If you have pain, take ___ [insert appropriate dosage form] at a time. Wait at least ___ hours before taking again. Do not take more than ___ [appropriate dosage form] in one day

(b) By October 2011, and updated as necessary, the board shall publish on its Web site translation of the directions for use listed in subdivision (a)(4) into at least five languages other than English, to facilitate the use thereof by California pharmacies.

(c) The board shall collect and publish on its Web site examples of labels conforming to these requirements, to aid pharmacies in label design and compliance.

(d) The pharmacy shall have policies and procedures in place to help patients with limited or no English proficiency understand the information on the label as specified in subdivision (a) in the patient's language. The pharmacy's policies and procedures shall be specified in writing and shall include, at minimum, the selected means to identify the patient's language and to provide interpretive services and translation services in the patient's language. The pharmacy shall, at minimum, provide interpretive services in the patient's language, if interpretive services in such language are available, during all hours that the pharmacy is open, either in person by pharmacy staff or by use of a third-party interpretive service available by telephone at or adjacent to the pharmacy counter.

(e) As used in this section, "appropriate dosage form" includes pill, caplet, capsule or tablet.

Notes

Cal. Code Regs. Tit. 16, § 1707.5

1. New section filed 11-17-2010; operative 1-1-2011 pursuant to Government Code section 11343.4(b) (Register 2010, No. 47).
2. Amendment of subsection (a)(1) filed 1-8-2015; operative 4-1-2015 (Register 2015, No. 2).
3. Amendment of subsection (a)(1)(B), new subsections (a)(1)(B)(i)-(ii), amendment of subsection (d), repealer of subsection (e) and subsection relettering filed 3-2-2017; operative 7-1-2017 (Register 2017, No. 9).

Note: Authority cited: Sections 4005 and 4076.5, Business and Professions Code. Reference: Sections 4005, 4076 and 4076.5, Business and Professions Code.

1. New section filed 11-17-2010; operative 1-1-2011 pursuant to Government Code section 11343.4(b) (Register 2010, No. 47).
2. Amendment of subsection (a)(1) filed 1-8-2015; operative 4/1/2015 (Register 2015, No. 2).
3. Amendment of subsection (a)(1)(B), new subsections (a)(1)(B)(i)-(ii), amendment of subsection (d), repealer of subsection (e) and subsection relettering filed 3-2-2017; operative 7/1/2017 (Register 2017, No. 9).