California Code of Regulations
Title 16 - Professional and Vocational Regulations
Division 17 - California State Board of Pharmacy
Article 2 - Pharmacies
Section 1707.5 - Patient-Centered Labels for Prescription Drug Containers; Requirements
Current through Register 2024 Notice Reg. No. 12, March 22, 2024
(a) Labels on drug containers dispensed to patients in California shall conform to the following format:
(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.
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.