N.Y. Comp. Codes R. & Regs. tit. 8 § 63.12

Current through Register Vol. 46, No. 39, September 25, 2024

Section 63.12 - Standardized patient-centered data elements to be used on all drug labels

In accordance with section 6830 of the Education Law, all prescription medicine dispensed to patients in this State must include standardized patient-centered data elements as prescribed by in this section.

(a) Definitions. As used in this section:

(1) Critical elements shall consist of:

(i) patient name;

(ii) directions for use by the patient, which directions shall be structured in full sentences; and

(iii) drug name and strength.

(2) Important elements shall consist of:

(i) name, address and telephone number of the pharmacy;

(ii) patient's address;

(iii) name of prescriber;

(iv) the date of filling or refilling of the prescription; and

(v) the prescription number or other identifying number assigned to the prescription.

(b) All prescription drug labels shall contain all of the critical elements and all of the important elements.

(1) Critical elements of each prescription label shall be:

(i) emphasized by being highlighted in color, in bold type, or both; and

(ii) printed in a minimum of a 12-point font.

(2) Important elements of each prescription label and any other information contained on the label shall not be highlighted in color or in bold type, shall be legible and shall not be presented in a fashion that undermines the emphasis on the critical elements.

N.Y. Comp. Codes R. & Regs. Tit. 8 § 63.12