BILL ANALYSIS
By: Davis, Yvonne
Committee Report (Substituted)
BACKGROUND AND PURPOSE
The Health and Safety Code requires the label on drugs to contain certain important information such as adequate drug use, warning information for improper use, side effects, and cautionary statements. This information is very important to ensure public awareness of the proper use of prescription drugs. The font size used in printing this vital information is often small and may prevent individuals, especially seniors, from making sound evaluations on the proper usage of prescription drugs. CSHB 948 grants rulemaking authority to the Texas State Board of Pharmacy to adopt rules to require the information contained on the label and labeling for prescription drugs to be in plain language and printed in an easily readable font size for the consumer. CSHB 948 also requires the information contained on the labeling to be relevant to the prescription.
RULEMAKING AUTHORITY
It is the committee's opinion that rulemaking authority is expressly granted to the Texas State Board of Pharmacy in SECTION 1 and SECTION 2 of this bill.
ANALYSIS
CSHB 948 requires the Texas State Board of Pharmacy (board) to adopt rules requiring the label on a dispensing container to be in plain language and printed in an easily readable font size, and to adopt rules specifying the information a pharmacist must provide to the consumer when dispensing certain prescriptions. The information must be written in plain language, relevant to the prescription, and printed in an easily readable font size.
EFFECTIVE DATE
September 1, 2007.
COMPARISON OF ORIGINAL TO SUBSTITUTE
CSHB 948 modifies the original bill by deleting the provision requiring information in Section 431.112(e)(2) and (k)(3) and information regarding cautionary statements required by Section 431.113(c)(2) of the Health and Safety Code to be printed in at least 8-point Times New Roman or Arial font on the label of a drug. It also deletes the provision that a drug that is not in compliance is subject to all provisions of Chapter 431 applicable to a misbranded drug.
The substitute adds provisions requiring the board to adopt rules requiring the label on a dispensing container to be in plain language and printed in an easily readable font size, and specifying the information a pharmacist must provide to the consumer when dispensing certain prescriptions. The information must be written in plain language, relevant to the prescription, and printed in an easily readable font size.