BILL ANALYSIS
By: Leibowitz
Committee Report (Substituted)
BACKGROUND AND PURPOSE
It is important that a prescription label contain useful information that can assist a patient in safely taking their medication. Today, many people keep their unused prescriptions and use them at a later date to self-medicate. However, there is no requirement that a use-by date be included on the prescription label to inform consumers when their medication is no longer effective.
CSHB 1953 puts new labeling requirements for the label of a prescription, including a use-by date for the medication. Many of the requirements set forth in CSHB 1953 are currently rules adopted by the State Board of Pharmacy. CSHB 1953 puts many of those rules in statute. The bill also grants the Texas State Board of Pharmacy to require additional information be included on prescription labels through its rulemaking authority.
RULEMAKING AUTHORITY
It is the committee's opinion that rulemaking authority is expressly granted to the Texas State Board of Pharmacy in SECTIONS 1 and 2 of this bill.
ANALYSIS
CSHB 1953 sets forth the labeling requirements for drugs dispensed by pharmacists. The label on the dispensing container must indicate the following information: the name, address, and telephone number of the pharmacy; date the prescription is dispensed; the name of the prescribing practitioner; name of the patient, or if the drug was prescribed for an animal, the species of the animal and the name of the owner; instructions for use; the quantity dispensed; the date after which the prescription should not be used, determined according to criteria established by board rule based on the United States Pharmacopeia-National Formulary standards if the drug is dispensed in a container other than the manufacturer's original container; unless otherwise directed by the practitioner, the actual drug dispensed indicated by certain information and any other information required by board rule.
The bill requires the Texas State Board of Pharmacy to adopt the rules necessary for implementation of this Act no later than December 1, 2007. Additionally, the legislation specifies that it applies only to drugs dispensed on or after the January 1, 2008.
EFFECTIVE DATE
September 1, 2007.
COMPARISON OF ORIGINAL TO SUBSTITUTE
The substitute deletes the words "the date after which the prescription should not be use, determined according to criteria established by board rule" and replaces them with "if the drug is dispensed in a container other than the manufacturer's original container, the date after which the prescription should not be used, determined according to criteria established by board rule based on standards in the United States Pharmacopeia-National Formulary."