BILL ANALYSIS

C.S.H.B. 19

By: Leibowitz

Public Health

Committee Report (Substituted)

BACKGROUND AND PURPOSE

Prescription labels contain information critical to the safe administration of medication.  Many people keep unused prescription medications for later use to self-medicate.  Currently, there is no statutory requirement for a use-by date to inform consumers when a medication is no longer effective. 

C.S.H.B. 19 creates new requirements for the label of a prescription medication, including a use-by date for the medication.  The bill grants the Texas State Board of Pharmacy rulemaking authority to require other information.

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

C.S.H.B. 19 amends the Occupations Code to require the label on the dispensing container of a prescription drug dispensed by a Class A or Class E pharmacy, in addition to providing other required information, to indicate the pharmacy's name, address, and telephone number; the date the prescription is dispensed; the name of the prescribing practitioner; the patient's name or, if prescribed for an animal, the species of animal and the owner's name; instructions for use; the quantity dispensed; the date after which the prescription should not be used if the drug is dispensed in a container other than the manufacturer's original container; and any other information required by Texas State Board of Pharmacy rule.  The bill authorizes the date after which the prescription should not be used to be recorded on any label affixed to the dispensing container.  The bill exempts from the additional label requirements a prescription drug dispensed to a person at the time of release from prison or jail if the prescription is for not more than a 10-day supply of medication.  The bill requires the board to adopt any rules necessary to implement the label requirements not later than January 1, 2010.

C.S.H.B. 19 makes its provisions applicable only to a drug dispensed on or after June 1, 2010. 

EFFECTIVE DATE

September 1, 2009.

COMPARISON OF ORIGINAL AND SUBSTITUTE

C.S.H.B. 19 differs from the original by adding the specification that the label requirements apply to a drug dispensed by a Class A or Class E pharmacy.  The substitute differs from the original by adding the authorization that the date after which the prescription should not be used may be recorded on any label affixed to the dispensing container.  The substitute differs from the original by adding the exemption from the label requirements for a prescription drug dispensed to a person at the time of release from prison or jail if the prescription is for not more than a 10-day supply of medication.  The substitute differs from the original by changing the date by which the board is required the board to adopt rules to implement the bill's provisions from not later than December 1, 2009, as in the original, to not later than January 1, 2010.  The substitute differs from the original by changing the date on which the label requirements apply to a dispensed drug from on or after January 1, 2010, as in the original, to on or after June 1, 2010.