BILL ANALYSIS
Senate Research Center C.S.H.B. 19
81R31034 BEF-D By: Leibowitz et al. (Zaffirini)
Committee Report (Substituted)
AUTHOR'S / SPONSOR'S STATEMENT OF INTENT
Currently, there is no statutory requirement for a use-by date to inform consumers when a medication is no longer effective. Under current law, the label on the drug dispensing container must indicate in plain language and in an easily readable font, the brand name of the drug or the generic name, if there is not a brand name, the strength of the drug, if the drug selected by the pharmacist is different than the one prescribed, the words "substituted for brand prescribed," and the name of the drug's manufacturer or distributor.
Labels on medication provide important information to ensure the safe administration of the medication. Many people keep unused prescription medication for later use. Providing additional information, such as the use-by date, will ensure that people are informed about the proper use, effectiveness, and risks associated with their medication.
C.S.H.B. 19 amends current law relating to requirements for drugs dispensed by pharmacists.
RULEMAKING AUTHORITY
Rulemaking authority is expressly granted to the Texas State Board of Pharmacy in SECTION 1 (Section 562.006, Occupations Code) and SECTION 2 (Section 562.0062, Occupations Code) of this bill.
SECTION BY SECTION ANALYSIS
SECTION 1. Amends Section 562.006, Occupations Code, by adding Subsections (a-1), (a-2), and (a-3), as follows:
(a-1) Requires that the label on the dispensing container of a drug dispensed by a Class A or Class E pharmacy, in addition to the information required by Subsection (a) (relating to certain requirements for the label on the dispensing container), indicate the name, address, and telephone number of the pharmacy; the date the prescription is dispensed; the name of the prescribing practitioner; the 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; 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 Texas State Board of Pharmacy (TSBP) rule based on standards in the United States Pharmacopeia-National Formulary; and any other information required by TSBP rule.
(a-2) Authorizes the information required by Subsection (a-1)(7) (relating to a requirement that certain containers labels indicate the date after which the prescription should not be used) to be recorded on any label affixed to the dispensing container.
(a-3) Provides that Subsection (a-1) does not apply to a prescription 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.
SECTION 2. Amends Subchapter A, Chapter 562, Occupations Code, by adding Section 562.0062, as follows:
Sec. 562.0062. REQUIRED STATEMENT REGARDING MEDICATION DISPOSAL. Requires TSBP by rule to require pharmacists, when dispensing certain drugs, to include on the dispensing container label or in the information required by Section 562.0061 (Other Prescription Information) a certain statement.
SECTION 3. Requires TSBP, not later than January 1, 2010, to adopt any rules necessary to implement Section 562.006(a-1), Occupations Code, as added by this Act.
SECTION 4. Requires TSBP, not later than June 1, 2010, to adopt rules under Section 562.0062, Occupations Code, as added by this Act.
SECTION 5. Provides that Sections 562.006(a-1) and 562.0062, Occupations Code, as added by this Act, applies only to a drug dispensed after June 1, 2010.
SECTION 6. Effective date: September 1, 2009.