HBA-JRA S.B. 511 76(R) BILL ANALYSIS Office of House Bill AnalysisS.B. 511 By: Madla Public Health 4/30/1999 Engrossed BACKGROUND AND PURPOSE Currently, Texas pharmacists are required to type or pre-print their labels with the words, "Caution: federal law prohibits dispensing without a prescription." The Food and Drug Administration (FDA) requires drug manufacturers to print "Caution: federal law prohibits dispensing without a prescription" on prescription labels for dangerous drugs. Recently, the FDA has allowed manufacturers to alter the labeling requirement by printing "Rx only." S.B. 511 redefines the term "dangerous drug" to include a drug or device that bears or is required to bear the legend: "Caution: federal law prohibits dispensing without a prescription" or, at a minimum, "Rx only." RULEMAKING AUTHORITY It is the opinion of the Office of House Bill Analysis that this bill does not expressly delegate any additional rulemaking authority to a state officer, department, agency, or institution. SECTION BY SECTION ANALYSIS SECTION 1. Amends Subdivision (15), Article 4542a-1, V.T.C.S., to redefine "dangerous drug" to include a drug or device that bears or is required to bear the legend: "Caution: federal law prohibits dispensing without a prescription" or, at a minimum, "Rx only." SECTION 2. Amends Subdivision (2), Section 483.001, Human Resources Code, to redefine "dangerous drug" to include a drug or device that bears or is required to bear the legend: "Caution: federal law prohibits dispensing without a prescription" or, at a minimum, "Rx only." SECTION 3. Effective date: September 1, 1999. SECTION 4. Emergency clause.