HBA-MPM C.S.S.B. 768 77(R) BILL ANALYSIS Office of House Bill AnalysisC.S.S.B. 768 By: Madla Public Health 4/17/2001 Committee Report (Substituted) BACKGROUND AND PURPOSE Current state law regulating the practice of pharmacy is not consistent with certain federal requirements and the actual practice of pharmacy in this state. The federal Food and Drug Administration has frequently changed the labeling requirements for prescription drugs and Texas law has not changed with the same frequency to comply. The Texas State Board of Pharmacy (TSBP) has either changed its rules or suggested changes to current law to amend outdated restrictions or limitations. C.S.S.B. 768 allows TSBP to comply with certain federal requirements, increases continuing education requirements for pharmacists, and strengthens TSBP's jurisdiction and ability to impose penalties relating to certain actions. RULEMAKING AUTHORITY It is the opinion of the Office of House Bill Analysis that rulemaking authority is expressly delegated to the Texas Board of Pharmacy in SECTION 6 (Section 562.108, Occupations Code) and SECTION 13 of this bill. ANALYSIS C.S.S.B. 768 amends the Occupations and Health and Safety codes to amend the definitions of "dangerous drug" and "prescription drug" to provide that such drugs bear the legend "Rx only" or another legend that complies with federal law (Sec. 551.003, Occupations Code, and Sec. 483.001, Health and Safety Code). C.S.S.B. 768 amends the Occupations Code to remove the stipulation from the definition of "pharmacistintern" to provide that internship programs be school-based (Sec. 551.003). The bill provides that the cancellation of a person's license to practice pharmacy and the suspension of a licensed pharmacy's license for failure to renew may not apply if the license is the subject of a pending investigation or disciplinary action (Secs. 559.003 and 561.005). The bill authorizes the Texas State Board of Pharmacy (TSBP) to discipline an applicant for or the holder of a license if the board finds that the applicant or license holder has used drugs or alcohol in an intemperate manner that in TSBP's opinion could endanger a patient's life (Sec. 565.001). The bill increases from 24 to 30 the minimum number of hours of continuing education in a 24-month period that satisfies the continuing education requirement for licensed pharmacists (Sec. 559.053). The bill prohibits a person from displaying in a place of business the word "apothecary" unless the facility is a licensed pharmacy (Sec. 560.002). C.S.S.B. 768 authorizes a Class A or Class C pharmacy to maintain controlled substances and dangerous drugs in an emergency medication kit used at a convalescent or nursing home or related institution or an intermediate care facility for the mentally retarded (institution) and authorizes the substances and drugs to be used only for the emergency medication needs of institution residents. TSBP is required to adopt rules no later than December 31, 2001 relating to emergency medication kits, including the amount and type of dangerous drugs and controlled substances that may be maintained in the kit, procedures regarding the use of the drugs from such a kit, recordkeeping requirements, and security requirements (Sec. 562.108 and SECTION 13). The bill amends the Health and Safety Code to repeal provisions entitling these institutions to maintain an emergency medication kit and requiring the Texas Board of Human Services (TBHS) to adopt rules regarding the amount, type, and procedure for use of controlled substances in the kit (SECTION 11). The bill transfers a complaint, investigation, or other proceeding pending under these provisions to TSBP without change in status (SECTION 13). The bill prohibits a pharmacist from dispensing a controlled substance or dangerous drug if the pharmacist knows or should have known that the prescription was issued without a valid patient-practitioner relationship (Secs 481.074 and 483.021). EFFECTIVE DATE September 1, 2001. COMPARISON OF ORIGINAL TO SUBSTITUTE C.S.S.B. 768 differs from the original by authorizing the Texas State Board of Pharmacy (TSBP) to discipline an applicant for or the holder of a license if the applicant or license holder has used drugs or alcohol in an intemperate manner that could endanger a patient's life (Sec. 565.001). The substitute authorizes a Class A or Class C pharmacy to maintain an emergency medication kit used at certain institutions and requires TSBP to adopt rules relating to the kit (Sec. 562.108). The substitute repeals provisions entitling certain institutions to maintain an emergency medication kit and requiring the Texas Board of Human Services to adopt rules regarding the kits (SECTIONS 11 and 13). The substitute removes provisions in the original authorizing TSBP to determine that confidentiality requirements do not apply to a disciplinary order if the license holder has been the subject of a previous disciplinary order that was confidential.