RLV S.B. 609 75(R)BILL ANALYSIS PUBLIC HEALTH S.B. 609 By: Madla (Van de Putte) 4-30-97 Committee Report (Unamended) BACKGROUND Currently, the pharmacy profession is regulated by provisions contained in the Texas Pharmacy Act, many of which are inadequate to address the challenges facing the pharmacy profession today. Problems have arisen regarding businesses illegally posing as mail-order pharmacies, a lack of standards for pharmacy technician training programs, outdated pharmacist-intern registration guidelines and professional degree requirements, and an archaic license fee system. PURPOSE S.B. 609 establishes the regulation of pharmacies and pharmacists, and provides a penalty. RULEMAKING AUTHORITY It is the committee's opinion that this bill grants rulemaking authority to the Texas State Board of Pharmacy (board) in SECTION 1 Section 5 {Texas Pharmacy Act (Article 4542a-1, V.T.C.S. Subsection (40))}. Amends existing rulemaking in SECTION 6 Section 17 {Texas Pharmacy Act (Article 4542a-1, V.T.C.S. Subsection (o)(1))}, from permissive authority of the board to a required authority. Rulemaking is granted to the board in SECTION 9 Section 20 {Texas Pharmacy Act (Article 4542a-1, V.T.C.S. Subsection (a))}, SECTION 10 Section 21 {Texas Pharmacy Act (Article 4542a-1, V.T.C.S. Subsection (a)(4))}, SECTION 11 Section 22 {Texas Pharmacy Act (Article 4542a-1, V.T.C.S. Subsection (a)(3))}, SECTION 12 Section 26 {Texas Pharmacy Act (Article 4542a-1, V.T.C.S. Subsection (b)(10))}, and in SECTION 23 {Section 483.042, Health and Safety Code, (Subsection(e))}. SECTION BY SECTION ANALYSIS SECTION 1. Amends Section 5, Texas Pharmacy Act, Article 4542a-1, V.T.C.S., to redefine "Administrative Procedure Act," "confidential record," "pharmacy," and "preceptor." Defines "pharmacy technician" and "Texas trade association." Deletes the definition of "supportive personnel." Makes conforming changes. SECTION 2. Amends Section 8(a), Texas Pharmacy Act, Article 4542a-1, V.T.C.S., prohibiting a licensed pharmacist member of the Texas State Board of Pharmacy (board) from being a salaried faculty member at a college of pharmacy; or an officer, employee, or paid consultant of a Texas trade association in the field of health care or a spouse of an officer, employee, or paid consultant. Makes conforming changes. SECTION 3. Amends Section 8, Texas Pharmacy Act, Article 4542a-1, V.T.C.S., by adding Subsection (f), to require the board to provide to its members information regarding their qualifications for office or employment and their responsibilities. SECTION 4. Amends Section 14(c), Texas Pharmacy Act, Article 4542a-1, V.T.C.S., to make standard recodification changes. SECTION 5. Amends Sections 15(c), (d), and (f), Texas Pharmacy Act, Article 4542a-1, V.T.C.S., to make conforming changes. SECTION 6. Amends Sections 17 (o), and (q), Texas Pharmacy Act, Article 4542a-1, V.T.C.S. as follows: Subsection (o)(1) requires the board to establish rules for the use and duties of pharmacy technicians, rather than supportive personnel that are supervised by the pharmacist, provided that the board may not adopt rules or regulations establishing certain ratios; and (2) authorizes the board to issue standards for recognition and approval of training programs for pharmacy technicians. Subsection (q) makes conforming and standard recodification changes. SECTION 7. Amends Section 17D(a), Texas Pharmacy Act, Article 4542a-1, V.T.C.S., to require the board, by rule, to adopt procedures governing informal disposition of a contested case under, and informal proceedings held in compliance with, Chapter 2001, Government Code. Makes conforming changes. SECTION 8. Amends Sections 19(a), (f), and (g), Texas Pharmacy Act, Article 4542a-1, V.T.C.S., to prohibit a person from operating a pharmacy unless the person first obtains a license to operate a pharmacy. Deletes the provision which prohibits this Act from applying to a pharmacist intern. Establishes that any person found by the board to have unlawfully engaged in the practice of pharmacy or unlawfully operated a pharmacy is subject to a civil penalty under Section 37A, rather than being subject to a fine not to exceed $1,000 for each offense. Makes conforming changes. SECTION 9. Amends Section 20(a) and (b), Texas Pharmacy Act, Article 4542a-1, V.T.C.S., as follows: Subsection (a) requires a pharmacist-intern registration to remain in effect as long as the person meets the qualifications for internship as specified by rules adopted by the board. Deletes language regarding internship training and examination requirements. Subsection (b) authorizes the board to restrict registration for any violation of this Act. Requires the board to enforce Section 26(a)(4) and on probable cause, to request a pharmacist-intern or pharmacist-intern applicant to submit to a mental or physical examination. Requires the board to issue an order requiring the pharmacist-intern or applicant to show cause why he will not submit to the exam and requires the board to schedule a hearing on the order within 30 days after notice is served. Requires the board to notify the pharmacist-intern/applicant by certified mail or personal service about the hearing. Establishes the protocol regarding the refusal of an intern or intern applicant to submit to the examination or to withdraw the request. SECTION 10. Amends Sections 21(a) and (e), Texas Pharmacy Act, Article 4542a-1, V.T.C.S. as follows: Subsection (a)(4) establishes that in order to qualify for a license to practice pharmacy, the applicant must submit evidence that the person has graduated and received a professional practice degree, as defined by the rules adopted by the board. Deletes language regarding a professional undergraduate or advanced professional degree from an accredited pharmacy degree program. Subsection (e) requires the board to notify each examinee of the results of the examination within 30 days after the date the board receives the results from a national testing service. Deletes the existing provisions regarding notification of examination results. SECTION 11. Amends Section 22(a), Texas Pharmacy Act, Article 4542a-1, V.T.C.S., to require an applicant for a license to practice pharmacy by reciprocity to have graduated and received a professional practice degree, as defined by board rules, and to pass the Texas Pharmacy Jurisprudence, rather than the Drug and Pharmacy Jurisprudence, examination. SECTION 12. Amends Section 26(b), Texas Pharmacy Act, Article 4542a-1, V.T.C.S. as follows: Subsection (b)(1) adds non-substantive clarifying language to this subsection. (10) adds the provision regarding engaging in fraud, deceit, or misrepresentation in operating or seeking to operate a pharmacy as defined by board rule, to this section on disciplining a holder of a pharmacy license. SECTION 13. Amends Section 26A(c), Texas Pharmacy Act, Article 4542a-1, V.T.C.S., to make a conforming change. SECTION 14. Amends Section 27, Texas Pharmacy Act, Article 4542a-1, V.T.C.S., to make a conforming change. SECTION 15. Amends Section 27A(d), Texas Pharmacy Act, Article 4542a-1, V.T.C.S., to make a conforming change. SECTION 16. Amends Section 27B(c), Texas Pharmacy Act, Article 4542a-1, V.T.C.S., to make a conforming change. SECTION 17. Amends Section 28(a), Texas Pharmacy Act, Article 4542a-1, V.T.C.S., to authorize the board, on the finding of grounds for discipline of a license holder or license renewer, to place the offender's license on probation and supervision and impose a probation fee to defer the costs of monitoring a licensee during the probation period, rather than imposing a civil penalty not to exceed a certain amount. Makes conforming changes. SECTION 18. Amends Section 29(e), Texas Pharmacy Act, Article 4542a-1, V.T.C.S. to make a conforming language change. SECTION 19. Amends Section 35, Texas Pharmacy Act, Article 4542a-1, V.T.C.S., to prohibit a person from advertising any store or place of business as a pharmacy or providing pharmacy services unless the facility is a pharmacy licensed under this Act. Makes a conforming change. SECTION 20. Amends Section 20, Texas Pharmacy Act, Article 4542a-1, V.T.C.S., by adding Section 37A, as follows: Sec. 37A. CIVIL PENALTY. Subsection (a) establishes that a person who violates the license requirements of this Act is liable to the state for a civil penalty of $1,000 for each day the violation continues. Subsection (b) requires the attorney general, district attorney, county attorney, or city attorney to sue in a district court of Travis County to collect the penalty, at the request of the board. Subsection (c) requires the board to refer the case to the local district attorney, county attorney or city attorney, if the attorney general fails to take action within 30 days of referral from the board. Requires the district attorney, county attorney, or city attorney to file suit in a district court to collect and retain the penalty. SECTION 21. Amends Sections 483.001(10) and (11)(f), Health and Safety Code, to redefine "pharmacy" and amend the definition of "practice of pharmacy." Makes a conforming change. SECTION 22. Amends Section 483.003(b), Health and Safety Code, to authorize the Texas Board of Health, rather than the Board of Pharmacy, to limit the availability of the abused drug by permitting its dispensing only on the prescription of certain practitioners. SECTION 23. Amends Section 483.042(e), Health and Safety Code, to provide that the labeling provisions of Subsection (a) do not apply to a dangerous drug prescribed or dispensed for administration to a patient who is institutionalized. Requires the board to adopt rules for the labeling of such a drug. Deletes the provision regarding the application of labeling guidelines to food production animals in an agricultural operation. SECTION 24. Repeals Chapter 107. Acts of the 41st Legislature, Regular Session, 1929 (Article 4542a, V.T.C.S.) regarding the State Board of Pharmacy and the regulation of the practice of pharmacy. SECTION 25. Repeals Section 26A(b), Article 4542a-1, V.T.C.S., as amended by Section 7, Chapter 789, Acts of the 73rd Legislature, Regular Session, 1993 regarding felony drug convictions; and the suspension and revocation of a license. SECTION 26. Establishes the effective date of this Act to be September 1, 1997. SECTION 27. Subsection (a) establishes the application of this Act applies to a license issued by the board on or after the effective date of the Act. Establishes that a license issued or renewed prior to that date is subject to the law in effect at the time the license was issued. Subsection (b) Establishes that Section 37A, Texas Pharmacy Act, as added, applies only to a violation of the licensing requirements of the Texas Pharmacy Act that occurs on or after the effective date. SECTION 28. Emergency clause.