SRC-CTC S.B. 768 77(R)BILL ANALYSIS Senate Research CenterS.B. 768 By: Madla Health & Human Services 6/8/2001 Enrolled DIGEST AND PURPOSE Currently, 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 (FDA) has frequently changed the labeling requirements for prescription drugs and Texas law has not changed with the same frequency to comply. The State Board of Pharmacy (board) has either changed its rules or suggested changes to current law to deal with outmoded restrictions or limitations. S.B. 768, among other things, allows the board to comply, by rule, with certain federal labeling requirements; allows pharmacy students to work as interns outside of their college-assigned programs; allows academic pharmacists to serve on the board, increases continuing education requirements for pharmacists; and strengthens the board's jurisdiction and penalty ability relating to certain actions. RULEMAKING AUTHORITY Rulemaking authority is expressly granted to the Texas State Board of Pharmacy in SECTION 7 (Section 562.015, Occupations Code) and SECTION 8 (Section 562.108, Occupations Code) of this bill. SECTION BY SECTION ANALYSIS SECTION 1. Amends Section 551.003, Occupations Code to redefine "dangerous drug," "pharmacist-intern," and "prescription drug." SECTION 2. Amends Section 559.003(d), Occupations Code, to provide that a person's license, if it has been expired for one year or more, is considered to have been canceled and prohibits the license from being renewed unless the license is the subject of a pending investigation or disciplinary action. SECTION 3. Amends Section 559.053, Occupations Code, to increase the continuing education requirement for a license holder from 24 hours during the preceding 24 months of the person's license period to 30 hours. SECTION 4. Amends Section 560.002(a), Occupations Code, to prohibit the word "apothecary" from being displayed in certain manners in or on a place of business unless the facility is a pharmacy licensed under this chapter. SECTION 5. Amends Section 561.005, Occupations Code, to provide an exception to the applicability of this section. SECTION 6. Amends Section 562.008(a), Occupations Code, to require the pharmacist, if a practitioner certifies on the prescription form that a specific prescribed brand is medically necessary, to dispense the drug as written by the practitioner. Requires the certification to be made as required by the dispensing directive adopted under Section 562.015. Provides that this subchapter does not permit a pharmacist to substitute a generically equivalent drug unless the substitution is made as provided by this subchapter. Deletes existing text of Section 562.008(a). SECTION 7. Amends Chapter 562A, Occupations Code, by adding Section 562.015, as follows: Sec. 562.015. DISPENSING DIRECTIVE; COMPLIANCE WITH FEDERAL LAW. Requires the Texas State Board of Pharmacy (board) to adopt rules to provide a dispensing directive to instruct pharmacists on the manner in which to dispense a drug according to the contents of a prescription. Sets forth certain requirements of the rules adopted under this section. Requires the board to provide an exemption from the directive adopted under this section for prescriptions transmitted electronically. Authorizes the board to regulate the use of electronic prescriptions in the manner provided by federal law, including rules. SECTION 8. Amends Chapter 562C, Occupations Code, by adding Section 562.108, as follows: Sec. 562.108. EMERGENCY MEDICATION KITS. Authorizes a Class A or Class C pharmacy to maintain controlled substances and dangerous drugs in an emergency medication kit used at a certain institution. Authorizes the controlled substances and dangerous drugs to be used only for the emergency medication needs of a resident at that institution. Requires the board to adopt rules relating to emergency medication kits. SECTION 9. Amends Section 565.001(a), Occupations Code, to authorize the board to discipline an applicant for or the holder of a license to practice pharmacy if the board finds that the applicant or license holder has used alcohol or drugs in an intemperate manner that, in the board's opinion, could endanger a patient's life, rather than developed a drug or alcohol dependency. SECTION 10. Amends Section 481.074(a), Health and Safety Code, to prohibit a pharmacist from dispensing a controlled substance if the pharmacist knows or should have known that the prescription was issued without a valid patient-practitioner relationship. SECTION 11. Amends Section 483.001(2), Health and Safety Code, to redefine "dangerous drug." SECTION 12. Amends Section 483.021(a), Health and Safety Code, to delete wording relating to a practitioner that issues a prescription for a dangerous drug. Requires a pharmacist who is requested to dispense a dangerous drug under a prescription issued by a practitioner to determine, in the exercise of the pharmacist's professional judgment, that the prescription is a valid prescription. Prohibits a pharmacist from dispensing a dangerous drug if the pharmacist knows or should have known that the prescription was issued without a valid patient-practitioner relationship. Deletes wording relating to requirements of a pharmacist requested to dispense a dangerous drug. SECTION 13. (a) Repealer: Sections 242.615 and 252.153, Health and Safety Code; Section 562.003, Occupations Code; Chapter 563A, Occupations Code. (b) Provides that the repeal of portions of the Occupations Code take effect June 1, 2002. SECTION 14. Sets forth certain requirements for the board in adopting the dispensing directive under Section 562.015, Occupations Code, as added by this Act. Requires the board to adopt rules required by Section 562.015, Occupations Code, as added by this Act, not later than June 1, 2002. SECTION 15. Provides that the text of Sections 559.053 and 561.005, Occupations Code, as set out in Sections 3 and 5 of this Act, give effect to changes made by Chapter 1518, Acts of the 76th Legislature, Regular Session, 1999, in accordance with Section 311.031(c), Government Code, which gives effect to a substantive amendment enacted by the same legislature that codifies the amended statute. Provides that to the extent of any conflict, this Act prevails over another Act of the 77th Legislature, Regular Session, 2001, relating to nonsubstantive additions to and corrections in enacted codes. SECTION 16. (a) Effective date: September 1, 2001, except as provided by Subsection (b), Section 13 of this Act. (b) Makes application of Section 559.053, Occupations Code, of this Act prospective. (c) Requires the board, not later than December 31, 2001, to adopt the rules required by Section 562.108, Occupations Code, as added by this Act. (d) Authorizes the board to enforce a rule adopted under Sections 242.615 and 252.153, Health and Safety Code. Provides that those rules remain in effect until the board adopts rules under Subsection (c) of this section. Provides that a complaint, investigation, or other proceeding pending under Section 242.615 or 252.153, Health and Safety Code, is transferred without change in status to the board.