1-1     By:  Madla                                             S.B. No. 768
 1-2           (In the Senate - Filed February 19, 2001; February 20, 2001,
 1-3     read first time and referred to Committee on Health and Human
 1-4     Services; March 26, 2001, reported adversely, with favorable
 1-5     Committee Substitute by the following vote:  Yeas 6, Nays 0;
 1-6     March 26, 2001, sent to printer.)
 1-7     COMMITTEE SUBSTITUTE FOR S.B. No. 768                   By:  Carona
 1-8                            A BILL TO BE ENTITLED
 1-9                                   AN ACT
1-10     relating to the regulation of the practice of pharmacy and the
1-11     dispensing of certain drugs.
1-12           BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:
1-13           SECTION 1.  Subdivisions (12), (30), and (36), Section
1-14     551.003, Occupations Code, are amended to read as follows:
1-15                 (12)  "Dangerous drug" means a drug or device that:
1-16                       (A)  is not included in Penalty Group 1, 2, 3, or
1-17     4, Chapter 481, Health and Safety Code, and is unsafe for
1-18     self-medication; or
1-19                       (B)  bears or is required to bear the legend:
1-20                             (i)  "Caution:  federal law prohibits
1-21     dispensing without prescription" or "Rx only" or another legend
1-22     that complies with federal law; or
1-23                             (ii)  "Caution:  federal law restricts this
1-24     drug to use by or on the order of a licensed veterinarian."
1-25                 (30)  "Pharmacist-intern" means:
1-26                       (A)  an undergraduate student who is enrolled in
1-27     the professional sequence of a college of pharmacy approved by the
1-28     board and who is participating in a [school-based] board-approved
1-29     internship program; or
1-30                       (B)  a graduate of a college of pharmacy who is
1-31     participating in a board-approved internship.
1-32                 (36)  "Prescription drug" means:
1-33                       (A)  a substance for which federal or state law
1-34     requires a prescription before the substance may be legally
1-35     dispensed to the public;
1-36                       (B)  a drug or device that under federal law is
1-37     required, before being dispensed or delivered, to be labeled with
1-38     [either of] the statement [following statements]:
1-39                             (i)  "Caution:  federal law prohibits
1-40     dispensing without prescription" or "Rx only" or another legend
1-41     that complies with federal law; or
1-42                             (ii)  "Caution:  federal law restricts this
1-43     drug to use by or on the order of a licensed veterinarian"; or
1-44                       (C)  a drug or device that is required by federal
1-45     or state statute or regulation to be dispensed on prescription or
1-46     that is restricted to use by a practitioner only.
1-47           SECTION 2.  Subsection (d), Section 559.003, Occupations
1-48     Code, is amended to read as follows:
1-49           (d)  If a person's license has been expired for one year or
1-50     more, the person's license is considered to have been canceled and
1-51     the person may not renew the license, unless the license is the
1-52     subject of a pending investigation or disciplinary action.
1-53           SECTION 3.  Section 559.053, Occupations Code, is amended to
1-54     read as follows:
1-55           Sec. 559.053.  PROGRAM HOURS REQUIRED.  A license holder
1-56     satisfies the continuing education requirement by presenting
1-57     evidence satisfactory to the board of completion of at least 30
1-58     [24] hours of continuing education during the preceding 24 months
1-59     of the person's license period.
1-60           SECTION 4.  Subsection (a), Section 560.002, Occupations
1-61     Code, is amended to read as follows:
1-62           (a)  A person may not display in or on a place of business
1-63     the word "pharmacy" or "apothecary" in any language, any word or
1-64     combination of words of the same or similar meaning, or a graphic
 2-1     representation that would lead or tend to lead the public to
 2-2     believe that the business is a pharmacy unless the facility is a
 2-3     pharmacy licensed under this chapter.
 2-4           SECTION 5.  Section 561.005, Occupations Code, is amended to
 2-5     read as follows:
 2-6           Sec. 561.005.  SUSPENSION OF PHARMACY LICENSE FOR NONRENEWAL.
 2-7     (a)  The board shall suspend the license and remove from the
 2-8     register of licensed pharmacies the name of a pharmacy that does
 2-9     not file a completed application and pay the renewal fee on or
2-10     before the date the license expires.
2-11           (b)  After review by the board, the board may determine that
2-12     Subsection (a) does not apply if the license is the subject of a
2-13     pending investigation or disciplinary action.
2-14           SECTION 6.  Section 564.002, Occupations Code, is amended to
2-15     read as follows:
2-16           Sec. 564.002.  CONFIDENTIALITY.  (a)  The records and
2-17     proceedings of the board, an authorized agent of the board, or a
2-18     pharmaceutical organization committee described under Section
2-19     564.001(a) or (b), in connection with a report under Section
2-20     564.001(a) or (b), are confidential and are not considered public
2-21     information for purposes of Chapter 552, Government Code.
2-22           (b)  After review by the board, the board may determine that
2-23     Subsection (a) does not apply to a disciplinary order of the board
2-24     if the license holder has been the subject of a previous
2-25     disciplinary order that was confidential under Subsection (a).
2-26           SECTION 7.  Subsection (a), Section 481.074, Health and
2-27     Safety Code, is amended to read as follows:
2-28           (a)  A pharmacist may not:
2-29                 (1)  dispense or deliver a controlled substance or
2-30     cause a controlled substance to be dispensed or delivered under the
2-31     pharmacist's direction or supervision except under a valid
2-32     prescription and in the course of professional practice;
2-33                 (2)  dispense a controlled substance if the pharmacist
2-34     knows or should have known that the prescription was issued without
2-35     a valid patient-practitioner relationship;
2-36                 (3)  fill a prescription that is not prepared or issued
2-37     as prescribed by this chapter;
2-38                 (4) [(3)]  permit or allow a person who is not a
2-39     licensed pharmacist or pharmacist intern to dispense, distribute,
2-40     or in any other manner deliver a controlled substance even if under
2-41     the supervision of a pharmacist, except that after the pharmacist
2-42     or pharmacist intern has fulfilled his professional and legal
2-43     responsibilities, a nonpharmacist may complete the actual cash or
2-44     credit transaction and delivery; or
2-45                 (5) [(4)]  permit the delivery of a controlled
2-46     substance to any person not known to the pharmacist, the pharmacist
2-47     intern, or the person authorized by the pharmacist to deliver the
2-48     controlled substance without first requiring identification of the
2-49     person taking possession of the controlled substance, except as
2-50     provided by Subsection (n).
2-51           SECTION 8.  Subdivision (2), Section 483.001, Health and
2-52     Safety Code, is amended to read as follows:
2-53                 (2)  "Dangerous drug" means a device or a drug that is
2-54     unsafe for self-medication and that is not included in Schedules I
2-55     through V or Penalty Groups 1 through 4 of Chapter 481 (Texas
2-56     Controlled Substances Act).  The term includes a device or a drug
2-57     that bears or is required to bear the legend:
2-58                       (A)  "Caution:  federal law prohibits dispensing
2-59     without prescription" or "Rx only" or another legend that complies
2-60     with federal law; or
2-61                       (B)  "Caution:  federal law restricts this drug
2-62     to use by or on the order of a licensed veterinarian."
2-63           SECTION 9.  Subsection (a), Section 483.021, Health and
2-64     Safety Code, is amended to read as follows:
2-65           (a)  A pharmacist who is requested to dispense a dangerous
2-66     drug under a prescription issued by a practitioner [described by
2-67     Section 483.001(12)(C)] shall determine, in the exercise of the
2-68     pharmacist's professional judgment, that[:]
2-69                 [(1)]  the prescription is [authentic;]
 3-1                 [(2)  the prescription was issued under] a valid
 3-2     prescription [patient-physician relationship; and]
 3-3                 [(3)  the prescribed drug is considered necessary for
 3-4     the treatment of illness].  A pharmacist may not dispense a
 3-5     dangerous drug if the pharmacist knows or should have known that
 3-6     the prescription was issued without a valid patient-practitioner
 3-7     relationship.
 3-8           SECTION 10.  (a)  In accordance with Subsection (c), Section
 3-9     311.031, Government Code, which gives effect to a substantive
3-10     amendment enacted by the same legislature that codifies the amended
3-11     statute, the text of Sections 559.053 and 561.005, Occupations
3-12     Code, as set out in Sections 3 and 5 of this Act, gives effect to
3-13     changes made by Chapter 1518, Acts of the 76th Legislature, Regular
3-14     Session, 1999.
3-15           (b)  To the extent of any conflict, this Act prevails over
3-16     another Act of the 77th Legislature, Regular Session, 2001,
3-17     relating to nonsubstantive additions to and corrections in enacted
3-18     codes.
3-19           SECTION 11.  (a)  This Act takes effect September 1, 2001.
3-20           (b)  The change in law made by this Act to Section 559.053,
3-21     Occupations Code, requiring additional hours of continuing
3-22     education, applies only to a 24-month license period that begins on
3-23     or after the effective date of this Act.  A 24-month license period
3-24     that begins before the effective date of this Act is governed by
3-25     the law in effect immediately before the effective date of this
3-26     Act, and the former law is continued in effect for that purpose.
3-27                                  * * * * *