77R12665 JMM-F
By Madla S.B. No. 768
Substitute the following for S.B. No. 768:
By Coleman C.S.S.B. No. 768
A BILL TO BE ENTITLED
1-1 AN ACT
1-2 relating to the regulation of the practice of pharmacy and the
1-3 dispensing of certain drugs.
1-4 BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:
1-5 SECTION 1. Sections 551.003(12), (30), and (36), Occupations
1-6 Code, are amended to read as follows:
1-7 (12) "Dangerous drug" means a drug or device that:
1-8 (A) is not included in Penalty Group 1, 2, 3, or
1-9 4, Chapter 481, Health and Safety Code, and is unsafe for
1-10 self-medication; or
1-11 (B) bears or is required to bear the legend:
1-12 (i) "Caution: federal law prohibits
1-13 dispensing without prescription" or "Rx only" or another legend
1-14 that complies with federal law; or
1-15 (ii) "Caution: federal law restricts this
1-16 drug to use by or on the order of a licensed veterinarian."
1-17 (30) "Pharmacist-intern" means:
1-18 (A) an undergraduate student who is enrolled in
1-19 the professional sequence of a college of pharmacy approved by the
1-20 board and who is participating in a [school-based] board-approved
1-21 internship program; or
1-22 (B) a graduate of a college of pharmacy who is
1-23 participating in a board-approved internship.
1-24 (36) "Prescription drug" means:
2-1 (A) a substance for which federal or state law
2-2 requires a prescription before the substance may be legally
2-3 dispensed to the public;
2-4 (B) a drug or device that under federal law is
2-5 required, before being dispensed or delivered, to be labeled with
2-6 [either of] the statement [following statements]:
2-7 (i) "Caution: federal law prohibits
2-8 dispensing without prescription" or "Rx only" or another legend
2-9 that complies with federal law; or
2-10 (ii) "Caution: federal law restricts this
2-11 drug to use by or on the order of a licensed veterinarian"; or
2-12 (C) a drug or device that is required by federal
2-13 or state statute or regulation to be dispensed on prescription or
2-14 that is restricted to use by a practitioner only.
2-15 SECTION 2. Section 559.003(d), Occupations Code, is amended
2-16 to read as follows:
2-17 (d) If a person's license has been expired for one year or
2-18 more, the person's license is considered to have been canceled and
2-19 the person may not renew the license unless the license is the
2-20 subject of a pending investigation or disciplinary action.
2-21 SECTION 3. Section 559.053, Occupations Code, is amended to
2-22 read as follows:
2-23 Sec. 559.053. PROGRAM HOURS REQUIRED. A license holder
2-24 satisfies the continuing education requirement by presenting
2-25 evidence satisfactory to the board of completion of at least 30
2-26 [24] hours of continuing education during the preceding 24 months
2-27 of the person's license period.
3-1 SECTION 4. Section 560.002(a), Occupations Code, is amended
3-2 to read as follows:
3-3 (a) A person may not display in or on a place of business
3-4 the word "pharmacy" or "apothecary" in any language, any word or
3-5 combination of words of the same or similar meaning, or a graphic
3-6 representation that would lead or tend to lead the public to
3-7 believe that the business is a pharmacy unless the facility is a
3-8 pharmacy licensed under this chapter.
3-9 SECTION 5. Section 561.005, Occupations Code, is amended to
3-10 read as follows:
3-11 Sec. 561.005. SUSPENSION OF PHARMACY LICENSE FOR NONRENEWAL.
3-12 (a) The board shall suspend the license and remove from the
3-13 register of licensed pharmacies the name of a pharmacy that does
3-14 not file a completed application and pay the renewal fee on or
3-15 before the date the license expires.
3-16 (b) After review by the board, the board may determine that
3-17 Subsection (a) does not apply if the license is the subject of a
3-18 pending investigation or disciplinary action.
3-19 SECTION 6. Subchapter C, Chapter 562, Occupations Code, is
3-20 amended by adding Section 562.108 to read as follows:
3-21 Sec. 562.108. EMERGENCY MEDICATION KITS. (a) A Class A or
3-22 Class C pharmacy may maintain controlled substances and dangerous
3-23 drugs in an emergency medication kit used at an institution
3-24 licensed under Chapter 242 or 252, Health and Safety Code. The
3-25 controlled substances and dangerous drugs may be used only for the
3-26 emergency medication needs of a resident at that institution.
3-27 (b) The board shall adopt rules relating to emergency
4-1 medication kits, including:
4-2 (1) the amount and type of dangerous drugs and
4-3 controlled substances that may be maintained in an emergency
4-4 medication kit;
4-5 (2) procedures regarding the use of drugs from an
4-6 emergency medication kit;
4-7 (3) recordkeeping requirements; and
4-8 (4) security requirements.
4-9 SECTION 7. Section 565.001(a), Occupations Code, is amended
4-10 to read as follows:
4-11 (a) The board may discipline an applicant for or the holder
4-12 of a license to practice pharmacy if the board finds that the
4-13 applicant or license holder has:
4-14 (1) violated this subtitle or a board rule adopted
4-15 under this subtitle;
4-16 (2) engaged in unprofessional conduct as defined by
4-17 board rule;
4-18 (3) engaged in gross immorality as defined by board
4-19 rule;
4-20 (4) developed an incapacity that prevents the
4-21 applicant or license holder from practicing pharmacy with
4-22 reasonable skill, competence, and safety to the public;
4-23 (5) engaged in fraud, deceit, or misrepresentation, as
4-24 defined by board rule, in practicing pharmacy or in seeking a
4-25 license to practice pharmacy;
4-26 (6) been convicted of a misdemeanor involving moral
4-27 turpitude or a felony;
5-1 (7) used alcohol or drugs in an intemperate manner
5-2 that, in the board's opinion, could endanger a patient's life
5-3 [developed a drug or alcohol dependency];
5-4 (8) failed to maintain records required by this
5-5 subtitle or failed to maintain complete and accurate records of
5-6 purchases or disposals of drugs listed in Chapter 481 or 483,
5-7 Health and Safety Code, or the Comprehensive Drug Abuse Prevention
5-8 and Control Act of 1970 (21 U.S.C. Section 801 et seq.);
5-9 (9) violated any provision of:
5-10 (A) Chapter 481 or 483, Health and Safety Code,
5-11 or the Comprehensive Drug Abuse Prevention and Control Act of 1970
5-12 (21 U.S.C. Section 801 et seq.), or rules relating to one of those
5-13 laws;
5-14 (B) Section 485.031, 485.032, 485.033, 485.034,
5-15 or 485.035, Health and Safety Code; or
5-16 (C) a rule adopted under Section 485.011, Health
5-17 and Safety Code;
5-18 (10) aided or abetted an unlicensed person in the
5-19 practice of pharmacy if the pharmacist knew or reasonably should
5-20 have known that the person was unlicensed at the time;
5-21 (11) refused entry into a pharmacy for an inspection
5-22 authorized by this subtitle if the pharmacist received notification
5-23 from which the pharmacist knew or reasonably should have known that
5-24 the attempted inspection was authorized;
5-25 (12) violated any pharmacy or drug statute or rule of
5-26 this state, another state, or the United States;
5-27 (13) been negligent in the practice of pharmacy;
6-1 (14) failed to submit to an examination after hearing
6-2 and being ordered to do so by the board under Section 565.052;
6-3 (15) dispensed a prescription drug while acting
6-4 outside the usual course and scope of professional practice; or
6-5 (16) had a license to practice pharmacy issued by
6-6 another state canceled, revoked, surrendered, or suspended for
6-7 conduct substantially equivalent to conduct described under this
6-8 subsection.
6-9 SECTION 8. Section 481.074(a), Health and Safety Code, is
6-10 amended to read as follows:
6-11 (a) A pharmacist may not:
6-12 (1) dispense or deliver a controlled substance or
6-13 cause a controlled substance to be dispensed or delivered under the
6-14 pharmacist's direction or supervision except under a valid
6-15 prescription and in the course of professional practice;
6-16 (2) dispense a controlled substance if the pharmacist
6-17 knows or should have known that the prescription was issued without
6-18 a valid patient-practitioner relationship;
6-19 (3) fill a prescription that is not prepared or issued
6-20 as prescribed by this chapter;
6-21 (4) [(3)] permit or allow a person who is not a
6-22 licensed pharmacist or pharmacist intern to dispense, distribute,
6-23 or in any other manner deliver a controlled substance even if under
6-24 the supervision of a pharmacist, except that after the pharmacist
6-25 or pharmacist intern has fulfilled his professional and legal
6-26 responsibilities, a nonpharmacist may complete the actual cash or
6-27 credit transaction and delivery; or
7-1 (5) [(4)] permit the delivery of a controlled
7-2 substance to any person not known to the pharmacist, the pharmacist
7-3 intern, or the person authorized by the pharmacist to deliver the
7-4 controlled substance without first requiring identification of the
7-5 person taking possession of the controlled substance, except as
7-6 provided by Subsection (n).
7-7 SECTION 9. Section 483.001(2), Health and Safety Code, is
7-8 amended to read as follows:
7-9 (2) "Dangerous drug" means a device or a drug that is
7-10 unsafe for self-medication and that is not included in Schedules I
7-11 through V or Penalty Groups 1 through 4 of Chapter 481 (Texas
7-12 Controlled Substances Act). The term includes a device or a drug
7-13 that bears or is required to bear the legend:
7-14 (A) "Caution: federal law prohibits dispensing
7-15 without prescription" or "Rx only" or another legend that complies
7-16 with federal law; or
7-17 (B) "Caution: federal law restricts this drug
7-18 to use by or on the order of a licensed veterinarian."
7-19 SECTION 10. Section 483.021(a), Health and Safety Code, is
7-20 amended to read as follows:
7-21 (a) A pharmacist who is requested to dispense a dangerous
7-22 drug under a prescription issued by a practitioner [described by
7-23 Section 483.001(12)(C)] shall determine, in the exercise of the
7-24 pharmacist's professional judgment, that[:]
7-25 [(1)] the prescription is [authentic;]
7-26 [(2) the prescription was issued under] a valid
7-27 prescription [patient-physician relationship; and]
8-1 [(3) the prescribed drug is considered necessary for
8-2 the treatment of illness]. A pharmacist may not dispense a
8-3 dangerous drug if the pharmacist knows or should have known that
8-4 the prescription was issued without a valid patient-practitioner
8-5 relationship.
8-6 SECTION 11. Sections 242.615 and 252.153, Health and Safety
8-7 Code, are repealed.
8-8 SECTION 12. (a) In accordance with Section 311.031(c),
8-9 Government Code, which gives effect to a substantive amendment
8-10 enacted by the same legislature that codifies the amended statute,
8-11 the text of Sections 559.053 and 561.005, Occupations Code, as set
8-12 out in Sections 3 and 5 of this Act, gives effect to changes made
8-13 by Chapter 1518, Acts of the 76th Legislature, Regular Session,
8-14 1999.
8-15 (b) To the extent of any conflict, this Act prevails over
8-16 another Act of the 77th Legislature, Regular Session, 2001,
8-17 relating to nonsubstantive additions to and corrections in enacted
8-18 codes.
8-19 SECTION 13. (a) This Act takes effect September 1, 2001.
8-20 (b) The change in law made by this Act to Section 559.053,
8-21 Occupations Code, requiring additional hours of continuing
8-22 education, applies only to a 24-month license period that begins on
8-23 or after the effective date of this Act. A 24-month license period
8-24 that begins before the effective date of this Act is governed by
8-25 the law in effect immediately before the effective date of this
8-26 Act, and the former law is continued in effect for that purpose.
8-27 (c) Not later than December 31, 2001, the Texas State Board
9-1 of Pharmacy shall adopt the rules required by Section 562.108,
9-2 Occupations Code, as added by this Act.
9-3 (d) The Texas State Board of Pharmacy may enforce a rule
9-4 adopted under Sections 242.615 and 252.153, Health and Safety Code.
9-5 Those rules remain in effect until the Texas State Board of
9-6 Pharmacy adopts rules under Subsection (c) of this section. A
9-7 complaint, investigation, or other proceeding pending under Section
9-8 242.615 or 252.153, Health and Safety Code, is transferred without
9-9 change in status to the Texas State Board of Pharmacy.