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. Subdivisions (12), (30), (36), Section 551.003,
1-6 Occupations 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:
1-25 (A) a substance for which federal or state law
2-1 requires a prescription before the substance may be legally
2-2 dispensed to the public;
2-3 (B) a drug or device that under federal law is
2-4 required, before being dispensed or delivered, to be labeled with
2-5 [either of] the statement [following statements]:
2-6 (i) "Caution: federal law prohibits
2-7 dispensing without prescription" or "Rx only" or another legend
2-8 that complies with federal law; or
2-9 (ii) "Caution: federal law restricts this
2-10 drug to use by or on the order of a licensed veterinarian"; or
2-11 (C) a drug or device that is required by federal
2-12 or state statute or regulation to be dispensed on prescription or
2-13 that is restricted to use by a practitioner only.
2-14 SECTION 2. Subsection (d), Section 559.003, Occupations
2-15 Code, is amended to read as follows:
2-16 (d) If a person's license has been expired for one year or
2-17 more, the person's license is considered to have been canceled and
2-18 the person may not renew the license unless the license is the
2-19 subject of a pending investigation or disciplinary action.
2-20 SECTION 3. Section 559.053, Occupations Code, is amended to
2-21 read as follows:
2-22 Sec. 559.053. PROGRAM HOURS REQUIRED. A license holder
2-23 satisfies the continuing education requirement by presenting
2-24 evidence satisfactory to the board of completion of at least 30
2-25 [24] hours of continuing education during the preceding 24 months
2-26 of the person's license period.
3-1 SECTION 4. Subsection (a), Section 560.002, Occupations
3-2 Code, is amended 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. Subsection (a), Section 562.008, Occupations
3-20 Code, is amended to read as follows:
3-21 (a) If a practitioner certifies on the prescription form
3-22 that a specific prescribed brand is medically necessary, the
3-23 pharmacist shall dispense the drug as written by the practitioner.
3-24 The certification must be made as required by the dispensing
3-25 directive adopted under Section 562.015. This subchapter does not
3-26 permit a pharmacist to substitute a generically equivalent drug
4-1 unless the substitution is made as provided by this subchapter [If
4-2 the practitioner's signature on the form required under Section
4-3 563.002 does not clearly indicate that the prescription must be
4-4 dispensed as written, the pharmacist may select a generically
4-5 equivalent drug].
4-6 SECTION 7. Subchapter A, Chapter 562, Occupations Code, is
4-7 amended by adding Section 562.015 to read as follows:
4-8 Sec. 562.015. DISPENSING DIRECTIVE; COMPLIANCE WITH FEDERAL
4-9 LAW. (a) The board shall adopt rules to provide a dispensing
4-10 directive to instruct pharmacists on the manner in which to
4-11 dispense a drug according to the contents of a prescription. The
4-12 rules adopted under this section must:
4-13 (1) require the use of the phrase "brand necessary" or
4-14 "brand medically necessary" on a prescription form to prohibit the
4-15 substitution of a generically equivalent drug for a brand name
4-16 drug;
4-17 (2) be in a format that protects confidentiality as
4-18 required by the Health Insurance Portability and Accountability Act
4-19 of 1996 (29 U.S.C. Section 1181 et seq.) and its subsequent
4-20 amendments;
4-21 (3) comply with federal and state law, including
4-22 rules, with regard to formatting and security requirements;
4-23 (4) be developed to coordinate with 42 C.F.R. Section
4-24 447.331(c); and
4-25 (5) include an exemption for electronic prescriptions
4-26 as provided by Subsection (b).
5-1 (b) The board shall provide an exemption from the directive
5-2 adopted under this section for prescriptions transmitted
5-3 electronically. The board may regulate the use of electronic
5-4 prescriptions in the manner provided by federal law, including
5-5 rules.
5-6 SECTION 8. Subchapter C, Chapter 562, Occupations Code, is
5-7 amended by adding Section 562.108 to read as follows:
5-8 Sec. 562.108. EMERGENCY MEDICATION KITS. (a) A Class A or
5-9 Class C pharmacy may maintain controlled substances and dangerous
5-10 drugs in an emergency medication kit used at an institution
5-11 licensed under Chapter 242 or 252, Health and Safety Code. The
5-12 controlled substances and dangerous drugs may be used only for the
5-13 emergency medication needs of a resident at that institution.
5-14 (b) The board shall adopt rules relating to emergency
5-15 medication kits, including:
5-16 (1) the amount and type of dangerous drugs and
5-17 controlled substances that may be maintained in an emergency
5-18 medication kit;
5-19 (2) procedures regarding the use of drugs from an
5-20 emergency medication kit;
5-21 (3) recordkeeping requirements; and
5-22 (4) security requirements.
5-23 SECTION 9. Subsection (a), Section 565.001, Occupations
5-24 Code, is amended to read as follows:
5-25 (a) The board may discipline an applicant for or the holder
5-26 of a license to practice pharmacy if the board finds that the
6-1 applicant or license holder has:
6-2 (1) violated this subtitle or a board rule adopted
6-3 under this subtitle;
6-4 (2) engaged in unprofessional conduct as defined by
6-5 board rule;
6-6 (3) engaged in gross immorality as defined by board
6-7 rule;
6-8 (4) developed an incapacity that prevents the
6-9 applicant or license holder from practicing pharmacy with
6-10 reasonable skill, competence, and safety to the public;
6-11 (5) engaged in fraud, deceit, or misrepresentation, as
6-12 defined by board rule, in practicing pharmacy or in seeking a
6-13 license to practice pharmacy;
6-14 (6) been convicted of a misdemeanor involving moral
6-15 turpitude or a felony;
6-16 (7) used alcohol or drugs in an intemperate manner
6-17 that, in the board's opinion, could endanger a patient's life
6-18 [developed a drug or alcohol dependency];
6-19 (8) failed to maintain records required by this
6-20 subtitle or failed to maintain complete and accurate records of
6-21 purchases or disposals of drugs listed in Chapter 481 or 483,
6-22 Health and Safety Code, or the Comprehensive Drug Abuse Prevention
6-23 and Control Act of 1970 (21 U.S.C. Section 801 et seq.);
6-24 (9) violated any provision of:
6-25 (A) Chapter 481 or 483, Health and Safety Code,
6-26 or the Comprehensive Drug Abuse Prevention and Control Act of 1970
7-1 (21 U.S.C. Section 801 et seq.), or rules relating to one of those
7-2 laws;
7-3 (B) Section 485.031, 485.032, 485.033, 485.034,
7-4 or 485.035, Health and Safety Code; or
7-5 (C) a rule adopted under Section 485.011, Health
7-6 and Safety Code;
7-7 (10) aided or abetted an unlicensed person in the
7-8 practice of pharmacy if the pharmacist knew or reasonably should
7-9 have known that the person was unlicensed at the time;
7-10 (11) refused entry into a pharmacy for an inspection
7-11 authorized by this subtitle if the pharmacist received notification
7-12 from which the pharmacist knew or reasonably should have known that
7-13 the attempted inspection was authorized;
7-14 (12) violated any pharmacy or drug statute or rule of
7-15 this state, another state, or the United States;
7-16 (13) been negligent in the practice of pharmacy;
7-17 (14) failed to submit to an examination after hearing
7-18 and being ordered to do so by the board under Section 565.052;
7-19 (15) dispensed a prescription drug while acting
7-20 outside the usual course and scope of professional practice; or
7-21 (16) had a license to practice pharmacy issued by
7-22 another state canceled, revoked, surrendered, or suspended for
7-23 conduct substantially equivalent to conduct described under this
7-24 subsection.
7-25 SECTION 10. Subsection (a), Section 481.074, Health and
7-26 Safety Code, is amended to read as follows:
8-1 (a) A pharmacist may not:
8-2 (1) dispense or deliver a controlled substance or
8-3 cause a controlled substance to be dispensed or delivered under the
8-4 pharmacist's direction or supervision except under a valid
8-5 prescription and in the course of professional practice;
8-6 (2) dispense a controlled substance if the pharmacist
8-7 knows or should have known that the prescription was issued without
8-8 a valid patient-practitioner relationship;
8-9 (3) fill a prescription that is not prepared or issued
8-10 as prescribed by this chapter;
8-11 (4) [(3)] permit or allow a person who is not a
8-12 licensed pharmacist or pharmacist intern to dispense, distribute,
8-13 or in any other manner deliver a controlled substance even if under
8-14 the supervision of a pharmacist, except that after the pharmacist
8-15 or pharmacist intern has fulfilled his professional and legal
8-16 responsibilities, a nonpharmacist may complete the actual cash or
8-17 credit transaction and delivery; or
8-18 (5) [(4)] permit the delivery of a controlled
8-19 substance to any person not known to the pharmacist, the pharmacist
8-20 intern, or the person authorized by the pharmacist to deliver the
8-21 controlled substance without first requiring identification of the
8-22 person taking possession of the controlled substance, except as
8-23 provided by Subsection (n).
8-24 SECTION 11. Subdivision (2), Section 483.001, Health and
8-25 Safety Code, is amended to read as follows:
8-26 (2) "Dangerous drug" means a device or a drug that is
9-1 unsafe for self-medication and that is not included in Schedules I
9-2 through V or Penalty Groups 1 through 4 of Chapter 481 (Texas
9-3 Controlled Substances Act). The term includes a device or a drug
9-4 that bears or is required to bear the legend:
9-5 (A) "Caution: federal law prohibits dispensing
9-6 without prescription" or "Rx only" or another legend that complies
9-7 with federal law; or
9-8 (B) "Caution: federal law restricts this drug
9-9 to use by or on the order of a licensed veterinarian."
9-10 SECTION 12. Subsection (a), Section 483.021, Health and
9-11 Safety Code, is amended to read as follows:
9-12 (a) A pharmacist who is requested to dispense a dangerous
9-13 drug under a prescription issued by a practitioner [described by
9-14 Section 483.001(12)(C)] shall determine, in the exercise of the
9-15 pharmacist's professional judgment, that[:]
9-16 [(1)] the prescription is [authentic;]
9-17 [(2) the prescription was issued under] a valid
9-18 prescription [patient-physician relationship; and]
9-19 [(3) the prescribed drug is considered necessary for
9-20 the treatment of illness]. A pharmacist may not dispense a
9-21 dangerous drug if the pharmacist knows or should have known that
9-22 the prescription was issued without a valid patient-practitioner
9-23 relationship.
9-24 SECTION 13. (a) The following are repealed:
9-25 (1) Sections 242.615 and 252.153, Health and Safety
9-26 Code;
10-1 (2) Section 562.003, Occupations Code; and
10-2 (3) Subchapter A, Chapter 563, Occupations Code.
10-3 (b) Subdivisions (2) and (3), Subsection (a) of this section
10-4 take effect June 1, 2002.
10-5 SECTION 14. (a) In adopting the dispensing directive under
10-6 Section 562.015, Occupations Code, as added by this Act, the Texas
10-7 State Board of Pharmacy shall consult with the Texas State Board of
10-8 Medical Examiners and any other licensing agency that regulates
10-9 health care providers who may be affected by the directive.
10-10 (b) The Texas State Board of Pharmacy shall adopt rules
10-11 required by Section 562.015, Occupations Code, as added by this
10-12 Act, not later than June 1, 2002.
10-13 SECTION 15. (a) In accordance with Subsection (c), Section
10-14 311.031, Government Code, which gives effect to a substantive
10-15 amendment enacted by the same legislature that codifies the amended
10-16 statute, the text of Sections 559.053 and 561.005, Occupations
10-17 Code, as set out in Sections 3 and 5 of this Act, gives effect to
10-18 changes made by Chapter 1518, Acts of the 76th Legislature, Regular
10-19 Session, 1999.
10-20 (b) To the extent of any conflict, this Act prevails over
10-21 another Act of the 77th Legislature, Regular Session, 2001,
10-22 relating to nonsubstantive additions to and corrections in enacted
10-23 codes.
10-24 SECTION 16. (a) Except as provided by Subsection (b),
10-25 Section 13 of this Act, this Act takes effect September 1, 2001.
10-26 (b) The change in law made by this Act to Section 559.053,
11-1 Occupations Code, requiring additional hours of continuing
11-2 education, applies only to a 24-month license period that begins on
11-3 or after the effective date of this Act. A 24-month license period
11-4 that begins before the effective date of this Act is governed by
11-5 the law in effect immediately before the effective date of this
11-6 Act, and the former law is continued in effect for that purpose.
11-7 (c) Not later than December 31, 2001, the Texas State Board
11-8 of Pharmacy shall adopt the rules required by Section 562.108,
11-9 Occupations Code, as added by this Act.
11-10 (d) The Texas State Board of Pharmacy may enforce a rule
11-11 adopted under Sections 242.615 and 252.153, Health and Safety Code.
11-12 Those rules remain in effect until the Texas State Board of
11-13 Pharmacy adopts rules under Subsection (c) of this section. A
11-14 complaint, investigation, or other proceeding pending under Section
11-15 242.615 or 252.153, Health and Safety Code, is transferred without
11-16 change in status to the Texas State Board of Pharmacy.
S.B. No. 768
_______________________________ _______________________________
President of the Senate Speaker of the House
I hereby certify that S.B. No. 768 passed the Senate on
April 5, 2001, by the following vote: Yeas 30, Nays 0, one present
not voting; May 21, 2001, Senate refused to concur in House
amendments and requested appointment of Conference Committee;
May 22, 2001, House granted request of the Senate; May 27, 2001,
Senate adopted Conference Committee Report by a viva-voce vote.
_______________________________
Secretary of the Senate
I hereby certify that S.B. No. 768 passed the House, with
amendments, on May 16, 2001, by a non-record vote; May 22, 2001,
House granted request of the Senate for appointment of Conference
Committee; May 26, 2001, House adopted Conference Committee Report
by a non-record vote.
_______________________________
Chief Clerk of the House
Approved:
_______________________________
Date
_______________________________
Governor