82S10278 NAJ-F
By: Laubenberg H.B. No. 69
A BILL TO BE ENTITLED
AN ACT
relating to the dispensing of certain drugs by physicians.
BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:
SECTION 1. Section 158.001, Occupations Code, is amended by
amending Subsection (b) and adding Subsection (d) to read as
follows:
(b) Except as provided by Subsection (d), a physician may
dispense dangerous drugs to the physician's patients and charge the
patients a reasonable fee for dispensing the drugs [This section
does not permit a physician to operate a retail pharmacy] without
complying with Chapter 558. Before dispensing a dangerous drug,
the physician must notify the patient that the prescription for the
dangerous drug may be filled at a pharmacy. A physician may not
under this section dispense a Schedule II-V controlled substance as
specified under Chapter 481, Health and Safety Code. The board
shall adopt rules to establish a procedure for the dispensing of
dangerous drugs by a physician.
(d) Subsection (b) does not apply to workers' compensation
insurance coverage as defined by Section 401.011, Labor Code.
SECTION 2. Chapter 158, Occupations Code, is amended by
adding Section 158.0011 to read as follows:
Sec. 158.0011. DISPENSING OF DANGEROUS DRUGS FOR WORKERS'
COMPENSATION INSURANCE COVERAGE IN CERTAIN RURAL AREAS. (a) In
this section, "reimbursement for cost" means an additional charge,
separate from that imposed for the physician's professional
services, that includes the cost of the drug product and all other
actual costs to the physician incidental to providing the
dispensing service. The term does not include a separate fee
imposed for the act of dispensing the drug itself.
(b) This section applies to an area located in a county with
a population of 5,000 or less, or in a municipality or an
unincorporated town with a population of less than 2,500, that is
within a 15-mile radius of the physician's office and in which a
pharmacy is not located. This section does not apply to a
municipality or an unincorporated town that is adjacent to a
municipality with a population of 2,500 or more.
(c) A physician who practices medicine in an area described
by Subsection (b) may:
(1) maintain a supply of dangerous drugs in the
physician's office to be dispensed in the course of treating the
physician's patients; and
(2) be reimbursed for the cost of supplying those
drugs without obtaining a license under Chapter 558.
(d) A physician who dispenses dangerous drugs under
Subsection (c) shall:
(1) comply with each labeling provision under Subtitle
J applicable to that class of drugs; and
(2) oversee compliance with packaging and
recordkeeping provisions applicable to that class of drugs.
(e) A physician who desires to dispense dangerous drugs
under this section shall notify both the Texas State Board of
Pharmacy and the board that the physician practices in an area
described by Subsection (b). The physician may continue to
dispense dangerous drugs in the area until the Texas State Board of
Pharmacy determines, after notice and hearing, that the physician
no longer practices in an area described by Subsection (b).
SECTION 3. Subtitle B, Title 3, Occupations Code, is
amended by adding Chapter 158A to read as follows:
CHAPTER 158A. AUTHORITY OF PHYSICIAN TO PROVIDE ABORTION-INDUCING
DRUGS
Sec. 158A.001. DEFINITIONS. In this chapter:
(1) "Abortion" means the act of using or prescribing
an instrument, a medicine, a drug, or any other substance, device,
or means with the intent to terminate a clinically diagnosable
pregnancy of a woman and with knowledge that the termination by
those means will, with reasonable likelihood, cause the death of
the woman's unborn child. An act is not an abortion if the act is
done with the intent to:
(A) save the life or preserve the health of an
unborn child;
(B) remove a dead, unborn child whose death was
caused by spontaneous abortion;
(C) remove an ectopic pregnancy; or
(D) treat a maternal disease or illness for which
the prescribed drug is indicated.
(2) "Abortion-inducing drug" means a medicine, a drug,
or any other substance prescribed or dispensed with the intent of
terminating a clinically diagnosable pregnancy of a woman and with
knowledge that the termination will, with reasonable likelihood,
cause the death of the woman's unborn child. The term includes
off-label use of drugs known to have abortion-inducing properties
that are prescribed with the intent of causing an abortion,
including misoprostol and methotrexate. The term does not include
a drug that may be known to cause an abortion but is prescribed for
other medical reasons.
(3) "Drug label" means a pamphlet accompanying an
abortion-inducing drug that:
(A) outlines the protocol tested and authorized
by the United States Food and Drug Administration and agreed to by
the drug company applying for authorization of the drug by that
agency; and
(B) delineates how a drug is to be used according
to approval by that agency.
(4) "Gestational age" means the amount of time that
has elapsed since the first day of a woman's last menstrual period.
(5) "Medical abortion" means the use of
abortion-inducing drugs to induce an abortion.
(6) "Pregnant" means the female reproductive
condition of having an unborn child in a woman's uterus.
(7) "Unborn child" means an offspring of human beings
from conception until birth.
Sec. 158A.002. DISTRIBUTION OF ABORTION-INDUCING DRUG. (a)
A person may not knowingly give, sell, dispense, administer,
provide, or prescribe an abortion-inducing drug to a pregnant woman
for the purpose of inducing an abortion in the pregnant woman or
enabling another person to induce an abortion in the pregnant woman
unless:
(1) the person who gives, sells, dispenses,
administers, provides, or prescribes the abortion-inducing drug is
a physician; and
(2) the provision or prescription of the
abortion-inducing drug satisfies the protocol tested and
authorized by the United States Food and Drug Administration as
outlined in the abortion-inducing drug's drug label.
(b) Before the physician gives, sells, dispenses,
administers, provides, or prescribes the abortion-inducing drug,
the physician must examine the pregnant woman and document, in the
woman's medical record, the gestational age and intrauterine
location of the pregnancy.
(c) The physician who gives, sells, dispenses, administers,
provides, or prescribes the abortion-inducing drug shall provide
the pregnant woman with a copy of the abortion-inducing drug's drug
label.
(d) The physician who gives, sells, dispenses, administers,
provides, or prescribes the abortion-inducing drug must:
(1) have a signed contract with another physician who
agrees to treat emergencies arising from use of the drug; and
(2) produce the signed contract on demand by the
pregnant woman or the board.
(e) The physician who gives, sells, dispenses, administers,
provides, or prescribes the abortion-inducing drug shall provide
the pregnant woman with the name and phone number of:
(1) the physician who would treat an emergency arising
from use of the drug; and
(2) the hospital at which an emergency arising from
use of the drug would be treated.
(f) A physician who contracts to treat an emergency arising
from use of an abortion-inducing drug must have active admitting,
gynecological, and surgical privileges at the hospital designated
to treat the emergency.
(g) The physician who gives, sells, dispenses, administers,
provides, or prescribes the abortion-inducing drug or the
physician's agent must schedule a follow-up visit for the woman to
occur not more than 14 days after the administration of the drug.
At the follow-up visit, the physician must:
(1) confirm that the pregnancy is completely
terminated; and
(2) assess the degree of bleeding.
(h) The physician who gives, sells, dispenses, administers,
provides, or prescribes the abortion-inducing drug or the
physician's agent shall make a reasonable effort to ensure that the
woman returns for the scheduled appointment. The physician or the
physician's agent shall include a brief description of any effort
made to comply with this subsection, including the date, time, and
name of the person making the effort, in the woman's medical record.
(i) If a physician provides an abortion-inducing drug to a
pregnant woman for the purpose of inducing an abortion as
authorized by this section and the physician knows that the woman
experiences a serious adverse event, as defined by the MedWatch
Reporting System, during or after using the drug, the physician
shall report the event to the United States Food and Drug
Administration through the MedWatch Reporting System within three
days of the event.
Sec. 158A.003. PENALTY. A penalty may not be assessed under
this subtitle against a pregnant woman who receives a medical
abortion.
SECTION 4. Section 164.052(a), Occupations Code, is amended
to read as follows:
(a) A physician or an applicant for a license to practice
medicine commits a prohibited practice if that person:
(1) submits to the board a false or misleading
statement, document, or certificate in an application for a
license;
(2) presents to the board a license, certificate, or
diploma that was illegally or fraudulently obtained;
(3) commits fraud or deception in taking or passing an
examination;
(4) uses alcohol or drugs in an intemperate manner
that, in the board's opinion, could endanger a patient's life;
(5) commits unprofessional or dishonorable conduct
that is likely to deceive or defraud the public, as provided by
Section 164.053, or injure the public;
(6) uses an advertising statement that is false,
misleading, or deceptive;
(7) advertises professional superiority or the
performance of professional service in a superior manner if that
advertising is not readily subject to verification;
(8) purchases, sells, barters, or uses, or offers to
purchase, sell, barter, or use, a medical degree, license,
certificate, or diploma, or a transcript of a license, certificate,
or diploma in or incident to an application to the board for a
license to practice medicine;
(9) alters, with fraudulent intent, a medical license,
certificate, or diploma, or a transcript of a medical license,
certificate, or diploma;
(10) uses a medical license, certificate, or diploma,
or a transcript of a medical license, certificate, or diploma that
has been:
(A) fraudulently purchased or issued;
(B) counterfeited; or
(C) materially altered;
(11) impersonates or acts as proxy for another person
in an examination required by this subtitle for a medical license;
(12) engages in conduct that subverts or attempts to
subvert an examination process required by this subtitle for a
medical license;
(13) impersonates a physician or permits another to
use the person's license or certificate to practice medicine in
this state;
(14) directly or indirectly employs a person whose
license to practice medicine has been suspended, canceled, or
revoked;
(15) associates in the practice of medicine with a
person:
(A) whose license to practice medicine has been
suspended, canceled, or revoked; or
(B) who has been convicted of the unlawful
practice of medicine in this state or elsewhere;
(16) performs or procures a criminal abortion, aids or
abets in the procuring of a criminal abortion, attempts to perform
or procure a criminal abortion, or attempts to aid or abet the
performance or procurement of a criminal abortion;
(17) directly or indirectly aids or abets the practice
of medicine by a person, partnership, association, or corporation
that is not licensed to practice medicine by the board;
(18) performs an abortion on a woman who is pregnant
with a viable unborn child during the third trimester of the
pregnancy unless:
(A) the abortion is necessary to prevent the
death of the woman;
(B) the viable unborn child has a severe,
irreversible brain impairment; or
(C) the woman is diagnosed with a significant
likelihood of suffering imminent severe, irreversible brain damage
or imminent severe, irreversible paralysis; [or]
(19) performs an abortion on an unemancipated minor
without the written consent of the child's parent, managing
conservator, or legal guardian or without a court order, as
provided by Section 33.003 or 33.004, Family Code, authorizing the
minor to consent to the abortion, unless the physician concludes
that on the basis of the physician's good faith clinical judgment, a
condition exists that complicates the medical condition of the
pregnant minor and necessitates the immediate abortion of her
pregnancy to avert her death or to avoid a serious risk of
substantial impairment of a major bodily function and that there is
insufficient time to obtain the consent of the child's parent,
managing conservator, or legal guardian; or
(20) violates Chapter 158A.
SECTION 5. Section 551.004(b), Occupations Code, is amended
to read as follows:
(b) This subtitle does not prevent a practitioner from:
(1) administering a drug to a patient of the
practitioner; or
(2) supplying dangerous drugs to a patient as provided
by Section 158.001(b).
SECTION 6. Section 158.003, Occupations Code, is repealed.
SECTION 7. (a) The Texas Medical Board shall adopt rules
to implement Section 158.001(b), Occupations Code, as amended by
this Act, not later than December 1, 2011.
(b) The changes in law made by Sections 158.001 and 551.004,
Occupations Code, as amended by this Act, and Section 158.0011,
Occupations Code, as added by this Act, apply to the dispensing of a
dangerous drug by a physician on or after December 1, 2011. The
dispensing of a dangerous drug before December 1, 2011, is governed
by the law in effect immediately before the effective date of this
Act, and the former law is continued in effect for that purpose.
(c) The changes in law made by Chapter 158A, Occupations
Code, as added by this Act, apply only to the provision or
prescription of an abortion-inducing drug on or after the effective
date of this Act. The provision or prescription of an
abortion-inducing drug before the effective date of this Act is
governed by the law in effect at the time the drug was provided or
prescribed, and the former law is continued in effect for that
purpose.
SECTION 8. This Act takes effect immediately if it receives
a vote of two-thirds of all the members elected to each house, as
provided by Section 39, Article III, Texas Constitution. If this
Act does not receive the vote necessary for immediate effect, this
Act takes effect on the 91st day after the last day of the
legislative session.