State Codes and Statutes
Statutes > Texas > Health-and-safety-code > Title-6-food-drugs-alcohol-and-hazardous-substances > Chapter-439-manufacture-and-distribution-of-certain-drugs
HEALTH AND SAFETY CODE
TITLE 6. FOOD, DRUGS, ALCOHOL, AND HAZARDOUS SUBSTANCES
SUBTITLE A. FOOD AND DRUG HEALTH REGULATIONS
CHAPTER 439. MANUFACTURE AND DISTRIBUTION OF CERTAIN DRUGS
SUBCHAPTER A. LAETRILE
Sec. 439.001. DEFINITION. In this chapter, "laetrile" means
amygdalin.
Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.
Sec. 439.002. MANUFACTURE AND SALE. Laetrile may be
manufactured in this state in accordance with Chapter 431 (Texas
Food, Drug and Cosmetic Act) and may be sold in this state for
distribution by licensed physicians.
Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.
Sec. 439.003. PRESCRIPTION AND ADMINISTRATION. (a) A licensed
physician may prescribe or administer laetrile in the treatment
of cancer.
(b) A physician is not subject to disciplinary action by the
Texas State Board of Medical Examiners for prescribing or
administering laetrile to a patient under the physician's care
who has requested the substance unless that board makes a formal
finding that the substance is harmful.
(c) A finding under Subsection (b) must be made in a hearing
conducted as provided by Chapter 2001, Government Code.
Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.
Amended by Acts 1995, 74th Leg., ch. 76, Sec. 5.95(49), eff.
Sept. 1, 1995.
Sec. 439.004. REGULATION BY HEALTH CARE FACILITY. (a) A
hospital or other health care facility may not forbid or restrict
the use of laetrile when it is requested by a patient and
prescribed or administered by a physician unless the Texas Board
of Health finds that the substance is harmful as prescribed or
administered by the physician.
(b) A finding under Subsection (a) must be made after a hearing
conducted as provided by Chapter 2001, Government Code.
Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.
Amended by Acts 1995, 74th Leg., ch. 76, Sec. 5.95(49), eff.
Sept. 1, 1995.
Sec. 439.005. RECORDS; DISCIPLINARY ACTIONS. (a) A physician
shall keep records of the physician's purchases and disposals,
including sales and dispensations, of laetrile. The records shall
include the date of each purchase or disposal by the physician,
the name and address of the person receiving laetrile, and the
reason for the disposal of laetrile to that person.
(b) The Texas State Board of Medical Examiners may suspend,
cancel, or revoke the license of any physician who:
(1) fails to keep complete and accurate records of purchases and
disposals of laetrile;
(2) prescribes or dispenses laetrile to a person known to be a
habitual user of narcotic or dangerous drugs or to a person who
the physician should have known was a habitual user of narcotic
or dangerous drugs;
(3) uses any advertising that tends to mislead or deceive the
public; or
(4) is unable to practice medicine with reasonable skill and
safety to patients because of any mental or physical condition,
including age, illness, or drunkenness, or because of excessive
use of drugs, narcotics, chemicals, or any other type of
material.
(c) Subsection (b)(2) does not apply to a person being treated
by the physician for narcotic use after the physician notifies
the Texas State Board of Medical Examiners in writing of the name
and address of the patient being treated.
Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.
SUBCHAPTER B. DIMETHYL SULFOXIDE
Sec. 439.011. DEFINITION. In this subchapter, "DMSO" means
sterile and pyrogen-free dimethyl sulfoxide.
Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.
Sec. 439.012. MANUFACTURE AND SALE. DMSO may be manufactured in
this state and may be sold in this state for human use when
prescribed or administered by a licensed physician or dispensed
by a licensed pharmacist as prescribed by a licensed physician.
Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.
Sec. 439.013. PRESCRIPTION, ADMINISTRATION, AND DISPENSATION.
(a) Except as prohibited by Subsection (b), a licensed physician
may prescribe or administer DMSO.
(b) A physician may not prescribe or administer DMSO in a
formulation not approved for human use by the Food and Drug
Administration of the United States Department of Health and
Human Services unless the physician:
(1) provides a written statement to the patient informing the
patient that DMSO, in the formulation to be prescribed or
administered, has not been approved for human use by the United
States Food and Drug Administration; and
(2) informs the patient of the alternative methods of treatment
for the patient's disorder and the potential of alternative
methods for cure.
(c) A licensed pharmacist may dispense DMSO on the written
prescription of a licensed physician.
Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.
Sec. 439.014. REGULATION BY HEALTH CARE FACILITY. (a) A
hospital or health care facility may not forbid or restrict the
use of DMSO prescribed or administered by a licensed physician
having staff privileges at that hospital or facility unless the
hospital or facility:
(1) makes a formal finding that the DMSO as prescribed or
administered by the physician is or will be harmful to the
patient; or
(2) determines that the prescription or administration of DMSO
creates an immediate danger to the public.
(b) A hospital or health care facility that forbids or restricts
the use of DMSO under Subsection (a)(2) shall conduct a hearing
on the restriction or prohibition as soon as practicable after
its determination.
Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.
Sec. 439.015. RECORDS; DISCIPLINARY ACTIONS. (a) A physician
shall keep records of the physician's purchases and disposals,
including sales and dispensations, of DMSO. The records shall
include the date of each purchase or disposal by the physician,
the name and address of the person receiving DMSO, and the reason
for the disposal of DMSO to that person.
(b) The Texas State Board of Medical Examiners may suspend,
cancel, or revoke the license of any physician who:
(1) fails to keep complete and accurate records of purchases and
disposals of DMSO in a formulation not approved for human use; or
(2) prescribes or administers DMSO in a manner that has been
proven, in a formal hearing held by the board, to be harmful to
the patient.
(c) The Texas State Board of Medical Examiners may temporarily
suspend the license of a physician who prescribes or administers
DMSO in a manner that, in the board's opinion, creates an
immediate danger to the public. The board must conduct a hearing
on the temporary suspension as soon as practicable after the
suspension.
Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.
Sec. 439.016. MISREPRESENTATION; CRIMINAL PENALTY. (a) A
person commits an offense if, in connection with advertising or
promoting the sale of DMSO, the person knowingly or intentionally
represents DMSO as a cure for any human disease, ailment, or
disorder.
(b) An offense under this section is a Class B misdemeanor.
Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.
Sec. 439.017. RESTRICTIONS ON MANUFACTURE, DISTRIBUTION, AND
SALE; CRIMINAL PENALTY. (a) A person commits an offense if the
person manufactures, distributes, or sells a dimethyl sulfoxide
formulation that is not sterile and pyrogen-free unless the
substance is packaged in a container with a label that includes:
(1) information about the concentration of the dimethyl
sulfoxide; and
(2) the following statement: "Avoid contact with your skin. This
dimethyl sulfoxide is not sterile and pyrogen-free DMSO approved
for human use. It may contain harmful impurities that can be
absorbed through the skin. Dimethyl sulfoxide is a potent solvent
that may have adverse effects on fabrics, plastics, and other
materials."
(b) An offense under this section is a Class B misdemeanor.
Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.
SUBCHAPTER C. PRESERVATION AND DISTRIBUTION OF CERTAIN UNUSED
DRUGS
Sec. 439.021. SHIPMENT TO FOREIGN COUNTRIES. (a) A consulting
pharmacist of a nursing home may select, from a supply of drugs
due for destruction, certain drugs to be used for shipment to a
foreign country as provided by this subchapter.
(b) The supply of drugs due for destruction are those drugs
accumulated because of the death of a resident of the nursing
home or because a physician has ordered the use of the drug to be
discontinued.
(c) Quarterly, before the drugs are destroyed, the consulting
pharmacist may, in the pharmacist's professional judgment, select
the drugs to be used under this subchapter and seal them in a box
for shipment.
(d) The consulting pharmacist shall account to the Texas
Department of Health for all drugs selected for shipment under
this subchapter.
(e) This subchapter does not apply if the unused drug is a
controlled substance as defined by Chapter 481 (Texas Controlled
Substances Act).
Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.
Sec. 439.022. ADMINISTRATION. (a) The Texas Board of Health
shall adopt rules consistent with federal and state law to
implement this subchapter, including rules relating to:
(1) the packaging and inventory of drugs for shipment;
(2) the manner of shipment of the drugs from original shipment
under this subchapter until the final destination; and
(3) safeguards to ensure the proper handling of and accounting
for all drugs shipped.
(b) The Texas Board of Health by rule shall determine, in
consultation with the United States Department of State and other
appropriate federal agencies, the foreign countries to receive
the drugs.
(c) The salvaging of drugs under this subchapter is not subject
to Chapter 431 (Texas Food, Drug and Cosmetic Act).
Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.
Sec. 439.023. CONTRACTS; FUNDS. (a) The Texas Department of
Health may contract with other entities, including local
governments and civic organizations, to implement this
subchapter.
(b) The department may accept gifts, grants, and any other funds
to implement this subchapter.
Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.
State Codes and Statutes
Statutes > Texas > Health-and-safety-code > Title-6-food-drugs-alcohol-and-hazardous-substances > Chapter-439-manufacture-and-distribution-of-certain-drugs
HEALTH AND SAFETY CODE
TITLE 6. FOOD, DRUGS, ALCOHOL, AND HAZARDOUS SUBSTANCES
SUBTITLE A. FOOD AND DRUG HEALTH REGULATIONS
CHAPTER 439. MANUFACTURE AND DISTRIBUTION OF CERTAIN DRUGS
SUBCHAPTER A. LAETRILE
Sec. 439.001. DEFINITION. In this chapter, "laetrile" means
amygdalin.
Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.
Sec. 439.002. MANUFACTURE AND SALE. Laetrile may be
manufactured in this state in accordance with Chapter 431 (Texas
Food, Drug and Cosmetic Act) and may be sold in this state for
distribution by licensed physicians.
Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.
Sec. 439.003. PRESCRIPTION AND ADMINISTRATION. (a) A licensed
physician may prescribe or administer laetrile in the treatment
of cancer.
(b) A physician is not subject to disciplinary action by the
Texas State Board of Medical Examiners for prescribing or
administering laetrile to a patient under the physician's care
who has requested the substance unless that board makes a formal
finding that the substance is harmful.
(c) A finding under Subsection (b) must be made in a hearing
conducted as provided by Chapter 2001, Government Code.
Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.
Amended by Acts 1995, 74th Leg., ch. 76, Sec. 5.95(49), eff.
Sept. 1, 1995.
Sec. 439.004. REGULATION BY HEALTH CARE FACILITY. (a) A
hospital or other health care facility may not forbid or restrict
the use of laetrile when it is requested by a patient and
prescribed or administered by a physician unless the Texas Board
of Health finds that the substance is harmful as prescribed or
administered by the physician.
(b) A finding under Subsection (a) must be made after a hearing
conducted as provided by Chapter 2001, Government Code.
Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.
Amended by Acts 1995, 74th Leg., ch. 76, Sec. 5.95(49), eff.
Sept. 1, 1995.
Sec. 439.005. RECORDS; DISCIPLINARY ACTIONS. (a) A physician
shall keep records of the physician's purchases and disposals,
including sales and dispensations, of laetrile. The records shall
include the date of each purchase or disposal by the physician,
the name and address of the person receiving laetrile, and the
reason for the disposal of laetrile to that person.
(b) The Texas State Board of Medical Examiners may suspend,
cancel, or revoke the license of any physician who:
(1) fails to keep complete and accurate records of purchases and
disposals of laetrile;
(2) prescribes or dispenses laetrile to a person known to be a
habitual user of narcotic or dangerous drugs or to a person who
the physician should have known was a habitual user of narcotic
or dangerous drugs;
(3) uses any advertising that tends to mislead or deceive the
public; or
(4) is unable to practice medicine with reasonable skill and
safety to patients because of any mental or physical condition,
including age, illness, or drunkenness, or because of excessive
use of drugs, narcotics, chemicals, or any other type of
material.
(c) Subsection (b)(2) does not apply to a person being treated
by the physician for narcotic use after the physician notifies
the Texas State Board of Medical Examiners in writing of the name
and address of the patient being treated.
Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.
SUBCHAPTER B. DIMETHYL SULFOXIDE
Sec. 439.011. DEFINITION. In this subchapter, "DMSO" means
sterile and pyrogen-free dimethyl sulfoxide.
Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.
Sec. 439.012. MANUFACTURE AND SALE. DMSO may be manufactured in
this state and may be sold in this state for human use when
prescribed or administered by a licensed physician or dispensed
by a licensed pharmacist as prescribed by a licensed physician.
Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.
Sec. 439.013. PRESCRIPTION, ADMINISTRATION, AND DISPENSATION.
(a) Except as prohibited by Subsection (b), a licensed physician
may prescribe or administer DMSO.
(b) A physician may not prescribe or administer DMSO in a
formulation not approved for human use by the Food and Drug
Administration of the United States Department of Health and
Human Services unless the physician:
(1) provides a written statement to the patient informing the
patient that DMSO, in the formulation to be prescribed or
administered, has not been approved for human use by the United
States Food and Drug Administration; and
(2) informs the patient of the alternative methods of treatment
for the patient's disorder and the potential of alternative
methods for cure.
(c) A licensed pharmacist may dispense DMSO on the written
prescription of a licensed physician.
Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.
Sec. 439.014. REGULATION BY HEALTH CARE FACILITY. (a) A
hospital or health care facility may not forbid or restrict the
use of DMSO prescribed or administered by a licensed physician
having staff privileges at that hospital or facility unless the
hospital or facility:
(1) makes a formal finding that the DMSO as prescribed or
administered by the physician is or will be harmful to the
patient; or
(2) determines that the prescription or administration of DMSO
creates an immediate danger to the public.
(b) A hospital or health care facility that forbids or restricts
the use of DMSO under Subsection (a)(2) shall conduct a hearing
on the restriction or prohibition as soon as practicable after
its determination.
Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.
Sec. 439.015. RECORDS; DISCIPLINARY ACTIONS. (a) A physician
shall keep records of the physician's purchases and disposals,
including sales and dispensations, of DMSO. The records shall
include the date of each purchase or disposal by the physician,
the name and address of the person receiving DMSO, and the reason
for the disposal of DMSO to that person.
(b) The Texas State Board of Medical Examiners may suspend,
cancel, or revoke the license of any physician who:
(1) fails to keep complete and accurate records of purchases and
disposals of DMSO in a formulation not approved for human use; or
(2) prescribes or administers DMSO in a manner that has been
proven, in a formal hearing held by the board, to be harmful to
the patient.
(c) The Texas State Board of Medical Examiners may temporarily
suspend the license of a physician who prescribes or administers
DMSO in a manner that, in the board's opinion, creates an
immediate danger to the public. The board must conduct a hearing
on the temporary suspension as soon as practicable after the
suspension.
Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.
Sec. 439.016. MISREPRESENTATION; CRIMINAL PENALTY. (a) A
person commits an offense if, in connection with advertising or
promoting the sale of DMSO, the person knowingly or intentionally
represents DMSO as a cure for any human disease, ailment, or
disorder.
(b) An offense under this section is a Class B misdemeanor.
Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.
Sec. 439.017. RESTRICTIONS ON MANUFACTURE, DISTRIBUTION, AND
SALE; CRIMINAL PENALTY. (a) A person commits an offense if the
person manufactures, distributes, or sells a dimethyl sulfoxide
formulation that is not sterile and pyrogen-free unless the
substance is packaged in a container with a label that includes:
(1) information about the concentration of the dimethyl
sulfoxide; and
(2) the following statement: "Avoid contact with your skin. This
dimethyl sulfoxide is not sterile and pyrogen-free DMSO approved
for human use. It may contain harmful impurities that can be
absorbed through the skin. Dimethyl sulfoxide is a potent solvent
that may have adverse effects on fabrics, plastics, and other
materials."
(b) An offense under this section is a Class B misdemeanor.
Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.
SUBCHAPTER C. PRESERVATION AND DISTRIBUTION OF CERTAIN UNUSED
DRUGS
Sec. 439.021. SHIPMENT TO FOREIGN COUNTRIES. (a) A consulting
pharmacist of a nursing home may select, from a supply of drugs
due for destruction, certain drugs to be used for shipment to a
foreign country as provided by this subchapter.
(b) The supply of drugs due for destruction are those drugs
accumulated because of the death of a resident of the nursing
home or because a physician has ordered the use of the drug to be
discontinued.
(c) Quarterly, before the drugs are destroyed, the consulting
pharmacist may, in the pharmacist's professional judgment, select
the drugs to be used under this subchapter and seal them in a box
for shipment.
(d) The consulting pharmacist shall account to the Texas
Department of Health for all drugs selected for shipment under
this subchapter.
(e) This subchapter does not apply if the unused drug is a
controlled substance as defined by Chapter 481 (Texas Controlled
Substances Act).
Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.
Sec. 439.022. ADMINISTRATION. (a) The Texas Board of Health
shall adopt rules consistent with federal and state law to
implement this subchapter, including rules relating to:
(1) the packaging and inventory of drugs for shipment;
(2) the manner of shipment of the drugs from original shipment
under this subchapter until the final destination; and
(3) safeguards to ensure the proper handling of and accounting
for all drugs shipped.
(b) The Texas Board of Health by rule shall determine, in
consultation with the United States Department of State and other
appropriate federal agencies, the foreign countries to receive
the drugs.
(c) The salvaging of drugs under this subchapter is not subject
to Chapter 431 (Texas Food, Drug and Cosmetic Act).
Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.
Sec. 439.023. CONTRACTS; FUNDS. (a) The Texas Department of
Health may contract with other entities, including local
governments and civic organizations, to implement this
subchapter.
(b) The department may accept gifts, grants, and any other funds
to implement this subchapter.
Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.
State Codes and Statutes
Statutes >
Texas >
Health-and-safety-code >
Title-6-food-drugs-alcohol-and-hazardous-substances >
Chapter-439-manufacture-and-distribution-of-certain-drugs HEALTH AND SAFETY CODE
TITLE 6. FOOD, DRUGS, ALCOHOL, AND HAZARDOUS SUBSTANCES
SUBTITLE A. FOOD AND DRUG HEALTH REGULATIONS
CHAPTER 439. MANUFACTURE AND DISTRIBUTION OF CERTAIN DRUGS
SUBCHAPTER A. LAETRILE
Sec. 439.001. DEFINITION. In this chapter, "laetrile" means
amygdalin.
Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.
Sec. 439.002. MANUFACTURE AND SALE. Laetrile may be
manufactured in this state in accordance with Chapter 431 (Texas
Food, Drug and Cosmetic Act) and may be sold in this state for
distribution by licensed physicians.
Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.
Sec. 439.003. PRESCRIPTION AND ADMINISTRATION. (a) A licensed
physician may prescribe or administer laetrile in the treatment
of cancer.
(b) A physician is not subject to disciplinary action by the
Texas State Board of Medical Examiners for prescribing or
administering laetrile to a patient under the physician's care
who has requested the substance unless that board makes a formal
finding that the substance is harmful.
(c) A finding under Subsection (b) must be made in a hearing
conducted as provided by Chapter 2001, Government Code.
Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.
Amended by Acts 1995, 74th Leg., ch. 76, Sec. 5.95(49), eff.
Sept. 1, 1995.
Sec. 439.004. REGULATION BY HEALTH CARE FACILITY. (a) A
hospital or other health care facility may not forbid or restrict
the use of laetrile when it is requested by a patient and
prescribed or administered by a physician unless the Texas Board
of Health finds that the substance is harmful as prescribed or
administered by the physician.
(b) A finding under Subsection (a) must be made after a hearing
conducted as provided by Chapter 2001, Government Code.
Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.
Amended by Acts 1995, 74th Leg., ch. 76, Sec. 5.95(49), eff.
Sept. 1, 1995.
Sec. 439.005. RECORDS; DISCIPLINARY ACTIONS. (a) A physician
shall keep records of the physician's purchases and disposals,
including sales and dispensations, of laetrile. The records shall
include the date of each purchase or disposal by the physician,
the name and address of the person receiving laetrile, and the
reason for the disposal of laetrile to that person.
(b) The Texas State Board of Medical Examiners may suspend,
cancel, or revoke the license of any physician who:
(1) fails to keep complete and accurate records of purchases and
disposals of laetrile;
(2) prescribes or dispenses laetrile to a person known to be a
habitual user of narcotic or dangerous drugs or to a person who
the physician should have known was a habitual user of narcotic
or dangerous drugs;
(3) uses any advertising that tends to mislead or deceive the
public; or
(4) is unable to practice medicine with reasonable skill and
safety to patients because of any mental or physical condition,
including age, illness, or drunkenness, or because of excessive
use of drugs, narcotics, chemicals, or any other type of
material.
(c) Subsection (b)(2) does not apply to a person being treated
by the physician for narcotic use after the physician notifies
the Texas State Board of Medical Examiners in writing of the name
and address of the patient being treated.
Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.
SUBCHAPTER B. DIMETHYL SULFOXIDE
Sec. 439.011. DEFINITION. In this subchapter, "DMSO" means
sterile and pyrogen-free dimethyl sulfoxide.
Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.
Sec. 439.012. MANUFACTURE AND SALE. DMSO may be manufactured in
this state and may be sold in this state for human use when
prescribed or administered by a licensed physician or dispensed
by a licensed pharmacist as prescribed by a licensed physician.
Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.
Sec. 439.013. PRESCRIPTION, ADMINISTRATION, AND DISPENSATION.
(a) Except as prohibited by Subsection (b), a licensed physician
may prescribe or administer DMSO.
(b) A physician may not prescribe or administer DMSO in a
formulation not approved for human use by the Food and Drug
Administration of the United States Department of Health and
Human Services unless the physician:
(1) provides a written statement to the patient informing the
patient that DMSO, in the formulation to be prescribed or
administered, has not been approved for human use by the United
States Food and Drug Administration; and
(2) informs the patient of the alternative methods of treatment
for the patient's disorder and the potential of alternative
methods for cure.
(c) A licensed pharmacist may dispense DMSO on the written
prescription of a licensed physician.
Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.
Sec. 439.014. REGULATION BY HEALTH CARE FACILITY. (a) A
hospital or health care facility may not forbid or restrict the
use of DMSO prescribed or administered by a licensed physician
having staff privileges at that hospital or facility unless the
hospital or facility:
(1) makes a formal finding that the DMSO as prescribed or
administered by the physician is or will be harmful to the
patient; or
(2) determines that the prescription or administration of DMSO
creates an immediate danger to the public.
(b) A hospital or health care facility that forbids or restricts
the use of DMSO under Subsection (a)(2) shall conduct a hearing
on the restriction or prohibition as soon as practicable after
its determination.
Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.
Sec. 439.015. RECORDS; DISCIPLINARY ACTIONS. (a) A physician
shall keep records of the physician's purchases and disposals,
including sales and dispensations, of DMSO. The records shall
include the date of each purchase or disposal by the physician,
the name and address of the person receiving DMSO, and the reason
for the disposal of DMSO to that person.
(b) The Texas State Board of Medical Examiners may suspend,
cancel, or revoke the license of any physician who:
(1) fails to keep complete and accurate records of purchases and
disposals of DMSO in a formulation not approved for human use; or
(2) prescribes or administers DMSO in a manner that has been
proven, in a formal hearing held by the board, to be harmful to
the patient.
(c) The Texas State Board of Medical Examiners may temporarily
suspend the license of a physician who prescribes or administers
DMSO in a manner that, in the board's opinion, creates an
immediate danger to the public. The board must conduct a hearing
on the temporary suspension as soon as practicable after the
suspension.
Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.
Sec. 439.016. MISREPRESENTATION; CRIMINAL PENALTY. (a) A
person commits an offense if, in connection with advertising or
promoting the sale of DMSO, the person knowingly or intentionally
represents DMSO as a cure for any human disease, ailment, or
disorder.
(b) An offense under this section is a Class B misdemeanor.
Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.
Sec. 439.017. RESTRICTIONS ON MANUFACTURE, DISTRIBUTION, AND
SALE; CRIMINAL PENALTY. (a) A person commits an offense if the
person manufactures, distributes, or sells a dimethyl sulfoxide
formulation that is not sterile and pyrogen-free unless the
substance is packaged in a container with a label that includes:
(1) information about the concentration of the dimethyl
sulfoxide; and
(2) the following statement: "Avoid contact with your skin. This
dimethyl sulfoxide is not sterile and pyrogen-free DMSO approved
for human use. It may contain harmful impurities that can be
absorbed through the skin. Dimethyl sulfoxide is a potent solvent
that may have adverse effects on fabrics, plastics, and other
materials."
(b) An offense under this section is a Class B misdemeanor.
Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.
SUBCHAPTER C. PRESERVATION AND DISTRIBUTION OF CERTAIN UNUSED
DRUGS
Sec. 439.021. SHIPMENT TO FOREIGN COUNTRIES. (a) A consulting
pharmacist of a nursing home may select, from a supply of drugs
due for destruction, certain drugs to be used for shipment to a
foreign country as provided by this subchapter.
(b) The supply of drugs due for destruction are those drugs
accumulated because of the death of a resident of the nursing
home or because a physician has ordered the use of the drug to be
discontinued.
(c) Quarterly, before the drugs are destroyed, the consulting
pharmacist may, in the pharmacist's professional judgment, select
the drugs to be used under this subchapter and seal them in a box
for shipment.
(d) The consulting pharmacist shall account to the Texas
Department of Health for all drugs selected for shipment under
this subchapter.
(e) This subchapter does not apply if the unused drug is a
controlled substance as defined by Chapter 481 (Texas Controlled
Substances Act).
Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.
Sec. 439.022. ADMINISTRATION. (a) The Texas Board of Health
shall adopt rules consistent with federal and state law to
implement this subchapter, including rules relating to:
(1) the packaging and inventory of drugs for shipment;
(2) the manner of shipment of the drugs from original shipment
under this subchapter until the final destination; and
(3) safeguards to ensure the proper handling of and accounting
for all drugs shipped.
(b) The Texas Board of Health by rule shall determine, in
consultation with the United States Department of State and other
appropriate federal agencies, the foreign countries to receive
the drugs.
(c) The salvaging of drugs under this subchapter is not subject
to Chapter 431 (Texas Food, Drug and Cosmetic Act).
Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.
Sec. 439.023. CONTRACTS; FUNDS. (a) The Texas Department of
Health may contract with other entities, including local
governments and civic organizations, to implement this
subchapter.
(b) The department may accept gifts, grants, and any other funds
to implement this subchapter.
Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.
Loading..
Close Window
Loading, Please Wait!
This may take a second or two.
