2005 Texas Health & Safety Code CHAPTER 439. MANUFACTURE AND DISTRIBUTION OF CERTAIN DRUGS

HEALTH & SAFETY CODE

CHAPTER 439. MANUFACTURE AND DISTRIBUTION OF CERTAIN DRUGS

SUBCHAPTER A. LAETRILE


	§ 439.001. DEFINITION.  In this chapter, "laetrile" means 
amygdalin.      

Acts 1989, 71st Leg., ch. 678, § 1, eff. Sept. 1, 1989.                    


	§ 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, § 1, eff. Sept. 1, 1989.                    


	§ 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, § 1, eff. Sept. 1, 1989.  Amended 
by Acts 1995, 74th Leg., ch. 76, § 5.95(49), eff. Sept. 1, 1995.


	§ 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, § 1, eff. Sept. 1, 1989.  Amended 
by Acts 1995, 74th Leg., ch. 76, § 5.95(49), eff. Sept. 1, 1995.


	§ 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, § 1, eff. Sept. 1, 1989.                    

SUBCHAPTER B. DIMETHYL SULFOXIDE


	§ 439.011. DEFINITION.  In this subchapter, "DMSO" means 
sterile and pyrogen-free dimethyl sulfoxide.

Acts 1989, 71st Leg., ch. 678, § 1, eff. Sept. 1, 1989.                    


	§ 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, § 1, eff. Sept. 1, 1989.                    


	§ 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, § 1, eff. Sept. 1, 1989.                    


	§ 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, § 1, eff. Sept. 1, 1989.                    


	§ 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, § 1, eff. Sept. 1, 1989.                    


	§ 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, § 1, eff. Sept. 1, 1989.                    


	§ 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, § 1, eff. Sept. 1, 1989.                    

SUBCHAPTER C. PRESERVATION AND DISTRIBUTION OF CERTAIN UNUSED DRUGS


	§ 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, § 1, eff. Sept. 1, 1989.                    


	§ 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, § 1, eff. Sept. 1, 1989.                    


	§ 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, § 1, eff. Sept. 1, 1989.