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.