CHAPTER 567. LABELING REQUIREMENTS FOR CERTAIN PRESCRIPTION DRUGS OR DRUG PRODUCTS - Texas Statutes

OCCUPATIONS CODE

TITLE 3. HEALTH PROFESSIONS

SUBTITLE J. PHARMACY AND PHARMACISTS

CHAPTER 567. LABELING REQUIREMENTS FOR CERTAIN PRESCRIPTION DRUGS

OR DRUG PRODUCTS

Sec. 567.001. CONTENTS OF PRESCRIPTION DRUG LABEL. (a) A

prescription drug or drug product manufactured and either sold or

distributed to a pharmacist in this state to be subsequently

dispensed to the consumer of the drug or drug product must have

affixed to the label of the drug or drug product:

(1) the name and business address of the original manufacturer

of the finished dosage form; and

(2) except as provided by Subsection (b), the name and business

address of each repackager or distributor of the prescription

drug or drug product before delivery of the prescription drug or

drug product to the pharmacist.

(b) The name and business address of a distributor is not

required to be affixed as prescribed by Subsection (a) if the

distributor acts only as a wholesaler or supplier and does not

repackage the drug or in any way modify the individual drug

package or container or the contents of the package or container

as received from the manufacturer, repackager, or other

distributor.

Acts 1999, 76th Leg., ch. 388, Sec. 1, eff. Sept. 1, 1999.

Sec. 567.002. APPLICABILITY OF LABEL REQUIREMENT. The

information required under Section 567.001 is not required to be

affixed to the container delivered to the patient.

Acts 1999, 76th Leg., ch. 388, Sec. 1, eff. Sept. 1, 1999.

Sec. 567.003. OFFENSE; CRIMINAL PENALTY. (a) A person commits

an offense if the person violates this chapter.

(b) An offense under this chapter is a Class C misdemeanor.

Acts 1999, 76th Leg., ch. 388, Sec. 1, eff. Sept. 1, 1999.