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