Law:Title 3. Health Professions. Subtitle J. Pharmacy And Pharmacists from Chapter 567. Labeling Requirements For Certain Prescription Drugs Or Drug Products (Texas)

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Subtitle J. Pharmacy And Pharmacists

Contents

Chapter 567. Labeling Requirements For Certain Prescription Drugs Or Drug Products

Section  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.



Section  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.



Section  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.


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