Sec. 431.412. PEDIGREE REQUIRED. (a) A person who is engaged in the wholesale distribution of a prescription drug, including a repackager but excluding the original manufacturer, shall provide a pedigree for each prescription drug for human consumption that leaves or at any time has left the normal distribution channel and is sold, traded, or transferred to any other person.
(b) Repealed by Acts 2007, 80th Leg., R.S., Ch. 980, Sec. 14.
(b-1) A retail pharmacy or pharmacy warehouse is required to comply with this section only if the pharmacy or warehouse engages in the wholesale distribution of a prescription drug.
(c) Repealed by Acts 2007, 80th Leg., R.S., Ch. 980, Sec. 14.
(d) A person who is engaged in the wholesale distribution of a prescription drug, including a repackager, but excluding the original manufacturer of the finished form of a prescription drug, and who is in possession of a pedigree for a prescription drug must verify before distributing the prescription drug that each transaction listed on the pedigree has occurred.
Added by Acts 2005, 79th Leg., Ch. 282 (H.B. 164), Sec. 3(g), eff. March 1, 2006.
Amended by:
Acts 2007, 80th Leg., R.S., Ch. 980 (S.B. 943), Sec. 11, eff. September 1, 2007.
Acts 2007, 80th Leg., R.S., Ch. 980 (S.B. 943), Sec. 14 eff. September 1, 2007.
Structure Texas Statutes
Title 6 - Food, Drugs, Alcohol, and Hazardous Substances
Subtitle A - Food and Drug Health Regulations
Chapter 431 - Texas Food, Drug, and Cosmetic Act
Subchapter N. Wholesale Distributors of Prescription Drugs
Section 431.4011. Ongoing Relationship
Section 431.4012. Applicability of Subchapter
Section 431.402. License Required
Section 431.403. Exemption From Licensing
Section 431.4031. Exemption From Certain Provisions for Certain Wholesale Distributors
Section 431.404. License Application
Section 431.4045. Inspection Required
Section 431.405. Qualifications for License
Section 431.406. Effect of Operation in Other Jurisdictions; Reports
Section 431.407. Criminal History Record Information
Section 431.4095. Renewal Notification; Change or Renewal
Section 431.410. Change of Location of Place of Business
Section 431.411. Minimum Restrictions on Transactions
Section 431.412. Pedigree Required
Section 431.413. Pedigree Contents
Section 431.414. Refusal to License; Suspension or Revocation of License