Sec. 431.403. EXEMPTION FROM LICENSING. (a) A person who engages in wholesale distribution of prescription drugs in this state for use in humans is exempt from this subchapter if the person is exempt under:
(1) the Prescription Drug Marketing Act of 1987 (21 U.S.C. Section 353(c)(3)(B));
(2) the regulations adopted by the secretary to administer and enforce that Act; or
(3) the interpretations of that Act set out in the compliance policy manual of the United States Food and Drug Administration.
(b) An exemption from the licensing requirements under this section does not constitute an exemption from the other provisions of this chapter or the rules adopted under this chapter to administer and enforce the other provisions of this chapter.
Added by Acts 2005, 79th Leg., Ch. 282 (H.B. 164), Sec. 3(g), eff. March 1, 2006.
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