Sec. 562.153. REQUIREMENTS FOR OFFICE USE COMPOUNDING. To dispense and deliver a compounded drug under Section 562.152, a pharmacy must:
(1) verify the source of the raw materials to be used in a compounded drug;
(2) comply with applicable United States Pharmacopoeia guidelines, including the testing requirements, and the Health Insurance Portability and Accountability Act of 1996 (Pub. L. No. 104-191);
(3) comply with all applicable competency and accrediting standards as determined by the board; and
(4) comply with board rules, including rules regarding the reporting of adverse events by practitioners and recall procedures for compounded products.
Amended by:
Acts 2005, 79th Leg., Ch. 28 (S.B. 492), Sec. 4, eff. September 1, 2005.
Structure Texas Statutes
Subtitle J - Pharmacy and Pharmacists
Chapter 562 - Practice by License Holder
Subchapter D. Compounded and Prepackaged Drugs
Section 562.152. Compounding for Office Use
Section 562.153. Requirements for Office Use Compounding
Section 562.154. Distribution of Compounded and Prepackaged Products to Certain Pharmacies
Section 562.155. Compounding Service and Compounded Drug Products
Section 562.156. Compounded Sterile Preparation; Notice to Board