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.