Showing posts with label New Texas Board of Pharmacy Rules Relating to Compounding Effective December 10. Show all posts
Showing posts with label New Texas Board of Pharmacy Rules Relating to Compounding Effective December 10. Show all posts

Tuesday, December 31, 2013

New Texas Board of Pharmacy Rules Relating to Compounding Effective December 10, 2013 unless noted otherwise

SUBCHAPTER B. COMMUNITY PHARMACY (CLASS A)

§291.33 Operational Standards, §291.36 Pharmacies Compounding Sterile Preparations (Class A-S)

The amendments to §291.33 clarify that Class A pharmacies will no longer be able to compound sterile preparations after August 31, 2014, unless the pharmacy obtains a Class A-S pharmacy license. New §291.36 outlines the requirements for pharmacies that compound sterile preparations, implements recommendations of the Texas State Board of Pharmacy appointment Task Force on Compounding Sterile Preparations (Task Force), and implements Senate Bill 1100 passed by the 83rd Regular Session of the Texas Legislature regarding compounding pharmacies.

SUBCHAPTER D. INSTITUTIONAL PHARMACY (CLASS C)

§291.74 Operational Standards, §291.76 Class C Pharmacies Located in a Freestanding Ambulatory Surgical Center, §291.77 Pharmacies Compounding Sterile Preparations (Class C-S)

The amendments to §291.74 and §291.76 clarify that Class C pharmacies will no longer be able to compound sterile preparations after August 1, 2014, unless the pharmacy obtains a Class C-S pharmacy license. New §291.77 outlines the requirements for pharmacies that compound sterile preparations, implements recommendations of the Texas State Board of Pharmacy appointment Task Force on Compounding Sterile Preparations (Task Force), and implements Senate Bill 1100 passed by the 83rd Regular Session of the Texas Legislature regarding compounding pharmacies.

SUBCHAPTER F. NON-RESIDENT PHARMACY (CLASS E)

§291.104 Operational Standards, §291.105 Records, §291.106 Pharmacies Compounding Sterile Preparations (Class E-S)

The amendments to §291.104 clarify that Class E pharmacies will no longer be able to compound sterile preparations after August 31, 2014, unless the pharmacy obtains a Class E-S pharmacy license. The amendments to §291.105 add requirements for auto-refill programs. New §291.106 outlines the requirements for pharmacies that compound sterile preparations, implements recommendations of the TSBP appointment Task Force on Compounding Sterile Preparations (Task Force), and implements Senate Bill 1100 passed by the 83rd Regular Session of the Texas Legislature regarding compounding pharmacies.

SUBCHAPTER G. SERVICES PROVIDED BY PHARMACIES

§291.133 Pharmacies Compounding Sterile Preparations
 
New §291.133 outlines operating standards for pharmacies that compound sterile preparations, implements the recommendations of the TSBP appointed Task Force on Compounding (Task Force), incorporates provisions included in the United States Pharmacopeia (USP) General Chapter 797, and implements Senate Bill 1100 passed during the 83rd Regular Session of the Texas Legislature regarding pharmacies compounding sterile preparations.

quoted from here