October 2016

 

Alliance Discusses Agenda and Appointees to TSBP Compounding Task Force

Alliance staff met with Gay Dodson in October to discuss the agenda and expected participants in the TSBP Compounding Task Force Scheduled to meet January 31, 2017.

The Task Force will focus on Implementation of Rules relating to USP 800--Hazardous Drugs to review the current laws and standards for pharmacies handling hazardous drugs and to recommend rules to implement the chapter.  We expect Task Force members and agenda to be announced in November. The Alliance has submitted Kelly Selby, Andy Komuves, and Ken Hughes to represent the Alliance on the Task Force.

 

TSBP November 1 Agenda Proposes Rules Related to Sterile and Non-sterile Preparations

The Texas State Board of Pharmacy will meet for its Quarterly Board Meeting Tuesday, November 1. The agenda proposes rules to reviewing the original prescription when compounding sterile and non-sterile preparations.

Amendments to §291.131 concerning pharmacists reviewing the original prescription when compounding non-sterile preparations, if adopted specify a pharmacist must review the original prescription record when dispensing a non-sterile compounded preparation, as follows;

A pharmacist shall review all compounding records for accuracy and conduct periodic in-process checks as defined in the pharmacy's policies and procedures. [and final checks to ensure that errors have not occurred in the compounding process.] and a pharmacist shall review all compounding records for accuracy, including the original prescription drug order, and conduct a final check.

Amendments to §291.133, if adopted, specify a pharmacist must review the original prescription record when dispensing a sterile compounded preparation, as follows:

A pharmacist shall review all compounding records for accuracy and conduct periodic in-process checks as defined in the pharmacy's policy and procedures, and a pharmacist shall review all compounding records for accuracy, including the original prescription drug order, and conduct a final check.

 

TSBP to Discuss National Pharmacy Organizations Request to Delay USP 800 Requirements at November 1 Quarterly Board Meeting

The TSBP November 1 meeting will include a review of the Drug Quality Security Act (DQSA) Stakeholders, coordinated by International Academy of Compounding Pharmacists, (IACP),  letter written to all State Boards of Pharmacy requesting a five-year delay in enforcement of USP 800 until July 1, 2021 (the official implementation date is July 1, 2018). USP General Chapter 800, Hazardous Drugs--Handling in Healthcare Settings will apply to all healthcare personnel who handle hazardous drug preparations. This grace period allows state-licensed practitioners to assess and plan for the significant operational and structural changes needed as well as budget, and obtain the necessary resources in an already strained financial environment. The letter states the following:

"In order to give our members the opportunity to perform the proper analyses, including budget implications and the impact upon the delivery of services to patients, and to fully integrate General Chapter <800> into their practice settings, we feel that a delay in enforcement is warranted, similar to the phased in approach that accompanied the introduction of USP General Chapter <797> Pharmaceutical Compounding -- Sterile."

"If the Texas State Board of Pharmacy agrees that a graduated approach to implementing General Chapter <800> is consistent with its mission and goals, we respectfully request that the Texas State Board of Pharmacy grant a five-year delay in enforcement of General Chapter <800> until July 1, 2021."

NIOSH Publishes 2016 Hazardous Drug List

The National Institute for Occupational Safety and Health (NIOSH) has published its 2016 Hazardous Drug List. This is the list that is referenced in USP General Chapter <800> Hazardous Drugs--Handling in Healthcare Settings. Since more drugs were added to the list, pharmacists will need to budget and plan for the significant operational and structural changes.  See updated NIOSH list here.

Alliance Hosts Dinner at PCCA International Seminar in Houston November 9

The Alliance will host a dinner at Massa's South Coast Grill Wednesday, November 9 at 7:15 p.m. in conjunction with the PCCA International Seminar in Houston. RSVP today to [email protected]. See details.

IACP's John Voliva Explains "Negative Lists," "Positive Lists," and "Demonstrably Difficult"

Read article

IACP Reports on FDA Pharmacy Compounding Advisory Committee November 3

FDA has recently announced the agenda and briefing materials for the third and final 2016 Pharmacy Compounding Advisory Committee meeting, which will be held on November 3. For this meeting, FDA will discuss five drugs for inclusion or exclusion for the "positive list" as well as a new class of drugs for the demonstrably difficult list. Read more.
 

 Compounding Advisory Committe

Chair
Rene Garza, Pharm.D.
Austin

Bruce McAnally, R.Ph.
Austin

Jim Hrncir, R.Ph. 
Irving

Kelly Selby, R.Ph.
Denton, TX 

Board Liaison
Ken Hughes
Houston, TX 

Board Liaison
Andy Komuves, RPh, FIACP
Dallas, TX