Human Medications, Human Drugs, Animal Medications, Animal Drugs, Pharmacy law, Pharmaceutical law, Compounding law, Sterile and Non Sterile Compounding 797 Compliance, Veterinary law, Veterinary
Compounding Law; Health Care; Awareness of all Types of Compounding Issues;
Pharmacy Benefit Managers (PBMs), Outsourcing Facilities
Food and Drug Administration and Compliance Issues
Tuesday, June 1, 2021
Texas Board of Pharmacy Relevant Information: Adopted and Proposed Rules, Disciplinary Actions, Reminder regarding Compounding Advisory Group
Adopted and Proposed Rules
Several TSBP Board Rules were adopted and proposed during the Board meeting on May 11, 2021. You may view a summary of the adopted and proposed rules here.
NOTE: TSBP now has a location on the website where you can monitor adopted and proposed rule changes. Please note that rule changes are not reflected immediately after a Board Meeting, but are posted as they become available in the Texas Register. For more information, click here.
Disciplinary Action Summaries & Remedial Plans
Click here to view the disciplinary action summaries discussed and/or entered at the May 11, 2021 Board Meeting.
Click here to view the remedial plans discussed and/or entered at the May 11, 2021 Board Meeting.
PLEASE NOTE: After the Board obtains evidence of alleged violations, a licensee is sent a preliminary notice letter of the Board’s intent to institute disciplinary action. The licensee then has an opportunity to show compliance with the law in an informal conference with a Board panel. If the licensee cannot show compliance with the law and desires to dispose of any pending allegations, the licensee may consent to the entry of an Agreed Board Order. It should be noted that while there is agreement on the part of the licensee to the entry of an Agreed Board Order, there is neither admission nor denial of guilt with respect to any matters that have come to the attention of the Board. If a licensee, or the Board, does not agree to terms of the Agreed Board Order, or if the licensee does not wish an informal conference, a disciplinary hearing is scheduled before an Administrative Law Judge from the Office of Administrative Hearings. The Administrative Law Judge, after hearing all evidence in the matter, will make a recommendation to the Board for action to be taken. The Board then makes a decision in the case, which is documented by the entry of a Board Order. On the finding of the existence of grounds for discipline of a licensee, the Board may suspend, revoke, restrict, fine, refuse to issue or renew, probate, reprimand, cancel, or retire a license. Although every effort is made to ensure that the above information is correct, you should submit an open records request through Board’s office here to confirm the accuracy of the listing before making any decision based upon this information.
NEWS & UPDATES
REMINDER: Compounding Advisory Group to discuss FDA MOU and other topics in June 2021 - Stakeholder input requested
The Board discussed the U.S. Food and Drug Administration (FDA) Memorandum of Understanding (MOU) at the February 2021 Board meeting and voted to add the MOU to the Compounding Advisory Group agenda at their upcoming meeting in June 2021.
The Compounding Advisory Group meeting will be held June 24, 2021 beginning at 9:30am. This meeting will elicit input from stakeholders regarding the MOU, and together with stakeholder input provide a recommendation to the Board for consideration at the August 2021 Board meeting. Along with the MOU, the Compounding Advisory Group will also discuss and elicit stakeholder comments regarding virtual training for individuals performing sterile compounding, discuss proposed changes of non-sterile compounding rules, discuss proposed changes for new classes of pharmacy, and develop recommendations for the Board based on these discussions. Stakeholders will be able to sign up for comment via the agenda once it is available.