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Inspections, Audits and Investigations

Time and again, pharmacists, pharmacy students and pharmacy technicians find themselves the recipients of notices to appear before the Texas State Board of Pharmacy (“the Board”).  These notices of violation result from inspections, audits, or investigations conducted by the Board staff on its own initiative or in response to a complaint from a consumer, another licensee, a pharmacy employee or another state or federal agency, such as the Texas Department of Public Safety, the DEA or the U.S. Attorney’s Office, that has conducted its own investigation, inspection, or audit.  At the time of the investigation, inspection or audit, the licensee is often requested to produce records and other documentation and to submit an affidavit or statement about the incident in question.  It is imperative that you contact legal counsel immediately before providing any information, as that documentation and statement will undoubtedly become evidence used against the individual licensee(s) and establishment in a disciplinary action before the Board.

Informal Conferences

The term “informal conference” is a misnomer utilized by state and federal agencies to lull the licensee into a false sense of security.  There is nothing informal about an informal conference.  All too often licensees appear before the Board, DPS or the U.S. Attorney’s Office without legal representation, thinking that they can merely state their side of the story concerning a given incident and reason with the disciplinary panel concerning the allegations and proposed administrative penalties and probation, suspension or revocations of their licenses.  To their dismay, many times they may find themselves faced with owing enormous penalties and having their licenses to practice encumbered with numerous restrictions or revoked altogether.

Prior to an informal conference, a licensee is given notice of the allegations against the license, as well as the particular statutes and rules he or she has allegedly violated.  The letter may include a proposed agreed order from the Board, and the licensee is given the choice of signing the order and returning it, or appearing at an informal conference to contest the allegations and proposed disciplinary action.   In matters involving audit shortages, impairment or other issues of concern to the Board, a licensee will receive only the notice of violations.  It is imperative that you respond in writing to the Board and appear at the informal conference.  Failure to respond or appear will result in the Board entering a disciplinary order against you.

At the informal conference, the licensee appears before a disciplinary panel consisting of Board staff, a Board member, and the Board’s legal counsel.  A Board enforcement attorney presents the case on behalf of the Board.  The panel is furnished with the evidence against the licensee before the hearing, and will ask the licensee questions about the allegations and permit the licensee to present his or her case.  Then the licensee is instructed to leave the room while the panel makes its decision.  The licensee is then asked to return to the room to hear the panel’s decision.  When faced with a room full of people making the decision about your license and professional future, you can imagine how essential it is that you be able to walk into the room with an attorney who can stand for you and represent your interests.

Hearings Before the State Office of Administrative Hearings

After the informal conference, the Board staff will mail a written order containing the panel’s decision for the licensee to sign.  If signed, then the order is presented to the full Board for its approval at the next meeting.  If you disagree with the panel’s decision, then your only option is to appeal the decision at a hearing before the State Office of Administrative Hearings.  This involves a more formal hearing before an administrative law judge in which the Board will present evidence and testimony in its case against you, and you will be given an opportunity to provide your own evidence and testimony.  The administrative law judge will make what is called a proposal for decision.  This means the judge will make a recommendation to the Board about how it should decide your case.  Unlike judges in civil courts, administrative law judges cannot make a ruling that the Board must follow.  The Board will review a proposal for decision, listen to the recommendations of the Board’s staff, and then make its decision.  Again, it is crucial that you have legal representation at the hearing and before the Board in order to ensure that your voice is heard and that your license to practice is protected.

Administrative Appeals

Only after a licensee has appealed the Board’s decision to the State Office of Administrative Hearings, and the Board has made its final decision, may a licensee then appeal his or her case to the district court.  This suit must be filed in Travis County and conducted before a district court judge.  From there the case may be appealed to the Court of Appeals and then, if accepted, to the Texas Supreme Court.  Such litigation is costly and time-consuming and, therefore, cases rarely reach these stages of appeal. 
Legal representation before the Texas State Board of Pharmacy from the beginning of any investigation, inspection or audit, and at the informal conference can give you, the licensee, a significant advantage in obtaining a more positive outcome, preserving your ability to practice your chosen profession.