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Texas Board of Pharmacy Defense

Understand how the TBP Affects Your Pharmaceutical Practice

What is the Texas Board of Pharmacy?

The Texas Board of Pharmacy (TBP) is a state regulatory agency responsible for overseeing and regulating the practice of pharmacy within the state.

Its primary mission is to protect public health by ensuring that pharmacists and pharmacies meet established standards and adhere to relevant laws and regulations.

How does the TBP affect my Pharmaceutical Practice?

Some of the key responsibilities and functions of the Texas Board of Pharmacy include:

  • Licensing and Registration: The board is responsible for issuing licenses and registrations to pharmacists, pharmacy technicians, and pharmacies operating within the state.

  • Compliance and Enforcement: It monitors and enforces compliance with state pharmacy laws and regulations. This includes conducting inspections of pharmacies and taking disciplinary actions when violations occur.

  • Continuing Education: The board often requires pharmacists and pharmacy technicians to complete continuing education to stay current with advancements in the field and ensure the safe and effective practice of pharmacy.

  • Drug Control: The board plays a role in regulating the distribution and dispensing of controlled substances and prescription medications to prevent abuse and ensure patient safety.

  • Rulemaking: It establishes rules and regulations related to pharmacy practice to maintain high standards of care and protect public health.

The Texas Board of Pharmacy is an essential regulatory body in the state, working to ensure the safe and responsible practice of pharmacy to benefit the people of Texas.

Type of TBP Cases

The Phan Law Firm handles a variety of cases related to pharmacy practice and regulation. These cases can involve pharmacists, pharmacy technicians, and pharmacies. Here are some common types of cases that the Firm may deal with:

  • Licensing Issues: Cases related to the initial issuance, renewal, or revocation of licenses for pharmacists and pharmacy technicians. This can include cases where individuals have not met the licensing requirements or have committed offenses that may affect their eligibility for licensure.

  • Dispensing Errors: Cases involving medication dispensing errors made by pharmacists or pharmacy technicians. These errors can lead to harm to patients and may result in disciplinary actions.

  • Drug Diversion: Cases related to the diversion of controlled substances or prescription medications for illegal purposes, such as drug trafficking or personal use by pharmacy staff.

  • Violations of Pharmacy Laws and Regulations: Cases where pharmacies or pharmacy personnel are found to violate state pharmacy laws and regulations, including issues related to record-keeping, labeling, and prescription filling.

  • Patient Complaints: Cases initiated based on complaints from patients or healthcare providers regarding the conduct or actions of pharmacists or pharmacies. These complaints can include issues related to patient counseling, customer service, and more.

  • Substance Abuse: Cases involving pharmacists or pharmacy technicians who have substance abuse problems and may be endangering patients’ safety through their actions.

  • Fraud and Misrepresentation: Cases where pharmacies or pharmacy personnel engage in fraudulent activities, such as billing for medications or services not provided or misrepresenting information to patients or insurance companies.

  • Non-Compliance with Controlled Substance Regulations: Cases involving pharmacies that fail to comply with regulations related to the storage, handling, and dispensing of controlled substances.

  • Continuing Education Violations: Cases where pharmacists or pharmacy technicians fail to meet continuing education requirements mandated by the board for license renewal.

  • Administrative Violations: Cases related to administrative matters, such as failure to maintain proper licensure records or comply with board communication requirements.

These are just some examples of the types of cases that the Phan Law Firm may handle. The specific details of each case can vary widely, and the board investigates and takes appropriate actions based on the facts and circumstances of each case.

Understanding the TBP Complaint Process

The Board Pharmacy Complaint

Unlike most other licensing agencies that issue a Board notice of complaint letter outlining a complaint without producing the type of evidence at this stage to determine whether a violation(s) occurred and requires ongoing investigation by the Board staff, the Board of Pharmacy operates differently in this regard.

Specifically, the Board of Pharmacy usually has already done much of its investigation against a pharmacist and/or pharmacy and has accumulated a great deal of evidence prior to issuing the notice of complaint letter to the pharmacist and/or pharmacy.

In the firm’s experience, the Board staff generally delays sending out an initial notice of complaint letter until the Board staff is assured that it has sufficient evidence to conclude that a violation has occurred under the Texas Pharmacy Act and/or its rules. When it is assured in this position, the Board staff then sends out the initial board notice of complaint letter. Of course, the Board, depending on what is being alleged, is still positioning itself to gather more evidence, including a statement from the pharmacist or pharmacy, as well as requesting the execution of medical releases for more information.

The Informal Resolution Process – The Informal Settlement Conference

In many complaints that arise against pharmacists and pharmacies, the Board of Pharmacy will generally extend an invitation to the pharmacist or pharmacy licensee and their attorney to attend an informal settlement conference at a location, date, and time that is certain. Although referred to as “informal,” it is anything but informal as this is a serious meeting where the pharmacist is requested to appear before the Board staff and its attorneys. This is a meeting designed to ask questions of the pharmacist or pharmacy in order to determine whether the allegation(s) are substantiated.

The informal settlement conference, it should be noted, affords the licensee and their attorney a forum to present their case (i.e., explain facts), argue their position (i.e., defenses), and demonstrate any extenuating circumstances and/or mitigation that might be present. In short, it is an opportunity for the licensee to respond to the allegation(s) alleged by the Board. At the end of the informal settlement conference, cases can be resolved through dismissal if the violation(s) is unsubstantiated. If not, and the Board staff believes that there are substantiated violation(s), it will recommend discipline (the disciplinary mark on a licensee’s license and terms, conditions, and/or restrictions) in a proposed Board order known as an Agreed Order. Because each case is different, the terms will vary and be contingent on various mitigating factors as well as aggravating factors.

There are untold considerations with respect to how best to present a pharmacist’s or pharmacy’s interests in an Informal Settlement Conference, and no two cases are ever identical, even for an attorney such as Mr. Phan, who has presided over hundreds of these cases, both from the prosecuting side with two separate licensing agencies and in private practice defending licensees. An attorney such as Mr. Phan, who is experienced in this area and who has represented pharmacists and pharmacies before the Board of Pharmacy, will be able to adequately prepare the licensee for this process, including the discussion of how best to handle difficult questions and issues that are inherent in all cases. Mr. Phan will be able to understand the composition of the Board of Pharmacy, their personalities, and their motivations (they vary depending on the staff makeup) to best advise the pharmacist or pharmacy as to how best to respond. Above all, Mr. Phan will be able to prepare and explain to the pharmacist or pharmacy the consequences and implications of each action.

A Finding(s) During the Investigatory Process of a Violation(s) and the Proposed Agreed Order

Suppose the Board of Pharmacy believes, during the course of its investigation, that a pharmacist or pharmacy has committed violations. In that case, it will issue a proposed disciplinary order, otherwise known as an Agreed Order.

The proposed Agreed Order will list specifically each violation and the provision in the law for that violation. The proposed Agreed Order will also contain the proposed permanent mark of discipline, which ranges from the least severe marks all the way to the most severe mark, a Revocation.

A pharmacist or pharmacy who receives this proposed Agreed Order must decide whether to accept the proposed discipline or to further contest the determinations of the Board of Pharmacy if he or she disagrees, either contested parts of the proposed Agreed Order that are objectionable or the entirety of the proposed Agreed Order.

It is important to understand that if a pharmacist or pharmacy agrees with the proposed Agreed Order and signs it, this will be disciplinary action on the pharmacist or pharmacy’s license that will be permanent for as long as the licensee holds a license.

Generally, the Board of Pharmacy proposed Agreed Orders that are recommended to attempt to follow a schedule that is consistent with the violation(s) juxtaposed to the severity of the violation(s). The proposed Agreed Order for discipline will ultimately center on the particular facts and substantiated findings of wrongdoing in your particular case. One should know that it is based on a formulaic schedule developed by the Board of Pharmacy and that it is not randomly administered based solely on the whims of the Board of Pharmacy.

The Formal Disciplinary Phase of a Board of Nursing Investigation – Formal Charges

If the pharmacist and pharmacy do not agree with the proposed Agreed Order, the Board of Pharmacy will file a document known as Formal Charges.

This is a legal document that specifies each allegation against the pharmacy and pharmacist and the legal authority for that claim. Once this document is filed, the complaint itself becomes public in nature as the Formal Charges are attached next to the pharmacist’s or pharmacy’s licensure information on the Board’s website. The Board of Pharmacy then begins the formal resolution process by filing the matter for a contested case hearing (i.e., trial) with the State Office of Administrative Hearings (SOAH) before an Administrative Law Judge (ALJ).

A Contested Case Hearing at the State Office of Administrative Hearings

In this formal proceeding, the Board of Pharmacy attempts to persuade the ALJ, with the evidence it has accumulated, that the pharmacist or pharmacy is in violation. Because the pharmacist or pharmacy is a party to this proceeding, he or she will assuredly be called as a witness to this proceeding.

One must know that a pharmacy or pharmacist who enters this phase of the proceedings will be afforded due process, but one must understand the process of this formal proceeding and not ignore it. If the Board of Pharmacy is successful in persuading the ALJ, the ALJ will issue a decision called a Proposal for Decision (PFD) with findings of fact and conclusions of law. If there are findings of violations found, the licensee invariably (with few exceptions) will receive discipline on their license from the Board.

Consideration of whether a pharmacist or pharmacy wishes to accept a recommended Agreed Order or continue to dispute the alleged violation(s) will turn on that particular case. There is no one-size-fits-all when this analysis is being made and advice provided to the licensee. There may be situations where, based on the fact that there is a violation(s) for which there is no plausible defense to defeat the violation(s), a pharmacist or pharmacy will have to give strong consideration to accepting and negotiating a more favorable Agreed Order for discipline.

With respect to negotiating a more favorable Agreed Order in the face of an undefeatable violation(s), consideration is given to providing mitigating factors and remedial evidence to further reduce the severity of the sanction and practice stipulations.

Important considerations if a Pharmacist or Pharmacy Licensee is under investigation by the Texas State Board of Pharmacy

During the Board of Pharmacy’s disciplinary complaint process, it is important to realize and recognize that there are attorneys and law firms that are devoted strictly to defending pharmacists and pharmacies. The Phan Law Firm, P.C., is proud to consider itself in this group and one of the leaders in this area, devoting its practice exclusively to defending pharmacists, pharmacies, and other health-related professionals.

Generally, the disciplinary process is initiated by a Board of Pharmacy complaint letter to the pharmacist and/or pharmacy, depending on who the alleged licensee is and the subject of the complaint.

A pharmacist or pharmacy will usually learn of a complaint either by receiving a Board of Pharmacy complaint letter notifying him or her of an investigation that has been opened against the pharmacist. This complaint letter will generally include a proposed Agreed Order being recommended by the Board Staff. The pharmacist is provided an opportunity to respond to the allegation(s) by written response.

The pharmacist may also be notified of an Informal Settlement Conference. First, the pharmacist may be advised that he or she may, if he or she disputes the allegation(s) or refuses to accept the recommended disciplinary action, request that the case be set for a contested case hearing (i.e., trial) at the State Office of Administrative Hearings. Second, a pharmacist or pharmacy may learn of the complaint when an investigator from the Board of Pharmacy, without prior notice provided, makes an in-person appearance to the pharmacist, either at his or her home or at the place of employment.

During this meeting, the Board investigator will inform the pharmacist and pharmacy of a Board complaint. If either of these situations arises, it is advisable that the pharmacist or pharmacy consult with an experienced professional license defense attorney immediately. The Phan Law Firm, P.C., will assist with the process. Both processes are gut-wrenching, and, in our experience, the tone and tenor follow an aggressive posture by the Board of Pharmacy, who makes terse demands and requests of the pharmacist or pharmacy.

Important considerations about the Board's Investigation Process

Pharmacists and pharmacies must be cognizant that due to the nature of work that its licensees perform, handling and dispensing countless thousands of controlled medications, the Texas State Board of Pharmacy facilitates its investigations with other similar state governmental agencies with an interest in ensuring compliance with controlled substances.

These other governmental agencies include the Texas Department of Public Safety, the Drug Enforcement Agency, and, where applicable, state and local law enforcement. These entities often share information and documents with each other. This means that the Board of Pharmacy is often privy to more information and is armed with this information as it investigates pharmacists and pharmacies.

Pharmacists, in particular, must understand that when they work for a large retail pharmacy, their interests and those of their employer, a large retail pharmacy, are different and, oftentimes, conflict. Pharmacists must understand the nature of this conflict in their response to the large retail pharmacy personnel and the large retailer’s attorney, who is most likely advancing the interests of the large retail pharmacy and not that of the pharmacist.

Texas Board of Pharmacy Defense Lawyer

At the Phan Law Firm, P.C., our attorney, Phong Phan, was the former in-house attorney at the two health-related professional licensing agencies, the Texas State Board of Dental Examiners and the Texas Board of Nursing. Both of these agencies share, in many ways, the same regulatory scheme and complaint and disciplinary process as the Texas Board of Pharmacy. Mr. Phan, during his time as an in-house attorney at these boards, worked closely with the Board’s Director of Enforcement, Executive Director, Board members, and the investigatory staff and advised the staff regarding all types of disciplinary cases and practice violations. He also advised the staff and Board members regarding eligibility issues for applicants seeking to become licensed but had issues (e.g., criminal history) that may have prevented their licensure upon application.

Because of his unique background, Mr. Phan fully understands the disciplinary process at the Board of Pharmacy during all phases, having prosecuted thousands of violations of involving health professionals. Mr. Phan is intimately familiar with the statute authorizing the Board’s authority to discipline pharmacists and pharmacies, including an equal familiarity with the Board’s rules. Mr. Phan, with the expertise earned during his time at these licensing boards, now defends licensees, especially pharmacists and pharmacy owners, in board disciplinary complaints. Mr. Phan does so without compromise and does so to best advance his client’s interests.

As one can see, the above process is daunting. Each step requires an attorney who can guide a pharmacist and pharmacy through that process and provide sound, careful legal advice at each step so that the pharmacist or pharmacy is in the best position to understand the consequences of each action and make the best decision for him or her depending on his or her unique facts. A pharmacist or pharmacy licensee often feels overwhelmed when faced with a Board complaint, not knowing who to turn. The Phan Law Firm, P.C., understands this. Candidly, the decision to hire an attorney is critical and important, one that is not to be taken lightly. Given the years of education and training by pharmacists, the firm expects that each potential pharmacist client will continue to do his or her due diligence in researching an attorney and finding an attorney and firm that can best obtain the right result for him or her.

One of the key considerations, the firm believes, is whether that attorney has experience with licensing boards such as the Board of Pharmacy and has defended pharmacists and pharmacy licensees before the Board of Nursing. The Phan Law Firm, P.C., is this firm.

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Texas Board Defense Lawyer

Former Texas Board of Nursing (BON) Assistant General Counsel, former Texas State Board of Dental Examiners (TSBDE) General Counsel, and former Texas State Prosecutor with an intimate understanding of the board complaint process, disciplinary proceedings, licensure issues, and SOAH contested case hearings.