Our pharmacy law attorneys defend pharmacies, pharmacists and technicians in Board of Pharmacy proceedings and license defense matters. Our team includes pharmacist-attorney Dr. Martha Rumore and former prosecutors who can evaluate the pharmacy records and the legal allegations together.
State boards of pharmacy have become more active than ever before, as the FDA arguably has adopted a less-rigorous role in the oversight of weight loss compounds and now peptides. State regulators are moving to fill the void left by the FDA, increasing the risk that a Board of Pharmacy action or investigation will be commenced against you or your pharmacy. Board of Pharmacy proceedings can involve serious professional discipline and even loss of license. Any Board of Pharmacy inquiry should be treated as a serious risk.
Our pharmacy law practice represents pharmacies, pharmacists, technicians, wholesalers, brokers and third-party logistics providers in investigations, licensing, disciplinary matters and regulatory compliance. The defense practice includes disciplinary conferences and formal revocation hearings, depending on the state involved. We practice across all 50 states, partnering with local counsel when required by the administrative tribunal.
Among other cases, we defend compounding and peptide cases, including by analyzing state-specific restrictions, advertising rules, research vs. pharmaceutical grade requirements, prescribing, delegation models, documentation and protocols. Our team includes a pharmacist-attorney and recognized industry thought leader in Dr. Martha Rumore, who possesses deep experience in all things related to FDA, compounding, peptides, and pharmacy standards of practice. If the board matter overlaps with controlled substance or DEA-related concerns, we leverage a former DEA official and Diversion Program Manager in Nancy Coffey to assist providers.
Clients turn to Health Law Alliance not just for our subject matter expertise, but for our deep bench of aggressive litigators and former government regulators. Together, we help you respond effectively to any board inquiry or license challenge.
The next step depends on the state, the license and the document received. These are the issues we review before preparing the response.
Confirm which agency sent the notice, whom it names and which license or permit is at issue. A pharmacy business, its pharmacist-in-charge and an individual pharmacist may have different interests. Determine who needs representation and whether there is a conflict before preparing a joint account. The same investigation can concern more than one person without giving them the same legal position.
A complaint inquiry, inspection report, formal accusation and hearing notice are different documents. The available response, conference or hearing depends on the state and the stage of the matter. Calendar the dates stated in the notice, retain the envelope or delivery record and confirm the applicable requirements. Do not assume another state’s procedure or a familiar response period applies.
Preserve the prescriptions, dispensing records, inventories, policies, messages and other records relevant to the allegations. Record what has already been provided to the board. A correction made now must remain distinguishable from the original entry. Counsel needs an accurate chronology, including facts that may be unfavorable, to evaluate the allegation and the available defense.
Identify the practice the board challenges, the rule it relies on and the records that support or contradict its account. An allegation about a prescription, an inventory discrepancy and a sterile-compounding condition require different evidence. The defense should explain the particular facts rather than provide a general description of how carefully the pharmacy operates.
Review the exact preparation, bulk ingredient, supplier, prescription and dispensing activity at issue. Identify the state requirement cited and any related FDA issue. Review consent forms, waivers and delegation protocols alongside the prescribing and sourcing records. A board concern about peptide or GLP-1 compounding should not be answered by assuming a supplier’s assurance or another compounder’s practice establishes compliance. The federal and state questions need to be evaluated together without treating them as interchangeable.
A board investigation may overlap with DEA registration concerns or a wholesaler’s decision about an account. Identify each process and its decision-maker. A board settlement does not automatically restore a DEA registration or a private supply relationship. Before considering any surrender, limitation or admission, assess its terms and possible implications for the other matters.
Identify who has direct knowledge of the events and who maintains the relevant records. Review the facts and documents before an interview or conference, and establish who will communicate on behalf of each represented party. Avoid guesses or an explanation that goes beyond the person’s knowledge. Counsel should assess the request and applicable procedure before advising how to participate.
If the review identifies a problem, preserve the original evidence and document the corrective work separately. Training, a procedure change or a quality review should have an identifiable scope and record. Counsel assesses how that work bears on the allegation and whether to present it to the board. A correction should not be described as an admission to every allegation in the notice.
A proposed agreement may affect the license, supervision, reporting, training or continued operation of the business. Review the actual terms, their duration and the obligations they create. Also assess other licenses, payer agreements and supply relationships where relevant. A resolution described as informal or agreed may still have consequences that need to be understood before signing.
If the matter proceeds to a hearing, identify the factual issues, the applicable state procedure and the evidence needed to present the defense. Evaluate any available review of an adverse decision under the governing law. At the same time, track related FDA, DEA, payer or nonresident-license matters so that one proceeding is not treated as the end of the entire problem.
Provide the complete notice, the affected license information and any response already submitted. We can then assess the state procedure, immediate deadlines and representation needed.
Our experienced attorneys have assisted thousands of providers in navigating the same challenges you are facing.
Representation covers pharmacy operations and individual license matters. The legal issues and available procedures depend on the state and the facts.
A complaint or an inspection report is not a final disciplinary decision. Depending on the state, the facts and the final order, a matter may put the following at issue:
Agency and company marks identify former professional experience of individual HLA team members. They do not imply affiliation, endorsement, or a client relationship.
Dr. Martha Rumore brings pharmacy knowledge and regulatory experience to investigations involving dispensing, compounding and pharmacy operations. Anthony Mahajan contributes his background as a federal prosecutor and former Chief Counsel at McKesson. The team evaluates the board’s case alongside any related FDA, DEA or business issue, with representation tailored to the state and the parties involved.
The right point to seek advice may be before a formal disciplinary charge.
Our pharmacy law practice, by area.
Additional questions about working with counsel. The answers below are general; specific situations require privileged consultation.
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