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.
A complaint, inspection report or request for records may raise questions about a pharmacy permit, an individual license or both. Start with what the board is actually examining and the authority it cites. The response should address the pharmacy practice and the state procedure involved, with a clear account of the supporting records.
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, with the available procedure determined by the state and the matter.
We defend peptide, compounding and DEA-related Board of Pharmacy matters and represent clients in state board hearings. For a compounding matter, we examine the formulation and operational records behind the allegation. For a controlled-substance matter, we assess related Drug Enforcement Administration (DEA) concerns as well as the board’s case. Food and Drug Administration (FDA) proceedings are considered separately where they are also involved. For pharmacy benefit manager (PBM) audits and DEA inspections, see our PBM audit attorneys and DEA defense attorneys.
Peptide-related matters
Our legal team works with pharmacists, prescribers, wholesalers to analyze state-specific restrictions, including advertising, vetting pharmaceutical grade sourcing, prescribing, delegation models, patient consent and waivers, documentation, and protocols to support your goals.
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 attorneys will review the board’s allegations, the applicable state requirements and the pharmacy records before preparing your response.
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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