Pharmacy & Compounding Fraud Defense
Former DOJ Fraud Section Prosecutors. Nationwide Defense for Pharmacists, Pharmacy Owners, Compounding Pharmacy Operators, Pharmaceutical Sales Representatives, and Healthcare Executives Facing Federal Pharmacy Fraud, Compounding Fraud, and TRICARE Fraud Investigations and Charges.
Based in Washington, D.C., Armstrong & Bradylyons PLLC defends pharmacists, pharmacy owners, compounding pharmacy operators, pharmaceutical sales representatives, prescribing physicians, pharmacy benefit manager executives, and healthcare executives in federal pharmacy fraud, compounding pharmacy fraud, and TRICARE fraud investigations and prosecutions nationwide.
The firm’s healthcare fraud defense practice is built on nearly a decade of combined experience at the Healthcare Fraud Unit of DOJ’s Fraud Section. Scott Armstrong served as lead counsel in a $120 million compounding pharmacy fraud case at DOJ involving pharmacy executives, pharmacists, prescribing physicians, and marketers. Scott, Drew Bradylyons, and Andrea Savdie tried 17 federal jury trials in healthcare fraud cases at DOJ’s Fraud Section involving over $2.8 billion in alleged false and fraudulent claims to federal healthcare programs. The firm uses that direct compounding pharmacy prosecution experience to defend individuals in pharmacy and compounding fraud cases at every stage: from the first grand jury subpoena, through federal indictment, and at trial.
Pharmacy and compounding fraud enforcement spans the full range of federal agencies. DOJ, HHS-OIG, the FBI, the DEA, the Defense Criminal Investigative Service (DCIS), the IRS Criminal Investigation Division, and the FDA all investigate and prosecute pharmacy fraud cases. TRICARE and the Department of Defense are particularly aggressive in compounding pharmacy cases. The firm defends individuals in every federal district where these agencies bring pharmacy and compounding fraud cases.
Armstrong & Bradylyons PLLC defends every pharmacy and compounding fraud case from the start as if it will go to trial. That is not a slogan. It is the operating principle of the firm, grounded in 25 federal jury trials in complex fraud cases in federal courts across the country.
Trial experience drives results at every stage. Pharmacy and compounding fraud cases are built on claims data analytics, prescription dispensing records, formulation analysis, reimbursement tracing, marketing and sales compensation analysis, and cooperating witness testimony. The firm builds the factual record from the first day of engagement: analyzing billing data, retaining pharmacy and pharmaceutical compounding experts, identifying weaknesses in the government’s formulation and dispensing evidence, and developing a case theory that can be presented to a jury at trial.
The firm’s attorneys know how federal prosecutors build these cases because they built them. Scott Armstrong served for nearly a decade at DOJ’s Fraud Section, where he served as lead trial counsel in 16 federal jury trials. Scott also served as lead counsel in a $120 million compounding pharmacy fraud case involving pharmacy executives, pharmacists, prescribing physicians, and marketers. That case involved the full range of issues that arise in compounding prosecutions: kickback arrangements between pharmacies and prescribers, formulation manipulation, fraudulent billing to federal healthcare programs, and the financial tracing of fraud proceeds. He also served as Director of DOJ’s Appalachian Regional Prescription Opioid Strike Force (ARPO), giving the firm deep experience in controlled substances and pharmacy dispensing investigations.
Drew Bradylyons served as Chief of EDVA’s Financial Crimes and Public Corruption Unit and, before that, supervised the Healthcare Fraud Unit’s Miami Strike Force at DOJ’s Fraud Section. That combined experience provides the firm with an unmatched understanding of how compounding pharmacy and retail pharmacy fraud cases are investigated, charged, and tried.
Pharmacy and compounding fraud enforcement is aggressive and expanding. DOJ, HHS-OIG, the FBI, DCIS, IRS-CI, and the FDA target pharmacies and compounding pharmacies with sustained criminal and civil enforcement. The enforcement covers retail pharmacies, compounding pharmacies, specialty pharmacies, mail-order pharmacies, and pharmacy benefit managers.
Compounding Pharmacy Fraud
Compounding pharmacy fraud has been a federal enforcement priority since TRICARE compound drug spending exploded from approximately $24 million in 2010 to over $500 million in 2014. Compound prescriptions represented less than one percent of all prescriptions but accounted for approximately 20 percent of TRICARE pharmacy costs. That trajectory triggered massive federal investigations that continue today.
In March 2025, two executives of a Louisiana compounding pharmacy were convicted after a six-week federal trial of conspiring to defraud TRICARE and New Jersey state health benefits programs of approximately $100 million. The pharmacy prepared compounded pain creams, scar creams, and other topical medications and paid kickbacks to marketers and prescribers for referrals. A defendant in a separate TRICARE compounding scheme received 18 years in federal prison for a $510 million pain cream fraud. Another defendant received 17 and a half years and $115 million in restitution for a compound cream scheme, with $405 million in assets forfeited.
The FDA is intensifying enforcement against compounding pharmacies. The FDA has issued more than 125 warning and untitled letters to compounding pharmacies, outsourcing facilities, and telehealth companies. The FDA’s enforcement of compounded semaglutide and GLP-1 therapies represents an emerging area. Pharmacies that compound, dispense, or market GLP-1 therapies face regulatory scrutiny that can escalate into criminal referrals to DOJ when the compounding violates the Federal Food, Drug, and Cosmetic Act.
Retail Pharmacy Fraud
Retail pharmacy enforcement is expanding beyond traditional dispensing cases. In April 2025, Walgreens agreed to pay up to $350 million for illegally filling unlawful opioid prescriptions and submitting false claims to the federal government. DOJ and state attorneys general are pursuing pharmacies and pharmacy benefit managers for dispensing controlled substances without adequate verification, billing for prescriptions not dispensed, short-filling prescriptions while billing for full quantities, submitting false prior authorization claims, and failing to comply with corresponding responsibility obligations.
Pharmacy and pharmacy benefit manager enforcement is expanding into pricing manipulation, copay assistance violations, and formulary management. DOJ settlements and state AG litigation are pressing theories that extend well beyond traditional manufacturer and distributor cases. For 2026, DOJ has identified pharmacy oversight as a key enforcement priority in its prescription drug fraud landscape.
FCA settlements and judgments in healthcare fraud exceeded $6.8 billion in FY 2025, the highest annual total in history, with healthcare fraud accounting for over $5.7 billion. Pharmacy fraud cases, including compounding fraud, TRICARE fraud, and controlled substances violations, represent a significant share of that enforcement activity.
The firm’s pharmacy fraud defense practice is built on healthcare fraud trial experience, deep knowledge of pharmacy and compounding regulations, and years of experience investigating and prosecuting complex healthcare fraud cases at DOJ’s Fraud Section. These tools are deployed at every phase of a case.
Challenging the Government’s Claims That Formulations Lacked Medical Necessity
Federal prosecutors allege that compounding pharmacies designed formulations to maximize reimbursement rather than to address specific patient needs. The government targets pharmacies that added unnecessary ingredients to inflate compound costs, that used unusual or exotic ingredients selected for their reimbursement value, and that produced formulations identical to commercially available alternatives. The firm retains independent pharmacology and pharmaceutical compounding experts to demonstrate that formulations were clinically appropriate, that ingredients served legitimate therapeutic purposes, and that compounding was consistent with patient-specific prescriptions and applicable FDA and state pharmacy board requirements.
Analyzing Marketing Arrangements and Prescriber Compensation Structures
The government alleges that pharmacies paid kickbacks to physicians, marketers, sales representatives, and referral agents for prescriptions. Prosecutors target compensation arrangements including per-prescription payments, percentage-based commissions, lavish entertainment, consulting fees, and medical advisory board payments that correlate with prescription volume. The firm analyzes every financial relationship against the Anti-Kickback Statute, EKRA, and applicable safe harbor regulations to identify defenses and demonstrate the legitimacy of compensation arrangements.
Defending Against Claims of Fraudulent Billing and Improper Dispensing
Federal prosecutors build pharmacy fraud cases on dispensing records, claims data, and reimbursement analysis. The government targets pharmacies that billed for prescriptions not dispensed, that short-filled prescriptions while billing for full quantities, that billed brand-name drugs while dispensing generics, that submitted false prior authorizations, or that dispensed controlled substances despite red flags. The firm retains billing and coding experts to demonstrate that dispensing practices complied with applicable regulations, that billing reflected prescriptions actually filled, and that the pharmacy met its corresponding responsibility obligations under 21 C.F.R. § 1306.04.
Attacking the Government’s Proof of Knowledge and Willful Conduct
Federal healthcare fraud and Anti-Kickback Statute violations require proof of knowing and willful conduct. Good faith matters. The firm presents evidence of compliance programs, reliance on legal counsel, legitimate business purposes for marketing and compensation arrangements, reliance on state pharmacy board guidance, and FDA compliance measures. Where the government relies on cooperating witness testimony from former employees, sales representatives, or prescribers, the firm attacks the reliability, credibility, and motivations of those witnesses. The firm’s attorneys have extensive experience cross-examining cooperating witnesses in federal healthcare fraud trials.
Federal pharmacy and compounding fraud investigations target individuals at every level: from the pharmacists who fill prescriptions and compound formulations, to the owners who direct business operations, the sales representatives who generate referrals, and the physicians who write prescriptions. Armstrong & Bradylyons PLLC defends these individuals in federal investigations, after indictment, and at trial.
Defense of Pharmacists
The firm defends pharmacists in federal healthcare fraud, Anti-Kickback Statute, and controlled substances investigations and prosecutions. Pharmacists face criminal exposure when the government alleges they dispensed controlled substances despite red flags indicating prescriptions lacked a legitimate medical purpose, participated in compounding schemes that added unnecessary ingredients to inflate reimbursement, billed for prescriptions not dispensed or for quantities greater than those actually provided, or failed to meet corresponding responsibility obligations. The firm defends pharmacists by demonstrating compliance with dispensing regulations, professional judgment, and the absence of fraudulent intent.
Defense of Pharmacy and Compounding Pharmacy Owners
The firm defends owners of retail pharmacies, compounding pharmacies, specialty pharmacies, and mail-order pharmacies in federal fraud investigations and prosecutions. Pharmacy owners are primary enforcement targets. Prosecutors pursue owners who allegedly directed the billing scheme, designed compensation structures to pay kickbacks for prescriptions, selected compound ingredients based on reimbursement value rather than medical necessity, or operated pharmacies that dispensed controlled substances in violation of federal law. The firm defends pharmacy owners by challenging the government’s evidence of personal knowledge, direction, and intent.
Defense of Pharmaceutical Sales Representatives and Marketers
The firm defends pharmaceutical sales representatives, marketers, and independent contractors charged in pharmacy and compounding fraud cases. Sales representatives face serious criminal exposure. The government treats commission-based compensation tied to prescription volume as strong evidence of kickback violations under both the AKS and EKRA. The firm defends sales representatives by analyzing compensation structures, demonstrating legitimate services rendered, and contesting the government’s theory that marketing activity constituted illegal inducement.
Defense of Prescribing Physicians
The firm defends physicians who face federal charges for their role in pharmacy and compounding fraud schemes. Physicians face exposure when the government alleges they wrote prescriptions for compound medications in exchange for kickbacks, prescribed medications without a genuine physician-patient relationship, or authorized refills without individualized patient evaluation. The firm defends physicians by establishing the clinical basis for prescribing decisions, demonstrating legitimate treatment relationships, and challenging the government’s evidence of kickback payments.
Defense of Pharmacy Executives and Compliance Officers
The firm defends pharmacy executives, chief compliance officers, and corporate officers of pharmacy companies, pharmacy benefit managers, and pharmaceutical distributors. Executives face criminal exposure when the government alleges they directed or approved practices that constituted fraud, designed compensation structures that violated the AKS, or failed to act on compliance concerns. The firm defends executives by challenging the government’s evidence of personal involvement and demonstrating the existence and operation of compliance programs.
Federal pharmacy and compounding fraud investigations follow a pattern. Understanding that pattern is the first step to defending against it. Scott Armstrong and Drew Bradylyons built these types of cases as senior prosecutors at DOJ’s Fraud Section. They know how federal investigators identify targets, develop evidence, and present cases to grand juries.
Claims Data Analytics and Reimbursement Pattern Analysis
The investigation starts with data. HHS-OIG, DCIS, CMS, and the FBI analyze pharmacy billing data to identify pharmacies with anomalous reimbursement patterns. The government flags pharmacies with disproportionately high compound prescription volumes, pharmacies whose average reimbursement per prescription significantly exceeds peer benchmarks, pharmacies with rapid billing growth inconsistent with patient population, and pharmacies whose compound formulations consistently use high-cost ingredients. The Health Care Fraud Data Fusion Center deploys advanced analytics to detect these patterns and generate proactive investigative referrals.
Formulation and Ingredient Analysis
In compounding cases, federal investigators analyze the formulations dispensed by the pharmacy. They examine whether the formulations contained ingredients that lacked medical necessity, whether ingredients were selected for reimbursement value rather than therapeutic purpose, whether the compounded medications duplicated commercially available products, and whether the formulations were consistent with the prescribing physician’s treatment plan. The government uses formulation analysis to argue that the compounds were designed to maximize billing, not to serve patient needs.
Marketing and Compensation Tracing
Federal investigators trace the financial relationships between the pharmacy, prescribing physicians, sales representatives, marketers, and referral agents. They compare payments to prescription volume. Percentage-based or per-prescription compensation is treated as strong evidence of kickback violations. Investigators analyze contracts, invoices, bank records, and commission statements to identify compensation that correlates with referral volume rather than legitimate services rendered.
TRICARE and DOD Investigation
TRICARE compounding fraud cases are investigated by the Defense Criminal Investigative Service (DCIS) in coordination with DOJ, the FBI, and IRS-CI. DCIS analyzes TRICARE pharmacy claims data to identify pharmacies with anomalous compound prescription billing. TRICARE cases often involve marketers who targeted military beneficiaries for compound pain creams, scar creams, and topical medications through telemarketing, direct mail, and social media campaigns. The government traces the entire referral chain from the marketer to the prescriber to the pharmacy.
FDA Regulatory and Criminal Referrals
The FDA investigates compounding pharmacies for violations of the Federal Food, Drug, and Cosmetic Act (FDCA). The FDA targets pharmacies that compound drugs that are copies of commercially available products, that compound using bulk drug substances not on the FDA’s approved list, that fail to meet current Good Manufacturing Practice (cGMP) requirements, or that operate as de facto manufacturers without proper registration. FDA enforcement actions can result in criminal referrals to DOJ. The FDA has issued more than 125 warning letters to compounding pharmacies and outsourcing facilities.
Qui Tam Whistleblower Complaints
Qui tam whistleblower complaints under the False Claims Act are a significant source of pharmacy fraud investigations. Former employees, pharmacists, sales representatives, and competitors file qui tam actions alleging fraudulent billing, kickback arrangements, and compounding violations. Many pharmacy fraud investigations begin with a sealed qui tam complaint.
Search Warrants and Electronic Evidence
Federal agents execute search warrants at pharmacies, compounding facilities, residences, and offices. They seize prescription records, dispensing logs, formulation records, financial records, cell phones, and computers. They obtain cloud warrants under 18 U.S.C. § 2703 for email accounts, text messages, and pharmacy management systems. Communications between pharmacy owners, sales representatives, prescribers, and billing staff are analyzed for evidence of kickback payments, formulation manipulation, and fraudulent billing.
Federal pharmacy and compounding fraud prosecutions draw on several criminal statutes. These cases frequently combine healthcare fraud with Anti-Kickback Statute violations, money laundering, and, in controlled substances cases, charges under the Controlled Substances Act. The government charges aggressively and stacks counts.
Healthcare Fraud (18 U.S.C. § 1347)
The primary charging statute. Healthcare fraud targets billing for prescriptions not dispensed, billing for compound formulations designed to inflate reimbursement, submitting false prior authorizations, short-filling prescriptions while billing for full quantities, and billing brand-name drugs while dispensing generics. The penalty is up to 10 years per count. If the fraud results in serious bodily injury, the maximum increases to 20 years.
Anti-Kickback Statute (42 U.S.C. § 1320a-7b)
The Anti-Kickback Statute is charged in nearly every pharmacy and compounding fraud case involving referral payments. Prosecutors target kickbacks to physicians, marketers, sales representatives, and referral agents for prescriptions filled by the pharmacy. Violations carry up to 10 years per violation.
Eliminating Kickbacks in Recovery Act (18 U.S.C. § 220)
EKRA applies to kickback payments for referrals to pharmacies, including compounding pharmacies. EKRA covers all payors, including TRICARE and private insurance. Its safe harbors are narrower than the AKS. Commission-based compensation to sales personnel violates EKRA even if permissible under the AKS. Penalties include up to 10 years and $200,000 per violation.
Wire Fraud (18 U.S.C. § 1343)
Wire fraud carries up to 20 years per count. In pharmacy cases, wire fraud captures electronic claim submissions, electronic prescriptions, and interstate communications in furtherance of the fraud scheme. The March 2025 Louisiana compounding pharmacy conviction included conspiracy to commit wire fraud.
Illegal Distribution of Controlled Substances (21 U.S.C. § 841)
Section 841 is charged when pharmacists knowingly fill unlawful prescriptions for controlled substances. For Schedule II substances, the maximum is 20 years per count. If death or serious bodily injury results, the mandatory minimum is 20 years. Walgreens’ $350 million settlement in April 2025 involved allegations of illegally filling unlawful opioid prescriptions.
Money Laundering (18 U.S.C. §§ 1956, 1957)
Money laundering charges are common in large pharmacy and compounding fraud prosecutions. A defendant had $405 million in assets forfeited in a compound cream fraud case. Money laundering carries up to 20 years per count.
Federal Program Exclusion, DEA Revocation, and Collateral Consequences
Beyond incarceration and fines, a conviction or settlement triggers mandatory exclusion from Medicare, Medicaid, TRICARE, and all federal healthcare programs under the authority of HHS-OIG. For pharmacies, exclusion means the pharmacy can no longer bill any federal program. The DEA revokes controlled substances registration. State pharmacy boards initiate separate disciplinary proceedings. For pharmacists, these collateral consequences permanently end a career.
What Types of Pharmacy and Compounding Fraud Does the Government Prosecute?
Federal prosecutors target several categories of pharmacy and compounding fraud. The most common are compounding formulations designed to maximize reimbursement rather than serve patient needs, paying kickbacks to physicians and marketers for prescriptions, billing for prescriptions not dispensed, short-filling prescriptions while billing for full quantities, billing brand-name drugs while dispensing generics, dispensing controlled substances despite red flags, submitting false prior authorizations, and compounding drugs that duplicate commercially available products.
TRICARE compounding fraud is a specific enforcement priority. Federal investigators traced the explosion in TRICARE compound drug spending from approximately $24 million in 2010 to over $500 million in 2014 to widespread kickback and overbilling schemes.
Why Is TRICARE a Particular Target in Compounding Pharmacy Fraud Cases?
TRICARE became a primary target because of the dramatic explosion in compound drug spending. TRICARE compound spending grew from approximately $24 million in 2010 to over $500 million in 2014. Compound prescriptions represented less than one percent of all prescriptions but accounted for approximately 20 percent of TRICARE pharmacy costs. That trajectory signaled fraud on a massive scale and triggered investigations by the Defense Criminal Investigative Service, DOJ, the FBI, and IRS-CI.
A defendant received 18 years for a $510 million TRICARE pain cream scheme. In March 2025, two Louisiana compounding pharmacy executives were convicted after a six-week trial of conspiring to defraud TRICARE and New Jersey programs of approximately $100 million. TRICARE compounding fraud prosecutions remain active.
What Are the Penalties for a Federal Pharmacy Fraud Conviction?
The penalties are severe. Healthcare fraud carries up to 10 years per count. Wire fraud carries up to 20 years per count. Anti-Kickback Statute violations carry up to 10 years per violation. EKRA violations carry up to 10 years and $200,000 per violation. Controlled substances distribution carries up to 20 years per count for Schedule II substances. Money laundering carries up to 20 years per count.
Sentences in compounding pharmacy cases are among the harshest in healthcare fraud. A defendant received 18 years for a $510 million scheme. Another received 17 and a half years with over $115 million in restitution and $405 million in forfeiture. Beyond prison, defendants face federal program exclusion, DEA revocation, state pharmacy license revocation, and restitution.
What Defenses Are Available in a Federal Compounding Pharmacy Fraud Case?
The available defenses depend on the specific allegations. Common defenses include the following:
Formulation legitimacy. Retaining independent pharmacology and pharmaceutical compounding experts to demonstrate that compound formulations served legitimate therapeutic purposes.
Safe harbor compliance. Demonstrating that marketing and compensation arrangements fell within recognized safe harbors under the AKS or EKRA.
FDA and state compliance. Demonstrating compliance with FDA compounding requirements and state pharmacy board regulations.
Good faith reliance. Presenting evidence of compliance programs, reliance on legal counsel, and legitimate business purposes.
Cross-examining cooperators. Attacking the credibility of cooperating witnesses with plea agreements and sentencing incentives.
What Triggers a Federal Pharmacy Fraud Investigation?
Federal pharmacy fraud investigations are typically triggered by TRICARE or Medicare claims data analytics identifying billing outliers, HHS-OIG or DCIS audits, qui tam whistleblower complaints filed by former employees or sales representatives under the False Claims Act, FDA inspections and warning letters, DEA audits of controlled substances dispensing, and referrals from insurance carriers.
Common red flags include unusually high average reimbursement per prescription, rapid compound prescription growth, disproportionate use of high-cost ingredients, high-volume controlled substances dispensing, and financial relationships between the pharmacy and prescribers that suggest kickback arrangements.
What Compounding Pharmacy Experience Does Scott Armstrong Bring?
Scott Armstrong served as lead counsel at DOJ’s Fraud Section in a $120 million compounding pharmacy fraud case involving pharmacy executives, pharmacists, prescribing physicians, and marketers. The case involved the full range of issues that arise in compounding pharmacy prosecutions: kickback arrangements between the pharmacy and prescribers, compound formulation manipulation to maximize reimbursement, fraudulent billing to federal healthcare programs, and financial tracing of fraud proceeds through multiple entities.
That direct compounding pharmacy prosecution experience distinguishes the firm. Scott built the case from investigation through charging. He analyzed the formulation evidence, developed the financial tracing, and managed the cooperating witness strategy. He uses that firsthand experience to build defenses for individuals facing compounding pharmacy fraud charges. He knows how federal prosecutors build and present these cases because he built and presented them.
Can a Pharmacist Be Charged Even If a Licensed Physician Wrote the Prescription?
Yes. Pharmacists have a corresponding responsibility under 21 C.F.R. § 1306.04 to ensure that a prescription was issued for a legitimate medical purpose. A pharmacist who fills a prescription despite red flags faces criminal liability. In compounding cases, pharmacists face additional exposure when the government alleges they compounded formulations designed to maximize reimbursement rather than serve the patient, or when they compounded prescriptions from physicians who had no genuine treatment relationship with the patient.
Are Compounding Pharmacies Facing FDA Criminal Referrals?
Yes. The FDA has intensified enforcement against compounding pharmacies. The FDA has issued more than 125 warning and untitled letters to compounding pharmacies and outsourcing facilities. Pharmacies that compound drugs in violation of the Federal Food, Drug, and Cosmetic Act face FDA enforcement actions that can escalate to criminal referrals to DOJ. The FDA’s enforcement of compounded semaglutide and GLP-1 therapies represents an emerging area of particular concern for pharmacies that compound, dispense, or market these products.
The DOJ’s new Health and Safety Unit, created in November 2025, assumed responsibility for prosecuting criminal FDCA violations, consolidating these cases within the Fraud Section. Compounding pharmacies that violate FDA requirements now face prosecution by the same unit that handles healthcare fraud.
How Does EKRA Apply to Pharmacy and Compounding Cases?
The Eliminating Kickbacks in Recovery Act (EKRA) applies to kickback payments for referrals to pharmacies, including compounding pharmacies. EKRA covers all payors: Medicare, Medicaid, TRICARE, and private insurance. Its safe harbors are narrower than the Anti-Kickback Statute. Commission-based compensation to sales representatives violates EKRA even if it would be permissible under the AKS.
EKRA creates particular risk for compounding pharmacy marketing arrangements. Compensation structures that were designed to comply with AKS safe harbors may violate EKRA. An experienced healthcare fraud defense attorney analyzes compensation arrangements against both the AKS and EKRA to identify exposure and develop defenses.
Is Compounded Semaglutide and GLP-1 Enforcement an Emerging Risk?
Yes. The FDA’s enforcement of compounded semaglutide and GLP-1 therapies represents an emerging enforcement area for compounding pharmacies. The FDA has issued warning letters to pharmacies compounding semaglutide products and has referred matters to DOJ. Pharmacies that compound, dispense, or market GLP-1 therapies face regulatory scrutiny over whether their compounding practices comply with FDCA requirements, including whether they are compounding copies of commercially available products, whether bulk drug substances are on the FDA’s approved list, and whether marketing claims are accurate.
Regulatory enforcement can escalate to criminal prosecution. Pharmacies should seek legal guidance to evaluate compliance exposure before enforcement actions are initiated.
Does Armstrong & Bradylyons Handle Pharmacy Fraud Cases Nationwide?
Yes. Armstrong & Bradylyons PLLC defends individuals in federal pharmacy fraud, compounding fraud, and TRICARE fraud investigations and prosecutions in every federal district court in the country.
Pharmacy and compounding fraud enforcement is active nationwide, with significant cases in the Southern District of Florida, the District of New Jersey, the Southern District of Texas, the Eastern District of Louisiana, the Middle District of Louisiana, the Central District of California, and across the Gulf Coast and Southeast.
Scott Armstrong and Drew Bradylyons have tried healthcare fraud cases and handled investigations in federal courts throughout the country during their combined 25-year DOJ career. The firm is based in Washington, D.C. and represents clients in every jurisdiction where DOJ, DCIS, HHS-OIG, the FDA, and the DEA investigate and prosecute pharmacy and compounding fraud cases.