Your counsel should understand the preparation being compounded, the ingredient being sourced and the rules the regulator is applying. Our team includes pharmacist-attorney Dr. Martha Rumore, working with former prosecutors to advise compounding businesses and defend them when an inspection becomes an enforcement matter.
Compliance, Licensing and Defense for Compounding Businesses
503A pharmacy and 503B outsourcing facility regulatory compliance and litigation
Due diligence in complex compounding transactions
Peptide and GLP-1 compounding
USP 795, 797 and 800 compliance review and accreditation support
Does Your Compounding Business Need Regulatory or Defense Counsel?
We advise 503A compounding pharmacies, 503B outsourcing facilities, active pharmaceutical ingredient (API) manufacturers and importers, wholesalers, third-party logistics (3PL) providers, brokers and management services organizations (MSOs), as well as telehealth companies, physician practices, wellness clinics and spas.
Compounding questions rarely stop at the prescription. The ingredient supplier, the preparation, the states in which you dispense and the claims on your website can each raise a different issue.
Our work covers legal guidance for pharmacists, physicians, allied health, compounding pharmacies, clinics, and spas, and telehealth nationwide: licensing and permits, inspections, accreditation, standard operating procedures, and defense of related fraud allegations. Martha’s pharmacy and regulatory background supports the assessment of the actual formulation, sourcing records and operating procedures behind those questions.
We coordinate FDA regulatory compliance and Board of Pharmacy defense with the compounding matter. A pharmacy should not have to reconcile one response to an FDA inspector with a different account given to its licensing board.
Legal Support for 503A Pharmacies and 503B Outsourcing Facilities
Our attorneys are experienced in the myriad patchwork of rules and FDA Guidances on GLP-1 and peptide compounding.
We advise on compounding operations and represent pharmacies, outsourcing facilities and suppliers when their practices are challenged.
503A compounding compliance
503B outsourcing facility compliance
GLP-1 compounding
Peptide compounding
Pharmacy operations support
Hormone & BHRT compounding
USP 795/797/800 review
Pharmacy and nonresident licensing
API importation and sourcing
Inspection preparation: FDA, Board of Pharmacy
Form 483 and warning letter responses
Board investigations and discipline
Policies, procedures and training
Labeling and advertising review
Adverse-event and recall support
Fraud allegations
Patent claims and cease-and-desist demands
Citizen petitions and regulatory comments
Delegation and supervision
Accreditation support
Transaction advice
Risk mitigation
Disclaimers and informed consent
Exposure
Potential Consequences of Compounding Noncompliance
Noncompliance can put your license, your products and your business at risk, and handling an inspection or a finding without counsel can make it harder to resolve. It can lead to:
Restrictions on professional license
Corrective work following an inspection
Product recall or supply interruption
Suspension or revocation proceedings
Controlled-substance registration issues
Advertising or manufacturer litigation
Federal or state enforcement proceedings
Changes to sourcing, labeling or distribution
Severe regulatory penalties
Legal action
Risks to patient safety
Reciprocal state discipline
Criminal or DOJ enforcement
Do Not Respond without a Plan
Our attorneys will review the compounding activity, the rules at issue and the records supporting your position before you respond.
You would not hire a sterile compounding pharmacist who has never heard of USP 797, so why would you use an attorney who does not understand the issues related to USP 797?
Traditional Compounding Pharmacies (503A) and Outsourcing Facilities (503B)
Defend FDA and Board of Pharmacy investigations of compounding pharmacies. We identify the specific facts and circumstances that triggered scrutiny, and craft unique and comprehensive defense strategies to address each prosecution theory.
Take appropriate action in response to incidents, complaints, and inspectional findings
Have a deep knowledge of state licensure board oversight of 503A compounding pharmacies including quality standards and requirements which can vary from state to state.
Provide guidance regarding do’s and don’ts for handling FDA Inspections. Know your rights before the FDA is knocking at your pharmacy door.
Assure all aspects of USP 797/795/800 Compliance
staff training for core competencies and best practices
risk category determination
policies & procedures development/implementation
Credentialing support
Draft legislation and provide comments on FDA’s proposed Guidances.
Citizen Petitions regarding compounding issues and submissions for inclusion on the bulks list
Enforce your Intellectual Property rights, patent or trademark your formulas, prepare nondisclosure agreements, conduct due diligence
Handle patent infringement claims and respond to “cease and desist” requests
Review Website labeling and advertising for FDA compliance. Prevent against false advertising accusations including Lanham Act and state unfair competition laws
Development of SOPs; facilitate ADR reporting in states where required; recall support.
Advise on regulatory aspects of API importation. Have you recently been notified by FDA that you are subject to an Import Alert or placed on the ‘Red’ list?
Defending against fraud allegations (overbilling, unnecessary ingredients, kickbacks) that often target compounding practices.
Providing legal counsel for sales force compliance, setup, and disputes.
503B: Defend government investigations of Outsourcing Facilities. We identify the specific facts and circumstances that triggered government scrutiny, and craft unique and comprehensive defense strategies to address each of the government’s prosecution theories.
503B: Have a deep knowledge of state licensure board oversight of Outsourcing Facilities including quality standards which varies from state to state
503B: Operationalize opportunities related to the Outsourcing Facility market and business viability
503B: For 503B outsourcing facilities, develop Policies and Procedures as well as training programs for GMP compliance
Former professional experience
Where Our Attorneys Served Before Health Law Alliance
Department of Justice
Agency and company marks identify former professional experience of individual HLA team members. They do not imply affiliation, endorsement, or a client relationship.
Pharmacist-Attorney
Dr. Martha Rumore
Dr. Martha Rumore is a pharmacist-attorney and registered patent attorney with over two decades of experience in 503A and 503B compounding, FDA regulatory, DEA, Board of Pharmacy (Medicine, Nursing), and pharmaceutical intellectual property matters.
She is a former pharmacy compounder. She teaches Food, Drug & Cosmetic Law at Hofstra University’s Maurice A. Deane School of Law, is a Fellow of the American Pharmacists Association and is a three-time recipient of the Larry Simonsmeier Legal Writing Award. She teaches training courses for physicians and pharmacists for peptides.
Common compounding questions, answered briefly. The answers below are general; specific situations require privileged consultation.
It is the list of bulk drug substances that FDA allows in 503A compounding even though they have no United States Pharmacopeia (USP) or National Formulary (NF) monograph and are not a component of an approved drug, and it grows only through rulemaking. FDA sorts earlier nominations into three categories: Category 1 gets an interim policy of no action while FDA evaluates the substance, provided every manufacturer in the chain is FDA-registered and a valid certificate of analysis comes with it. Category 2 carries identified safety risks, Category 3 lacked enough information, and nominations made on or after January 7, 2025 are not categorized. We check a substance’s status before you stock it.
Under 503A a peptide can be compounded only if it has a United States Pharmacopeia (USP) or National Formulary (NF) monograph, is a component of an FDA-approved drug, or is on the 503A bulks list. Most peptides sold for wellness or “research” use meet none of these tests: FDA has put several peptides in Category 2 (identified safety risks) and has published safety concerns about many others whose nominations were withdrawn. The active ingredients of the main GLP-1 weight-loss drugs are components of approved drugs, but now that their shortages are over a compounded version is generally barred as essentially a copy of the approved drug, unless the prescriber documents a change that makes a significant difference for that patient. We review the specific peptide and its source before you compound it.
Pharmaceutical grade, for 503A, means the active pharmaceutical ingredient (API) meets the United States Pharmacopeia (USP) or National Formulary (NF) monograph where one exists, comes from an FDA-registered establishment and arrives with a valid certificate of analysis. “Research use only” (RUO) material sits outside that supply chain, and the label does not settle it: FDA looks at the seller’s actual intended use and has cited peptide sellers for selling unapproved drugs. Food-grade ingredients are made to food specifications by makers usually registered as food facilities, not drug establishments, so they normally cannot meet 503A’s sourcing conditions. Compounding with either takes the preparation outside 503A, and FDA can treat the result as an unapproved or adulterated (substandard) drug, so we check a supplier’s registration and paperwork before you buy.
Section 503A requires a valid certificate of analysis (CoA) for each bulk drug substance from an FDA-registered establishment, and since the statute does not define “valid”, the working benchmark is FDA’s guidance for active ingredient makers, ICH Q7 (International Council for Harmonisation). That means the substance and grade, batch number, release date and expiry or retest date, each test with its acceptance limits and numerical results, and the original manufacturer’s name, address and telephone number, signed and dated by its quality department. A repackager’s certificate should name the testing laboratory, reference the original manufacturer and attach the original batch certificate. FDA also urges compounders to know their bulks supplier, since a certificate is only as good as the laboratory behind it, and we review supplier files when an inspection questions your sourcing.
Yes. A manufacturer’s patent or trademark claim is separate from FDA compliance, so being compliant does not answer it. We review the letter, the rights it asserts, your product and your advertising before you answer, and we handle both questions.
Under the Federal Food, Drug, and Cosmetic Act a compounded drug is misbranded if its advertising or promotion is false or misleading. Under the Federal Trade Commission (FTC) Act every objective claim needs a reasonable basis before it runs, which for health and safety claims means competent and reliable scientific evidence. Because compounded drugs are not FDA-approved, FDA has treated calling a product “generic”, “the same active ingredient” or a brand name as misleading, and off-label claims need the same substantiation. We review campaigns before they run and answer warning letters when they arrive.
Yes, and lawfulness turns on structure and on the states involved. Many states bar anyone but a licensed physician from owning a medical practice or sharing its fees, payments between platform, prescriber and pharmacy can be kickbacks, and 503A still requires a valid prescription for each patient. In March 2026 FDA warned 30 telehealth companies for implying their compounded glucagon-like peptide-1 (GLP-1) drugs were the same as the approved drugs and for branding products under the platform’s name as if it were the compounder. We design the entity, the contracts and the prescription flow before launch.
Two tests decide it: each preparation needs its own patient’s valid prescription, and the payments must survive anti-kickback review. A white-label network, where a platform brands the product and routes prescriptions to member pharmacies, fails the second test when the platform or prescriber is paid per prescription, and adds an advertising problem when the platform’s name implies it is the compounder. FDA warned telehealth companies for exactly that in March 2026, and for glucagon-like peptide-1 (GLP-1) drugs the essentially-a-copy limit, which bars compounding a near-duplicate of an approved drug, applies as well now that the shortages are over. We map the arrangement before you sign.
It depends on the boards of pharmacy at both ends: central fill and shared-services rules are state law and vary, so the same arrangement can be permitted in one state and barred in the next. Under 503A every preparation must be for a named patient’s valid prescription, with only small amounts made ahead based on prescriptions you have actually filled for that prescriber or patient. Compounding stock for other pharmacies or clinics without patient prescriptions is 503B outsourcing-facility work, which requires FDA registration and current good manufacturing practice (cGMP). We review the state rules and the contracts before you take the first order.
Yes. We assist with comments on proposed FDA guidance, citizen petitions and submissions concerning bulk substances. We assess the proposed position and supporting record. A submission is a request for agency action; it does not establish that the requested position is already law.
The fee terms depend on the work agreed in your engagement. We will discuss the scope and fees after reviewing the matter. An inspection response, a licensing project and continuing regulatory counsel may require different scopes.
No. An attorney-client relationship is established through a written engagement agreement. Use the consultation to identify the matter, any deadline and the parties involved so the firm can complete its intake process and discuss representation.
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