Defense across FDA, DEA, and the state board.
Request a Free Case ReviewHealth Law Alliance has gained a unique insight into representing and advising traditional compounding pharmacies operating under Section 503A of the Drug Quality and Security Act (DQSA) of 2013. FDA continues to clarify its compounding policies via a myriad of guidances, the 506e shortage list, Green and Red lists for API manufacturers/importers, the 503A bulks list, the difficult to compound lists and through notice-and-comment rulemaking.
On the horizon are rules regarding peptide compounding and a reemergence of the Memorandum of Understanding (MOU) for interstate distribution of compounded drug products. FDA continues to inspect 503A facilities, issue 483's, Warning Letters, and set limitations on interstate distribution of compounded products as well as when bulk ingredients may be compounded in the first place. 503A compounders can expect FDA to increase its regulatory grasp over them in the future.
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Anthony's background as a former federal prosecutor and executive for major healthcare companies provided a level of expertise and insight that made all the difference. His deep understanding of healthcare law, particularly in litigation and compliance matters, helped navigate complex legal issues with ease.
An inspection closes with observations, and the response to them is the record the agency weighs before escalating. What is corrected, what is committed to in writing, and when, shapes whether a matter ends at the observation stage.
Health Law Alliance handles the response and any parallel appeal, licensing matter or referral as one coordinated matter, so the strategy does not change hands as the matter moves between forums.
The bench includes a former Assistant U.S. Attorney nominated for the DOJ Director's Award, senior healthcare-company counsel, and attorney-providers with experience across healthcare audits and investigations.
Agency and company marks identify former professional experience of individual HLA team members. They do not imply affiliation, endorsement, or a client relationship.
Outcomes are summarized for confidentiality. Client names, precise geography, and identifying facts are redacted.
Recoupment Reversed
A 503A compounding pharmacy received an FDA Form 483 with multiple observations following an unannounced inspection. HLA addressed each observation in a privileged 15-business-day written response with corrective action plans tied to the substantive USP 797 and DQSA framework. FDA closed the matter without escalating to a Warning Letter.
Network Reinstated
A compounding pharmacy was referred to the state board of pharmacy following a complaint regarding compounded semaglutide dispensing during the FDA shortage period. HLA's response to the board reconstructed the dispense-date Bulks List status, the underlying patient-specific prescriptions, and the USP 797 compliance posture. The state board closed the matter with no discipline.
State Board Closed
A 503B outsourcing facility received FDA Inspectional Observations citing cGMP gaps in process validation and environmental monitoring. HLA coordinated the written response, the remediation plan, and the follow-on FDA communication. The matter resolved through documented remediation without escalation to a Warning Letter or consent decree.
Attorney advertising. Prior results do not guarantee a similar outcome. Case summaries are generalized for confidentiality and are not a substitute for legal advice on your specific audit.
Eight questions that come up on almost every first call.
Before you draft your Form 483 response, have a privileged conversation with a pharmacist-attorney bench that has handled 503A and 503B matters across the country. We work the substantive findings, from USP 797 environmental data to beyond-use date assignment and batch-record integrity. Free, confidential, no retainer.