Karla Palmer

As a litigator with over 30 years’ experience, Karla advises clients throughout the pharmaceutical supply chain – from manufacturers and distributors to outsourcing facilities, pharmacies and doctors – on a range of legal and regulatory issues. These matters include DEA and FDA regulations and guidance, government inspections and investigations, Form 483 observations, warning letters, consent decrees, and administrative and federal proceedings. She represents entities and individuals in matters involving their DEA registration, including investigations, orders to show cause, immediate suspension matters, hearings and federal appeals of the same. Karla is a nationally recognized leader in the compounding space, both for Section 503A and 503B facilities. She regularly counsels clients on all aspects of compliance with state and federal statutes, regulations and guidance. Karla has written about and addressed industry audiences across the country on FDA and compliance, including all aspects of the passage and implementation of the 2013 Drug Quality and Security Act including both compounding and supply chain issues, its guidance documents, and implementing regulations.