As a litigator with 28 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 (including Form 483s) and investigations, warning letters, consent decrees, and administrative and federal proceedings.
She has written about and addressed industry audiences across the country on 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. She is well-versed on pharmacy compounding laws, regulations and guidance, the regulation of CBD, and regularly counsels clients on these matters. She has defended clients before the DEA and in federal courts on significant CSA matters involving the handling of controlled substances and List 1 chemicals. Karla advises clients and speaks regularly on a wide array of DEA compliance matters.
Karla and her husband Tom have four children, and live in Northern Virginia.