Regulatory Issues
Pharmacies, especially 503a and 503b facilities, and pharma manufacturers are some of the most highly regulated businesses in existence. The Food and Drug Administration (FDA), Drug Enforcement Administration (DEA), State Departments of Health, State Boards of Pharmacy, and a host of other agencies all can claim jurisdiction over your business. Understanding each agency's rules, intent, and expectations along with jurisdictional overlaps and conflicts is an ongoing and challenging effort. 503QM has regulatory experts and healthcare / FDA expert legal counsel available to help you understand the current legal landscape and determine your regulatory compliance.