With passage of the Compounding Quality Act in 2013, pharmacy law became the most nuanced, challenging, and hotly-contested area of FDA oversight. It has also been in a constant state of flux as regulatory policy evolves on every aspect of pharmacy business.
This is the law we practice.
Pharmacy Law Counsel has represented compounders since long before the CQA was enacted. In fact, we were called upon by industry to educate legislators on Capitol Hill while they were drafting its provisions. And we have been avidly representing 503A and 503B clients ever since.
For these reasons, Pharmacy Law Counsel is widely recognized as a leading authority on the Compounding Quality Act. We have worked with facilities of all sizes, and on every regulation and policy that FDA has sought to enforce. Our experience with FDA is deep and wide.
From pre-inspection counseling and SOPs, to audits, recalls, 483s and warning letters, Pharmacy Law Counsel can walk you through compliance. If you are deciding whether to register as an outsourcing facility or exploring areas like traditional sterile, repackaging, vetting suppliers, or marketing with medical affairs, our team has the advanced degrees, decades of experience, and the insight necessary to advise on even the most complex regulatory issues. We are also able to identify the often-untapped streams of revenue available to compounders, hidden inside the nooks and crannies of pharmacy law. These are the reasons Regulatory Means Business.
Schedule a courtesy consultation today about how we can assist you with pharmacy law counsel.