Our Story

Restore Health Consulting started in 2013 as a clinical consulting firm. During this time, the compounding pharmacy industry was undergoing a complete transformation. The New England Compounding Pharmacy had operated under insanitary conditions and distributed adulterated injectable products across the nation leading to the greatest tragedy the compounding industry had ever seen. This prompted congress to sign the Drug Quality and Security Act (DQSA) with a goal of preventing future tragedies from happening again. The DQSA also gave birth to the 503B outsourcing facility designation, where a compounding pharmacy could manufacture compounds and distribute them without a prescription as long as they followed CGMP. It was also in 2013 that state Boards of Pharmacy began to tighten compounding regulations, increase frequency of inspections, and push pharmacies to a safer level of practice. By 2016, several compounding pharmacies had closed (due to either the increase in costs to become compliant or from a mandatory regulatory shut-down), 503B outsourcing facilities began cropping up, and regulations for both entities began to tighten further.

Through this industry shift, Restore Health Consulting saw the need to expand its service offerings to include quality assurance, regulatory compliance, business and operations services to help health systems, pharmacies, and outsourcing facilities achieve compliance and thrive in the highly regulated pharmacy compounding industry.

Today, Restore Health Consulting works with associate pharmacy and GMP consultants and offers a wide variety of consulting services to help the healthcare and pharmaceutical industries operate profitably and efficiently while staying compliant with regulations.