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A Top-to-Bottom Approach to 503B Compliance
Pharmacies large and small face challenges in complying with new requirements under the federal Drug Quality and Security Act of 2013, with some content to operate as "503A" compounders and others choosing the path of "503B" and registering as Outsourcing Facilities.
The latter category is not for the faint of heart as it requires a tremendous level of financial resources, operational integrity and, of course, regulatory scrutiny.
Jeffrey M. Watson, who recently joined the Gates Healthcare team as an Associate, is intimately familiar with what it takes to comply with the DQSA.
As Vice President of Quality Assurance at Leiter's Compounding, he oversaw all sterile and non-sterile operations and led more than a dozen quality assurance employees as the company developed an FDA-registered Outsourcing Facility.
He also previously worked for 23 years at the Food and Drug Administration as a microbiologist and consumer safety officer specializing in all systems related to pharmaceutical receipt, manufacturing, storage, testing, distributing, facilities, equipment and monitoring.
Watson has unparalleled insights into current Good Manufacturing Practices (cGMP) and proven tactics for starting up and maintaining a successful Outsourcing Facility. His FDA background, along with the rest of Gates Healthcare's pharmaceutical team, provides a top-to-bottom approach to compliance with 503B requirements.
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