Understanding the Drug Quality and Security Act

Evaluating your 503b Outsourcing Partner

Question #1:
Explain your understanding of the DQSA in its current form, as well as what you think we can expect in the future.

Question #2:
What are 2-3 "things" you look for to qualify and evaluate your 503b outsourcing partner?

Question #3:
What resources are available to physicians to perform their due diligence?

Question #4:
Some of the medications provided to you from a 503b facility are technically used off-label. What do you think we should look for to ensure patients receive safe and effective medications?

Chirag Shah, MD, MPH
Dr. Shah is a vitreoretinal specialist with Ophthalmic Consultants of Boston. He performs advanced retinal surgery for vitreoretinal diseases, including macular holes, epiretinal membranes, retinal detachments and proliferative vitreoretinopathy, and is involved with numerous clinical trials. His past and current research interests include macular degeneration, retinal vein occlusion, diabetic retinopathy and retinal detachment.