FDA Provides Some Guidance for 503B Facilities

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On January 16th, 2018, FDA Commissioner, Scott Gottlieb, M.D. issued the 2018 Compounding Policy Priorities Plan. This document outlines, what the commissioner describes as, key priorities the agency will pursue to implement the federal law on compounding and to advance the FDA’s public health mission.

This plan signals some major changes in compounding regulations that will certainly impact the operations of both 503A and 503B compounding facilities.

The revised Compounding Policy Plan tends to provide the most needed guidance and regulation especially for 503A facilities, regarding insanitary conditions and establish policies & procedures consistent with the guidance. Very important thing is the Agency’s intention to create a guidance document on the “definition of a facility” in section 503B.

Additionally, 503A facilities sharing a location with a 503B operation should be excited to finally get some guidance from the Agency. It may not be the news they want to hear, but at least there should be some finite guidance on the subject. (Click here to read the original FDA plan)

What’s really exciting is the announcement of the Agency of their intent to work closely with state boards of pharmacy regarding compounding activities. The Agency is not clear whether the revised draft MOU will be open for comment, so all affected facilities should be checking regularly as the finalized version could significantly impact their operations.


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