Regulatory Responses to 503B Compounding Pharmacies

Learning Level: Intermediate
Time: 1100 - 1200 ET
Session Length: 1 hour

Most 503B compounding facilities, or compounding outsourcing facilities are challenged to prepare and submit regulatory responses to the US Food and Drug Administration (FDA). FDA inspections are considered as having stringent regulatory requirements and usually to be extremely different from a Board of Pharmacy inspection. During the presentation, a brief overview of the FDA inspection process will be reviewed. Explaining what a FDA 483 observation is, what are the FDA expectations for 483 observation responses, and what are the regulatory outcomes associated with FDA 483 observations. Examples of 503B 483 observations and 503B compounding outsourcing facility's responses will be reviewed and discussed.

Learning Objectives

  1. Understand a FDA 483 observation
  2. FDA Expectations for 483 observation responses
  3. Regulatory outcomes associated with FDA 483 observations



Cynthia T. Culmo
Senior Associate in the Compliance Practices
Lachman Consultants Services Inc.

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