Sections of the FDA’s Drug Quality and Security Act (DQSA) distinguish compounding pharmacies (503A) from outsourcing facilities (503B). Due to several factors, many of which are related to drug shortages and the USP 797/USP 800 updates, 503A pharmacies are considering partnering with 503B entities for compounded sterile preparations and/or hazardous materials. We’ll discuss the differences between 503A pharmacies and 503B outsourcing facilities, review Section 503B and summarize how to effectively evaluate 503B compounding pharmacies for a potential partnership.

On November 1, 2023, revised USP Chapters 795 and 797 are official. If adopted by your state board of pharmacy, the requirements listed within these Chapters must be met. All PCCA formulations in our formula database now contain updated language and beyond-use dates (BUDs) in compliance with USP Chapters 795 and 797.

Read what we’re doing to ensure PCCA Formulas for compounding sterile preparations comply with USP Chapter 797 revisions.

A modular compounding cleanroom is a great way to meet evolving regulatory requirements and standards. Learn the basics of a modular cleanroom in the first in a series of articles on Modular Compounding Cleanrooms.