International Journal of Pharmaceutical Compounding

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One Decade In and Counting: How 503B Outsourcing Facilities Are Finding Their Place in the Industry

Author(s): Alexander Michael R, Combs Blinn E, Howard Brad

Issue: May/Jun 2025 - Volume 29, Number 3
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Page(s): 182-189

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Abstract: It has been just over a decade since Congress passed the Drug Quality and Security Act of 2013, creating “outsourcing facilities” through the addition of Section 503B to the Federal Food, Drug, and Cosmetic Act.1 Since its passage, approximately 90 outsourcing facilities have registered with the FDA. Practitioners, pharmacies, clinics, and other industry participants have begun to incorporate the services outsourcing facilities provide into their business practices. As outsourcing facilities have opened, the market has had to feel out what role these facilities play in the industry. So where do things stand now, and what does the future hold for outsourcing facilities and their place in the healthcare market?

Related Categories: BUSINESS, LEGAL, MARKETING, UNITED STATES PHARMACOPEIA CONVENTIONS

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