503B compounding
503As and 503Bs Can Work Together
Cooperation among 503A and 503B compounders will be needed to navigate dangerous regulatory shoals in 2025, experts ...
MAY 19, 2025

4 Strategies for Vetting Your 503B Vendors
Most health-system pharmacies will outsource at least some of their sterile product compounding, but 503B vendors ...
MARCH 14, 2025

Giving Compounders ‘Tail Period’ May Ease Weight-Loss Rx Supply
Drug compounding facilities should be allowed to produce products beyond the FDA’s current hard compounding ...
NOVEMBER 19, 2024

503Bs and Their Role in Responding to Drug Shortages
With drug shortages at an all-time high, hospital and health-system pharmacies are increasingly turning to 503B ...
JULY 26, 2024

Strategies for Effective 503B Partnerships
Your health-system pharmacy has decided to partner with a new 503B sterile compounding outsourcing facility, or the ...
JUNE 19, 2024

A 503B’s Journey Underscores Challenges and Opportunies of the DIY Approach
SSM Health was the first health system in the nation to establish its own 503B compounding facility. Its recent ...
MARCH 4, 2024

3 Actions That Might Give 503Bs a New Look in 2024
Difficult-to-compound medications, outsourcing guidelines and a new draft guidance on the bulk drug substance lists ...
DECEMBER 27, 2023

Why Duke Opted Out of Becoming a 503B
Duke University Health System has been doing bulk nonsterile compounding since well before there was a USP Chapter ...
NOVEMBER 29, 2023

Health System 503B Profile: SSM Health
SSM Health, one of the largest health systems in the nation with 23 hospitals in Illinois, Missouri, Oklahoma and ...
NOVEMBER 7, 2023

What’s the Impact of FDA Draft Guidance on Wholesaling Compounded Drugs?
503B drug compounding facilities, community pharmacists, drug manufacturers, and other stakeholders are debating ...
OCTOBER 10, 2023

Leiters Unveils New Brand Identity Reflecting Its Ongoing Commitment to Healthcare
Leiters announced that it is rebranding the company to better represent its growing market leadership in healthcare ...
JULY 3, 2023

Leiters Announces Facility Acquisition to Increase Capacity, Accommodate Growth and Expand Portfolio
The 110,000-square-foot facility was previously used to manufacture prescription products, including sterile ...
FEBRUARY 10, 2022