503A
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
GLP-1 Compounding: Expect Inspections
503A compounding pharmacies can expect more inspections from their state boards of pharmacy and audits from PBMs ...
MARCH 14, 2025
GLP-1 Compounding: Expect Inspections
503A compounding pharmacies can expect more inspections from their state boards of pharmacy and audits from PBMs ...
FEBRUARY 13, 2025
‘A War Brewing’ Over GLP-1 Agonist Production
Are glucagon-like peptide-1 agonist drugs such as semaglutide and tirzepatide too complex for 503A and 503B ...
NOVEMBER 21, 2024
Taking Charge of Your Cleanroom Build
Whether you’re planning and building a cleanroom from the ground up or inheriting the build or renovation of ...
MAY 23, 2023
503B Quality Assurance And Other Lessons Learned
As of Sept. 14, 2022, nine years after the Drug Supply Chain Security Act created two designations for sterile drug ...
JANUARY 26, 2023
503A Facilities Could Be Subject to FDA Inspection
Health-system pharmacists who compound medications just for their own patients are accustomed to periodic ...
JANUARY 23, 2020
503B Collaborative Takes Off
A 2012 meningitis outbreak, which killed more than 100 people and ultimately was traced back to mold-tainted ...
SEPTEMBER 16, 2019
House Subcommittee Meeting Points To Compounding Turf War
All drugs should be compounded under suitable quality standards, but who should be ensuring those standards among ...
FEBRUARY 6, 2018
