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October 28, 2026CompoundingHHS lets 503A pharmacies compound six peptides under an interim enforcement discretion policyOctober 28, 2026Trial resultRetatrutide beats Ozempic on blood sugar and weight in head-to-head TRANSCEND-T2D-2 trialOctober 23, 2026FDA approvalFDA extends once-weekly insulin icodec (Awiqli) to children 10 and older with type 2 diabetesOctober 21, 2026CompoundingCitizen petition asks FDA not to allow compounding of seven peptides reviewed by its advisory committeeOctober 1, 2026Trial resultSurvodutide SYNCHRONIZE-2 phase 3 results in obesity with type 2 diabetes published in NEJMSeptember 30, 2026Trial resultEloraTZP (eloralintide plus tirzepatide) phase 2 results presented at EASD 2026September 30, 2026Trial resultOrforglipron ACHIEVE-4 cardiovascular safety trial published in The LancetSeptember 29, 2026Trial resultFull TRIUMPH-2 retatrutide results published in The LancetSeptember 24, 2026FDA approvalFDA approves insulin efsitora alfa (Onswik), a once-weekly basal insulin for type 2 diabetesSeptember 21, 2026WADAWADA publishes 2027 Prohibited List, naming peptides as examples of non-approved substances

October 28, 2026CompoundingHHS lets 503A pharmacies compound six peptides under an interim enforcement discretion policyOctober 28, 2026Trial resultRetatrutide beats Ozempic on blood sugar and weight in head-to-head TRANSCEND-T2D-2 trialOctober 23, 2026FDA approvalFDA extends once-weekly insulin icodec (Awiqli) to children 10 and older with type 2 diabetesOctober 21, 2026CompoundingCitizen petition asks FDA not to allow compounding of seven peptides reviewed by its advisory committeeOctober 1, 2026Trial resultSurvodutide SYNCHRONIZE-2 phase 3 results in obesity with type 2 diabetes published in NEJMSeptember 30, 2026Trial resultEloraTZP (eloralintide plus tirzepatide) phase 2 results presented at EASD 2026September 30, 2026Trial resultOrforglipron ACHIEVE-4 cardiovascular safety trial published in The LancetSeptember 29, 2026Trial resultFull TRIUMPH-2 retatrutide results published in The LancetSeptember 24, 2026FDA approvalFDA approves insulin efsitora alfa (Onswik), a once-weekly basal insulin for type 2 diabetesSeptember 21, 2026WADAWADA publishes 2027 Prohibited List, naming peptides as examples of non-approved substances

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Compounding, the whole story · Part 3: 503A vs. 503B

The outsourcing facility door (503B)

Lesson 5.3.2 · 6 min read · Advanced plan

What you'll learn

503B was created in 2013 after the 2012 fungal meningitis outbreak.
Outsourcing facilities compound sterile drugs, register with FDA, and don't have to be licensed pharmacies.
They can supply offices and hospitals without patient-specific prescriptions.
In return, they follow CGMP, face FDA inspections, report to FDA twice a year and pay annual fees.

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