Compounding Pharmacy
503A and 503B compounding pharmacy defense, FDA warning letters, GLP-1 compounding, and USP 797/800.
Compounded GLP-1 Sourcing: Active Ingredient Suppliers Under Scrutiny
FDA detains noncompliant GLP-1 API shipments at the border, and 503A requires compounding pharmacies to verify supplier registrati…
USP 797 Immediate-Use Compounding: Where the Exception Ends
USP 797's immediate-use exception has strict conditions on timing, product limits, and labeling that batch production often violat…
USP 797 Category 1, 2 and 3 CSPs Explained
USP 797 sorts every compounded sterile preparation into Category 1, 2 or 3, and the category sets its environment, testing and bey…
FDA Greenlights 503A Compounding for Certain Peptides
FDA's new enforcement discretion policy temporarily lets 503A pharmacies compound six peptides, including BPC-157 and TB-500. What…
Texas Compounding Rules: Class A, C and Sterile Pharmacy Requirements
Texas organizes pharmacy compounding by license class. Here is what separates Class A and C from the sterile designations, and wha…
Sermorelin and Growth Hormone Secretagogue Compounding Status
Sermorelin remains eligible for compounding even as FDA's Category 2 list reaches related growth hormone secretagogues. What it me…
Selling Compounded Drugs to Other Pharmacies Under 503A
A 503A pharmacy may distribute compounded drugs only against a valid, patient-specific prescription, not as stock to another pharm…
Responding to an FDA Untitled Letter Sent to a Compounder
An FDA untitled letter cites violations below the threshold for a warning letter, but a compounding pharmacy's response still dete…
Potency Testing Failures and Out-of-Specification Results for Compounders
What a compounding pharmacy must do when a finished preparation's potency or assay result falls outside its own specification: qua…