Compounding Pharmacy
503A and 503B compounding pharmacy defense, FDA warning letters, GLP-1 compounding, and USP 797/800.
DEA Registration Requirements for Compounding Pharmacies
How compounding pharmacies register with DEA to handle controlled substances, and where FDA and DEA oversight overlap under 503A a…
Compounding Technician Training and Competency Records
What USP 797 and USP 800 require for compounding technician competency, the events that trigger retraining, and the records inspec…
Compounding Copies of Commercially Available Drugs
FDA's essentially-a-copy test under Section 503A, the change-for-a-patient exception, and the documentation compounding pharmacies…
Compounding After a Drug Leaves the Shortage List
An FDA declaratory order ending a drug shortage also ends the 503A/503B exception that let pharmacies compound it, forcing a wind-…
Compounded Controlled-Substance Anesthetics: Regulatory and DEA Exposure
At-home compounded controlled-substance anesthetic models raise DEA registration exposure and FDA warnings compounding pharmacists…
Cleanroom Certification and Recertification Timelines
How often USP requires sterile compounding cleanrooms to be certified and recertified, what certifiers measure, and what a failed…
cGMP Expectations for Outsourcing Facilities
How 21 CFR Parts 210 and 211 push 503B outsourcing facility cGMP past USP compounding standards, and where FDA cites facilities mo…
Bulk Drug Substance Sourcing and the Section 503A Lists
How the FDA 503A Bulks List nomination process works, the sourcing paperwork pharmacies need, and the enforcement exposure an unli…
Peptides & 503A Compounders: FDA PCAC Meeting and Beyond
A PCAC meeting with close to 2000 comments on the public docket and a recommendation that goes against FDA staff recommendations!…