We follow several webpages on FDA.gov where interactions between FDA and compounding entities are posted. These include:
Compounding: Inspections, Recalls, and other Actions or CIRoA for short
Registered Outsourcing Facilities or ROFs for short
ORA FOIA Electronic Reading Room or FOIA for short
- For background, ORA stands for FDA’s “Office of Regulatory Affairs.” FOIA is “Freedom of Information Act.” The “Electronic Reading Room” is the electronic version of the ORA Reading Room, where all actions against everybody, ever are stored.
- As citizens, we can read any federal agencies non-classified actions via a FOIA request.
- FDA keeps a physical library (reading room) where the public can drop in and read FDA documents, but to expedite our reading, FDA posts certain records electronically to this webpage for public availability either (1) proactively at their discretion or (2) because they have been frequently requested through the FOIA process.
- FDA hates rework as much as we do and after they get a few requests for a particular document, they realize it is popular and they just post it to this webpage and tell citizens to go look there.
- When you click on a hyperlink to an FDA Form 483, you will likely see several places where the original language is replaced by (b)(4). The (b)(4) refers to FOIA section (b)(4) and indicates that the language was redacted to protect the inspected entity from disclosure of proprietary information or trade secrets.
2019 Warning Letters or 2019 WLs for short. This webpage is just what the name implies and is where several Warning Letters to compounding-based organizations get posted here that have not yet been posted on the other webpages I mainly monitor.
Compounding Risk Alerts or CRAs for short FDA seems to use this webpage to communicate its scientific and technical thoughts regarding issues the compounding and prescribing communities should be cautious about.