§353b Outsourcing facilities

Summary

Lets an outsourcing facility skip some normal drug rules only if it meets many safety, registration, reporting, and labeling rules. The facility must register with the FDA each year between October 1 and December 31, pay required fees, and be open to FDA inspections on a risk-based schedule. It must send reports in June and December listing drugs it made in the prior six months, submit reports electronically unless waived, and send adverse event reports to the FDA. The facility can only use bulk drug substances if the FDA has put them on a special list or if the drug is on the official drug shortage list, and those bulk ingredients must meet any official monographs, come from a registered manufacturer, and have a valid certificate of analysis. All non-bulk ingredients must follow United States Pharmacopeia or other FDA-recognized standards if available. The final drug cannot be one withdrawn for safety or effectiveness, or essentially a copy of an approved drug. For drugs with special safety plans (REMS), the facility must show it will use comparable safety controls. The drug label must say it is compounded, list the outsourcing facility contact, lot, drug name, dosage form and strength, quantity, compounding and expiration dates, storage directions, “Not for resale” (or “Office Use Only”), and an ingredients list, plus any other FDA-required info. The facility may compound with or without individual patient prescriptions but must follow all these rules. Definitions: compounding – making or changing a drug; outsourcing facility – a place that compounds sterile drugs and registers with FDA; essentially a copy of an approved drug – nearly identical to an approved drug; approved drug – a drug approved by FDA; sterile drug – a drug that must be free of microbes for certain uses.