Another Reminder from the FDA that Compounded Drugs are NOT FDA-Approved--but registered outsourcing facilities that had have had a recent satisfactory FDA inspection have some assurance that applicable current good manufacturing practice standards at the time of inspection have been met.

4.       If FDA has inspected a human drug compounding outsourcing facility, can I be sure that the drugs I purchase from that facility are safe?

 

Drugs made by compounders, including those made at human drug compounding outsourcing facilities, are NOT FDA-approved. This means that they have not undergone the same premarket review as approved drugs. They lack an FDA review of safety and efficacy and of manufacturing quality. Therefore, when an FDA-approved drug is commercially available, FDA recommends that practitioners prescribe the FDA-approved drug rather than a compounded drug unless the prescribing practitioner has determined that a compounded product is necessary for the particular patient and would provide a significant difference for the patient as compared to the FDA-approved commercially available drug product. 

 

Although the drugs will not be FDA approved, purchasers of drugs compounded at a registered outsourcing facility that has had a recent satisfactory FDA inspection will have some assurance that the conditions at that facility met applicable current good manufacturing practice standards at the time of the inspection, and the compounded drugs are labeled with the required information. It should be noted, however, that FDA inspections are just a snapshot in time. Conditions at the facility can change at any time. And FDA only reviews a small sample of the records available at a facility during an inspection and must draw conclusions about the conditions and practices at the facility from that small sample of records. Purchasers should look at other available information about the facility that can provide them with additional insight with regard to the facility’s operations.

 

quoted from here