Another Worry for Compounding Pharmacies – The OIG Plans to Take a Look At Them!

According to the 2017 Work Plan of the Department of Health and Human Services (DHHS) Office of the Inspector General (OIG), OIG plans to evaluate the reliance of hospitals on drug compounding outsourcing facilities.  This appears to be an expansion in the FDA oversight responsibilities of the OIG. Large-scale facilities that compound without a patient-specific prescription are regulated under Section 503B of the Food,

Compounding Pharmacies – Still in the Cross Hairs

Based on multiple FDA inspections and observations over many years, both brand pharma and generic companies have learned how to be better prepared for an FDA inspection and what to expect from an FDA inspection.  However, judging by the numerous Warning Letters that have been issued to Compounding Pharmacies in the last 2 years to 503A (43 total) and 503B (37 total),