Hybrid Pharma is proud to announce registration with the FDA for 503B status
What is a 503B Outsourcing Facility?
The new law allows an entity that compounds sterile drugs to register as an outsourcing facility. Once registered, an outsourcing facility must meet certain conditions in order to be exempt from the FDCA’s approval requirements and the requirement to label products with adequate directions for use. Under the new law, the drugs must be compounded in compliance with CGMP by or under the direct supervision of a licensed pharmacist in a registered facility (section 503B(a)
The new, voluntary 503B program allows compounders who ship nonpatient-specific prescriptions of sterile and (maybe) nonsterile compounded pharmaceuticals to register with the FDA and be held to much higher standards than others in that category ever had to meet. The FDA will regulate and inspect 503B pharmacies, and the 503B list is supposed to be a de facto FDA “Good Housekeeping” seal of approval.