A Few Key Points About Outsourcing Facilities Under the DQSA

"The term 'outsourcing facility' is a statutory created one which means a facility at one geographic location or address that:

(i) is engaged in the compounding of sterile drugs; 

(ii) has elected to register as an outsourcing facility; and 

(iii) complies with all of the requirements of the applicable provisions in the DQSA. 

An outsourcing facility is not required to be a licensed pharmacy

An outsourcing facility may or may not obtain prescriptions for identified individual patient.

If a facility producing sterile preparations elects not to voluntarily register with the FDA as an outsourcing facility,  it is then subject to the rules on misbranding and new drugs.