Clinical Research Solutions
Using a Matrix Approach to Media Fills in Sterile Compounding
Using a Matrix Approach to Media Fills in Sterile Compounding: A survey of FDA Form 483 observations issued to the 503B pharmacy industry reveals that outsourcing compounders are struggling to...
Clinical Research Solutions
The 503b Outsourcing Facility Compliance Dilemma
At the time of this writing, there were 59 registered 503b outsourcing facilities posted on the FDA’s website. All firms that had been inspected were issued FDA inspectional observations in the form...
Clinical Research Solutions
Outsourcing Facilities and GMP: The Quality Systems Challenge
Compounding is a practice in which a licensed pharmacist, a licensed physician, or, in the case of an outsourcingfacility, a person under the supervision of a licensed pharmacist, combines, mixes, or...
Clinical Research Solutions
Outsourcing Facilities and GMP: The Validation Challenge
Compounding is a practice in which a licensed pharmacist, a licensed physician, or, in the case of an outsourcing facility, a person under the supervision of a licensed pharmacist, combines, mixes,...
Clinical Research Solutions
Outsourcing Facilities and GMP: A New Relationship
Compounding is a practice in which a licensed pharmacist, a licensed physician, or, in the case of an outsourcing facility, a person under the supervision of a licensed pharmacist, combines, mixes,...
Clinical Research Solutions
What is the Future for Pharmaceutical Compounding Companies?
The Food and Drug Administration (FDA) may soon be cracking down on compounding pharmacies according to a recent bill introduced in the United States Legislature. The bill (Drug Quality and Security...